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Disease Management

Diabetes
for
DISCLAIMER: The information contained in this annotated bibliography was obtained from the publications listed. The National
Pharmaceutical Council (NPC) has worked to ensure that the annotations accurately reflect the information contained in the
publications, but cannot guarantee the accuracy of the annotations or the publications. There are articles available on the
treatment of diabetes that are not included in this bibliography, which may include relevant information not covered herein. The
inclusion of any publication in this bibliography does not constitute an endorsement of that publication by NPC or an endorsement
of the services, programs, treatments, or other information contained in such publication.

This bibliography is designed for informational purposes only, and should not be construed as professional advice on any specific
set of facts and circumstances. This bibliography is not intended to be a comprehensive source of disease management services
or programs in the treatment of diabetes, or a substitute for informed medical advice. If medical advice or other expert assistance
is required, readers are urged to consult a qualified health care provider or other professional. NPC is not responsible for any
claims or losses that may arise from any errors or omissions in the information contained in this bibliography or in the listed publi-
cations, whether caused by NPC or originating in any of the listed publications, or any reliance thereon, whether in a clinical or
other setting.

© February 2004 National Pharmaceutical Council, Inc.


Disease Management for Diabetes

Introduction providing support services to assist the physician in


monitoring the patient.
Faced with rising health care costs and limited resources, • Provision of services designed to enhance patient self-
health care providers continually seek new ways to provide management and adherence to the patient’s treatment
high-quality, cost-efficient care.1,2 Years ago, disease plan.
management emerged as a strategy with the potential to • Routine reporting and feedback to the health care
achieve this goal.3 The Boston Consulting Group first used providers and to the patient.
the phrase “disease management” in its current sense in a • Communication and collaboration among providers and
1993 report. Since that time, disease management
between the patient and the patient’s providers.
programs, techniques, and models have been designed by
• Collection and analysis of process and outcomes
the pharmaceutical industry, managed care, pharmacy
measures along with a system to make necessary
benefit management (PBM) plans, and most recently by state
changes based on the findings of the process and
Medicaid programs.1,4–8
outcomes measures.
The Centers for Medicare and Medicaid Services and the
Disease Management Association of America define disease
Disease management programs are used widely for many
management as a system of coordinated health care
chronic diseases, but the most common diseases include
interventions and communications for populations with
asthma, congestive heart failure, diabetes mellitus, and
conditions in which patient self-care efforts are significant.9,10
hypertension. Considerations in selecting a disease for
Disease management supports the clinician-patient
disease management often include:11,12
relationship and plan of care, and emphasizes prevention of
disease-related exacerbations and complications using
• Availability of treatment guidelines with consensus
evidence-based practice guidelines and patient
about what constitutes appropriate and effective care.
empowerment tools.9,10 Disease management also evaluates
• Presence of generally recognized problems in therapy
clinical, humanistic, and economic outcomes on an ongoing
that are well documented in the medical literature.
basis with the goal of improving overall health.9–11 The goals
• Large practice variation and a range of drug treatment
of disease management include:9–11
modalities.
• Improving patient self-care through patient education, • Large number of patients with the disease whose
monitoring, and communication with members of the therapy could be improved.
health care team. • Preventable acute events that often are associated with
• Improving physician performance through feedback the chronic disease (e.g., emergency department or
and/or reports on patient progress in compliance with urgent care visits).
protocols. • Outcomes that can be defined and measured in
• Improving communication and coordination of services standardized and objective ways and that can be
between patient, physician, disease management modified by application of appropriate therapy (e.g.,
organization, and other providers. decreased number of emergency department visits or
• Improving access to services, including prevention hospitalizations).
services and prescription drugs as needed. • The potential for costs savings within a short period
(e.g., less than 3 years).
Disease Management for Diabetes

The following functions are the main components of


disease management:9–11 Three major not-for-profit organizations whose mission is
to promote quality health care have recognized the
• Identification of patient populations. contribution of disease management activities to quality
• Use of evidence-based practice guidelines. health care by establishing disease management certification
• Support of adherence to evidence-based medical or accreditation programs. The Joint Commission on
practice guidelines by providing practice guidelines to Accreditation of Healthcare Organizations, an independent,
physicians and other providers, reporting on the not-for-profit organization and the nation’s predominant
patient's progress in compliance with protocols, and standards-setting and accrediting body in health care, offers

[1]
disease-specific care program certification. Program services, whereas others choose to develop their own
certification is based on an assessment of compliance with programs. Each method has advantages and disadvantages;
consensus-based national standards, effective use of success often depends on the organization and its level of
established clinical practice guidelines to manage and resources and commitment.
optimize care, and activities for performance measurement
and improvement.13 Managed Care Organizations and
The National Committee for Quality Assurance recently Pharmacy Benefit Management Firms
began accrediting disease management programs on the Managed care organizations and PBM firms were the first
basis of standards that are patient oriented, practitioner to implement disease management programs. PBM firms
oriented, or both. It also offers organizations certification for offer disease management programs and services to
program design (i.e., content development), systems (i.e., employers and managed care clients as part of their overall
clinical information and other support systems), or patient benefit management services.17 The 1998 Novartis Pharmacy
contact (e.g., for nurse call centers and other organizations Benefit Report indicated that 75% of PBM pharmacy
without comprehensive activities).14 Many disease directors were expending resources to develop disease
management organizations were so eager to undergo the management programs for conditions that respond to or
accreditation or certification process that they volunteered to depend on pharmaceutical products and services.17 HMOs
do so before the standards were finalized.15 reported that 16% of their disease management programs
The Utilization Review Accreditation Commission (URAC), were provided through a PBM firm.17 Most employers
also known as the American Accreditation HealthCare reported using PBM firms to manage costs, and many
Commission, establishes standards for the health care and employers used PBM firms to provide disease management
insurance industries. By establishing standards, education services.
and communication programs, and a process of The American Association of Health Plans (AAHP)
accreditation, URAC motivates purchasers, providers, and represents more than 1,000 HMOs, preferred provider
patients to achieve excellence, thus promoting continuous organizations, and other network-based plans. Members of
improvement in the quality and efficiency of health care the association provide health care to more than 200 million
delivery. URAC has accreditation programs for disease Americans nationwide. The AAHP 2002 annual survey of
management as well as case management, claims health plans found that 99.5% of health plans offer a disease
processing, core accreditation, credential verification, health management program.18
call centers, health networks, health plans, health provider
State Medicaid Programs
credentialing, health utilization management, health Web
In the rapidly changing environment of Medicaid managed
sites, Health Insurance Portability and Accountability Act
care, it is essential for Medicaid directors and their top
privacy and security, independent review organizations,
managed care staff to remain abreast of innovations in
vendor certification, and workers’ compensation utilization
organization and payment that are occurring to serve the
management. URAC also has goals for disease management
special needs of the Medicaid population. Traditionally, state
accreditation and case management.16
Medicaid programs either have retained insurance risk and
paid on a fee-for-service basis or have outsourced risk and
Penetration and Trends contracted with Medicaid HMOs. Disease management
The ultimate goal of disease management is to produce represents a method of managed care in the middle between
Disease Management for Diabetes

optimal health outcomes for patients. Therefore, virtually all traditional fee-for-service and HMOs. Four types of models
stakeholders in health care want to be involved. Disease are emerging:19
management is of interest to providers, patients, managed
care organizations, insurance companies, government 1. Medicaid health outcomes partnerships are usually
agencies, PBM firms, and employer purchasing coalitions.7,11 applied to an existing fee-for-service primary care case
Most disease management programs are implemented management program. Medicaid programs focus on
through health maintenance organizations (HMOs), PBM high-priority diseases, offering a number of support
firms, or Medicaid agencies.9–12 Some organizations choose systems to help existing Medicaid providers better serve
to hire a vendor and contract out disease management the patients assigned to them.20

[2]
2. Disease management organizations are outside Diabetes disease management programs continue to gain
contractors who are retained by the state to address in popularity as providers try to contain health care costs.
particular diseases, either by supplementing existing Diabetes affects roughly 1 in 20 Americans, but the disease
Medicaid providers and their case management accounts for 1 of every 10 health care dollars spent in the
activities or by taking over responsibility for targeted United States.22 Diabetes is among the leading health
patients. indicators identified in Healthy People 2010, a set of health
3. Pay-for-performance approaches establish new rules for objectives for the nation to achieve in the first decade of the
scope of practice or referrals and involve nontraditional new century.23
providers in the care of patients with specific diseases. Diabetes often is selected as a disease for intervention for
The nontraditional providers are paid a special fee the following reasons:
contingent on improving health outcomes or lowering • High-cost patients can be identified easily based on the
costs. patterns of drug use (e.g., chronic refills of insulin or
4. Centers of excellence focus on particular disease antidiabetic agents).
episodes for high-cost, high-volume diseases and select • Consistent clinical practice guidelines are available with
a network of hospitals, physicians, and other providers core recommendations that apply to both children and
who are already organized to receive a prospective, adults.
bundled payment per episode of care. To meet criteria • Validated outcome measures (e.g., hospital admissions,
for designation as a center of excellence, an emergency department admissions) that can help
organization must provide written documentation of the measure the effectiveness of the interventions are
quality and outcomes of care for a selected disease. available.
• Communication programs are available and have been
Most states are actively involved in the disease shown to work in the treatment of diabetes.
management process. By far, the diseases most often • Patient education materials are plentiful.
focused on in these programs are asthma and diabetes. • Feedback and information necessary for behavior
Other diseases and conditions included in state disease modification in health care practitioners can be
management programs are arthritis, congestive heart failure, generated easily.
depression, gastrointestinal disease, hemophilia, HIV
infection/AIDS, hyperkinetic activity, dyslipidemia, mental Economic Impact
health, otitis media, pregnancy, smoking, ulcer, and upper In 2002, the total cost of diabetes was approximately
respiratory infections.19 Current information about state $132 billion, of which $92 billion was for direct medical costs
disease/case management activities is available on the Web and $40 billion was for indirect costs associated with lost
at http://www.dmnow.org/state_activities/. productivity due to disability and death.24 Inpatient hospital
Concerns have been raised about inadequate monitoring care and nursing home care accounted for approximately
of clinical outcomes in patients with diabetes by state $40 billion and $14 billion, respectively, of the direct medical
Medicaid agencies when implementing cost-containment costs.24 Nearly 17 million days of hospitalization and more
strategies for the Medicaid pharmaceutical benefit.21 than 82 million nursing home days were attributed to
Additional research is needed to determine whether cost- diabetes in 2002.24
containment strategies adversely affect patient outcomes. The total per capita health care expenditure for patients
with diabetes (including health care costs not associated with
Disease Management for Diabetes

Why Focus on Diabetes? diabetes) amounted to more than $13,000 in 2002.24 In


contrast, the total per capita health care expenditure for
In the 1990s, managed care organizations began an people without diabetes was only about $2,500.24
intense utilization review process to identify areas in which
cost control measures would be appropriate. Diabetes was Epidemiology
one of the first diseases selected because there is great Approximately 6.2% of the U.S. population—an estimated
opportunity to treat this disease more effectively and to 17 million Americans—have diabetes mellitus.22 However,
develop programs that will help payers and plans manage only about two in three of these patients are aware that they
the high costs associated with it (see “Economic Impact”). have the disease. Diabetes is the sixth leading cause of

[3]
death and the leading cause of both treated end-stage renal develops in childhood or early adulthood, it was once
disease and new cases of blindness in the United States. referred to as juvenile diabetes, although it also occurs in
Diabetes increases the risk for heart disease and stroke two- adults.25,26
to fourfold. Diabetes also causes nerve damage and The great majority—about 90%—of patients with diabetes
increases the risk for lower-limb amputation.22 mellitus have type 2, or non–insulin-dependent, diabetes.
Certain racial and ethnic groups (e.g., African Americans, Type 2 diabetes is characterized by insulin resistance
Hispanics/Latinos, Asian Americans, Pacific Islanders, Native (reduced sensitivity of cells to insulin), a relative insulin
Americans) are at increased risk for diabetes.22 Other risk deficiency, or both.25 In people with type 2 diabetes, the
factors for diabetes mellitus include a family history of the pancreas may not produce enough insulin, the body’s cells
disease, age greater than 45 years, obesity, lack of regular may be unable to utilize the insulin that is produced, or both.
exercise, dyslipidemia (high triglyceride or low high-density Type 2 diabetes usually develops in adulthood, and most
lipoprotein cholesterol levels), a history of gestational patients with type 2 disease are obese.25,26
diabetes, and delivery of a baby weighing nine pounds or
more at birth. Diabetes Health Goals
The basic goals of diabetes therapy remained largely
What Is Diabetes? unchanged for many years. Many clinicians assumed that
Diabetes mellitus is a heterogeneous group of chronic strict management of blood glucose levels was beneficial to
metabolic disorders that result in hyperglycemia—excess the patient’s welfare, although few clinical data supported
blood levels of glucose, which provides energy to cells. The this idea. The report of the Diabetes Control and
various forms of the disease are caused by defects in insulin Complications Trial (DCCT) was made available in 1993.27
secretion, insulin action, or both.25,26 The hormone insulin, This long-term study evaluated (1) whether intensive
which is produced by the pancreas, is vital for the transport management of blood glucose levels prevents the
of glucose to body cells. When glucose levels in the blood development of diabetes complications (primary prevention)
are too high, the body’s cells become starved for energy. and (2) whether intensive management prevents or limits the
Over time, blood vessels may be damaged, leading to eye progression of diabetes complications (secondary
problems (retinopathy), kidney problems (nephropathy), nerve prevention).27 The 1,441 patients in the trial had type 1
problems (neuropathy), and cardiovascular, cerebrovascular, diabetes and were randomly assigned to intensive and
and peripheral vascular disease.25 Hyperglycemia also conventional treatment groups (Table 1).27 The study results
causes excessive urination (polyuria) and excessive thirst are shown in Table 2.
(polydipsia).25,26 The dramatic findings of the DCCT changed goals for the
Approximately 10% of patients with diabetes have type 1, treatment of type 1 diabetes.27 The findings from the DCCT
or insulin-dependent, diabetes, which is characterized by an have led to plans to apply similar principles to managing type
absolute lack of insulin. Type 1 disease is caused by an 2 diabetes because the cellular changes causing
autoimmune process that destroys the pancreatic beta cells complications in both type 1 and type 2 disease are very
that produce insulin.25,26 Because type 1 diabetes usually similar.27

Table 1. Treatment Plan in Diabetes Control and Complications Trial


Disease Management for Diabetes

Treatment Parameter Conventional Intensive


Insulin 1 or 2 daily injections 3 daily injections or insulin pump
Testing Daily monitoring, urine or blood Blood monitoring several times a day
Diet and exercise instruction Quarterly Monthly
Follow-up exam Quarterly Monthly
Care contact As needed by patient Weekly by nurse

Source: Reference 27.

[4]
AND “diabetes.” Because disease management is a relatively
new concept, articles were manually culled from journals that
Table 2. Results of Diabetes are known to publish reports about disease management
Control and programs but that had not been indexed by MEDLINE (e.g.,
Complications Trial: Disease Management and Health Outcomes).
Risk Reductions in The primary criteria for inclusion of a study report in the
Intensive Cohorta analysis were (1) an educational intervention to improve
treatment and management of diabetes and (2) meas-
Complication Reduction (%) urement of the impact of that intervention.
Sustained retinopathy 63
Macular edema 26 Methodologies
Severe nonproliferative or
proliferative retinopathy 47 Reports on 67 diabetes disease management programs
Laser treatment 51 (Appendix B and Appendix C) met the inclusion criteria (other
Urinary albumin excretion (>40 mg/24 hrs) 39 programs that did not meet the criteria are described in
Urinary albumin excretion (>300 mg/24 hrs) 54
Clinical neuropathy at 5 yrs 60
Appendix D). Various methods were used to identify patients
to participate in the disease management programs. Nine
a
Includes both primary prevention and secondary prevention. programs were developed exclusively for children, an age
group in whom diabetes must be carefully monitored to
Source: Reference 27.
prevent future complications. Children were included with
adults in another six programs. The size of the patient
Table 3 lists commonly used authoritative guidelines for population in these studies ranged from 17 to 4,400.
managing diabetes. Up-to-date information on treatment Most of the interventions were educational programs for
guidelines from various sources also is available online from patients. Sixteen were educational programs directed at
the National Guideline Clearinghouse health care providers (usually nurses or physicians). Twenty-
(http://www.guideline.gov/). The management of diabetes, five programs were based on guidelines widely accepted by
based on information in the guidelines, is discussed in the medical community (e.g., the American Diabetes
Appendix A. Table 4 is a list of organizations with information Association). Most of the educational programs that were
about diabetes for patients. targeted to patients were administered by specially trained
nurses or health educators (i.e., non-physicians). In some of
Review of the Diabetes Disease the studies, educational programs were administered by a
Management Literature team of providers such as physicians, physician assistants,
nurses, diabetes nurse educators, nutritionists, pharmacists,
A comprehensive search of the diabetes disease social workers, and podiatrists.
management literature was conducted to identify reports on Various formats and settings were used for the educational
the impact of educational interventions to improve diabetes programs. Individualized and small-group sessions
treatment and management. These reports discuss the supplemented by audiovisual and printed information were
impact of specific educational interventions or programs on common. Program content typically included diabetes self-
diabetes treatment and management. These may not be management principles, concepts about the disease, and
comprehensive disease management programs. information about diet, exercise, and weight loss. Newsletters,
Disease Management for Diabetes

The database searched was MEDLINE, the National written in easy-to-understand language, often were used.
Library of Medicine’s premier database of more than 12 Most programs were conducted in an outpatient clinic setting,
million bibliographic citations and abstracts from more than although a few programs were provided in hospitals (i.e., to
4,600 journals in the fields of medicine, nursing, dentistry, inpatients), physicians’ offices, and pharmacies.
veterinary medicine, health care systems, and preclinical Thirty-five of the studies that evaluated disease
sciences. The decision to index a journal in MEDLINE is management programs were randomized, controlled trials.
based on scientific policy and quality considerations. In eight studies, patients served as their own controls. In 14
The MEDLINE database was searched from January 1990 studies, outcomes were assessed over a 1-year period after
to October 2003, using the terms “disease management” the intervention.

[5]
Table 3. Authoritative Guidelines for Managing Diabetesa

1. American Association of Clinical 4. American Dietetic Association


Endocrinologists/American College of Endocrinology Nutrition practice guidelines for type 1 and type 2 diabetes
Medical guidelines for the management of diabetes mellitus. mellitus (December 2001). Available in print and on CD-ROM
Available in print (Endocr Pract. 2002;8[suppl 1]:41–82) and at www.eatright.org and 120 South Riverside Plaza, Suite
online at: http://www.aace.com/clin/guidelines/ 2000, Chicago, IL 60606-6995 (1-800-877-1600, extension
diabetes_2002.pdf. 5000).

Position statement on insulin resistance syndrome. Available in 5. American Society of Health-System Pharmacists
print (Endocr Pract. 2003;9:240–252) and online at: Therapeutic position statement on strict glycemic control in
http://www.aace.com/clin/guidelines/ACEIRSPositionStatement patients with diabetes. Available in print (Am J Health Syst
.pdf. Pharm. 2003;60:2357–2362) and online at:
http://www.ashp.org/bestpractices/tps/Therapeutic%20Positio
2. American College of Physicians n%20Statement%20Strict%20Glycemic%20Control%20in%20
The evidence base for tight blood pressure control in the man- Patients%20with%20Diabetes.pdf.
agement of type 2 diabetes mellitus. Available in print (Ann
Intern Med. 2003;138:587–592) and online at: 6. Centers for Disease Control and Prevention
http://www.annals.org/cgi/reprint/138/7/587.pdf. Recommendations for health care system and self-
management education interventions to reduce morbidity and
Treatment of hypertension in type 2 diabetes mellitus: blood mortality from diabetes. Available in print (Am J Prev Med.
pressure goals, choice of agents, and setting priorities in dia- 2002;22[suppl 4]:10–4) and online at: http://www.
betes care. Available in print (Ann Intern Med. thecommunityguide.org/diabetes/dm-AJPM-recs.pdf.
2003;138:593–602) and online at:
http://www.annals.org/cgi/content/full/138/7/593 7. U.S. Preventive Services Task Force
Screening for type 2 diabetes mellitus in adults: recommenda-
3. American Diabetes Association tions and rationale. Available in print (Ann Intern Med.
Clinical practice recommendations, including position state- 2003;138:212–214) and online at: http://www.ahrq.gov/
ments, technical reviews, and consensus statements. Available clinic/3rduspstf/diabscr/diabetrr.htm.
in print annually in a supplement to the January issue of
Diabetes Care, which is published by the American Diabetes
Association, and online at: http://care.diabetesjournals.org/
a
Clinical practice is subject to constant change, and the guidelines in this list may become outdated or be superceded by newer ones. The reader is encour-
aged to consult the National Guideline Clearinghouse (http://www.guideline.gov/), a public resource for evidence-based clinical practice guidelines sponsored
by the Agency for Healthcare Research and Quality (formerly the Agency for Health Care Policy and Research) in partnership with the American Medical
Association and the American Association of Health Plans, for the most current guidelines.

Outcomes the intervention in all 20 of the studies in which cognitive


Clinical values (e.g., glycosylated hemoglobin, fasting outcomes were measured. Nine studies demonstrated
blood glucose levels, medication requirements, body weight, improved understanding and self-management practices as a
blood pressure, serum cholesterol, triglyceride levels) were result of the intervention. All nine of the studies in which
used as outcome measures in most of the studies. Foot patient adherence to the drug regimen or education program
Disease Management for Diabetes

examinations also were used as an outcome measure in was evaluated demonstrated a positive influence of the
many of the studies. The number of emergency department intervention on adherence.
visits or hospital admissions was used as an outcome The use of medications was an outcome measure in 14
measure in six studies. In three of these six studies, the studies. The intervention led to improved medication use or
intervention significantly reduced the number of emergency understanding in eight of these studies. The dispensing of
department visits or hospital admissions. Three studies found drugs recommended for the treatment of diabetes was not
a significant reduction in physician office visits as a result of measured in any of the studies.
the intervention. Cost-effectiveness was measured in 10 of the 65 studies,
Diabetes knowledge increased significantly as a result of and 2 studies determined that the cost savings were

[6]
attributable to the intervention (e.g., a reduced number of
physician office visits). The studies that measured cost-
effectiveness portend that the cost-benefit ratio of providing Table 4. Organizations with
a diabetes disease management program will decrease (i.e., Information About
become more favorable) as the intervention is applied to a Diabetes for
larger patient population. Over time, the fixed costs Patients
associated with developing a disease management program
will be spread over larger numbers of patients.
American Association of Diabetes Educators
The Future of Disease Management 100 West Monroe, Suite 400
Chicago, IL 60603
Disease management can improve patient outcomes and 1-800-338-3633
http://www.aadenet.org
quality of life while potentially reducing overall costs. It is an
important approach to integrated care. American Diabetes Association
As health care payers incorporate disease management Attn: National Call Center
1701 North Beauregard Street
principles into the delivery of care, they need to become
Alexandria, VA 22311
more sophisticated in contracting with outside vendors for 1-800-DIABETES (1-800-342-2383)
these services. The Disease Management Association of E-mail: AskADA@diabetes.org
America works with potential customers to address issues http://www.diabetes.org

associated with contracting, such as data contracting and Centers for Disease Control and Prevention
risk sharing. Currently, the Disease Management Association National Center for Chronic Disease Prevention and Health
of America has more than 100 members that provide disease Promotion
Diabetes Public Health Resource
management services.
P.O. Box 8728
Disease management vendors have begun using the Silver Spring, MD 20910
Internet to reach out to target populations. The Internet 1-877-CDC-DIAB
http://www.cdc.gov/diabetes
allows two-way communication between clinicians and
patients, as well as immediate and free access to National Diabetes Education Program
educational materials. Compared with traditional office visits (a partnership of the National Institutes of Health, the Centers
and postal mailings, the Internet may save time and money. for Disease Control and Prevention, and more than 200 pub-
lic and private organizations)
Initially the Internet may be used to educate Medicaid http://ndep.nih.gov
physicians, nurses, pharmacists, and other providers about
disease management. As more people gain access to National Diabetes Information Clearinghouse
(a service of the National Institute of Diabetes & Digestive &
personal computers and enter the “information
Kidney Diseases)
superhighway,” the Internet will become an increasingly 1 Information Way
powerful tool. Bethesda, MD 20892-3560
1-800-860-8747 or 301-654-3327
Disease management is a useful, efficient approach to
Fax: 301-907-8906
health care. It will continue to gain widespread acceptance E-mail: ndic@info.niddk.nih.gov
among health plans that provide care for patients with http://diabetes.niddk.nih.gov
chronic disease.
Disease Management for Diabetes

[7]
Appendix A.
Management of Diabetes

The goals of treatment for diabetes are to reduce and control blood insulin injections.35 Other patients with type 2 diabetes may attempt
glucose levels, relieve the symptoms of the disease, and prevent to control their diabetes through diet and exercise for a 3-month
complications.28 Numerous studies have demonstrated that inten- trial period.35 However, only 10% of patients with type 2 disease
sive treatment and careful control of blood glucose levels can can control their blood glucose levels with diet and exercise
reduce the risk of complications from diabetes.27,29–32 The American alone.35 Various oral antidiabetic agents (or insulin) may be used in
Diabetes Association recommends the formulation of an individual- conjunction with diet and exercise to control blood glucose levels
ized diabetes management plan in collaboration with the patient.28 in these patients.
A high degree of patient involvement in self-management should be
part of this plan, including frequent self-monitoring of blood glu- Insulin. Injections of insulin help cells take in glucose, thereby
cose.28 Long-term control of blood glucose levels can be assessed reducing blood glucose levels. Insulin is usually given as an
by measuring the extent to which glucose is bound to the A1c com- intermediate-acting insulin or a mixture of an intermediate-acting
ponent of hemoglobin. This glycosylated hemoglobin value is insulin plus a short-acting or rapid-acting insulin. Injections should
expressed as a percentage and should be less than 7% in patients be administered at least twice daily.35 Some patients may require
with diabetes.28 three or more daily insulin injections or continuous subcutaneous
infusions with an insulin pump.35
A proven method to curb the escalating costs of diabetes-related
morbidity and mortality is through education and disease manage- Oral Antidiabetic Agents. Classes of oral antidiabetic agents include
ment.27–29 The successful management of diabetes requires lifestyle sulfonylureas, biguanides, alpha-glucosidase inhibitors, meglitinides,
changes for the patient (e.g., diet, exercise, self-monitoring of blood and thiazolidinediones. Each class has a unique mechanism of
and possibly urine). The patient must be involved in the decision- action, pharmacologic effects, and adverse-effect profile. If
making process and must learn as much as possible about dia- monotherapy with an oral antidiabetic agent (plus diet and exercise)
betes, including why the symptoms of diabetes occur and how is ineffective in controlling blood glucose levels, adding a second
they can be alleviated through control of blood glucose levels. antidiabetic agent (preferably with a different mechanism of action) or
Education is essential for motivating patients to manage their dis- insulin is recommended.35 Using two or more oral antidiabetic agents
ease, encouraging changes in lifestyle, and improving patient out- with different mechanisms of action may provide an additive blood
comes. Disease management programs provide an excellent way glucose–lowering effect and minimize adverse effects.35 If combina-
to integrate education into the management of the disease. tion therapy is not effective, insulin monotherapy is recommended.35

Nonpharmacologic Interventions Sulfonylureas. Sulfonylureas are the best-established oral antidia-


Medical nutrition therapy (i.e., diet) and exercise are important betic agents and are a rational choice for initial drug therapy.35 They
aspects of nonpharmacologic treatment for diabetes.33,34 Weight act primarily to increase insulin secretion by pancreatic beta cells
loss is a vital part of treatment for type 2 diabetes because it can and can cause hypoglycemia.25 Weight gain also can occur with
help improve the sensitivity of cells to insulin and the uptake of sulfonylurea therapy.25
glucose by cells.
Biguanide. Currently, metformin is the only drug in the biguanide
A goal of medical nutrition therapy is to attain and maintain blood class. Metformin reduces blood glucose concentrations by increas-
glucose levels in the normal range or as close to normal as possi- ing glucose uptake in the peripheral muscles and decreasing the
ble.33 Patients with type 2 diabetes typically have dyslipidemia, and amount of glucose produced and released in the liver.25 It also
another goal for these patients is to improve the lipid profile.33 improves the lipid profile.35 The most common adverse effects from
Blood pressure levels that reduce the risk for vascular disease are metformin are diarrhea and other gastrointestinal disorders.25
another goal for patients with type 2 disease.33 Caloric restriction Metformin is contraindicated in patients with renal impairment
and weight loss are recommended for patients who are overweight, because of the risk of lactic acidosis, a potentially serious compli-
because weight loss may help normalize blood glucose levels.33 cation.25
Disease Management for Diabetes

Physical activity can improve insulin sensitivity (i.e., help cells take Alpha-Glucosidase Inhibitors. The alpha-glucosidase inhibitors
in more glucose), which can lower elevated blood glucose levels.34 acarbose and miglitol inhibit the action of intestinal enzymes that
Exercise also provides many other health benefits, including break down carbohydrates.25 These oral antidiabetic agents delay
improved energy levels and increased self-esteem. glucose absorption and are particularly useful for patients with
postprandial hyperglycemia (high blood sugar levels after eating).
Pharmacologic Interventions However, they are not as effective as sulfonylureas and biguanides
All patients with type 1 diabetes require insulin injections. Patients in providing long-term control of blood glucose levels.35 Alpha-
with type 2 disease who have multiple symptoms, are severely glucosidase inhibitors do not cause hypoglycemia or weight gain.
hyperglycemic, are pregnant, or have ketosis (increased ketone However, they can cause flatulence, diarrhea, and abdominal
production due to the breakdown of fat for energy) also should use cramps.25,36

[8]
Appendix A.
Management of Diabetes (continued)

Repaglinide. Repaglinide is a meglitinide that stimulates insulin Nateglinide is taken three times daily, within 30 minutes before
release by pancreatic beta cells, although it is not a sulfonylurea. meals.36 Hypoglycemia and weight gain can occur during nateglin-
Repaglinide is indicated as monotherapy or, if blood glucose con- ide therapy.36
trol cannot be achieved with repaglinide or metformin alone, in
combination with metformin.36 Repaglinide and metformin together Thiazolidinediones. Thiazolidinediones are the newest class of
act synergistically to reduce glucose levels to lower levels than can antidiabetic agents. They increase insulin sensitivity and action in
be achieved with either drug alone.36 liver, muscle, and fatty tissues. Thiazolidinediones reduce blood
glucose concentrations and improve the lipid profile.36 These
Repaglinide usually is taken two to four times a day, within 30 min- agents do not stimulate insulin secretion or cause hypoglycemia.36
utes before meals.36 Adverse effects include hypoglycemia and However, they can cause weight gain.36
weight gain. Patients who are elderly, debilitated, or malnourished
or who have adrenal, pituitary, or hepatic insufficiency are particu- Troglitazone, the first thiazolidinedione to become available, has
larly susceptible to hypoglycemic reactions.36 been withdrawn from the market because of reports of severe liver
toxicity resulting in death or requiring transplantation.37 The risk of
Nateglinide. Nateglinide is a non-sulfonylurea with a mechanism of severe liver toxicity appears to be lower with the newer thiazolidine-
action that is similar to that of repaglinide; it stimulates the release diones rosiglitazone and pioglitazone.36 Nevertheless, periodic
of insulin by pancreatic beta cells.36 Like repaglinide, nateglinide is monitoring of liver enzymes is recommended during treatment with
indicated for use as monotherapy or in combination with met- these agents.36
formin.36 Nateglinide and metformin have a synergistic blood
glucose–lowering effect.36

Disease Management for Diabetes

[9]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes
The impact of a diabetes nurse educator on nurses’ knowl- health care facilities. Culturally appropriate illustrations were devel-
edge of diabetes and nursing interventions in a home care oped for teaching illiterate patients. After 3 years, trained diabetes
setting. health care teams were in place and diabetes services were provid-
Adams CE, Cook DL. ed in all regional and 63% of subregional facilities. The number of
The Diabetes Educator. 1994;20:49–53. patients with diabetes registered before the program was 4,719,
and after the program, the number was 13,643. Prohibitively high
The impact of a diabetes nurse educator on the diabetes knowl- prices of antidiabetic medications and supplies were a problem.
edge of and patient care provided by registered nurses at home The experience implementing this program can serve as a model
health care agencies was assessed by comparing a home health for other developing countries.
care agency that had a diabetes nurse educator with an agency
without a diabetes nurse educator. The responsibilities of the dia- Evaluation of an activated patient diabetes education
betes nurse educator included completing needs assessments for newsletter.
both patients and staff; developing nursing standards of care, staff Anderson RM, Fitzgerald JT, Funnell MM, Barr PA, Stepien CJ, Hiss
education programs, and specific methods for implementing and RG, Armbruster BA.
evaluating care; designing diabetes self-care content that is user The Diabetes Educator. 1994;20:29–34.
friendly; and providing ongoing support for staff nurses.
In a nonrandomized study, 1,863 patients with type 1 or 2 diabetes
The average score on a test of basic diabetes knowledge was were recruited from physician offices, pharmacies, clinic waiting
77.3% at the agency with a diabetes nurse educator (N=45 regis- rooms, and diabetes patient education programs in nine Michigan
tered nurses) and 70.0% at the agency without the educator (N=17 communities. The patients were asked to return a postage-paid
registered nurses), a difference that is significant. Patient care was postcard if they wished to receive a free monthly newsletter about
assessed using a retrospective chart review of 31 patient charts at diabetes. The newsletter was approximately one page long and
each agency and a list of 33 items addressing patient admission, provided readable, concise, and action-oriented information about
care plan, ongoing care (assessment, patient education, nursing diabetes care. The newsletter also encouraged patients to become
care treatments, and evaluation), and discharge. This list was assertive consumers of diabetes care who are prepared to interact
based on guidelines of the American Diabetes Association and with physicians, nurses, and dietitians during diabetes care visits.
American Association of Diabetes Educators and federal and state Each of the 21 newsletters mailed during the 2-year study period
regulations governing home health care. Patient care scores were addressed a specific topic (e.g., diabetic retinopathy) and conclud-
significantly higher at the agency with the diabetes nurse educator ed with a specific recommended action for patients to take (e.g.,
than at the agency without the educator. Patient care outcomes ask the physician for a referral for an eye examination). The cost
(e.g., glycosylated hemoglobin) were not studied. The investigators of providing the newsletters was about 25 cents per person per
concluded that the role of the diabetes nurse educator should month.
include educating staff nurses and setting up standards of patient
care as well as educating patients. Among 720 patients who received and read most or all of the
newsletters, the newsletters were rated “Helpful” or “Very Helpful”
A national diabetes care and education programme: the by 77% of patients with type 2 diabetes who were not using
Ghana model. insulin, 70% of patients with type 2 diabetes who were using
Amoah AG, Owusu SK, Acheampong JW, Agyenim-Boateng K, insulin, and 57% of patients with type 1 diabetes. Patients who
Asare HR, Owusu AA, Mensah-Poku MF, Adamu FC, Amegashie found the newsletters “Helpful” or “Very Helpful” were older and in
RA, Saunders JT, Fang WL, Pastors JG, Sanborn C, Barrett EJ, poorer overall health and had more complications, lower incomes,
Woode MK. and a lesser understanding of diabetes than patients who rated the
Diabetes Res Clin Pract. 2000 Aug;49(2-3):149–57. newsletters “Not Helpful” or “Somewhat Helpful.” Patients were
more likely to discuss newsletter topics with family or friends than
A national diabetes care and education program was created in a with physicians, nurses, or dietitians and were least likely to discuss
Disease Management for Diabetes

developing country (Ghana) through international collaboration topics with nurses and dietitians. The topic most frequently dis-
between medical schools, industry, and governmental health care cussed with physicians was the importance of annual eye examina-
institutions. Ghana’s population of 18 million (85% of whom are tions. Few of the newsletters resulted in changes in diabetes care;
less than 45 years old) is served by 2 teaching hospitals, 9 regional on average, 7.8% of patients made changes in response to a
hospitals, and 100 subregional hospitals. Two core teams com- newsletter. The topic resulting in change in the largest percentage
prising a physician, a nurse, and a dietitian underwent intensive of patients (13.1%) was the importance of daily self-testing of blood
training in a multidisciplinary approach to diabetes care and educa- glucose levels. Patients who found the newsletters “Helpful” or
tion. The core teams subsequently developed a patient education “Very Helpful” were significantly more likely to make changes in dia-
booklet and a professional diabetes education curriculum for train- betes care than patients who rated the newsletters “Not Helpful” or
ing health care providers at regional and subregional hospitals and “Somewhat Helpful.”

[10]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
Learning to empower patients: results of professional edu- care group (8.7%), although there was room for improvement to
cation program for diabetes educators. reach the goal of 7% in both groups. Participants in the interven-
Anderson RM, Funnell MM, Barr PA, Dedrick RF, David WK. tion group were twice as likely as participants in the usual care
Diabetes Care. 1991;14:584–9. group to maintain or increase family involvement with diabetes-
related tasks.
A counseling and educational skills training program was conduct-
ed for 23 diabetes educators (including 20 nurses and 2 dietitians) Diabetes QI program cuts complications by 60%.
who responded to a flyer mailed to diabetes educators in Michigan. Anon.
The program was designed to equip the educators to use a patient Hosp Case Manag. 2003;11(7):103–4.
empowerment approach to diabetes patient education, which
requires health care providers to help patients increase their self- A quality improvement initiative was undertaken to improve the pro-
awareness of their values, needs, and goals for diabetes care; vision of diabetes disease management in an Iowa health system
assume greater autonomy; and make informed decisions about that provided care to 58,000 patients with diabetes. The health
their own care. The program for diabetes educators involved a system had 11 hospitals, each of which had a diabetic teaching
3-day simulated diabetes care regimen (two daily saline injections, center (clinic). The initiative involved developing a strategic plan
self-monitoring of blood glucose four times daily, a 1,200-kcal/day and standardizing care. A standardized patient education curricu-
diet, daily foot care and aerobic exercise, and extensive record lum was adopted, and staff training was provided in patient educa-
keeping) to give the educators a greater sense of the challenges tion and data collection. Group patient education sessions were
faced by patients. The simulated diabetes care regimen was fol- used instead of individual sessions to improve clinic operational effi-
lowed by a 3-day intensive skills-based workshop, using a four- ciency. Reminder calls to patients for return appointments also
phase learning sequence with information (lectures, handouts, and were used.
reprints) on educational and counseling skills, demonstration of
counseling skills, videotaped small-group practice in counseling, The average glycosylated hemoglobin decreased from 9.2% to
and review of videotaped counseling sessions. Values clarification, 7.0% (i.e., glycemic control improved) over a 6-month period.
the impact of communication style on approach to diabetes educa- Hourly clinic operational costs decreased by 20% as a result of the
tion, and effective and ineffective teaching also were addressed in switch from individual to group patient education sessions.
the program.
A comparison of learning activity packages and classroom
Counseling skills in simulated and actual patient encounters instruction for diet management of patients with non–insulin-
improved significantly as a result of the program. A questionnaire dependent diabetes mellitus.
completed before and after the program revealed that the attitudes Arsenau DL, Mason AC, Wood OB, Schwab E, Green D.
of the diabetes educators toward patient autonomy also improved The Diabetes Educator. 1994;20:509–14.
significantly. Attitudes toward the need for special training for dia-
betes educators did not change significantly. Participants consid- Forty patients attending a diabetes education program at a
ered the 3-day simulated diabetes care regimen a valuable learning hospital-based diabetes center volunteered to participate in a ran-
experience that increased their appreciation of patients’ concerns. domized 5-month study comparing the effectiveness of diabetes
education using an individualized method of learning with that of
Boost glycemic control in teen diabetics through “family- formal classroom sessions. The individualized learning program
focused teamwork.” was based on goals of the American Diabetes Association and
Anon. American Dietetic Association. It comprised pretest and posttest
Dis Manag Advis. 2003;9:120–2. materials, goals and learning objectives, factual information (using
inexpensive existing materials), and activities. Program content
Family-focused teamwork is an approach to improving glycemic was reviewed by two registered dietitians, a nutrition specialist, and
control in teenagers with type 1 diabetes that was developed by an education specialist. Follow-up visits were conducted 2 and 5
Disease Management for Diabetes

researchers at Joslin Diabetes Center in Boston, Massachusetts. months after randomization.


Sharing of responsibility by the teenager and his or her parents is a
key element in the approach. A series of educational modules was There were no significant differences between the two groups in
developed and used over the course of a year at routine visits. To fasting plasma glucose, glycosylated hemoglobin, knowledge,
make the program cost-effective, college graduates without a behavior (a measure of compliance), or body weight at the 2-month
health care background administered the modules instead of more follow-up visit. The behavior score in the individualized group was
costly health care professionals. A randomized controlled study significantly increased (indicating improved compliance) and body
was conducted of 105 children 8–17 years of age to compare the weight was significantly decreased at the 2-month follow-up visit
intervention with usual care. After 1 year, glycemic control was sig- compared with baseline. However, behavior scores decreased and
nificantly better in the intervention group (8.2%) than in the usual fasting plasma glucose concentrations increased significantly in the

[11]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
subsequent 3 months. Knowledge and body weight improved over They were provided with blood glucose monitoring equipment and
the course of the 5-month study in the individualized group. encouraged to participate in the 5-week diabetes education pro-
gram attended by the nurse case management group.
At the time of the 2-month follow-up in the classroom group, there
were significant decreases in fasting plasma glucose and glycosy- The nurse case management group had a greater decrease in gly-
lated hemoglobin levels and an increase in behavior scores com- cosylated hemoglobin values than did the usual care group (1.7%
pared with baseline. Behavior correlated with glycemic control. versus 0.6%, respectively) over the course of the 12-month study.
Glycosylated hemoglobin and behavior scores improved over the The difference between the two groups was evident after 6 months
course of the 5-month study. and was maintained for the subsequent 6 months. The reduction
in glycosylated hemoglobin was greater with nurse case manage-
Change in knowledge was the only variable that differed significant- ment than with usual care in the subset of patients with type 1 dia-
ly between the two groups. Increases in knowledge did not corre- betes and in the subset of patients with type 2 disease. There was
late with improved glycemic control or body weight. The results of no significant difference between the two groups in blood pressure,
the study suggest that an individualized method of education is as serum cholesterol and triglyceride levels, body weight, insulin
effective as traditional classroom instruction in educating patients requirements, hospital admissions, emergency department visits, or
with diabetes. The individualized method may be more cost- frequency of severe hypoglycemic episodes. Self-reported health
effective, particularly for patients who live a long distance from the status improved significantly in the nurse case management group.
classroom site or for whom the classroom schedule is inconvenient
(e.g., employed patients with inflexible work schedules). Choice of A diabetes control program in a public health care setting.
an education method for patients with diabetes might take into Baker SB, Vallbona C, Pavlik V, Fasser CE, Armbruster M, McCray
consideration various patient factors. R, Baker RL.
Public Health Rep. 1993;108(5):595–604.
Nurse case management to improve glycemic control in dia-
betic patients in a health maintenance organization. Protocols for the prevention and care of diabetes-related complica-
Aubert RE, Herman WH, Waters J, Moore W, Sutton D, Peterson tions of the eyes, lower extremities, and cardiovascular system
BL, Bailey CM, Koplan JP. were developed and implemented in nine community health cen-
Ann Intern Med. 1998;129:605–12. ters. These facilities were located in urban low-income neighbor-
hoods in Houston, Texas, and served approximately 4,300 patients.
A 12-month randomized, controlled trial was conducted to com- A culturally sensitive patient education curriculum was provided in
pare diabetes control in patients receiving nurse case management four 2-hour sessions by a diabetes nurse educator and a nutrition-
with that in patients receiving usual care at primary care clinics in a ist. Health care professionals received continuing medical educa-
group-model health maintenance organization. Patients were iden- tion, and there was financial incentive for nurses to become certi-
tified from pharmacy records and a database of patients who had fied diabetes educators. These efforts are part of a program that is
visited a physician for diabetes care, been hospitalized for diabetes, ongoing, although some results are available after 5 years of expe-
been seen by a utilization management nurse, or been referred to rience.
an ophthalmologist for a diabetic retinal examination. Seventeen
patients with type 1 diabetes and 121 patients with type 2 disease There was an increase in eye examinations from 8% to 26% of the
were randomized to the nurse case management group or the patient population. A reduction in the incidence of legal blindness
usual care group. The nurse case manager (a registered nurse and from 9.5 to 2.7 per 1,000 patients was observed after 4 years. A
certified diabetes educator) was trained to follow detailed manage- cost-benefit analysis of providing 12 months of screening and pre-
ment algorithms under the direction of a board-certified family med- ventive treatment for diabetic eye disease suggests a benefit-to-
icine physician and an endocrinologist. The algorithms were cost ratio of at least 2.77 for such a program.
designed to improve glycemic control by adjusting drug therapy,
planning meals, and reinforcing exercise recommendations. The percentage of the population with annual foot examinations
Disease Management for Diabetes

Patients assigned to the nurse case management group were increased from 18% to 44%. Control of blood pressure was
instructed about blood glucose monitoring at an initial visit with the achieved in 77% of patients. However, there were no significant
nurse case manager and returned for a follow-up visit 2 weeks later improvements in body weight or blood glucose control.
for reevaluation and adjustment of the treatment plan. Patients
also were referred to a 5-week, 12-hour diabetes education pro- The average percentage of correct responses to test questions
gram that addressed diet and exercise among other topics. about diabetes increased from 65% to 85% in patients. The rate at
Patients received weekly or biweekly follow-up telephone calls to which proliferative retinopathy and nonproliferative retinopathy (or
discuss blood glucose values, adjust drug therapy, and reinforce fundus abnormalities) were correctly identified by physicians in
dietary and exercise recommendations. Patients in the usual care slides or photographs was 79% and 77%, respectively, in 1990
group received diabetes care from their primary care physicians. and 95% and 86%, respectively, in 1991. In retrospective chart

[12]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
reviews, 83% of patients with hypertension and 92% of patients niques assessed visual function and diabetes knowledge, provided
with ischemic heart disease received appropriate medications and instruction in basic diabetes knowledge and self-care, and assisted
dosages. in the selection of self-management devices. Demonstration of
proficient self-care technique was considered a successful out-
Intensive education improves knowledge, compliance, and come.
foot problems in type 2 diabetes.
Barth R, Campbell LV, Allen S, Jupp JJ, Chisholm DJ. Success was achieved in 72% of participants. The adaptive dia-
Diabetic Med. 1991;8:111–17. betes education program was more successful in restoring inde-
pendent diabetes self-care practices in patients who were young or
The effectiveness of an intensive foot care intervention program and had early visual impairment (legal blindness with some residual
a conventional one were compared in 62 patients with type 2 dia- functional vision) than in patients who were older or had late visual
betes. Patients were recruited through an extensive radio and impairment (light perception only or total blindness). The success
newspaper campaign, from referrals by general practitioners and rate was 57% in patients with late visual impairment compared with
from people attending the Diabetes Center, St. Vincent’s Hospital 81% in patients with early visual impairment, possibly because
and other diabetes centers in Sydney, Australia. residual vision may facilitate the acquisition of self-care skills.

There were two types of programs (conventional and intensive). The impact of a staged management approach to diabetes
The conventional program included information on diabetes educa- foot care in the Louisiana public hospital system.
tion (what is diabetes, diet and exercise), complications of diabetes, Birke JA, Horswell R, Patout CA Jr, Chen SL.
and a 1 hour lecture on foot care (washing, drying, and inspecting J La State Med Soc. 2003;155(1):37–42.
the feet; cutting toenails, treating minor foot problems, appropriate
footwear, and dealing with extreme temperatures). The intensive The impact of a statewide (Louisiana), public hospital-based, dis-
program also had comprehensive diabetes education and foot care ease management initiative (DMI) for diabetes and a citywide
information but patients were encouraged to perform daily foot care (Baton Rouge) staged-management diabetes foot program (DFP)
procedures so as to avoid foot problems and reduce the risk of on (1) diabetes foot-related hospitalizations and (2) lower extremity
diabetic complications. Detailed foot care recommendations and amputations was assessed in a retrospective, nonrandomized
demonstrations were given. Practice sessions on foot care were study of a low-income patient population. The DMI included goals
performed during the study. for the medical management of diabetes consistent with American
Diabetes Association frequencies for performing various tests and
The intensive group showed significantly greater improvement than examinations and for counseling patients on nutrition and self-
the conventional group in foot care knowledge (p<0.001), compli- management. The Lower Extremity Amputation Prevention
ance with the recommended foot care routine (p=0.012), and Program, which includes annual foot screening, patient education
compliance with the initial advice to consult a podiatrist (other than about foot care, assistance in selection of proper footwear, daily
the project podiatrist) for further treatment (p=0.008). At the first foot self-inspection, and management of simple foot problems,
follow-up visit, the intensive group also showed a significantly was implemented as part of the DMI.
greater reduction in the number of foot problems requiring treat-
ment than the conventional group. It is not possible to investigate The staged management DFP was established to provide referral
whether the intensive group’s significant improvement in knowl- care for high-risk foot problems so that patients receive prompt
edge, compliance, and foot problems will reduce the number of treatment. Patients with diabetes were stratified by risk for foot
amputations. injury based on various factors (e.g., loss of protective sensation,
foot deformities, poor circulation, history of ulceration), and inter-
ventions and follow-up were provided in accordance with the
Effectiveness of a diabetes education program adapted for degree of risk.
people with vision impairment.
Disease Management for Diabetes

Bernbaum M, Wittry S, Stich T, Brusca S, Albert SG. The diabetes foot-related hospitalization rate during the year after
Diabetes Care. 2000 Sep;23(9):1430–2. program implementation was significantly lower than during the
year before implementation both in the five facilities outside Baton
The use of adaptive self-care skills (e.g., the use of adaptive equip- Rouge where only the DMI was used and in the three facilities in
ment such as syringe magnifiers, syringe loading devices, and glu- Baton Rouge where the DMI and DFP programs were used. The
cose monitoring systems with speech capability and tactile aids for reduction in hospitalization rate over time was greater with DMI plus
proper blood sample placement) was studied in 163 visually- DFP (44%) than with DMI alone (15%).
impaired patients with type 1 or type 2 diabetes over a 10-year
period at a university-based hospital clinic. The mean age was 56 The lower extremity amputation rate during the year after program
years. Diabetes educators specializing in adaptive diabetes tech- implementation was significantly lower than during the year before

[13]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
implementation both in facilities outside Baton Rouge where only Evaluation of a holistic treatment and teaching programme
the DMI was used and in facilities in Baton Rouge where the DMI for patients with type 1 diabetes who failed to achieve their
and DFP programs were used. There was no difference between therapeutic goals under intensified insulin therapy.
groups in the reduction in lower extremity amputation rate over Bott U, Bott S, Hemmann D, Berger M.
time (29% with DMI alone and 33% with DMI plus DFP). Diabet Med. 2000 Sep;17(9):635–43.

Randomized, controlled trial of diabetic patient education: The impact of a specialized educational program was studied in 83
improved knowledge without improved metabolic status. experienced patients with type 1 diabetes who failed to achieve
Bloomgarden ZT, Karmally W, Metzger MJ, Brothers M, their treatment goals for glycemic control or quality of life despite
Nechemias C, Bookman J, Faierman D, Ginsberg-Fellner F, Rayfiled the use of intensified insulin therapy and participation in standard
E, Brown WV. educational programs. Patients were referred to the program
Diabetes Care. 1987;10(3):263–72. because of frequent hypoglycemic events, motivational problems, a
need to refresh their diabetes knowledge, or a need for greater
In a randomized, controlled trial, the effect of a traditional diabetes flexibility in the insulin treatment regimen. The specialized program
patient education program on metabolic control (HbA1c) and other was provided for small groups (4–6 patients) over a 5-day period
variables was assessed in 266 patients at a large, hospital-based (20 hours of education) on an inpatient basis. Insulin therapy,
diabetes clinic. All 749 insulin-treated, “predominantly type II” dia- hypoglycemia, diet, and patient-specific concerns were addressed.
betic patients on the clinic roster were randomly assigned to an Psychosocial problems (especially lack of motivation) and coping
education group or a control group. Of these patients, 345 agreed strategies were the focus of intensive group discussions.
to participate in the program and 266 (education group=127; con-
trol group=139) completed the study. Patients in both groups had Face-to-face or telephone interviews were conducted an average
contact at each clinic visit with their physician and nurse, who of 17.5 months (range 9–31 months) after the specialized program.
reviewed medications and specific problems. Patients in the educa- Compared with baseline values, there was no change in the mean
tion group were also offered nine monthly education sessions, glycosylated hemoglobin A1c at follow-up. However, there was a
which included sessions and audiovisual materials in Spanish for significant decrease in the incidence of severe hypoglycemia (need
Hispanic patients. Material reviewed in these sessions included for glucose i.v. or glucagon injection) from 0.62 episodes per
basic physiology; foot, skin, and dental care; insulin administration patient/year at baseline to 0.16 episodes per patient/year at follow-
and emergencies; complications and risk factors, and nutritional up. Hospital admission decreased from 9.3 days per patient/year
information, which was presented via card games, films, filmstrips, to 6.2 days per patient/year, a difference that is not significant. The
and slides. Sixty-two percent (N=79) of the patients in the educa- number of sick leave days per patient/year decreased significantly
tion group attended seven or more sessions and were considered from 17.0 at baseline to 7.7 at follow-up. Thus, the specialized
“graduates.” educational program exploring motivation and other psychosocial
aspects of self-management improved outcomes in experienced
During the 1.5-year observation period, HbA1c fell from 6.8% to patients with poor glycemic control.
6.1% in the education group and 6.6% to 6.3% in the control
group, representing an insignificant difference (p=0.1995). Post- A community-based, culturally sensitive education and
intervention comparison of fasting blood glucose, triglycerides, cho- group-support intervention for Mexican Americans with
lesterol, insulin dosages, blood pressure, and foot lesion scores NIDDM: a pilot study of efficacy.
also failed to show significant intergroup variation. Whereas women Brown SA, Hanis CL.
in the education group gained less weight than those in the control The Diabetes Educator. 1995;21:203–10.
group, this effect was not attributed to the intervention. However,
post-intervention comparison of the groups did reveal a significant A 9-week pilot study was conducted to determine the feasibility of
increase in cognitive scores in the education group, but not the providing culturally sensitive diabetes patient education and group
control group, that was attributed to the program (p=0.0073). support to Mexican Americans in a rural community setting. Seven
Disease Management for Diabetes

Subgroup analysis also revealed that program graduates showed subjects were randomly selected from a cohort of 353 patients with
significantly greater improvement in behavior scores than either type 2 diabetes who had been followed in another study for 12
nongraduates or controls. The authors noted that, as the group years. Eight weekly 2-hour diabetes education sessions (culturally
population sizes were sufficient to detect a significant difference in relevant videotape presentations, discussions, demonstrations, and
the primary outcome measure—mean HbA1c, between the educa- a visit to a grocery store to learn to read and interpret food labels)
tion and control groups, patient education may not be an effica- and one 2-hour support group session were conducted in the
cious therapeutic intervention in most adults with type 2 diabetes. Spanish language. A family member or friend participated in all
sessions to provide support for the patient. Sessions were con-
ducted by a clinical nurse specialist, registered dietitian, and com-
munity lay worker, all of whom were Mexican American. Program

[14]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
content was based on a curriculum guide from the American Intervention study for smoking cessation in diabetic
Association of Diabetes Educators and included nutrition (especially patients: a randomized controlled trial in both clinical and
reduction in fat, sodium, and calorie intake), exercise, self- primary care settings.
monitoring of blood glucose, drug therapy, and disease complica- Canga N, De Irala J, Vara E, Duaso MJ, Ferrer A, Martinez-
tions. The sessions reflected cultural preferences (e.g., food prepa- Gonzalez MA.
ration methods) and addressed religious influences (e.g., diabetes Diabetes Care. 2000 Oct;23(10):1455–60.
as punishment for wrongdoing, conflict from thinking that assuming
responsibility for health interferes with God’s will). The sessions The impact of a nurse-led, face-to-face, individually structured
were conducted in the context of social activities (e.g., cooking intervention to help smokers quit smoking was assessed in a 6-
demonstrations) at a county agricultural extension office (i.e., a month, randomized, controlled trial of 280 patients with type 1 or 2
nonthreatening site with an informal, social atmosphere). The use diabetes at two urban hospitals and 15 urban primary care centers.
of medical terminology was minimized, and tools for assessing The intervention involved a 40-minute interview, optional transder-
knowledge of diabetes were designed to obviate the need for a mal nicotine replacement therapy, and a follow-up support pro-
high reading level. gram. In the interview, the advantages of smoking cessation were
emphasized, a cessation date was negotiated with the patient, and
Two subjects were dropped from the analysis because of serious self-help materials were provided. The intervention was based on
family illness and coronary artery bypass surgery, respectively. the protocols established in How to Help Your Patients Stop
Three months after the intervention, glycosylated hemoglobin and Smoking: A National Cancer Institute Manual for Physicians.
fasting blood glucose levels and knowledge of diabetes self- Subjects assigned to the control group received routine care,
management were significantly improved compared with baseline in including advice to quit smoking.
the remaining five subjects. The subjects found the presence of
family members or other support persons helpful. The group size After 6 months, the incidence of smoking cessation (validated by
was judged appropriate. The subjects needed additional time to urine cotinine concentrations) was 7.5 times higher in the interven-
learn the nutritional content of foods. An additional four weekly tion group (17.0%) than in the control group (2.3%). In patients
educational sessions were requested by the subjects. Subjects who failed to quit smoking, the mean number of cigarettes smoked
particularly appreciated the grocery store visit, use of culturally rele- daily decreased significantly from baseline in both groups but the
vant videotapes, and sharing of healthy recipes. reduction was greater in the intervention group (4.6 cigarettes/day)
than in the control group (1.6 cigarettes/day). Thus, the nurse-led
Effects of behavior-modifying education in the metabolic intervention was effective in modifying smoking behavior in patients
profile of the type 2 diabetes mellitus patient. with diabetes.
Cabrera-Pivaral CE, Gonzalez-Perez G, Vega-Lopez G, Gonzalez-
Hita M, Centeno-Lopez M, Gonzalez-Ortiz M, Martinez-Abundis E, Diabetes care organization, process, and patient outcomes:
Gonzalez Ojeda A. effects of a diabetes control program.
J Diabetes Complications. 2000 Nov-Dec;14(6):322–6. Carlson A, Rosenqvist U.
The Diabetes Educator. 1991;17:42–8.
The effects of a behavior-modifying educational program on the
metabolic profile (serum glucose, total cholesterol, and triglyceride The effects of a diabetes control program with continuing medical
levels) were assessed in a randomized, controlled trial of 49 education for health care providers and organizational change on
patients with type 2 diabetes who were not using insulin. Both the several organization, process, and outcome measures in patients
experimental group and control group attended classes once a with diabetes were evaluated in an 18-month, randomized, con-
week for 9 months. The behavior-modifying educational program trolled study. Thirty-four primary health care centers in Sweden
was designed to improve nutritional habits. Classes addressed were randomized to the intervention (the diabetes control program)
basic and applied nutrition concepts and involved workshops, group or a control group. A random sample of 20% of the patients
teamwork, and discussions. A traditional educational intervention in a registry of patients with diabetes at each center was selected
Disease Management for Diabetes

(i.e., didactic instruction in anatomy and physiology and memoriza- for study.
tion of nutritional facts) was used for the control group.
Routine measurement of glycosylated hemoglobin and perform-
The average serum glucose level decreased significantly from 210 ance of eye examinations were significantly higher in the interven-
mg/dL at baseline to 147 mg/dL at the end of the study in the tion group than in the control group. There were no significant dif-
experimental group. Total cholesterol and triglyceride levels also ferences between the two groups in access to or continuity of care,
decreased significantly from baseline. There were no significant patient education, or dietary knowledge. Self-monitoring of blood
changes in metabolic profile in the control group. Thus, behavior- glucose was significantly more common in the intervention group
modifying education was more effective for providing metabolic than in the control group, although the degree of metabolic control
control than traditional education. was similar in the two groups. Multivariate analysis by multiple

[15]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
regression revealed that routine diabetes care and patient-rated tion, medication counseling, monitoring, and insulin initiation or
quality of care were related to patient education, which in turn was adjustment. Goals for glycemic control were in accordance with
related to dietary knowledge, self-care practices, and metabolic American Diabetes Association standards. Patients met with a
control. The link between metabolic control and organization and pharmacist for an initial 30- to 60-minute visit during which the
process variables was weak. patient’s knowledge of diabetes, eating patterns, and glycemic
control were assessed and the patient’s medical history and med-
Group visits in medically and economically disadvantaged ications were reviewed. Follow-up visits were scheduled on an
patients with type 2 diabetes and their relationships to clini- individualized basis at approximately 1-month intervals. Glycemic
cal outcomes. control and symptoms were assessed and insulin was adjusted as
Clancy DE, Brown SB, Magruder KM, Huang P. needed at these visits. Patients also were monitored by telephone
Top Health Inf Manage. 2003;24(1):8–14. at 1- to 4-week intervals, depending on glycemic control.
Appointments were scheduled with the primary care provider at
The use of group visits (the intervention) was compared with usual least every 6 months. Pharmacists also arranged for visits with
care in a randomized controlled study of 120 adults with poorly physicians, dietitians, social workers, and psychologists as needed.
controlled type 2 diabetes (glycosylated hemoglobin >8.5%) at a
university-based clinic. Most patients were female and African Patients were followed for up to 45 weeks (27.1 weeks on aver-
American, with a mean self-reported educational level of 10.6 years age). The average glycosylated hemoglobin decreased from 11.1%
and an average health literacy level of grade 7.5. Most patients at baseline to 8.9% at the last follow-up visit, a change that is sig-
lacked insurance (30%) or were covered by Medicaid (44%) or nificant. Six (26%) patients achieved a value in the target range
Medicare (19%). (less than 8%). Average fasting blood glucose concentrations and
average random blood glucose concentrations also decreased sig-
In the intervention group, groups of 19 or 20 patients met monthly nificantly from baseline. Ten (43%) patients achieved a fasting
for 6 months. Each 2-hour group visit included a presentation on a blood glucose value in the target range (140 mg/dL or less), and 19
health-related topic (e.g., nutrition, exercise, sick day management, (83%) patients achieved a random blood glucose value in the target
stress management), a question-and-answer session, and individ- range (180 mg/dL or less). Eight (35%) patients experienced 85
ual attention to patient needs (e.g., immunizations). A control episodes of symptomatic hypoglycemia (one patient who failed to
group received usual care. adhere to recommendations for diet, alcohol use, and exercise
accounted for 48 of these episodes). None of the patients was
After 6 months, glycemic control and lipid profiles had improved in seen at the emergency department or hospitalized. Thus,
both groups, with no significant differences between groups. improved glycemic control was associated with pharmacists’ efforts
Patients in the intervention group had significantly higher scores in as part of a multidisciplinary team.
the Trust in Physician Scale, a measure of patients’ sense of trust
in their health care providers, than patients in the control group. The effect of intensive treatment of diabetes on the develop-
The use of the Patient Care Assessment Tool (a validated measure ment and progression of long-term complications in insulin-
of patient satisfaction with various aspects of primary care) revealed dependent diabetes mellitus.
trends toward improved coordination of care, community orienta- The Diabetes Control and Complications Trial Research Group.
tion, and cultural competence in the intervention group, although N Engl J Med. 1993;329:977–86.
the differences between the two groups were not significant.
Significantly greater compliance with American Diabetes In what was a landmark study, 1,441 patients with type 1 diabetes
Association standards of medical care process indicators (e.g., were followed for an average of 6.5 years to compare the impact of
annual performance of eye examinations) was observed in the intensive therapy (an external insulin pump or three or more daily
intervention group than in the control group at the end of the study. insulin injections and frequent blood glucose monitoring) with that
of conventional therapy (one or two daily insulin injections) on
Management of patients with type 2 diabetes by pharmacists microvascular complications (retinopathy and nephropathy) and
Disease Management for Diabetes

in primary care clinics. neuropathy. Glycosylated hemoglobin and blood glucose levels
Coast-Senior EA, Kroner BA, Kelley CL, Trilli LE. were significantly lower in the intensive therapy group than in the
Ann Pharmacother. 1998;32:636–41. conventional therapy group. Intensive therapy reduced the risk for
developing retinopathy by 76% (compared with conventional thera-
The impact of clinical pharmacists working as part of a multidiscipli- py) in the 726 patients with no retinopathy at baseline. Intensive
nary team on glycemic control in patients with type 2 diabetes who therapy slowed the progression of retinopathy by 54% and reduced
require insulin was evaluated. The study was conducted at two the development of proliferative or severe nonproliferative retinopa-
primary care clinics at a university-affiliated Veterans Affairs medical thy by 47% in the 715 patients with mild retinopathy at baseline.
center. Primary care providers referred 23 patients with inadequate Intensive therapy also reduced the occurrence of microalbuminuria
glycemic control to the pharmacists, who provided patient educa- and albuminuria (two measures of nephropathy) by 39% and 54%,

[16]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
respectively, and reduced the occurrence of clinical neuropathy by Disease management proves itself at Geisinger.
60%. The development of hypercholesterolemia (elevated serum Edlin M.
concentrations of low-density lipoprotein cholesterol) was signifi- Healthplan. 2003;44(4):55–8.
cantly lower in the intensive therapy group compared with the con-
ventional therapy group. The risk of macrovascular disease (i.e., The impact of implementation of a diabetes disease management
major cardiovascular and peripheral vascular events) was reduced program at a rural not-for-profit health plan was evaluated by per-
by 41% by intensive therapy, although the difference between the forming a chart review. A subset of 3,118 of 6,799 health plan
intensive therapy group and the conventional therapy group was enrollees with diabetes participated in the disease management
not significant. The risk of severe hypoglycemia was increased program; participants were referred by a physician or self-referred.
approximately three-fold by intensive therapy compared with con- The program involved one to four annual visits with a nurse in the
ventional therapy, a difference that is significant. primary care setting (depending on the presence of diabetes com-
plications) and patient education by nurse educators about self-
Diabetes managed care and clinical outcomes: the Harbor management techniques and preventive care. Treatment guidelines
City, California, Kaiser Permanente Diabetes Care System. were developed by physicians using Health Plan Employer Data
Domurat ES. and Information Set (HEDIS) measures that establish frequencies
Am J Manag Care. 1999;5:1299–1307. for various tests (e.g., glycosylated hemoglobin, lipids, kidney func-
tion, eye exams). Nurse educators promoted guideline use in the
The impact of Diabetes Care System (DCS), a computer-supported course of providing patient care.
diabetes care management program, on clinical outcomes in a
California health maintenance organization (HMO) was assessed Participants in the disease management program had higher rates
using data from a 3-year period. Approximately 30% of HMO of testing (i.e., higher HEDIS scores); better glycemic control (after
members with diabetes were targeted by DCS because of factors only 3 months); and fewer emergency department visits and inpa-
that placed them at high risk for disease complications or prob- tient days than nonparticipants. An annual cost savings of $4 mil-
lems. Care for these patients was provided by a team of health lion (nearly $1,300 per participant) was realized, which more than
care professionals, and data from individual visits, group encoun- offsets the program cost of $1.8 million.
ters, and telephone contacts were tracked in a computer database.
The other 70% of patients with diabetes received usual care. A project to reduce the burden of diabetes in the African-
Goals for blood glucose and blood pressure control were estab- American Community: Project DIRECT.
lished in accordance with American Diabetes Association clinical Engelgau MM, Narayan KMV, Geiss LS, et al.
practice recommendations. J Natl Med Assoc. 1998;90:605–13.

Screening rates for glycosylated hemoglobin (a measure of long- Project DIRECT (Diabetes Interventions Reaching and Educating
term glycemic control), urinary protein, and serum lipids were signif- Communities Together) is a 5-year community-based demonstra-
icantly higher in the 2,617 patients managed by DCS compared tion project that targets African Americans because of the high
with the 5,993 patients receiving usual care. Similarly, the rate of prevalence of diabetes and risk for complications from the disease
follow-up testing in patients with an elevated glycosylated hemoglo- in this patient population. It will be a collaborative effort involving
bin was significantly higher in the DCS patients than in the usual community leaders, health care providers, and the Centers for
care patients (77% versus 44%, respectively). Significant reduc- Disease Control and Prevention. The project comprises (1) health
tions in glycosylated hemoglobin levels were observed in patients in promotion initiatives to improve diet and physical activity in patients
both groups with initial elevations. There was a significant reduc- with diabetes; (2) outreach efforts to increase community aware-
tion in blood pressure in the DCS patients with an elevated blood ness of diabetes risk factors, screening for patients with undiag-
pressure but no change in blood pressure in usual care patients nosed diabetes, and integration of previously diagnosed patients
with elevated blood pressure. Inpatient utilization decreased signifi- into the health care system; and (3) efforts to improve diabetes self-
cantly between 1995 and 1997 in a subset of 386 patients man- care practices, increase access to care, and quality of care provid-
Disease Management for Diabetes

aged through the DCS program during that period and in 1997 ed by primary care providers. The interventions are not based on
was significantly lower than in 287 patients who were discontinued specific practice guidelines. Approximately 4,400 households will
from the DCS program because of patient factors and resource be contacted in each of two communities in North Carolina with a
limitations. Screening rates for glycosylated hemoglobin, urinary large population of African Americans and similar socioeconomic
protein, and serum lipids in patients who were no longer managed profiles and health care resources. One community (Raleigh) will
through DCS were significantly lower than rates in patients man- participate in the project, and the other community (Greensboro)
aged through DCS on a long-term basis. Thus, computerized will serve as a control. Participation in programs, screening rates,
tracking of patient care improved clinical outcomes. changes in diabetes practice, glycosylated hemoglobin concentra-
tion (i.e., long-term blood glucose control), and patient knowledge
and skills are among the process and outcome measures that will

[17]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
be evaluated. Many of the data will be collected by questionnaire. A community-based case management model for hyperten-
sion and diabetes.
In a 1993 pilot study, 45% of 902 participating individuals were Ginn M, Frate DA, Keys L.
African American. Half of these African Americans were physically J Miss State Med Assc. 1999 July; 40(7):226–8.
inactive (light or no physical activity during most weeks) and half
were overweight. The prevalence of diagnosed and undiagnosed The effect of a community-based case management approach on
diabetes was higher in African Americans than in members of other disease knowledge, self-perceived health status, and actual health
races. African Americans also were more likely to smoke and have status in 754 patients with diabetes, hypertension, or both was
uncontrolled hypertension and less likely to have a primary health assessed in a 24-month uncontrolled study. A case management
care provider. In patients of all races with diabetes, the level of pre- program involving client assessment, care plan development,
ventive care was low; only 42% had undergone a diabetes eye implementation, client service monitoring, and periodic assessment
examination and 50% had their feet examined by a health care was used at 12 ambulatory clinics and one hospital. These facili-
provider within the previous year. ties were located in five rural Mississippi counties with barriers to
health care, including a lack of financial resources and insurance,
Diabetes support groups improve health care of older inadequate distribution of primary care providers, transportation
diabetic patients. limitations, and low educational levels. Case managers were hired
Gilden JL, Hendryx MS, Clar S, Casia C, Singh SP. from the local community and trained in methods for educating and
J Am Geriatr Soc. 1992;40:147–50. managing patients.

A study of 32 elderly (68 years of age on average) male patients Knowledge about diabetes and hypertension and self-reported
with diabetes was conducted to determine whether diabetes health status improved significantly over the course of the study.
knowledge, quality of life, and glycemic control are affected by pro- The percentage of patients with good blood pressure control (sys-
viding support group sessions in conjunction with a diabetes edu- tolic blood pressure <140 mm Hg and diastolic blood pressure <90
cation program. The diabetes education program comprised six mm Hg) increased from 33.5% at baseline to 47% after 24 months,
weekly sessions on the disease, nutrition, drug management, psy- a difference that is significant. The percentage of patients with
chosocial adjustment, stress management skills, and self-care (e.g., good blood glucose control (60–120 mg/dL) also increased (from
self-monitoring of blood glucose, foot care). The 11 patients in 13.9% to 18.9%) over this period, although the change from base-
Group A participated in the diabetes education program followed line was not significant.
by an 18-month support group program with monthly sessions
consisting of continuing education, coping skills training, group dis- Brief, computer-assisted diabetes dietary self-management
cussions, and structured social activities. Support group sessions counseling: effects on behavior, physiologic outcomes, and
were self-directed by patients and supervised by a social worker, quality of life.
with continuing education provided by members of the diabetes Glasgow RE, Toobert DJ.
care team (a diabetologist, nurse educator, dietitian, social worker, Med Care. 2000 Nov;38(11):1062–73.
psychologist, podiatrist, and pharmacist) as appropriate. The 13
patients in Group B participated only in the diabetes education pro- The reach (percentage of eligible patients participating), adoption
gram (they were on a waiting list for the support group program). (willingness of primary care physicians to participate), and effective-
Eight patients in Group C participated in neither the diabetes edu- ness of a behavioral dietary intervention with or without diabetes
cation program nor the support group program. self-management support were assessed in 320 patients with type
2 diabetes in a 6-month study. The behavior intervention involved
Patients who received both the support group intervention and dia- assessment and analysis of dietary habits and barriers to dietary
betes education program (Group A) had significantly better scores self-management and establishment of goals for reducing dietary
in measures of diabetes knowledge, quality of life, and depression fat intake using a multimedia touch-screen computer. Diabetes
than patients in the other two groups at the end of the study. self-management support involved follow-up telephone calls and
Disease Management for Diabetes

Glycemic control (fasting blood glucose and glycosylated hemoglo- community resources enhancement (e.g., newsletters, information
bin) was significantly worse in Group C (patients who did not par- on dining out and shopping).
ticipate in either program) than in patients in the other two groups
but there was no significant difference between Group A and Seventy-six percent of eligible patients and 40 of 42 primary care
Group B. At the 2-year follow-up, the patients who participated in physicians agreed to participate. On average there was a 50%
the support group program (Group A) were more successful in reduction in dietary fat intake. However, there were small reduc-
maintaining diabetes knowledge and had a better quality of life than tions in glycosylated hemoglobin A1c and the ratio of total choles-
patients in Group B who received diabetes education without terol to high-density lipoprotein cholesterol (a predictor of heart dis-
group support. ease) that were not significant. There was relatively little change in
illness-related quality of life. Follow-up phone calls and community

[18]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
resources enhancement did not add to efficacy of the behavioral contact and office visits for support. Diet was chosen as a focus
intervention. because it is an objective of Healthy People 2010. An endocrinolo-
gist and internist who specialize in diabetes were the managers of
A brief office-based intervention to facilitate diabetes dietary the intervention.
self-management.
Glasgow RE, Toobert DJ, Hampson SE. Follow-up components include phone calls and videotape or inter-
Diabetes Care. 1996 Aug; 19(8):833–42. active video instruction as needed. Initial process results suggest
success in producing modest, targeted behavior changes among a
There is a pressing need for brief practical interventions that broad cross section of patients. If long-term results are equally
address diabetes management. Using a randomized design, a positive, this intervention could provide a prototype for a feasible,
medical office-based intervention focused on behavioral issues rele- cost-effective way to integrate patient views and behavioral man-
vant to dietary self-management was evaluated. There were 206 agement into office-based care for diabetes. Outcomes measured
adult diabetes patients randomized to usual care or brief interven- include weight, eating patterns (fat content), serum cholesterol, and
tion, which consisted of touch-screen computer-assisted assess- glycemic control (glycosylated hemoglobin) and will be measured
ment to provide immediate feedback on key barriers to dietary self- but are not yet available.
management, and goal-setting and problem-solving counseling for
patients. Follow-up components to the single session intervention Coping skills training for youths with diabetes on intensive
included phone calls and interactive video or videotape instruction therapy.
as needed. Grey M, Boland EA, Davidson M, Yu C, Tamborlane WV.
Applied Nursing Research. 1999;12:3–12.
Results using multivariate analyses of covariance revealed that the
brief intervention produced greater improvements than usual care A 6-month randomized, controlled study was conducted to evalu-
on a number of measures of dietary behavior (e.g., fewer calories ate the impact of coping and skills training (CST) on metabolic con-
from saturated fat, fewer high-fat eating habits and behaviors) at trol in adolescents with type 1 diabetes who were initiating intensive
the 3-month follow-up. There were also significant differences insulin therapy. Seventy-seven patients selected from a university-
favoring intervention on changes in serum cholesterol levels and based pediatric diabetes service were randomized to the interven-
patient satisfaction but not on glycosylated hemoglobin. The inter- tion group, which received CST and intensive insulin therapy, or the
vention effects were relatively robust across a variety of characteris- control group, which received intensive insulin therapy alone.
tics, the two participating physicians, and intervention staff mem- Patients were admitted for 1 day to a research center to obtain
bers. baseline data and review treatment goals and methods. The health
care providers were blinded to the study group assignment of
If the results of this study were to be generalized to other settings, patients. Intensive insulin therapy involved three or more daily
this intervention could provide a prototype for a feasible cost-effec- insulin injections or the use of an external insulin pump and self-
tive way to integrate patient views and behavioral management into monitoring of blood glucose at least four times daily. CST was
office-based care for diabetes. designed to teach problem-solving skills and communications.
Four to eight 1- to 1.5-hour weekly small-group sessions followed
A brief office-based intervention to facilitate diabetes dietary by monthly sessions were led by a master’s-prepared nurse practi-
self-management. tioner with experience in pediatric psychiatry and diabetes. Role-
Glasgow RE, Toobert DJ, Hampson SE, Noell JW. playing in various social situations (e.g., making food choices with
Health Educ Res. 1995;10:467–78. friends and decisions about drugs and alcohol) was used in these
sessions.
An office-based intervention to prompt both patients and providers
to focus on behavioral issues relevant to dietary self-management Both the intervention group (intensive insulin therapy plus CST) and
was developed for approximately 200 adult patients with type 1 or the control group (intensive insulin therapy alone) had a significant
Disease Management for Diabetes

2 diabetes who are at least 40 years of age (data for the initial 95 reduction in glycosylated hemoglobin after 6 months, although the
are presented in this article). Patients were identified via letter reduction was faster and greater in the intervention group. CST
about the study, with informed consent statements sent to patients neither reduced nor increased the rate of acute complications of
who have diabetes and a scheduled appointment at an office- intensive therapy (i.e., severe hypoglycemic episodes). Patients in
based practice, followed by a phone call from an investigator. the intervention group had significantly better general self-efficacy
(personal competence, power, resourcefulness) and diabetes-
The intervention used computer-assisted and interactive video pro- related quality of life, reported that diabetes had less of a negative
cedures that assess patient views and behaviors related to dia- impact on quality of life, and had fewer worries about diabetes in
betes care and self-management; assistance for patients in setting relation to quality of life than patients in the control group.
dietary goals and problem-solving strategies; and follow-up phone

[19]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
Effect of multiple patient reminders in improving diabetic individual with a doctor of pharmacy degree and 2 years of clinical
retinopathy screening. training in general medicine) differ from the outcomes of care pro-
Halbert RJ, Leung KM, Nichol JM, Legorreta AP. vided by a physician. The pharmacist-managed care was closely
Diabetes Care. 1992 May;22(5):752–5. monitored by a physician to ensure that care would be adequate,
although care plans written by the pharmacist were rarely altered.
The impact of multiple patient reminders on improving the rate of The attrition rate was significantly lower and the kept-clinic-appoint-
diabetic retinopathy screening was evaluated in 19,523 diabetic ment rate was significantly higher in the experimental group (phar-
members of a large, network-based, health maintenance organiza- macist-managed care) than in the control group (physician-man-
tion (HMO). Claims and pharmacy databases were used to identify aged care). These differences may reflect greater patient satisfac-
all HMO members ≥18 years with diabetes and their diabetic retinal tion with pharmacist-managed care. There was no significant dif-
examination (DRE) status. Patients were then randomized to single ference between the two groups in compliance with drug therapy,
(N=9614) or multiple (N=9909) reminder intervention groups. Both emergency department visits, hospital admissions, fasting blood
groups received mailed educational materials and a reminder for glucose level, or diastolic blood pressure. Systolic blood pressure
DRE. Their treating physician groups also received a letter explain- was significantly lower in the control group compared with the
ing the program, current American Diabetes Association (ADA) experimental group, possibly in part because the control group had
guidelines for retinal examinations, and a list of their diabetic a larger percentage of patients with both diabetes and hyperten-
patients, indicating DRE status. The single intervention group (the sion than the experimental group (diabetes contributes to vascular
control group) received no additional reminders, while the multiple changes and hypertension). Care provided by the clinical pharma-
intervention group (the study group) received additional reminders cist was safe and effective.
3, 6, and 9 months after baseline if the claims database indicated
no record of DRE. Monthly DRE rates were determined for the 7 Is the quality of diabetes care better in a diabetes clinic or in
months preceding the first intervention (patient reminder) and sub- a general medicine clinic?
sequent 12 months. Ho M, Marger J, Beart J, Yip I, Shekelle P.
Diabetes Care. 1997;20:472–5.
There was a short-lived (~ 2-month) increase in monthly DRE rates
in both intervention groups following the initial intervention (first A retrospective chart review was conducted to compare the quality
reminder). After a second reminder was sent to the multiple inter- of ambulatory diabetes care delivered by specialists (faculty dia-
vention group, the percentage of patients who underwent DRE was betologists, endocrine fellows, medical residents, a diabetic nurse
higher than that in the single intervention group. However, DRE educator, a podiatrist, and an optometrist) at a diabetes mellitus
rates between groups did not significantly differ after the third clinic (DMC) with that provided by generalists (faculty internists,
reminder, nor did monthly differences in rates exist. There was a medical fellows, medical residents, and nurse practitioners) at a
significant difference in overall annual DRE rates between groups general medicine clinic (GMC) in 1993 and 1994. Computerized
(p=0.023). Analysis of direct costs of reminders (only printing and medication profiles and clinic enrollment lists were used to identify
postage) in the multiple reminders group suggested an incremental 112 patient medical records, half of which documented care pro-
cost of $80 per additional eye examination. vided in the DMC and half of which reflected care delivered at the
GMC. Process criteria for “good” quality of diabetes care were
Multiple patient reminders are more effective than single reminders developed using American Diabetes Association guidelines. A sub-
in improving rates of diabetic retinopathy screening in a managed set of minimally acceptable criteria was chosen because of a
care setting. However, incremental improvement is small and does strong link with good patient outcomes in clinical trials (e.g., blood
not extend beyond a second reminder. Future research should pressure and glycosylated hemoglobin measurements, urinalysis) or
explore other avenues of improving DRE rates (e.g., telephone because of their importance for continuity of care. Compliance
follow-up of nonresponders, increased provider involvement, with criteria for self-monitoring of blood glucose levels, foot exami-
provider reminders). Given the costs of multiple reminders, financial nation, comprehensive eye examination, and referral for diabetes
resources may be better utilized on other approaches for reducing education when glycemic control was poor was significantly greater
Disease Management for Diabetes

diabetic complications. in the DMC patient medical records than in the GMC records.
Compliance with the criterion for inquiry about cardiac symptoms
Evaluation of a clinical pharmacist in caring for hypertensive was significantly higher in the GMC than in the DMC. None of the
and diabetic patients. medical records from either clinic met all the criteria for “good”
Hawkins DW, Fiedler FP, Douglas HL, Eschbach RC. quality of care. Significantly more DMC patient medical records
Am J Hosp Pharm. 1979;36:1321–5. than GMC records met the minimally acceptable criteria (73% ver-
sus 52%, respectively). The most common shortcoming for both
A 29-month randomized, controlled study of 1,722 patients with clinics was failure to perform a comprehensive eye examination.
diabetes, hypertension, or both was conducted to determine Differences between specialists and generalists in knowledge about
whether the outcomes of care provided by a clinical pharmacist (an diabetes management could explain these results.

[20]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
Empowering diabetes out-patients with structured educa- the initial 1-hour session and $7.50 for additional sessions.
tion: short-term and long-term effects of functional insulin Approximately 10 new patients joined the service each month.
treatment on perceived control over diabetes.
Howorka K, Pumprla J, Wagner-Nosiska D, Grillmayr H, Schlusche Pharmacists were able to provide more instructional time than typi-
C, Schabmann A. cally is provided by physicians, thereby improving patient under-
J Psychosom Res. 2000 Jan;48(1):37–44. standing. Patients were grateful to have ready access to pharma-
cists for information or help solving problems. Physicians had more
The short- and long-term effects of structured education about time available to spend with other patients once pharmacists
functional insulin treatment (insulin dosing according to self-moni- assumed the patient education responsibility. Communication
toring of blood glucose levels and food intake, thereby avoiding the between pharmacists and physicians improved.
need for adherence to a prescribed schedule of doses and meals)
were studied in outpatients with type 1 diabetes. Study 1 was a 4- Impact of community-based diabetes education on program
week randomized, controlled study of 32 patients. Both the inter- attenders and nonattenders.
vention group and the control group received general diabetes edu- Irvine AA, Mitchell CM.
cation but only the intervention group received training in functional The Diabetes Educator. 1992;18:29–33.
insulin treatment (FIT). Patients undergoing FIT training learned cri-
teria for adapting insulin dosing before meals and for the correction The impact of community-based diabetes education on patients
of hyperglycemia. Study 2 was a 3-year uncontrolled pilot study of with diabetes who dropped out of the program was compared with
68 patients. The effect of training in FIT on perceived control over that on patients who continued in the program. In three
diabetes and diabetes-related health beliefs was assessed in both Appalachian communities that were comparable in size and char-
studies using questionnaires. acter, adults with diabetes were referred by physicians and sent a
letter inviting them to participate in the study. Sixty-one patients
In study 1, FIT training induced feelings of independence from situ- attended three initial evening meetings at a local church over the
ational control while self-managing diabetes. There was no change course of 1 week. The diabetes education program was designed
in the control group over the 4-week period. After 3 years, FIT to increase knowledge, self-care, and metabolic control and was
training improved perceived self-efficacy, treatment satisfaction, and conducted by a nurse educator, nutritionist, psychologist, and
glycemic control, resulting in a feeling of empowerment. Patients physical therapist. Classes were held on alternate Thursdays over
felt greater freedom from the control of physicians and treatment a 3-month period on various topics, including the disease, diet,
restrictions. Perceived treatment cost-effectiveness (the difference stress, medication, blood glucose testing, complications, and exer-
between measures of benefits from treatment and barriers to treat- cise. The 24 subjects who attended fewer than half (two or fewer)
ment) improved significantly due to decreases in barriers to treat- of the education classes were considered the Attrition group. The
ment. other 19 subjects, who attended three or more of the education
sessions, were considered the Education group. A control group
Pharmacist-managed diabetes education service. of 18 patients received no special education. This control group
Huff PS, Ives TJ, Almond SN, Griffin NW. was further divided on the basis of whether subjects attended all
Am J Hosp Pharm. 1983;40:991–4. three testing sessions. Data for members of the control group who
did not attend all three testing sessions (pretest, posttest, and 3-
Ten years of experience with a diabetes education service provided month follow-up) were combined with data for the Attrition group to
by pharmacists to ambulatory patients was described in 1983. create a Nonattenders group, and data for members of the control
Funding was provided by the U.S. Public Health Service of the group who attended all three testing sessions were combined with
Department of Health and Human Services, and pharmacists were data for the Education group to form an Attenders group.
reimbursed for the service. The education program was developed
in accordance with American Diabetes Association patient educa- Diabetes knowledge increased significantly over the course of the
tion guidelines. Patients were referred to the service by a primary study in the Attenders group but not in the Nonattenders group.
Disease Management for Diabetes

care provider after diagnosis. A diabetes questionnaire was admin- There was no significant difference between the two groups in
istered to assess the patient’s knowledge of diabetes. The ques- change in attitude toward living with diabetes (self-esteem, denial,
tionnaire was used to establish a teaching plan and short- and locus of control, degree to which regimen intrudes on lifestyle, atti-
long-term treatment goals. An initial 1-hour counseling session tude toward physician). Attitudes improved over the course of the
was conducted to address the pathophysiology of the disease, study in both groups. There was no significant change over time in
complications, importance of patient compliance, role of diet and any group in self-reported adherence to the treatment regimen for
drug therapy, administration technique, adverse effects, and self- diet, exercise, medication use, glucose testing, or number of
monitoring. Patient progress in the educational process was docu- pounds overweight. Foot care improved significantly in Attenders
mented. Additional 15-minute sessions at follow-up visits were but not in Nonattenders. Glycosylated hemoglobin improved signif-
provided as needed. Patients were assessed a fee of $15.00 for icantly in the Education group but not in the Control group.

[21]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
Nonattenders tended to be less educated, have a lower income, Post-intervention evaluation revealed that glycemic control signifi-
be younger, have had diabetes for twice as long, report more barri- cantly improved in the intervention group and remained unchanged
ers to self-care, and have poorer health than Attenders. The in the control subjects. Final GHb and FPG concentrations in the
results of this study suggest that Attenders may have characteris- intervention group were significantly decreased compared with
tics that allow them to benefit from minimal intervention and that baseline, and significant intergroup differences existed for final
Nonattenders may require special efforts to overcome barriers to GHb, FPG, and the mean absolute change in GHb. No significant
participating in programs. changes in blood pressure control, lipid profiles, renal function
parameters, body weight, or quality-of-life measures were docu-
Evaluation of pharmaceutical care model on diabetes man- mented within or between groups, except for a decrease in the final
agement. serum creatinine in controls. There were 17 reported hypoglycemic
Jaber LA, Halapy H, Fernet M, Tummalapalli S, Diwakaran H. events in the intervention group versus two in the control group; all
Ann Pharmacother. 1996;30:238–43. were mild to moderate, accompanied by classic symptoms, and
recognized and successfully treated by patients.
This study assessed the effectiveness of a comprehensive pharma-
ceutical care model in improving management of type 2 diabetes in These results suggest that this disease-specific model of pharma-
39 African American patients in a clinic setting. Potential subjects ceutical care effectively improved glycemic control in a clinic-based
consisted of urban African American patients with type 2 diabetes population of urban African American, diabetic patients. Given the
who were currently attending a university-affiliated, internal medi- lack of change in other parameters (e.g., body weight, lipids, blood
cine outpatient clinic. Medical chart review was used to exclude pressure), this improvement was primarily attributed to optimization
patients with certain medical conditions or a recent history of clinic of glycemic control and enhancement of patient knowledge versus
visit noncompliance; the remaining 156 (eligible) patients were con- instruction about diet and exercise. Cost analysis of this program
tacted by letter followed by a telephone call. The 45 patients who was not performed.
agreed to participate were assigned to an intervention group or
control group in a random, parallel design fashion. These patients Effects of diet and exercise interventions on control and
were followed up over a period of 4 months, and 39 patients (17 quality of life in non–insulin-dependent diabetes mellitus.
intervention-group patients; 22 controls) completed the study. Kaplan RM, Hartwell SL, Wilson DK, Wallace JP.
J Gen Intern Med. 1987;2:220–7.
Patients in the intervention group received pharmaceutical care
consistent with, but broader than, that described by Helper and An 18-month randomized trial evaluated the effects of diet, exer-
Strand’s disease-specific model of pharmaceutical care. This cise, diet plus exercise, or education on glycosylated hemoglobin,
pharmacist-administered care consisted of (1) disease-specific weight, and quality of life in 70 diabetic patients. Following recruit-
pharmacotherapeutic evaluation and dosage adjustments, (2) com- ment by radio announcements, newspaper notices, and physicians,
prehensive, individualized patient education about diabetes and its adult volunteers with a confirmed diagnosis of type 2 diabetes and
complications, (3) training in the recognition and treatment of hypo- a fasting plasma glucose of > 3.62 mmol/L were randomly
glycemia and hyperglycemia, (4) medication counseling, (5) specific assigned to one of four 10-week programs: (1) diet, (2) exercise, (3)
instructions about diet and exercise, and (6) training in the self-moni- diet plus exercise, or (4) education (control). Participants in all
toring of blood glucose (SMBG). Follow-up visits were conducted groups were given both the American Diabetes Association-recom-
weekly until targeted glycemic control was reached and then every 2 mended exchange diet (approximately 1,200 calories/day) and an
to 4 weeks for the study duration. Patients in the control group test-based exercise prescription and asked to attend weekly 2-hour
attended an initial assessment at the clinic and an exit interview at meetings for 10 consecutive weeks. Volunteers in the education
the study’s conclusion; they were instructed to continue with stan- group, designed to be a control group, attended lectures by health
dard care, which usually involved clinic visits every 3 to 4 months. care specialists that provided information about diabetes care but
not specific instructions for behavioral changes. Subjects in the
Clinical, laboratory, and quality of life assessments were performed diet, exercise, and diet-plus-exercise intervention groups attended
Disease Management for Diabetes

at baseline and at the end of the study (i.e., at 4 months). Primary weekly sessions that incorporated behavioral modification methods
outcome measures consisted of fasting plasma glucose (FPG) and (e.g., diaries to monitor eating/exercise; identification of reinforcers
glycosylated hemoglobin (GHb). Secondary outcome endpoints and contingencies; use of distractors) and other strategies (e.g.,
included blood pressure, lipid levels, and measures of renal function instruction in stretching and foot care) to increase compliance with
as well as quality of life. Information about compliance with medica- diet and/or exercise plans.
tions, diet, and exercise, as well as the frequency of hypo- and
hyperglycemic episodes, was obtained at each clinic visit. In addi- Baseline parameters were similar among groups. Compared with
tion, SMBG records were reviewed and FBG, weight, and blood controls, the diet group demonstrated weight loss at 3 and 6
pressure were measured. months, but had regained this weight by the 18-month evaluation.
The greatest reduction in mean glycosylated hemoglobin at 18

[22]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
months was found in the diet-plus-exercise group (p<0.05), whose patient diabetes care. Patients for this study were recruited from
mean weight remained essentially unchanged throughout the study. two large medical groups contracted to provide health care to
Significant differences in quality of life were noted between the diet- HMO members. One of the groups (site A) was a typical participat-
plus-exercise and control groups (p<0.01) and the diet and control ing medical group (PMG); the other site (site B) was an IPA. A sin-
groups (p<0.05), but not the exercise and control groups, at 18 gle separate site was selected as a control for site A, and 13 non-
months. The estimated cost of the diet and exercise program was experimental physician office sites served as the control for site B.
$1,000 per patient. Quality of life-based cost/utility analysis sug- ICD codes were used to generate a list of patients with diabetes at
gested the cost of a single “well year” produced by this program each control and experimental site. Approximately 15 patients per
would be $10,870. month were randomly selected from this list to enter the program
over the course of 6 months at experimental sites. Due to insuffi-
Effects of a formalized diabetes education. cient enrollment, physicians at each experimental facility were sub-
Karlander SG, Kindstedt K. sequently permitted to assign patients for inclusion. Patients in the
Acta Med Scand. 1983;213:41–3. control group were selected a few months after enrollment had
begun at the experimental sites on the basis of an available gly-
The effects of a formalized diabetes education program on dia- cosolated hemoglobin level.
betes and nutrition knowledge and metabolic control were
assessed in a 1-year controlled study of ambulatory patients with A provider team at each experimental site, consisting of a nurse or
diabetes. All patients attending a diabetes clinic were invited to physician assistant (PA), an endocrinologist, and a staff assistant,
participate, although another 32 patients matched for age were not received a training manual, specially designed protocols and forms,
asked to participate and served as controls. Two daily lessons and a computer information system. Protocols were designed to
about the disease and nutrition, respectively, were conducted on improve diabetes and lipid management as well as compliance with
each day of the 5-day program. Oral presentations were supple- referrals and laboratory studies. The computer system was
mented with color slides, and patients were encouraged to ask designed to (1) track patient clinical and laboratory data, (2) track
questions and participate in discussions. An illustrated text that patient appointments and generate reminders, and (3) provide algo-
summarized each lesson was provided. rithms to adjust insulin dosages based on results of blood glucose
self-monitoring. Training in the application of the program lasted 2
Eighty-three patients with diabetes participated in the formal edu- weeks for nurses/PAs and one day for physicians. These experi-
cation program. Their scores on tests of knowledge of diabetes mental teams also attended quarterly meetings with diabetologists
and nutrition increased significantly immediately after the formal to discuss program progress. Providers at control sites were not
program and 1 year after the program compared with baseline. informed that a study was being carried out.
Patients in the control group tended to have lower scores than
patients in the intervention group. Scores for the control group at As part of the program, all patients treated at experimental sites
the second visit (usually 2 months after the initial visit) were underwent an initial evaluation and were then seen at least quarter-
unchanged compared with the first visit. The only significant ly. Telephone calls and weekly visits were used for patients requiring
changes in metabolic control in the intervention group 1 year after more frequent monitoring. The computer ordered baseline laborato-
the formal education program were a reduction in relative body ry values (glycosolated hemoglobin, fasting plasma glucose, full
weight from 133% to 126% in the subset of patients managed with lipid panel, serum creatinine, urinalysis); follow-up glycosolated
diet alone and a decrease in serum cholesterol from 6.3 mmol/L to hemoglobin and fasting plasma glucose were obtained every 2
5.8 mmol/L in the subset of patients receiving oral antidiabetic drug months, and the remaining laboratory studies were repeated yearly.
therapy. There were no significant changes in blood glucose level, Data collection from controls was less complete to avoid alerting
urinary glucose excretion, glycosylated hemoglobin, or serum cho- providers and patients that a study was being conducted. Only
lesterol or triglycerides. The investigators concluded that efforts to patients whose charts provided a glycosolated hemoglobin level
improve diabetes control must address patient attitudes toward the within a one-year interval were selected as controls, and a single
disease and not be limited to imparting facts. follow-up level was obtained at the end of the study.
Disease Management for Diabetes

Effect of a comprehensive nurse-managed diabetes pro- Provider team adherence to protocols was assessed by follow-up
gram: an HMO prospective study. data obtained from 117 experimental patients at site A, 123 experi-
Legorreta AP, Peters AL, Ossorio RC, Lopez RJ, Jatulis D, mental patients at site B, 88 control patients for site A, and 62 con-
Davidson MB. trol patients for site B (N=390). At site A, 12-month and baseline-
Am J Manag Care. 1996;2:1024–30. to-endpoint decreases in glycosolated hemoglobin were significant-
ly greater in the experimental group than the control group. Low-
This 18-month prospective, nonrandomized, control trial assessed density lipoprotein cholesterol levels also improved in the former,
whether a diabetes management program involving special proto- but were not measured in controls. Referral for yearly ophthalmo-
cols linked to a computer system could provide cost-effective out- logic examination was 100%. The same staff was employed for the

[23]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
duration of the study, and nurse adherence to protocols was care principles. Subjects were randomized to take home the dia-
judged to be close. At site B, baseline-to-endpoint analysis, but not betes video game or an entertainment pinball video game (subjects
12-month data, showed a significantly greater decrease in glycoso- using the pinball game served as controls).
lated hemoglobin levels in experimental group patients than con-
trols. However, these levels remained above desirable levels. Over the 6-month study period, the average total playing time for
Improvement in low-density lipoprotein cholesterol levels was also the diabetes video game was 34 hours, which was not significantly
found in the experimental group, but only 52% of patients at site B different from the playing time in the control group. There was a
were referred for ophthalmologic examination. Considerable staff 77% decrease from baseline in urgent care and emergency medical
turnover was also found at site B, which was thought to have con- visits in the diabetes video game group but there was no change in
tributed to disruption of the program and the level of care provided. the control group (an average of 2.4 visits per year in the control
This disruption was associated with lower levels of protocol adher- group). There were improvements in diabetes-related self-efficacy
ence and reduced proficiency with the computer systems com- (ability to affect outcomes), communication with parents about dia-
pared with that for the staff at site A. Comparison of glycosolated betes, and daily diabetes self-care in the diabetes video game
hemoglobin data from experimental groups A and B also demon- group but not in the control group.
strated a stronger treatment effect at site A.
Pharmacists’ interventions using an electronic medication-
These results suggest that physician-supervised nurses who follow event monitoring device’s adherence data versus pill counts.
protocols linked to a computer system can provide high-quality Matsuyama JR, Mason BJ, Jue SG.
outpatient diabetes care associated with improved glycemic con- Ann Pharmacother. 1993;27:851–5.
trol, lipid levels, and patient compliance with referrals. Differences in
patient improvements between experimental groups as sites A and A randomized, double-blind study was conducted to compare the
B were attributed to higher staff turnover at site B, resulting in pro- usefulness of adherence data from an electronic medication-event
gram and care disruption. monitoring system (MEMS) with that of pill counts in assisting phar-
macists in making recommendations for diabetes therapy (patient
Impact of endocrine and diabetes team consultation on hos- education or change in drug, dosage, or schedule). MEMS is a
pital length of stay for patients with diabetes. medication vial cap with a microprocessor that records each date
Levetan CS, Salas JR, Wilets IF, Zumoff B. and time that the vial is opened. Computer medication profiles and
Am J Med. 1995;99:22–8. laboratory data for all patients with scheduled medicine clinic
appointments at Veterans Affairs medical center ambulatory clinics
The length of hospital stay of consecutive patients with diabetes in Boise, Idaho, were screened for patients receiving a sulfonylurea
was compared when (1) consultation by a diabetes team (nurse for 3 months or longer with a consistent dosage and poor to fair
educator, registered dietitian, and endocrinologist) was obtained, (2) metabolic control between July 1990 and May 1991. Patients
a traditional consultation by an endocrinologist was obtained, and were randomized to the MEMS group or a control (pill count)
(3) no consultation was obtained. The average length of stay of group. Patients in both groups received a 35-day supply of med-
patients in the diabetes team consultation group (3.6 days) was ication in a vial with the MEMS cap and returned to the pharmacy
significantly shorter than values for the endocrinologist-consultation for a refill after 30 and 60 days, at which time pill counts were per-
group (5.5 days) and the no-consultation group (8.2 days). Each formed. Initially, the data from the microprocessor were retrieved
day delay in consultation resulted in an increase of 1 day in length only for patients in the MEMS group, and pill count data were ana-
of stay. lyzed only for patients in the control group. There was no signifi-
cant difference between the two groups in measured non-adher-
Management of chronic pediatric diseases with interactive ence rates (60% in the MEMS group and 35% in the control
health games: theory and research findings. group). Seven (47%) of 15 pharmacist recommendations based on
Lieberman DA. adherence data in the MEMS group and two (12%) of 17 recom-
J Ambulatory Care Manage. 2001 Jan;24(1):26–38. mendations in the control group were for patient education, a dif-
Disease Management for Diabetes

ference that is significant. To determine how consistent the two


A 6-month randomized controlled trial evaluated the effects of a adherence measurement methods (MEMS and pill counts) were,
diabetes self-management video game in 59 children and adoles- MEMS data were later retrieved for the control group and com-
cents with diabetes. The diabetes video game had two main char- pared with the pill count data, and pill count data were later ana-
acters who were presented with challenges modeled after the chal- lyzed for the MEMS group. The pill count data were inconsistent
lenges faced by patients with diabetes. Players were called upon with the MEMS data for seven (47%) of the 15 patients in the
to help their character monitor blood glucose, take appropriate MEMS group. The MEMS data were inconsistent with the pill
insulin doses, and eat appropriate foods. Winning the game count data for nine (53%) of the 17 patients in the control group. If
required success in performing these tasks. Multiple-choice ques- the pharmacists had had access to the MEMS data for four of the
tions posed by a video character were used to teach diabetes self- patients in the control group, they would have recommended

[24]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
patient education. For two of these patients, this recommendation glycemic control. The registry served as a reminder of the recom-
would have been made instead of a dosage increase because a mended elements of care (e.g., foot examinations). Delivery of care
pattern of inconsistent medication-taking behavior was evident with was redesigned to provide for patient group visits as well as individ-
MEMS. These results demonstrate that MEMS allows pharmacists ual patient visits and to establish a decentralized team of diabetes
to individualize recommendations to a greater extent than the pill experts that sees patients jointly with primary care providers. The
count method. decentralized team traveled to each clinic several times a year and,
along with the primary care team, saw each patient for approxi-
Demonstrating the added value of community health nursing mately 30–40 minutes.
for clients with insulin-dependent diabetes.
Mazzuca KB, Farris NA, Mendenhall J, Stoupa RA. The prevalence of testing for glycosylated hemoglobin and eye
J Community Health Nurs. 1997;14:211–24. examinations both increased over the 3-year period after imple-
mentation of the program. Nearly two-thirds of patients with dia-
A randomized, controlled study was performed to determine betes received annual eye examinations by the end of the 3-year
whether community health nursing (weekly or biweekly home visits period. In the first year of the program, half of all patients with dia-
to provide health teaching and guidance, health referrals, coordina- betes had a foot examination compared with fewer than 20%
tion of care, and client advocacy) improves the self-care competen- before program implementation. Microalbuminuria screening also
cy and health status of adults with insulin-treated diabetes and increased markedly after program implementation. The prevalence
poor glycemic control. Teaching addressed nutrition, exercise, foot of smoking decreased from 14% in 1994 to 10% in 1996.
care, and blood glucose monitoring. Patients who had received
care at a university-based internal medicine clinic were contacted Thirty randomly selected practices that collaborated with the
by telephone by investigators and invited to participate in the study. decentralized diabetes expert team (group A) were compared with
Community health nursing students who were in their senior year 30 randomly selected practices that did not work with this team
provided community health nursing to the experimental group over (group B). The rates of eye examination and glycosylated hemo-
a 32-week period. The students were supervised by a nursing fac- globin testing increased in group A but did not change in group B
ulty investigator. between 1994 and 1996. In 1996, both rates were significantly
higher in group A than in group B. However, the average glycosy-
Twenty-two of 29 subjects completed the study. Self-care behav- lated hemoglobin level in 1996 in group A was not significantly dif-
iors improved significantly over the course of the study in the 11 ferent from that in group B (7.7% and 7.8%, respectively). The
subjects in the intervention group; managing complications (hypo- rates of foot examination and microalbuminuria screening were
glycemia and hyperglycemia), adhering to a meal and snack regi- more than threefold higher in group A compared with group B.
men, testing and recording blood glucose levels, and calling the The percentage of randomly selected primary care physicians who
physician about foot changes are aspects of self-care that rated diabetes resources (e.g., access to certified diabetes educa-
improved most. Self-care behaviors decreased slightly over the tors) as good or excellent increased between 1992 and 1996.
course of the study in the control group. There was no significant
difference between the two groups in outcomes for dietary adher- A controlled trial of Web-based diabetes disease manage-
ence (nutritional content), foot care, blood glucose levels, overall ment: the MGH diabetes primary care improvement project.
diabetes knowledge, or functional health status and well-being. Meigs JB, Cagliero E, Dubey A, Murphy-Sheehy P, Gildesgame C,
These results may reflect the limitations of the instruments used to Chueh H, Barry MJ, Singer DE, Nathan DM.
measure outcomes, the small sample size, the use of novice nurs- Diabetes Care. 2003;26(3):750–7.
es instead of experienced nurses, and the complexity of outcomes
research. The impact of a Web-based information management/decision
support tool was evaluated in a randomized controlled trial of 598
A population-based approach to diabetes management in a adults with diabetes who attended a hospital-based internal medi-
primary care setting: early results and lessons learned. cine clinic. The intervention involved the use of the Web-based
Disease Management for Diabetes

McCulloch DK, Price MJ, Hindmarsh M, Wagner EH. tool, which linked patient-specific information with evidence-based
Effective Clinical Practice. 1998;1:12–22. treatment recommendations.

The effect of a program of support for primary care providers who The 1-year period after the intervention was compared with the
care for patients with diabetes on provider satisfaction and health 1-year period before the intervention. Testing of glycosylated
outcomes was assessed over a 3-year period beginning in 1994 at hemoglobin and low-density lipoprotein cholesterol and foot
a not-for-profit staff-model health maintenance organization in screening increased significantly in the intervention group com-
Washington state. The support program comprised an online pared with the control group. Values of glycosylated hemoglobin
patient registry and the use of evidence-based clinical guidelines for (i.e., glycemic control) improved in the intervention group but not in
eye and foot examinations, screening for microalbuminuria, and the control group. Lipid and blood pressure control improved and

[25]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
eye examination rates increased in both groups. The investigators Community-based chronic disease management program for
concluded that the Web-based patient-specific decision support African Americans.
tool has the potential to improve evidence-based parameters of Nine SL, Lakies CL, Jarrett HK, Davis BA.
diabetes care. Outcomes Manag. 2003;7(3):106–12.

A computer-generated reminder system improves physician The impact of a chronic disease management program for African
compliance with diabetes preventive care guidelines. American persons with diabetes, hypertension, or both was evalu-
Nilasena DS, Lincoln MJ. ated over a 1-year period in a community setting in West Virginia.
Proc Annu Symp Comput Appl Med Care. 1995;640–5. The chronic disease management program comprised exercise,
medical nutrition therapy (dietary counseling and meal planning),
A 6-month, randomized, controlled study was conducted to evalu- support groups, cooking schools, and service coordination (goal
ate the impact of a computer-generated reminder system on physi- setting and phone calls from and home visits by a service coordina-
cian compliance with guidelines for diabetes preventive care. tor). Seventy-five patients, most of whom were African American,
Internal medicine resident physicians in their second or third year at volunteered to participate.
the University of Utah who were providing care to patients with dia-
betes at outpatient general internal medicine clinics were random- Significant reductions from baseline in systolic and diastolic blood
ized to an intervention group or control group. Residents in the pressure were observed after 1 year. Reductions in glycosylated
intervention group were provided with a patient-specific report list- hemoglobin also were observed but the reductions were significant
ing patient health data and upcoming or overdue preventive health only in the 12 patients with elevated baseline values (>7%). Quality
activities (e.g., physical examinations, laboratory tests, referrals, of life improved but the change from baseline was not significant.
patient education). Diabetes preventive care guidelines published
by the American Diabetes Association addressing renal care, foot The impact of an educational program on improving dia-
care, eye care, glycemic control, macrovascular care, and neuro- betes knowledge and changing behaviors of nurses in long-
logic care were the basis for the computerized-reminder system. term care facilities.
Residents in the control group received a generic patient report Parker MT, Keggett-Frazier N, Vincent PA, Swanson MS.
without specific recommendations. All patients with diabetes type The Diabetes Educator. 1995;21:541–5.
1 or 2 who were treated by the residents were included in the
study; these patients were identified by reviewing clinic, pharmacy, The impact of a diabetes education program on knowledge and
and laboratory records. Encounter forms with patient clinical data diabetes care practices of the nursing staff was ascertained in two
were completed by residents in both groups after patient visits. long-term-care facilities (LTCFs) in eastern North Carolina. The
nursing staff at another LTCF served as a control group. The edu-
A score for compliance of the resident physician with diabetes pre- cation program comprised seven biweekly sessions conducted by
ventive care guidelines was calculated for each patient visit. The diabetes educators over a 12-week period. A lecture format with
average compliance score 1 month after implementation of the slides and a question-and-answer period was used. Topics includ-
reminder system was significantly higher compared with baseline in ed medications, patient monitoring (blood glucose and ketones),
the intervention group (54.9% after 1 month versus 38.0% at base- managing hyperglycemia and hypoglycemia, diet, foot care, illness
line). The average compliance score in the control group also care, and exercise and patient-family education. Each educational
increased significantly over the same period (51.0% after 1 month session was 20 minutes long to facilitate nursing staff participation.
versus 34.6% at baseline); there was no significant difference A diabetes knowledge test was developed using guidelines of the
between the two groups in the change in compliance. Possible American Association of Diabetes Educators and the American
explanations for these unexpected findings include the short dura- Diabetes Association. This test was administered at the start of the
tion of the study (many aspects of patient care are recommended study (before the education program in the intervention group) and
annually), the Hawthorne effect (i.e., the altered behavior in the at the end of the study. Patient charts from before and after the
control group could have been the result of the fact that the sub- intervention were reviewed to determine whether carbohydrates
Disease Management for Diabetes

jects were under observation), or other factors. The highest com- were provided to patients with hypoglycemia, ketones were tested
pliance scores were for laboratory tests and referrals, and the low- and a physician was contacted when a patient exhibited hyper-
est scores were for patient education. The use of encounter forms glycemia, insulin was administered in the abdomen (a preferred site
facilitated documentation of clinical data and compliance with because of the rapid rate of absorption), and toenails were cut by a
guidelines for diabetes preventive care. podiatrist.

Thirty-five registered nurses and licensed practical nurses partici-


pated in the study. They had 8 years of nursing experience on
average. Only one nurse had diabetes, and another 14 had a fami-
ly member with the disease. The intervention and control groups

[26]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
did not differ significantly in nursing education, nursing experience, The effect of automated calls with telephone nurse follow-up
experience with patients with diabetes, or participation in diabetes on patient-centered outcomes of diabetes care: a random-
continuing education programs. The average pretest diabetes ized, controlled trial.
knowledge score was 67% for both groups. The average posttest Piette JD, Weinberger M, McPhee SJ.
score was significantly higher in the intervention group (73%) than Med Care. 2000 Feb;38(2):218–30.
in the control group (69%). The difference between the average
pretest and posttest scores in the control group was not significant. Patient-centered outcomes, including depression, anxiety, self-effi-
The retrospective chart review revealed that the frequency of giving cacy (patients’ confidence in participating in their own care), days in
carbohydrates to patients with hypoglycemia, administering insulin bed because of illness, days cut down on activities because of ill-
in the abdomen, and having toenails cut by a podiatrist increased ness, diabetes-specific health-related quality of life, satisfaction with
over the course of the study in the intervention group. However, care, and general quality of life were assessed in the study of auto-
the change was not significant. Thus, additional training as well as mated telephone assessment and nurse follow-up that is described
education is needed to improve diabetes care practices in the nurs- above (Piette JD, Weinberger M, et al. Am J Med. 2000
ing staff at LTCFs. Jan;108(1):20–7). Patients in the intervention group (i.e., participat-
ing in automated telephone assessment) had significantly fewer
Do automated calls with nurse follow-up improve self-care symptoms of depression and days in bed because of illness and
and glycemic control among vulnerable patients with dia- significantly greater self-efficacy to perform self-care activities than
betes? patients in the control (usual care) group. Anxiety levels, diabetes-
Piette JD, Weinberger M, McPhee SJ, Mah CA, Kraemer FB, specific health-related quality of life, and general health-related
Crapo LM. quality of life were similar in the two groups.
Am J Med. 2000 Jan;108(1):20–7.
Impact of automated calls with nurse follow-up on diabetes
The effects of automated telephone assessment and nurse follow- treatment outcomes in a Department of Veterans Affairs
up on self-care (self-monitoring of blood glucose, foot inspection, Health Care System: a randomized controlled trial.
weight monitoring, and medication adherence) and glycemic con- Piette JD, Weinberger M, Kraemer FB, McPhee SJ.
trol were assessed in a 12-month randomized, controlled study of Diabetes Care. 2001 Feb;24(2):202–8.
248 English- or Spanish-speaking adult patients with diabetes
managed by medication. The intervention involved biweekly, auto- The effects of automated telephone assessment and nurse follow-
mated telephone assessment (patient use of the touch-tone tele- up (see the summaries of the two reports by Piette JD, Weinberger
phone keypad to enter blood glucose readings and other data for M, et al., above) on patients’ self-care, symptoms, satisfaction with
review by a nurse) and self-care education calls with nurse follow- care, and glycemic control were assessed in 272 patients with dia-
up. The self-care education component of the automated tele- betes at a Veterans Affairs clinic in a 12-month randomized con-
phone assessment was a 3- to 5-minute interactive module on diet trolled study. Only 44% of patients had a baseline glycosylated
and weight control. The nurse follow-up involved telephone calls to hemoglobin A1c level of 8% or higher, which is the level at which
patients to address problems identified in a review of data entered intervention is recommended (i.e., more than half of patients had
in the automated telephone assessment. The control group good glycemic control). After 12 months, patients in the interven-
received usual care. tion group reported significantly more frequent self-monitoring of
blood glucose and foot inspections and were more likely to be
Self-monitoring of blood glucose, foot inspection, and weight moni- seen in podiatry clinics and diabetes specialty clinics than patients
toring were more frequent and problems with medication adher- in the control (usual care) group. Among patients with a baseline
ence were less common in the intervention group than in the usual glycosylated hemoglobin A1c of 8% or higher, the mean value after
care group. The differences were significant. Mean glycosylated 12 months was significantly lower in the intervention group than in
hemoglobin A1c values after 12 months were slightly lower in the the control group (8.7% versus 9.2%, respectively). Significantly
intervention group than in the usual care group but the difference fewer symptoms of poor glycemic control and greater satisfaction
Disease Management for Diabetes

was not significant. More than twice as many patients in the inter- with care were reported by patients in the intervention group than
vention group as in the usual care group (17% versus 8%, respec- by patients in the control group.
tively) had glycosylated hemoglobin A1c values in the normal range.
Mean serum glucose levels were 41 mg/dL lower in the intervention Adherence to protein restriction in patients with type 2 dia-
group than in the usual care group, a difference that is significant. betes mellitus: a randomized trial.
Symptoms of hyperglycemia and hypoglycemia were less common Pijls LT, de Vries H, van Eijk JT, Donker AJ.
in the intervention group than in the usual care group. Similar per- Eur J Clin Nutr. 2000 Apr;54(4):347–52.
centages of subjects in the two groups were hospitalized or seen in
the emergency department. The effect of a dietary counseling on protein restriction was
assessed in a 12-month randomized, controlled study of 125

[27]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
patients with type 2 diabetes and microalbuminuria, relatively high than control group patients to initiate a discussion of behavioral
albuminuria, or diabetes for at least 5 years and a high dietary pro- change. Twenty-two (69%) of 32 clinicians were judged to have a
tein intake. The experimental and control groups both received moderate to good understanding of the methods and principles
counseling on restricting dietary intake of saturated fats. The underlying the intervention. However, only six (19%) clinicians rou-
experimental group also received counseling on reducing dietary tinely applied these principles in practice.
protein intake, with partial replacement of proteins by unsaturated
fats and carbohydrates. Improve control of type 2 diabetes mellitus: a practical
education/behavior modification program in a primary care
Dietary protein intake (measured indirectly using urinary urea excre- clinic.
tion) was significantly lower in the experimental group than in the Ridgeway NA, Harvill DR, Harvill LM, et al.
control group after 6 months but the difference was smaller and South Med J. 1999 Jul;92(7):667–72.
not significant after 12 months. Factors predicting reduction in
dietary protein intake included satisfaction with preexisting diet, low This study evaluated the efficacy and ease of administration of edu-
body mass index, and living alone. Dietary counseling resulted in cation/behavior modification classes in improving disease control in
only modest protein restriction. 38 diabetic patients in a primary care clinic population. A comput-
erized audit identified diabetic patients who visited the clinic in the
A randomized controlled trial of an intervention designed to preceding year, and physicians recommended participation to
improve the care given in general practice to type II diabetic patients who met the following inclusion criteria: (1) a diagnosis of
patients: patient outcomes and professional ability to type 2 diabetes, (2) poor glycemic control, (3) ≥ 20% over ideal
change behaviour. body weight, and (4) able to attend monthly clinic visits and com-
Pill R, Stott NCH, Rollnick SR, Rees M. prehend presented material. Patients were randomized to an inter-
Family Practice. 1998;15:229–35. vention group or control group, and metabolic parameters, body
weight, health-related quality of life, and cognitive knowledge of
A 3-year randomized, controlled study was conducted to evaluate diabetes were assessed at baseline and regular intervals.
the effect of training for clinicians (general practitioners and practice
nurses) on outcomes for patients with type 2 diabetes. The training The intervention group attended 90-minute classes taught by a
addressed a patient-centered intervention, which was designed to (1) registered nurse and registered dietitian monthly for 6 months, with
encourage clinicians to negotiate individual patient care plans based a follow-up session at 12 months. Didactic portions of the classes
on patients’ perceptions of their disease and readiness to change were based on the Life Skills program, featuring lectures, teaching
their lifestyles and (2) to work toward realistic targets for behavior slides, and handouts about diabetes, its treatment, and conse-
change. Thirty-three general practices with 252 patients with type 2 quences. Diet and exercise were emphasized as important means
diabetes were randomized to the experimental group or the control of controlling diabetes. Behavior modification involved (1) individual
group. Clinicians in the experimental group received at least 3 hours sessions with instructors to individualize diets, prescribe exercise,
(divided into two sessions) of training in the patient- and set goals; (2) use of worksheets and contracts to emphasize
centered intervention. This training involved discussions, demonstra- need for patient responsibility; (3) class participation, encourage-
tions, and role-playing. A research nurse provided continuing sup- ment, and praise; and (4) brief classroom appearances by physi-
port, visited the practice sites, sent newsletters every 3 to 4 months, cians.
and held two group meetings during the course of the study.
Statistically significant reductions in mean fasting blood glucose
There were no significant differences between the experimental and (FBG), glycosylated hemoglobin (GHb), total cholesterol, and low-
control groups in glycosylated hemoglobin level or the number of density lipoprotein cholesterol (LDL-C) values were observed at the
complications. Patient satisfaction with recent consultations and end of the intervention in the intervention group (N=18; p< 0.05).
treatment improved significantly over the course of the study in the These values remained decreased, but not significantly different
control group but not in the experimental group, although the latter from baseline, at the 12-month follow-up, when a significant
Disease Management for Diabetes

group had little room for improvement. Physical functioning also decrease in mean body weight was noted (p=0.0166).
improved in the control group. Most of this improvement was in Improvement in the control group (N=20) was limited to small
female subjects (the control group had a larger percentage of decreases in GHb and body weight at 6 months (P<0.02), which
women than did the experimental group). did not persist at significant levels at 12 months. The Diabetes
Education Society’s Life Skills test revealed that patients in the
Analysis of audiotapes of patient consultation sessions revealed intervention group improved and had significantly greater knowl-
that nurses covered more topics and addressed diet, alcohol use, edge about diabetes than those in the control group post-interven-
smoking, and body weight more often than did physicians. The tion. Results from quality life assessments (i.e., Medical Outcomes
differences were more marked in the experimental group than in Study 36-item, short-form survey; diabetes-related problems ques-
the control group. Experimental group patients were more likely tionnaire) showed no significant intergroup differences.

[28]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
The short-lived clinical improvements in the intervention group were the performance of foot examinations over a 12-month period, with
consistent with those seen with different techniques, as was the a greater improvement in the flow sheet-plus-provider-feedback
lack of difference in quality of life between groups. The cost of the clinic than in the flow sheet-only clinic. There was little change in
program was estimated to be $95 per patient for educational mate- this variable in the control groups. The percentages of patients
rials and teaching salaries only. Thus, the class was considered receiving annual testing for glycosylated hemoglobin, eye examina-
inexpensive as well as easy to administer, well suited to primary tion, and assessment for diabetic nephropathy did not improve sig-
care clinics, and clinically worthwhile. nificantly in either intervention group. These percentages
decreased in the control groups.
Pharmacist-led, primary care-based disease management
improves hemoglobin A1c in high-risk patients with diabetes. In the flow sheet-only clinic, the percentage of patients with poor
Rothman R, Malone R, Bryant B, Horlen C, Pignone M. glycemic control (glycosylated hemoglobin >9.5%) decreased sig-
Am J Med Qual. 2003;18(2):51–8. nificantly, and ADA targets for this variable were met. No other sig-
nificant changes in patient outcomes (lipid profile and blood pres-
The impact of a pharmacist-based diabetes care program was sure) were observed in either intervention group or in the control
evaluated retrospectively in 138 patients with type 2 diabetes and groups.
poor glycemic control (glycosylated hemoglobin 8% or higher). The
intervention involved diabetes education, limited physical examina- Although the impact of the diabetes management flow sheet on
tion (e.g., foot exams), initial treatment recommendations, the use provider compliance with ADA standards and patient outcomes
of medication algorithms, and frequent patient follow-up with the was minimal, providers participating in the study believed that use
support of a computer database. Patient education addressed glu- of the flow sheet plus feedback increased their awareness of dia-
cose control and monitoring, management of hypoglycemia, nutri- betes management guidelines.
tion and exercise, proper foot and eye care, and medication man-
agement. Motivational interviewing to improve adherence to a behav-
ioral weight-control program for older obese women with
After 6 months, a significant reduction in mean glycosylated hemo- NIDDM.
globin was observed. A recent diagnosis of diabetes (within the Smith DE, Heckemeyer CM, Kraty PP, Mason DA.
previous 4 months) and a high baseline glycosylated hemoglobin Diabetes Care. 1997;20:52–4.
value were associated with improvement in glycosylated hemoglo-
bin. Age, race, gender, and educational status did not predict out- The impact of adding motivational interviewing strategies to a
come. behavioral obesity program on treatment adherence, glycemic con-
trol, and weight loss was explored in a randomized pilot study.
Evaluation of a quality improvement intervention for diabetes Twenty-two obese women who were 50 years of age or older and
management. had type 2 diabetes were recruited by advertisements and a patient
Schmidt SO, Burns C, Feller DB, Chang KL, Hernandez B, letter. All patients participated in a 16-session group behavioral
McCarthy J, Burg MA. weight-control program with moderate calorie restriction
J Healthc Qual. 2003;25(3):26–32. (1,200–1,500 kcal/day), fat intake restriction (30–40 g/day),
increased physical activity, and home monitoring of blood glucose.
The impact of two quality improvement interventions on physicians’ Weekly group meetings provided nutritional information and training
diabetes management behaviors was assessed in six outpatient in how to modify eating and exercise behavior. Patients maintained
clinics associated with a university-affiliated family practice depart- and periodically submitted diaries in which calorie consumption and
ment. One intervention was the use of a diabetes management physical activity were noted daily and fasting blood glucose levels
flow sheet to be inserted in the patient chart where it would serve were recorded three times weekly. Patients randomized to the
as a prompt for the health care provider as well as a tool to edu- motivational group also participated in three motivational interview-
cate the provider on American Diabetes Association (ADA) guide- ing sessions (one at the beginning of the study and two during the
Disease Management for Diabetes

lines for treating patients with diabetes (ADA recommended fre- study) conducted by a psychologist experienced in the technique.
quencies for various tests and examinations). The second interven- Motivational interviews assessed the patient’s ambivalence about
tion involved the use of the diabetes management flow sheet plus behavior change, elicited and formulated personal goals, and
quarterly provider feedback on the results of chart audits of per- solved problems that presented barriers to change. Objective data
formance in treating patients (i.e., compliance with ADA recommen- on health and behavior were reviewed with the patient to delineate
dations). One clinic served as the “flow sheet-only” site, another discrepancies between current status and goals. The interviewer
clinic served as the “flow sheet-plus-provider-feedback” site, and used open-ended questions and a reflective listening approach,
the other four clinics served as control sites. avoiding confrontation. Realistic and objective goals were devel-
oped collaboratively with the patient.
Compared with baseline, both interventions significantly improved

[29]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
The motivational group demonstrated significantly better adherence Professional responses to innovative in clinical method: dia-
to the behavioral obesity program than did the standard (control) betes care and negotiating skills.
group. The group session attendance, number of diaries submit- Stott NC, Rees M, Rollnick S, Pill RM, Hackett P.
ted, and blood glucose monitoring frequency were greater in the Patient Educ Couns. 1996 Oct;29(1):67–73.
motivational group. Blood glucose control also was better in the
motivational group than in the standard group; the glycosylated This randomized controlled trial evaluated the responses of family
hemoglobin at the end of the 16-week study was 9.8% in the moti- doctors and nurses to application of an innovative clinical technique
vational group and 10.8% in the standard group. Both groups lost (visual agenda-setting technology) designed to facilitate patient-
a significant amount of weight over the course of the study (on clinician interaction in routine diabetes care and promote patient
average, 5.5 kg in the motivational group and 4.5 kg in the stan- lifestyle changes. Doctors and nurses at 30 family practices identi-
dard group). However, there was no significant difference between fied as being “interested and active in diabetes care” (i.e., recent
the two groups in weight loss, possibly because of the small sam- professional participation in continuing education sessions) were
ple size (16 patients due to attrition). invited to participate. Twenty-nine practices agreed to participate,
and doctors and nurses in these practices were randomly assigned
Telecommunication support for rural women with diabetes. to an experimental group (doctors=16, nurses=18) or a control
Smith L, Weinert C. group (doctors=14, nurses=15). Over the 3-year course of the
Diabetes Educ. 2000 Jul-Aug;26:645–55. study, these professionals provided care to 200 patients with type
2 diabetes within their practices.
Thirty women with diabetes who lived in rural areas far from the
closest source of health care participated in a 10-month random- The intervention began with a visit to each practice to explore how
ized, controlled trial of the use of computer-based telecommunica- the doctor(s) and nurse(s) felt about care of patients with diabetes
tions technology to provide support, information, and education. A and their intra-practice organization of such care. The contents of
control group received usual modes of support and communica- an “Agenda Setting Pack” were then discussed and demonstrated
tion. Subjects in the computer group were not required to be com- in various ways, including role-playing, to members of the interven-
puter literate to participate. The computer software had four com- tion group. This Pack consisted of a visual agenda-setting chart, a
ponents, including conversation among patients (i.e., a support readiness-to-change ruler, a diary, and a balance chart (to weigh
group function), private dialogue between a patient and a nurse or pros and cons of a given change). The former chart appeared as a
between two patients, a “health chat” guided by a certified dia- series of pictures (e.g., food, exercise, cigarettes, medication) with
betes educator with diabetes information, and a bulletin board with the words “To Change or Not To Change” at the top.
postings of pertinent information by the investigators. The comput-
er software compiled data on computer access frequency and Next, each intervention, family practice-based team was encour-
duration. Telephone interviews and mail questionnaires were used aged to negotiate the number of formal training sessions based on
to assess social support, quality of life, psychosocial adaptation to perceived need. All opted for a least two 1.5-hour sessions in
illness (i.e., well-being), and attitudes about the impact of the com- which application of the visual materials to patients, using negotia-
puter intervention. tion and motivational interviewing techniques, was reviewed.
Continuing contact with the members of the experimental group
The average time spent on the computer each month was highest was achieved with bimonthly newsletters, personal contacts, and
the first month (129 minutes) and decreased in subsequent group meetings. In addition, invitations for audio recordings of clini-
months, possibly because of the novelty or the need to learn to use cal consultations were accepted by more than 90% of nurses and
the software during the first month. Quality of life scores were 56% of doctors.
higher for women in both groups who had more education and
improving health. The computer group had slightly better psy- Evaluation via questionnaire halfway through the study (i.e., at 18
chosocial adjustment to illness scores than the control group. months) revealed that 71% of the clinicians frequently used the
Attitudes toward the use of telecommunications technology were Agenda Setting Chart and 22% occasionally used the chart; 6%
Disease Management for Diabetes

positive and 77% of subjects in the computer group recommended reported rare use and one group failed to return the questionnaire.
its use “very highly.” Conversation among patients (i.e., the support Many participants also made selective use of the remaining materi-
group function) was the most frequently used software component. als designed for “the more selective or ambivalent patient.” For
The program provided a great deal of support to 77% of women in example, the diary was used “sometimes” by 55% of the doctors
the computer group. and nurses in the experimental group and “most of the time” by
19%. The readiness-to-change ruler was used sometimes by 42%
and most of the time by 35%. The balance chart was used some-
times by 45% and most of the time by 22%.

Additional evaluation and sharing of experiences occurred at group

[30]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
meetings designed for the experimental group. The first meeting, Development of a primary prevention program: insight
attended by 83% of participating nurses and 56% of participating gained in the Zuni diabetes prevention program.
doctors, was run as a workshop intended to explore use of the Teufel NI, Ritenbaugh CK.
method, identify problems, and share successes. The second Clin Pediatr. 1998;37:131–42.
meeting (7 months later) was a workshop based on a series of
tape-recorded role-plays between a clinician and patient. Diabetes prevention programs are essential in Native American
Evaluations following both meetings confirmed that doctors and communities that are experiencing high rates of non–insulin-
nurses found sharing of experiences in a group useful, and 90% of dependent diabetes. The Zuni Diabetes Prevention program is a
these professionals agreed or strongly agreed that a style of con- community-based primary prevention project designed to reduce
sultation with patients with type 2 diabetes that uses negotiation is the prevalence of diabetes risk factors among high-school-age
helpful. While tape-recorded encounters were used in a number of youths. The size of the population is not specified (it is unclear
cases, a detailed analysis of these events was not included in this how many patients participated for the first 2 years of this 4-year
report. Neither evaluation of the control group nor comparison of study and provided longitudinal data for that period).
parameters between the intervention and control groups was
addressed. The program strives to enhance knowledge of diabetes and to sup-
port increased physical activity, increased fruit and vegetable
Patient education in the management of diabetes mellitus. intake, and reduced soft drink consumption. The primary mecha-
Tan ASL, Yong LS, Wan S, Wong ML. nisms of intervention are diabetes education, school-based well-
Singapore Med J. 1997;38:156–60. ness center supportive social networks, and modification of the
food supply to reduce fat content and consumption of sugary bev-
The effects of a diabetes education program on diabetes knowl- erages and increase fiber content.
edge, dietary practices, medication compliance, self-monitoring of
blood or urine glucose, and glycosylated hemoglobin were assessed There was collaboration between the public school district and uni-
in a controlled study of 278 patients with diabetes who attended a versity department of family and community medicine. Mid-project
primary health care clinic in Singapore. The first 100 patients were results indicate a significant reduction in soft drink consumption
assigned to the control group (five patients eventually dropped out), and an increase in glucose/insulin rations, suggesting a decline in
which received usual treatment and advice on managing diabetes the incidence of hyperinsulinemia. Outcomes measured include
from their physician. Subsequent patients were assigned to the body mass index, dietary intake of fiber and sugary beverages,
intervention group, which participated in a diabetes education pro- heart rate, and fasting and postprandial glucose and insulin levels.
gram. The program consisted of at least six individual or small-
group counseling sessions at which patient booklets on the disease, Within 2 years after the intervention, the consumption of sugary
treatment, handling of emergencies, self-monitoring of blood glu- beverages, body mass index, and heart rate had decreased (a
cose, meal planning, and general health care were reviewed. These decreased heart rate suggests improved cardiovascular fitness) and
sessions were conducted by a nurse trained in counseling tech- dietary fiber intake and glucose-to-insulin ratios had increased (an
niques. Four larger group sessions also were held, with lectures, increase in the glucose-to-insulin ratio suggests a reduced preva-
videotaped presentations, group discussions, and food displays. lence of hyperinsulinemia and risk for type 2 diabetes). Only the
Family members were encouraged to attend these sessions. changes in sugary beverage consumption and insulin levels were
significant but the other changes suggest the adoption of healthy
Compared with baseline, scores on tests of diabetes knowledge behaviors that might reduce the prevalence of risk factors for type
(disease, complications, management, and self-care) were signifi- 2 disease as the study continues.
cantly higher 1 year after the completion of the education program
in both the intervention and control groups. The magnitude of the Early lifestyle intervention in patients with non–insulin-
increase was greater in the intervention group than in the control dependent diabetes mellitus and impaired glucose tolerance.
group. Dietary practices (recommendations to increase fiber intake Uusitupa MIJ.
Disease Management for Diabetes

and decrease intake of calories and fats) improved significantly from Ann Med. 1996;28:445–9.
baseline in the intervention group. There were no significant
changes in the control group. Medication compliance increased A controlled study was conducted in 86 obese Finnish patients
significantly in both groups and was higher in the intervention group recently diagnosed with type 2 diabetes to determine the impact of
than in the control group. There was no significant change in the nonpharmacologic interventions (i.e., diet, exercise) on glycemic
percentage of patients in either group who self-monitored blood or control and cardiovascular risk factors (e.g., serum lipids, blood
urine glucose. Glycosylated hemoglobin decreased significantly pressure). After a 3-month period during which all patients
from baseline in the intervention group. However, the change from received basic education about the disease and dietary advice
baseline in the glycosylated hemoglobin was not significant in the about losing weight and reducing the intake of saturated fat and
control group. cholesterol, patients were randomized to an intervention group or a

[31]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
conventional treatment group. The intervention group made six vis- able to answer patient questions, (3) a special educational program
its to an outpatient clinic at 2-month intervals for intensive therapy focusing on blood glucose monitoring for a subset of patients with
with (1) a restricted dietary intake of calories, total fat (<30%), satu- poor glycemic control, and (4) an integrated care program, includ-
rated fats (<10%), and cholesterol (<300 mg/day), which was moni- ing an educational program with didactic elements and interactive
tored by examining food records and measuring serum lipids and group discussion on basic self-care skills and diabetes pathophysi-
(2) exercise training (30–60 minutes three to four times per week), ology and complications.
which was monitored by analyzing daily exercise records. The
intervention was not based on specific treatment guidelines. Disease knowledge increased in all four programs and was main-
tained at follow-up. The increase in disease knowledge was signifi-
The intervention led to a reduction in intake of saturated fats and cantly greater in programs with an educational component (pro-
calories. Dietary changes in the conventional treatment group were grams 3 and 4) than in those without an educational component
smaller than in the intervention group. The total weight loss from (programs 1 and 2). Similarly, self-care behavior (dietary adher-
the time of diagnosis until the end of the 12-month intervention ence, self-monitoring of blood glucose, physical exercise, and foot
period was greater in the intervention group than in the convention- inspection) was increased in all four programs after 6 months and
al treatment group (6.9 kg versus 3.8 kg, respectively). Weight loss was maintained after 12 months. The increases in self-care behav-
and beneficial changes in metabolic control (fasting blood glucose) ior were significantly greater in the programs with an educational
and lipid profile (e.g., high-density lipoprotein cholesterol, triglyc- component than in those without an educational component.
erides) were observed during the intervention period only in the There was no change in disease perception in any of the programs.
intervention group. There was a trend toward reduced blood pres- Disease knowledge and self-care behavior were positively related
sure in both groups. (i.e., disease knowledge correlated with self-care behavior).

Follow-up assessment 1 year after the completion of the interven- A nurse-coordinated intervention for primary care patients
tion period revealed that glycemic control was maintained by a sig- with non–insulin-dependent diabetes mellitus: impact on
nificantly larger percentage of patients in the intervention group glycemic control and health-related quality of life.
than in the conventional treatment group, although deterioration in Weinberger M, Kirkman MS, Samsa GP, et al.
control was found in both groups. Significantly fewer patients in J Gen Intern Med. 1995;10:59–66.
the intervention group were receiving oral antidiabetic agents than
patients in the conventional treatment group (34.8% versus 12.5%, The impact of nurse-initiated telephone contacts between office
respectively). visits to primary care physicians was evaluated in 275 patients with
type 2 diabetes at a Veteran Affairs general medical clinic (GMC). A
A randomized, controlled study to assess the impact of nonphar- computerized audit identified patients who had ever filled a pre-
macologic interventions (weight reduction, dietary saturated fat scription for insulin or an oral hypoglycemic at the medical center
restriction, and increased physical activity) on the development of pharmacy and had visited the GMC in the preceding year. Patients
type 2 diabetes in patients with impaired glucose tolerance (a con- who met the inclusion criteria (i.e., diagnosis of type 2 diabetes,
dition that often leads to diabetes) is under way at five centers in current use of insulin or oral hypoglycemic agent, receiving regular
Finland. Preliminary results after 1 year of data collection in the care at GMC, telephone access) were invited to participate via let-
5- or 6-year study suggest a weight loss and improvement in glu- ter, phone, or clinic visit. Following baseline data collection,
cose tolerance in only the intervention group. patients were randomly assigned to three intervention groups (fol-
lowed by three study nurses) or a control group.
Education integrated into structured general practice care
for type 2 diabetic patients results in sustained improvement Patients in the intervention group received monthly (or more fre-
of disease knowledge and self-care. quent) phone calls from the study nurses intended to provide edu-
van den Arend IJ, Stolk RP, Rutten GE, Schrijvers GJ. cation, facilitate and reinforce compliance, monitor health status,
Diabet Med. 2000 Mar;17(3):190–7. facilitate resolution of identified problems, and facilitate access to
Disease Management for Diabetes

primary care; patients were also encouraged to contact study


The effects of four structured programs for diabetes care with and nurses should questions arise. Patients in the control group
without integrated education on disease knowledge, self-care received usual care (i.e., physician visit every 3–4 months), with no
behavior (dietary adherence, self-monitoring of blood glucose, systematic provider-initiated education, monitoring of health status,
physical exercise, and foot inspection), and disease perception or telephone reminders between clinic visits.
were assessed in 243 patients with type 2 diabetes after 6 months
(i.e., after the program) and after 12 months (i.e., at follow-up to Baseline sociodemographic, clinical, and health-related quality of
ascertain whether effects were lasting). The programs included life (HRQOL) data were similar between groups. During the study,
(1) care guided by protocol, with oral and written patient informa- 2,399 nurse-patient telephone contacts were made, with only 162
tion, (2) care with computerized support and a diabetes nurse avail- (6.8%) initiated by the patients. The mean number of contacts per

[32]
Appendix B.
Reports of the Impact of Disease Management Interventions
on Treatment of Diabetes (continued)
intervention patient was 13, and advice was provided to the patient Lifestyle intervention in overweight individuals with a family
in 57% of phone contacts. One-year follow-up data, available for history of diabetes.
151 of the 275 randomized patients, revealed significant intergroup Wing RR, Venditti E, Jakicic JM, Polley BA, Lang W.
differences with respect to both fasting blood sugar (FBS) and gly- Diabetes Care. 1998;21:350–9.
cosylated hemoglobin (GHb)(p<0.05), which favored the interven-
tion group. However, no statistically significant intergroup differ- The effect of diet, exercise, or a combination of diet and exercise
ences existed for scores on the Medical Outcomes Study 36-item, on body weight, risk factors for cardiovascular disease (lipid profile,
short-form survey (used to assess HRQOL) or patient-reported blood pressure), and the development of type 2 diabetes was
diabetes-related signs and symptoms. Thus, between-office nurse- assessed in a 2-year controlled study of 154 non-diabetic individu-
initiated telephone contacts, designed to serve as pragmatic, als at risk for the disease because of overweight and a parent with
low-intensity adjuncts to physician-administered care, modestly diabetes. Subjects were recruited through newspaper advertise-
improved glycemic control, but not HRQOL or diabetes-related ments. Subjects randomized to the control group received a self-
signs and symptoms, in patients with type 2 diabetes. help manual with information about healthy eating, exercise, and
behavioral strategies for weight control. Subjects randomized to
Telemedicine improved diabetic management. the diet, exercise, and diet plus exercise groups attended weekly
Whitlock WL, Brown A, Moore K, Pavliscsak H, Dingbaum A, group sessions for the first 6 months of the study, biweekly ses-
Lacefield D, Buker K, Xenakis S. sions for the next 6 months, and two 6-week refresher courses
Mil Med. 2000 Aug;165(8):579–84. during the second year of the study. These sessions were con-
ducted by a multidisciplinary team of health care providers, includ-
The effects of weekly home telemedicine visits by a nurse case ing registered dietitians, exercise physiologists, and behavior thera-
manager to review blood glucose levels, body weight, blood pres- pists. In the diet group, calorie intake was severely restricted
sure, hypoglycemic episodes, exercise and nutrition goals, and (800–1,000 kcal/day with 20% of calories as fat) for the first 8
well-being were assessed in a 3-month randomized, controlled weeks of the study and relaxed thereafter (1,200–1,500 kcal/day).
study of 28 adult patients with type 2 diabetes. A glycosylated Meal plans and shopping lists were provided. The exercise group
hemoglobin A1c level greater than 8% was an eligibility criterion. was encouraged to gradually increase physical activity to 1,500
The nurse case manager maintained frequent contact with the kcal/week. Supervised exercise was performed at weekly sessions
patients’ physician by electronic mail, and the physician made for 10 weeks.
monthly home telemedicine visits to evaluate the patients. A con-
trol group received routine diabetes care. Both the telemedicine Weight loss and improvement in fasting glucose and insulin, lipid
group and the control group were encouraged to participate in mul- parameters, and blood pressure over the first 6 months of the
tidisciplinary diabetes education classes held at a medical center. study were significantly greater in the diet group and diet plus exer-
cise group than in the exercise group and control group. However,
After 3 months, there was a significant reduction in glycosylated attendance at group sessions decreased during the second 6
hemoglobin A1c in the telemedicine group (from a mean of 9.5% to months of the study and some of the weight loss was regained in
8.2%) but not in the control group. Similarly, a significant reduction all groups. After 1 year, the diet group and diet plus exercise group
in total body weight was observed over the course of the study in had maintained 60% and 72% of the weight loss, respectively.
the telemedicine group (from a mean of 214 to 207 pounds) but These two groups had significantly greater weight loss than the
not in the control group. Triglyceride levels decreased in the exercise group and control group. By the end of the 2-year study,
telemedicine group and low-density lipoprotein levels increased in the lipid profile and blood pressure had returned to baseline levels
the control group but other lipid values did not change significantly. and glycemic control had worsened in all groups. Type 2 diabetes
There was no change in quality of life in either group. The nurse had developed in 17% of subjects. Weight loss over the 2-year
case manager’s and physician’s subjective impression of the useful- study period and impaired glucose tolerance at baseline were pre-
ness of telemedicine was favorable but the use of the technology dictors of type 2 diabetes. A modest weight loss (4.5 kg) reduced
was hampered by technical difficulties. the risk of type 2 diabetes by 30% (compared with no weight loss),
Disease Management for Diabetes

even in subjects with impaired glucose tolerance at baseline.

[33]
Appendix C.
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Adams CE, Two home Home health care Completing American Registered Diabetes nurse
Cook DL, 1994 health care agencies were needs Diabetes nurses (45 at educator
agencies, one selected at the assessments Association, the agency with
with a diabetes convenience of for both patients American a diabetes
nurse educator the researcher. and staff; Association of nurse educator
and the other developing Diabetes and 17 at the
without a nursing Educators, and agency without
diabetes nurse standards federal and state an educator)
educator of care, staff regulations
education governing home
programs, and health care
specific methods
for implementing
and evaluating
care; designing
diabetes self-care
content that is
user friendly;
and providing
ongoing support
for staff nurses

Amoah AG, Patients with Not specified Intensive training No established Health care Core team
Owusu SK, diabetes in a of two core teams guidelines were providers at
et al., 2000 developing comprising a available. regional and
country with a physician, a nurse, subregional
population of and a dietitian in hospitals and
18 million, a multidisciplinary facilities and
85% of whom approach to patients with
are less than diabetes care diabetes
45 years old, and education,
served by 2 who subsequently
teaching developed a
hospitals, 9 patient education
regional booklet and a
hospitals, and professional
100 sub- diabetes
regional education
hospitals and curriculum for
health care training health
facilities care providers at
Disease Management for Diabetes

regional and sub-


regional facilities

RCT=randomized controlled trial

[34]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Patient’s basic Not applicable Correlational None Home health Registered nurses at a
knowledge and (outcomes research design care agencies home health care agency
patient care provided a (nonexperimental with a diabetes nurse
score on a snapshot of the design) educator scored
list of 33 items status of the two significantly higher on a
addressing home health care test of basic diabetes
patient admission, agencies, and the knowledge than nurses
care plan, ongoing length of time that at a home health care
care (assessment, the diabetes nurse agency without a
patient education, educator was diabetes nurse educator.
nursing care present at the one The standard of patient
treatments, and home health care provided by the
evaluation), and care agency home health care
discharge was not specified) agency with the
diabetes nurse educator
was significantly higher
than that provided by
the other agency.

Training of health 3 years Not randomized None Hospital-based After 3 years, trained
care providers or controlled clinics diabetes health care teams
and provision of were in place and diabetes
diabetes services services were provided in
all regional and about
63% of subregional
hospitals. The number of
patients with diabetes
registered before the
program was 4,719 and
after the program, it was
13,643.
Disease Management for Diabetes

[35]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Anderson RM, 1,863 patients Recruited from Newsletter with Not specified Patients with Not specified
Fitzgerald JT, with type 1 or physician offices, readable, concise, type 1 or 2
et al., 1994 2 diabetes in pharmacies, clinic action-oriented diabetes
Michigan waiting rooms, and information about
diabetes patient diabetes and
education encouragement to
programs; patients become assertive
were asked to consumers of
return a postage- diabetes care
paid postcard who are prepared
if they wished to to interact with
receive a free physicians,
monthly newsletter nurses, and
about diabetes dietitians

Anderson RM, 23 diabetes Volunteers 3-day simulated Not specified Diabetes Not specified
Funnell MM, et al., educators (20 responding to diabetes care educators
1991 nurses, 2 mailed flyer regimen (two daily
dietitians, 1 saline injections,
“other”) self-monitoring
of blood glucose
four times daily,
1,200 kcal diet,
daily foot care
and aerobic
exercise, and
extensive record
keeping) followed
by a 3-day
intensive skills-
based workshop,
using a four-phase
learning sequence
with information
on educational and
counseling skills,
demonstration of
counseling skills,
videotaped
small-group
practice in
Disease Management for Diabetes

counseling, and
review of
videotapes

Anon, 2003 105 patients Not specified Family-focused Not specified Teenagers College graduates
(Dis Manag Advis. 8–17 years teamwork without health
2003;9:120–122) of age care background

RCT=randomized controlled trial

[36]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Overall response to 2 years (21 Nonrandomized None Community The newsletters were most
newsletters (patient newsletters) (patients were helpful to patients with
ratings of whether at home) type 2 diabetes who were
the newsletters elderly or in poor overall
were helpful) and health or who had
specific reactions complications, low incomes,
to individual or a poor understanding of
issues (i.e., topics) diabetes. The likelihood of
of newsletter change in diabetes care in
(whether and with response to newsletters
whom issue was was low in all patients.
discussed and
whether change
was made)

Diabetes educators’ 6 days Not randomized None Not applicable Counseling skills and
counseling skills, or controlled attitudes toward patient
attitudes toward autonomy improved
patient autonomy, significantly as a result of
and need for the intervention.
special training for
diabetes educators

Disease Management for Diabetes

Glycemic control 1 year RCT None Home Glycemic control was


significantly better in the
intervention group than the
usual care group.

[37]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Anon, 2003 (Hosp 58,000 patients Not specified Care Not specified Patients, staff Lead diabetic educator
Case Manag. with diabetes standardization, or coordinator
2003;11(7):103–104) patient and
staff education

Arsenau DL, 40 patients Patients attending An individualized American Diabetes Patients with Registered dietitians,
Mason AC, et al., with diabetes a diabetes method of learning Association and diabetes nutrition specialist,
1994 education program instead of American Dietetic and education
were asked to classroom Association specialist reviewed
participate. instruction content and design
of individualized
learning programs
from existing
sources.

Aubert RE, 17 patients Group-model Nurse case Not specified Patients with Registered nurse
Herman WH, with type 1 HMO pharmacy management diabetes who was a certified
et al., 1998 diabetes and records and a using written diabetes educator
121 patients database of algorithms under
with type 2 patients who had the direction of a
disease visited a physician family physician
for diabetes care, and
been hospitalized endocrinologist
for diabetes, been (close patient
seen by a utilization monitoring,
management nurse, continuous
or been referred to reinforcement of
an ophthalmologist dietary and
for a diabetic retinal exercise
examination recommendations,
and systematic
drug therapy
adjustments by
a nurse case
manager)
Disease Management for Diabetes

RCT=randomized controlled trial

[38]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Glycosylated 6 months Non-randomized Hourly clinic Health system The average glycosylated
hemoglobin operational costs (clinic) hemoglobin decreased from
decreased by 20%. 9.2% to 7.0%.

Fasting plasma 5 months RCT Individualized Hospital-based The individualized method


glucose, glycosylated learning was judged diabetes center of education was as
hemoglobin, cost-effective. (presumably effective as traditional
percentage of ideal clinic) classroom instruction in
body weight, educating patients with
knowledge, and diabetes and may be more
behavior scores cost-effective but the
individualized method did
not improve glycemic
control.

Glycosylated 12 months RCT None Primary care Glycemic control improved


hemoglobin, clinics in a to a significantly greater
fasting blood group-model extent with nurse case
glucose levels, HMO management than with
medication usual care.
requirements, body
weight, blood
pressure, serum
cholesterol and
triglyceride levels,
self-rated health
status, episodes of
severe hypoglycemia,
emergency
department visits,
and hospital
admissions

Disease Management for Diabetes

[39]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Baker SB, 4,300 patients Not specified Development and American Diabetes Patients with Physicians, physician
Vallbona C, with diabetes implementation Association, diabetes and assistants, nurses,
et al., 1993 of protocols for National health care diabetes nurse
prevention and Cholesterol professionals educator, nutritionists,
care of diabetes- Education social workers,
related Program podiatrists
complications,
general
management of
diabetes, education
of patients and
professionals

Barth R, 62 participants Patients were Conventional Programs were Patients with Not specified
Campbell LV, recruited through program: Diabetes designed by the type 2 diabetic
et al., 1990 an extensive radio education, current standards patients, (age
and newspaper lectures on foot of practice in >30 years,
campaign, from care, footwear, Australia overweight)
referrals by general and dealing with (unclear if there
practitioners and extreme were actual
from people temperatures. guidelines).
attending the
Diabetes Center, Intensive program:
St. Vincent’s In addition to
Hospital, and other diabetes education,
diabetes centers in foot care
Sydney, Australia information and
demonstrations
were given.

Bernbaum M, 163 visually Participants were Adaptive diabetes Not specified Patients with Diabetes educators
Wittry S, et al., impaired referred but method education program type 1 or
2000 patients with not specified. with adaptive 2 diabetes
Disease Management for Diabetes

type 1 or equipment (e.g.,


type 2 diabetes syringe magnifiers,
syringe loading
devices, glucose
monitoring systems
with speech
capability, and
tactile aids for
proper blood
sample placement)
RCT=randomized controlled trial

[40]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Blood glucose level, 5+ years (study Retrospective chart Costs of 12 months Community health Preliminary results suggest
body weight, is ongoing) reviews (not of treatment for centers in urban that screening and
prevalence of randomized or diabetic eye low-income preventive treatment for
uncontrolled controlled) disease (benefits neighborhoods diabetic eye disease is
hypertension, number and benefit-to-cost cost-effective. The
of patients receiving ratio were percentage of patients with
eye examinations, projected) eye examinations
incidence of legal increased and the
blindness, number of incidence of legal blindness
patients receiving foot decreased. Foot
examinations, patient examinations and blood
knowledge, pressure control both
appropriateness of improved, although body
prescribing, physician weight and blood glucose
proficiency in control have not improved.
assessing visual Patient knowledge and
impairment physician accuracy in eye
examinations both
increased.

Routine follow-up 6 months Experimental design Implementation of Diabetes Center The intensive group
visits to the podiatrist with 2 samples the intensive and Garvan showed greater
(other than project program is more Institute of Medical improvements than the
podiatrist), foot care costly than the Research, St. conventional group in
knowledge, and conventional Vincent’s Hospital, foot care knowledge,
routine foot care program because Sydney, Australia compliance with the
compliance the intensive group recommended foot care
requires more routine, and compliance
manpower per with the initial advice to
person. consult a podiatrist for
further treatment. The
intensive group also
showed a significant
reduction in the number of
foot problems that required
treatment compared to the
conventional group.

Demonstration of 10 years Not randomized or None University-based The success rate in


proficient self-care controlled hospital clinic restoring diabetes self-care
technique practices was 72% overall,
Disease Management for Diabetes

including 81% in patients


with early visual
impairment (legal
blindness with some
residual functional vision)
and 57% in patients with
late visual impairment
(legal blindness with some
residual functional vision).

[41]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Birke JA, >14,000 Not specified Disease American Diabetes Patients Not specified
Horswell R, et al., patients management Association (multidisciplinary)
2003 initiative (DMI) with
or without staged
management
diabetes foot
program (DFP)

Bloomgarden ZT, 266 diabetic Clinic roster was Nine monthly Not specified Patients Not specified
Karmally W, patients used to identify all education sessions
et al., 1987 insulin-treated (audiovisual
clinic patients who materials, card
were contacted by games) reviewing
telephone to diabetes
establish an physiology; foot,
appointment skin, and dental
for interview hygiene; insulin
administration and
emergencies;
complications and
risk factors; and
nutrition. Separate
sessions and
audiovisual
materials in
Spanish were
available for
Hispanic
participants.

Bott U, Bott S, 83 patients with Patients were 5-day inpatient Not specified Patients with Educators and
et al., 2000 type 1 diabetes referred because small-group type 1 diabetes others not specified
of inability to educational
achieve therapeutic sessions (20
goals for glycemic hours) on insulin
control or quality of therapy,
life on an outpatient hypoglycemia, diet,
basis (e.g., frequent psychosocial
Disease Management for Diabetes

hypoglycemic problems, and


events, other patient-
motivational specific concerns
problems, need
for diabetes
knowledge
refresher, need for
greater flexibility in
insulin treatment
regimen)
RCT=randomized controlled trial

[42]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Diabetes foot-related 2 years Retrospective, None Hospital The hospitalization rate was
hospitalizations and nonrandomized reduced by both the DMI
lower extremity alone and DMI + DFP but
amputations the reduction was greater
with the combination. DMI
alone and DMI + DFP both
reduced amputation rates;
there was no difference in
the reduction between the
two groups.

Glycosolated 1.6 years in RCT None Large diabetes A traditional diabetes


hemoglobin levels, education group; clinic in a patient education program
fasting blood 1.5 years in metropolitan failed to significantly
glucose, weight, control group teaching hospital change glycosolated
lipid levels, hemoglobin levels, fasting
development of foot blood glucose levels, lipid
lesions, control of levels, body weight, foot
hypertension, use of lesion scores, and use of
medical care, medical care in a clinic
knowledge of diabetes population of insulin-treated
and behavior diabetics. While knowledge
of diabetes and behavior
was improved in program
graduates, the authors
concluded that patient
education may not be an
efficacious therapeutic
intervention in most adults
with type 2 diabetes.

Glycosylated Follow-up after a Not randomized or Days of Hospital There was no change from
hemoglobin levels, mean of 17.5 controlled hospitalization and baseline in the mean
incidence of severe months (range sick leave glycosylated hemoglobin at
hypoglycemia (need 9–31 months) follow-up but there was a
for glucose i.v. or significant decrease in the
glucagon injection), incidence of severe
days of hospitalization hypoglycemia. The number
and sick leave of sick leave days per
Disease Management for Diabetes

patient/year decreased
significantly from 17.0 at
baseline to 7.7 at follow-up.

[43]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Brown SA, 353 Mexican Random selection Eight weekly Curriculum Mexican American Clinical nurse specialist,
Hanis CL, 1995 American of seven Mexican 2-hour guide from patients with registered dietitian,
patients with American subjects culturally sensitive American diabetes and a and community
type 2 diabetes with diabetes from diabetes education Association of family member or lay worker, all of
a cohort of 353 sessions Diabetes Educators friend for support whom were
patients who had (videotape Mexican American
been followed in presentations,
another study for discussions,
12 years demonstrations,
visit to a grocery
store) and one
2-hour support
group session
conducted in
Spanish
language

Cabrera-Pivaral CE, 49 patients with Not specified Behavior-modifying Not specified Patients with Not specified
Gonzalez-Perez G, type 2 diabetes intervention (basic type 2 diabetes
et al., 2000 not using insulin and applied not using insulin
nutrition concepts
with workshops,
teamwork, and
discussions)

Canga N, 280 patients Review of clinical A nurse-led, face- Protocols Patients with type A nurse trained
De Irala J, with type 1 or records and to-face, individually established in 1 or 2 diabetes in smoking
et al., 2000 2 diabetes contact by structured How to Help Your cessation
registered at telephone or intervention to Patients Stop counseling
2 urban written help smokers quit Smoking: A
hospitals and correspondence smoking, optional National Cancer
15 urban transdermal Institute Manual
primary care nicotine for Physicians
centers replacement
therapy, and
follow-up support
program
Disease Management for Diabetes

RCT=randomized controlled trial

[44]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Knowledge of 9 weeks in 1992 Pilot study of randomly None County agricultural Glycosylated hemoglobin
diabetes, health or 1993 with selected subjects extension office and fasting blood glucose
behaviors, body follow-up (no control group) in a rural levels and knowledge of
weight, metabolic 3 months later community diabetes self-management
control were significantly improved
3 months after the
intervention.

Serum glucose, 9 months RCT None Not specified Significant reductions in


total cholesterol, and serum glucose, total
triglyceride levels cholesterol, and
triglyceride levels occurred
in the experimental group
over the course of the
study. No significant
changes occurred in the
control group.

Success in smoking 6 months RCT None Hospitals and The incidence of smoking
cessation (with primary care cessation was 17.0% in the
biochemical validation centers intervention group and
of urine cotinine 2.3% in the control group.
concentrations) or In subjects who failed to
reduction in quit, the mean number of
number of cigarettes smoked daily
cigarettes smoked decreased significantly in
daily both groups but the
reduction was greater in the
intervention group than in
the control group.
Disease Management for Diabetes

[45]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Carlson A, A 20% sample Diabetic patient Continuing Not specified Health care Health care
Rosenqvist U, (N=806 patients) registry at each medical education providers and
1991 selected center courses for health patients with
randomly from care providers diabetes
4,492 patients and organizational
with diabetes change
who visited 34
primary health
care centers in
the past year in
Sweden

Clancy DE, 120 patients Electronic medical Group visits with American Diabetes Patients Primary care
Brown SB, with poorly records search and presentations, Association (ADA) internal medicine
et al., 2003 controlled telephone or on-site questions and physician and
type 2 diabetes solicitation answers, and diabetes nurse
individual care educator

Coast-Senior EA, 23 patients with Referral by primary Patient education, Goals for glycemic Patients with Pharmacists
Kroner BA, type 2 diabetes care providers medication control were in type 2 diabetes
et al., 1998 who require because of counseling, accordance with referred to a
insulin therapy inadequate monitoring, insulin American Diabetes pharmacist by
glycemic control initiation or Association primary care
adjustment standards providers to
improve glycemic
control
Disease Management for Diabetes

RCT=randomized controlled trial

[46]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Organization 18 months RCT (centers, not None Not specified The intervention improved
providers variables (nurse individual patients, quality of care and
involvement, were randomized) with self-monitoring of blood
resources, multivariate analysis glucose but it did not
competence), by multiple regression improve metabolic
performance of to identify factors control.
routine measurements contributing to
(glycosylated variance in selected
hemoglobin, eye organization, process,
examination), patient and outcome variables
access to and
continuity of care,
patient education,
dietary knowledge,
self-monitoring of
blood glucose,
metabolic control,
patient-rated quality
of care

Glycemic control, 6 months RCT None Clinic Glycemic control and lipids
lipid profiles, trust in improved in both groups.
physician, patient Trust in physician, patient
satisfaction with care, satisfaction, and
compliance with ADA compliance with process
process of care indicators were greater in
indicators the intervention group than
in the control group.

Glycemic control Up to 45 weeks Not randomized None Two primary care Pharmacists’ efforts as part
(glycosylated or controlled clinics at a of a multidisciplinary team
hemoglobin, fasting university-affiliated improved glycemic control
blood glucose and Veterans Affairs significantly in patients with
random blood medical center type 2 diabetes who require
glucose levels), insulin.
symptomatic
hypoglycemic
episodes, emergency
department visits,
hospitalizations
Disease Management for Diabetes

[47]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Diabetes Control 1,441 patients Not specified Intensive therapy Not specified Patients with Physicians
and Complications with type 1 with an external type 1 diabetes
Trial Research Group. diabetes insulin pump or
The effect of intensive three or more
treatment of diabetes daily insulin
on the development injections and
and progression of frequent blood
long-term glucose monitoring
complications in (versus
insulin-dependent conventional
diabetes mellitus, therapy with one
1993 or two daily insulin
injections)

Domurat ES, 1999 30% of HMO HMO members Use of Diabetes American Diabetes Patients with Team of health
members with Care System Association diabetes care professionals
diabetes (DCS), a
(2,617 patients) computer-
supported
diabetes care
management
program

Edlin M, 2003 3,118 of 6,799 Patient self-referral Promotion of Health Plan Physicians and Nurse educators
health plan or physician referral guideline use by Employer Data and patients
enrollees with physicians, 1–4 Information Set
diabetes annual patient measures
visits, and patient
education on
self-management
techniques and
preventive care
Disease Management for Diabetes

RCT=randomized controlled trial

[48]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Glycosylated 6.5 years (average) Multicenter, RCT None Not specified Intensive therapy delays
hemoglobin and blood (presumably at the onset and slows the
glucose levels, eye home with progression of retinopathy,
examinations for intermittent clinic nephropathy, and
retinopathy, urinary visits) neuropathy in patients with
albumin excretion for type 1 diabetes.
nephropathy, clinical
neurologic
examination for
neuropathy; low-
density lipoprotein
cholesterol,
cardiovascular and
peripheral vascular
events

Glycosylated 3 years Pre-post comparison None California HMO Screening rates for
hemoglobin, blood glycosylated hemoglobin,
pressure, urinary urinary protein, and serum
protein, and lipids were significantly
serum lipids higher in the 2,617 patients
managed by DCS
compared with the 5,993
patients receiving usual
care. The rate of follow-up
testing in patients with an
elevated glycosylated
hemoglobin was
significantly higher in the
DCS patients than in the
usual care patients.

Glycosylated 24 months Chart review $1,300 per member Home, clinic, and Participants had higher
hemoglobin testing, or total of $4 million hospital rates of testing, screening,
lipid screening, eye saved annually, and eye exams; better
exams, kidney which more than glycemic control; and fewer
screening; glycemic offsets program cost emergency department
control, health care of $1.8 million visits and inpatient days
utilization than nonparticipants.
Disease Management for Diabetes

[49]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Engelgau MM, 4,400 Not specified Health promotion Not specified Community in Not specified
Narayan KM, households in initiatives (e.g., southeast section (collaborative effort
et al., 1998 each of two walking programs, of Raleigh, N.C., involving community
communities publication of with large African leaders, health care
(one with large articles on low-fat American providers, Centers
population of diets); outreach population for Disease
African efforts to increase Control and
Americans at awareness of Prevention)
high risk and diabetes risk
the other as factors, screening
a control) for undiagnosed
diabetes, and
tracking of
previously
diagnosed
patients; self-
management
workshops and
medical record
reviews and other
efforts involving
primary care
providers to
improve quality of
diabetes care

Gilden JL, 32 elderly Not specified 18 monthly Not specified Patients Social workers
Hendryx MS, (average age support group
et al., 1992 68 yrs) male sessions with
patients with continuing
diabetes at a education, coping
Veterans skills training,
Affairs group discussions,
medical center and structured
social activities

Ginn M, 754 patients Not specified Community-based Not specified Patients with Case managers
Frate DA, with diabetes, case management diabetes, hired from the
et al., 1999 hypertension, (client assessment, hypertension, or local community
or both care plan both and trained in
Disease Management for Diabetes

development, methods for


implementation, educating and
client service managing patients
monitoring, and
periodic
assessment)

RCT=randomized controlled trial

[50]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Patient participation Pilot study was Process and outcome None Community Provided only for
in programs, conducted in 1993 measures assessed (presumably clinic) pilot study in which 902
screening rates, (duration primarily by individuals participated
changes in diabetes unspecified); questionnaire (45% African American);
practice, glycosylated Project DIRECT half of African Americans
hemoglobin will take 5 years. were physically inactive and
concentration (i.e., half were overweight;
long-term blood African Americans had a
glucose control), higher prevalence of
patient knowledge diagnosed and
and skills undiagnosed diabetes and
were more likely to smoke
and have uncontrolled
hypertension and less
likely to have single health
care providers than
members of other races;
all diabetic patients had a
low level of preventive care
(eye and foot exams).

Diabetes knowledge, 2 years Partially None Clinic Diabetes


psychosocial factors randomized knowledge and
(self-care-related and controlled quality of life
quality of life, were better in
stress, family patients who
involvement in care, attended support
and social group sessions
involvement), than in patients
depression, and who did not.
glycemic control

Knowledge of 24 months Uncontrolled None 12 ambulatory Knowledge about diabetes


hypertension and longitudinal study clinics and one and hypertension,
diabetes, self- hospital in rural self-reported health status,
reported health Mississippi and blood pressure control
Disease Management for Diabetes

status, blood increased significantly.


pressure control Blood glucose control also
status, diabetes increased, although the
control status difference from baseline
was not significant.

[51]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Glasgow RE, Approximately Letter about study Computer-assisted Not specified Patients with An endocrinologist
Toobert DJ, 200 adult with informed and interactive diabetes and internist who
et al., 1995 patients with consent video procedures specializes in
type 1 or 2 statement sent that assess diabetes
diabetes who to patients who patient views and
are at least have diabetes behaviors related
40 years of and a scheduled to diabetes
age (data for appointment at care and self-
the initial 95 an office-based management;
are presented practice, followed assistance for
in this article) by a phone call patients in
from investigator setting dietary
goals and problem-
solving strategies;
follow-up phone
contact and office
visits for support

Glasgow RE, 206 adult Letter about study Computer-assisted Diet chosen as Patients with An endocrinologist
Toobert DJ, et al., diabetic with informed and interactive focus because is diabetes and internist who
1996 patients consent statement video procedures an objective of specializes in
sent to patients that assess Healthy People diabetes
who have diabetes patient views and 2010
and a scheduled behaviors related
appointment at to diabetes care
an office-based and self-
practice, followed management;
by a phone call assistance for
from investigator patients in setting
dietary goals and
problem-solving
strategies;
follow-up phone
contact and office
visits for support
Disease Management for Diabetes

RCT=randomized controlled trial

[52]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Weight, eating Not specified RCT None Physicians’ Baseline data from only
patterns (fat content), offices initial visit and 1- and
serum cholesterol, 3-week follow-up phone
and glycemic calls for 51 of initial 95
control patients reveal that 90% of
(glycosylated those randomized to
hemoglobin) intervention achieved
dietary goals at 1-week
follow-up and 96% did so at
3-week follow-up.

Weight, eating 12 months RCT None Physicians’ The intervention produced


patterns (fat content), offices greater improvement than
serum cholesterol, usual care in a number of
and glycemic control measures of dietary
(glycosylated behavior (e.g., fewer
hemoglobin) calories from saturated fat,
fewer high-fat eating habits
and behaviors) at the
3-month follow-up. There
were also significant
differences favoring
intervention in changes in
serum cholesterol levels
and patient satisfaction but
not in glycosolated
hemoglobin. The
intervention effects were
relatively robust across a
variety of patient
characteristics, the two
participating physicians,
and intervention staff
members.
Disease Management for Diabetes

[53]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Glasgow RE, 320 adult Letter about Behavioral dietary Not specified Patients with type A nurse/certified
Toobert DJ, 2000 patients with project sent by intervention 2 diabetes diabetes educator,
type 2 diabetes primary care (dietary goal registered dietitian,
providers to setting) with or doctoral-level
patients, followed without diabetes psychologist, and
by a phone call self-management an education
from investigator support: major
(1) follow-up
telephone calls
and (2) community
resources
enhancement (e.g.,
newsletters,
information on
dining out and
shopping)

Grey M, 77 adolescents Not specified Coping (problem Not Patients with A master’s prepared
Boland EA, with type 1 (selected from a solving) and skills guideline-based diabetes nurse practitioner
et al., 1999 diabetes who university-based training (four to with experience
were beginning pediatric diabetes eight 1- to in pediatric
intensive service) 1.5-hour weekly psychiatry and
insulin therapy small-group diabetes
sessions followed
by monthly
sessions using
role-playing in
various social
situations)

Halbert RJ, 19,523 diabetic Reviewed claims Mailed patient Current ADA Physicians were Physicians
Nichol JM, members of and pharmacy reminders for guidelines sent a letter
et al.,1999 an HMO databases to screening sent to explaining the
identify all examinations; also physicians program that
diabetic members provided reports included current
of HMO ≥18 years of patient DRE guidelines
Disease Management for Diabetes

as well as their status to patients


diabetic retinal and treating
examination physicians,
(DRE) status educational
materials to
patients, and
current American
Diabetes
Association retinal
examination
RCT=randomized controlled trial guidelines to
treating physicians

[54]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Reach (percentage 6 months RCT None Clinic Seventy-six percent


of eligible patients of eligible patients and
participating), 40 of 42 primary care
adoption (willingness physicians agreed to
of primary care participate. On average,
physicians to there was a 50% reduction
participate), patient in dietary fat intake.
behavior (e.g., fat However, there were small
intake), physiologic reductions in glycosylated
measures hemoglobin and the ratio of
(glycosylated total cholesterol to
hemoglobin, lipids), high-density lipoprotein
illness-related cholesterol that were not
quality of life significant. There was
relatively little change in
illness-related quality of life.
Follow-up phone calls and
community resources
enhancement did not add
to efficacy of the behavioral
intervention.

Metabolic control, 6 months RCT (health care None Admitted for After 6 months, coping and
self-efficacy providers blinded to 1 day to skills training (CST)
(personal study group university-based improved metabolic
competence, assignment) research center control and quality of life
power, to obtain baseline in adolescents with type 1
resourcefulness), data and review diabetes who were
impact of diabetes treatment goals initiating intensive insulin
on quality of life, and methods therapy. CST did not
worries about affect the rate of severe
diabetes, rate of hypoglycemic episodes.
severe hypoglycemic
episodes

Diabetic retinal 7 months pre- and RCT (no Analysis of direct HMO Rates of DRE were higher
examination (DRE) 1 year post- nonintervention control costs of reminders in the multiple intervention
intervention group, but single (only printing and group than the single
intervention treated postage) in multiple intervention group after a
as control group) reminders group second patient reminder,
showed incremental but significant intergroup
Disease Management for Diabetes

cost of $80 per differences did not exist


additional eye following subsequent
examination. reminders. Financial
resources for multiple
patient reminders for DRE
may be better spent on
alternative approaches for
reducing complications of
diabetes.

[55]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Hawkins DW, 1,722 patients Not specified, Management of Not guideline Patients Clinical pharmacist
Fiedler FP, with diabetes, but included all patients by based (PharmD with
et al., 1979 hypertension, patients enrolled pharmacists (with 2 years of clinical
or both in a hospital-based physician training in
medical follow-up supervision) general medicine)
clinic compared with
physician
management

Ho M, 112 medical Randomly selected Comparison is American Patients with Specialists (faculty
Marger J, records for from computerized between a Diabetes diabetes diabetologists,
et al., 1997 diabetes medication profiles general medicine Association endocrine fellows,
patients and clinic clinic staffed by guidelines medical residents,
is the sample enrollment list generalists diabetic nurse
size in a (faculty educator, podiatrist,
population of internists, and optometrist)
35,000 patients, medical fellows, at diabetes
not necessarily medical residents, mellitus clinic
with diabetes and nurse
practitioners) and
a diabetes mellitus
clinic staffed by
specialists (faculty
diabetologists,
endocrine fellows,
medical residents,
diabetic nurse
educator, podiatrist,
and optometrist)
Disease Management for Diabetes

RCT=randomized controlled trial

[56]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Kept-clinic- 29 months RCT None Clinic Care provided by the


appointment rate, clinical pharmacist and
medication care provided by the
compliance rate, physician were equivalent
emergency in controlling blood glucose
department visits, and diastolic blood
hospital admissions, pressure. The kept-clinic-
blood pressure and appointment rate was
fasting blood glucose higher and the clinic
measurements dropout rate was lower in
the experimental group
(pharmacist-managed care)
compared with the control
group (physician-managed
care), suggesting greater
patient satisfaction with
care provided by the clinical
pharmacist.

Compliance with 2 years Retrospective chart None University- Quality of care at a


process-of-care review affiliated Veterans diabetes specialty clinic
criteria and a subset Affairs was better than at a
of minimally medical center, general medicine clinic.
acceptable criteria general medical
chosen because of clinic, and
a strong link with diabetes mellitus
good patient outcomes clinic
in clinical trials or
importance for
continuity of care

Disease Management for Diabetes

[57]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention
Howorka K, 32 and 68 Patients were Structured Not specified Patients with Not specified
Pumprla J, et al., adult patients recruited from a education about type 1 diabetes
2000 with type 1 population of functional insulin
diabetes for about 400 treatment (insulin
study 1 and according to dosing according
study 2, eligibility criteria to blood glucose
respectively (e.g., duration of levels and food
diabetes at least intake, thereby
1 year) avoiding the need
for adherence to a
prescribed schedule
of doses and meals)

Huff PS, Ives TJ, Not specified Referral by primary Diabetes American Patients Pharmacists and
et al., 1983 care provider questionnaire Diabetes physicians
assessed Association
patient
knowledge
of diabetes
and was used
to establish a
teaching plan and
treatment goals.
An initial 1-hour
counseling
session was
conducted to
address disease
pathophysiology,
complications,
importance of
patient compliance,
role of diet and
drug therapy,
administration
technique,
Disease Management for Diabetes

adverse effects,
and self-monitoring.
Patient progress in
the educational
process was
documented.
Additional
15-minute
sessions at follow-
up visits were
RCT=randomized controlled trial provided as
needed.

[58]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results
Perceived control 4 weeks for study RCT for study 1, Perceived treatment Not specified On a short-term basis,
over diabetes and 1 and 3 years for uncontrolled pilot cost-effectiveness functional-insulin-treatment
diabetes-related study 2 study for study 2 as the difference (FIT) training induced
health beliefs between measures feelings of independence
of benefits from because of situational
treatment and control. After 3 years, FIT
barriers to training improved
treatment perceived self-efficacy,
treatment satisfaction, and
glycemic control, resulting
in a feeling of
empowerment. Perceived
treatment cost-
effectiveness improved
significantly due to
decreases in
barriers to treatment.

None specified Not specified Survey None Ambulatory care Pharmacists were able to
clinic provide more instructional
time than typically is
provided by physicians,
thereby improving patient
understanding. Patients
were grateful to have ready
access to pharmacists for
information or help
solving problems.
Physicians had more
time available to spend
with other patients once
pharmacists assumed the
patient education
responsibility.
Communication between
pharmacists and
physicians improved.
Disease Management for Diabetes

[59]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Irvine AA, 61 adults with 250 patients Diabetes Not specified Patients with Nurse educator,
Mitchell CM, diabetes referred by education program diabetes nutritionist,
et al., 1992 physicians were to increase psychologist, and
sent a letter inviting knowledge, self- physical therapist
them to participate care, and
and attend initial metabolic control
meetings in a local
church three
evenings during
1 week.
Disease Management for Diabetes

RCT=randomized controlled trial

[60]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Self-reported 3 months Controlled, but None Community (three Subjects who did not drop
adherence to not randomized Appalachian out of the education
treatment regimen communities that program and subjects in
(diet and weight, were comparable the control group who
exercise, self- in size and attended all three testing
monitoring of character) sessions (Attenders) had
glucose levels, significant increases in
medication use, diabetes knowledge and
and foot care), foot care over the course
metabolic control of the study (however,
(glycosylated these Attenders may have
hemoglobin), attitudes characteristics that
toward living with allow for improvement
diabetes (self-esteem, regardless of whether
denial, locus of education is provided).
control, degree to Subjects who dropped out
which regimen of the education program
intrudes on lifestyle, and subjects in the
attitude toward control group who did
physician), knowledge not attend all three
of diabetes, barriers testing sessions
to self-care (Nonattenders) had no
improvement in diabetes
knowledge or foot care.
These Nonattenders tended
to be less educated, have
a lower income, be
younger, have had diabetes
for twice as long, report
more barriers to self-care,
and have poorer health
than Attenders. Special
efforts may be required to
promote program
attendance in patients with
these characteristics.
Disease Management for Diabetes

[61]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Jaber LA, 39 adults Diabetic patients Comprehensive Not specified Urban African Pharmacists
Halapy H, currently attending pharmaceutical American clinic
et al., 1996 a clinic who met care model, patients
the inclusion including
criteria and education,
responded to medication
contact via mail counseling,
and telephone instruction about
diet, exercise, and
home blood
glucose monitoring,
and evaluation/
adjustment of
hypoglycemic
regimen

Kaplan RM, 70 adults Invitations to Four types of Not specified Patients Not specified
Hartwell SL, participate via intervention
et al., 1987 public radio strategies—diet
announcements, alone, exercise
newspaper notices, alone, diet plus
and physicians exercise, or
education alone
(control)

Karlander SG, 83 patients with All patients attending 5-day formal Not specified Patients with Not specified
Kindstedt K, diabetes (and a diabetes diabetes education diabetes
et al., 1983 another 32 clinic were invited program with
patients with to participate (32 two daily
diabetes as patients with lessons about
controls) diabetes matched the disease and
for age were not nutrition,
asked to participate respectively, using
and served as lecture, slides,
controls; how these questions-and-
Disease Management for Diabetes

patients were answers, and


identified was not printed text
explained in the
article).

RCT=randomized controlled trial

[62]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Primary outcome 4 months RCT None A university- A comprehensive model of


measures: fasting affiliated internal pharmaceutical care
plasma glucose medicine effectively improved
and glycosylated outpatient clinic glycemic control, but not
hemoglobin; blood pressure, lipid levels,
secondary outcome body weight, or measured
endpoints: blood quality-of-life parameters, in
pressure, lipid levels, a clinic-based population of
renal function, and urban African American
quality of life patients with type 2
diabetes. Changes in
glycemic control were
attributed to improved
patient understanding of
diabetes and optimization
of oral hypoglycemic
regimens.

Glycosylated 18 months Randomized trial (no Estimated cost of Not specified A combination
hemoglobin, body non-intervention diet and exercise diet-plus-exercise program
weight, quality of life control group, but program was produced the greatest
education group $1,000 per patient; reduction in glycosylated
as control group) estimated cost of hemoglobin, as well as
a single “well year” significant improvement in
produced by this quality of life, compared with
program was interventions consisting of
$10,870. diet, exercise, or education
alone. These improvements
were largely uncorrelated
with body weight changes.

Knowledge about 1 year Nonrandomized, None Ambulatory clinic Knowledge of diabetes and
diabetes and but controlled nutrition were significantly
nutrition, metabolic improved immediately and
control (blood 1 year after the
glucose, urinary intervention. Knowledge
glucose excretion, did not change between
relative body the initial visit and
weight, serum second visit 2 months later
cholesterol and in the control group.
triglycerides, and, Metabolic control was not
Disease Management for Diabetes

in some patients, affected by the intervention.


glycosylated
hemoglobin)

[63]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Legorreta AP, 390 patients Use of ICD-9 codes Provider teams Not specified Health care Not specified who
Peters AL, with type 1 or to generate list of (nurses, physician providers (nurses, assessed
et al., 1996 type 2 diabetes diabetic patients at assistants, physician assistants, adherence to
study sites endocrinologists) endocrinologists) protocols by
were trained in received training health professional
application of in program teams; nurses
diabetes administration; managed
management patients were application of
program that uses recipients of program to
protocols linked program. patients
to a computer
system to improve
disease
management and
compliance with
referrals and
laboratory tests.

Levetan CS, 104 patients Consecutive Consultation Not specified Patients Diabetes team
Salas JR, with diabetes patients provided by a (nurse educator,
et al., 1995 diabetes team registered dietitian,
and endocrinologist)

Lieberman DA, 59 children and Not specified Diabetes self- Not specified Children and Not specified
2001 adolescents management adolescents with
with diabetes video game diabetes
Disease Management for Diabetes

RCT=randomized controlled trial

[64]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Provider 18 months Prospective, non- None Large medical A nurse-administered


adherence to randomized, groups contracted diabetes management
protocols by controlled trial to provided health program, employing
measurement of care to HMO special protocols linked
patient laboratory members, to a computer system,
values (glycosolated including a effectively improved
hemoglobin, fasting typical glycemic control, lipid
plasma glucose, full participating levels, and referral rates in
lipid panel, serum medical group diabetic patients treated in
creatinine, urinalysis) and IPA an outpatient setting.

Length of stay Not specified Not specified None Hospital Length of stay in the
diabetes team consultation
group (3.6 days) was
significantly shorter than in
the endocrinologist
consultation group (5.5
days) and the no-
consultation group
(8.2 days).

Amount of video 6 months RCT None Home There was a 77% decrease
game playing time, from baseline in urgent
diabetes-related care and emergency
urgent care and medical visits in the
emergency medical diabetes video game group
visits, diabetes-related but no change in the
self-efficacy (ability to control group. There were
affect outcomes), improvements in
communication with diabetes-related
parents about diabetes, self-efficacy,
daily diabetes communication with
self-care parents about diabetes, and
daily diabetes self-care in
Disease Management for Diabetes

the diabetes video game


group but not in the control
group.

[65]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Matsuyama JR, 47 patients with Screening of Use of an American Patients with Pharmacists
Mason BJ, et al., poor to fair computer electronic Diabetes diabetes
1993 metabolic medication medication- Association receiving oral
control of profiles and event guidelines for antidiabetic drug
diabetes laboratory values monitoring metabolic control therapy
mellitus of all patients system (MEMS), (metabolic
receiving a a medication control was not
sulfonylurea vial cap with a a primary
for 3 months or microprocessor outcome
longer with a that records measure)
consistent dosage each date and
and poor to fair time that the
metabolic control vial is opened

Mazzuca KB, 22 adults with Patients who had Community Not specified Adults with Community health
Farris NA, et al., diabetes who received care at a health nursing diabetes who nursing students
1997 were receiving university-based intervention were receiving in their senior year
insulin therapy internal medicine (weekly or insulin therapy who were under
and had poor clinic were biweekly home and had poor the supervision of
glycemic contacted by visits to provide glycemic control a nursing faculty
control telephone by health teaching investigator
investigators. and guidance,
health referrals,
coordination of
care, and client
advocacy;
teaching
addressed
nutrition, exercise,
foot care, and
blood glucose
monitoring)
Disease Management for Diabetes

RCT=randomized controlled trial

[66]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Dates and times 2 months Double-blind RCT None Veterans The MEMS data allowed
medication vial Affairs pharmacists to individualize
was opened medical center recommendations to a
and pill counts ambulatory greater extent than the pill
after 30 and clinics count method
60 days

Self-reported 32 weeks RCT None Community Community health nursing


self-care behaviors (patient homes) produced a significant
(managing improvement in self-care
complications, blood competency in adults with
glucose monitoring, insulin-treated diabetes,
diet, reporting foot although it did not improve
changes, exercise), health status.
dietary adherence
(3-day dietary
recall), foot care
(ulcer formation),
blood glucose levels,
diabetes knowledge,
functional health
status and
well-being

Disease Management for Diabetes

[67]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

McCulloch DK, 30 practices Not specified Support program American Patients Physicians
Price MJ, et al., (unclear as to comprised an Diabetes
1998 the number of online patient Association
patients) registry and use
of guidelines for
eye and foot
examinations,
screening for
microalbuminuria,
and glycemic
control; registry
served as a
reminder of the
recommended
elements of care;
delivery of care
redesigned to
provide for patient
group visits as
well as individual
visits and to
establish a
decentralized
team of
diabetes experts
that sees patients
jointly with
primary care
providers; team
traveled to each
clinic several times
a year and, along
with the primary
care team, saw
each patient for
approximately
30–40 minutes

Meigs JB, 598 patients ICD-9 codes, with Web-based American Physicians and Data collection by
Cagliero E, with diabetes randomization by patient-specific Diabetes patients nurses
et al., 2003 coin toss information Association,
Disease Management for Diabetes

management/ National
decision support Cholesterol
tool Education
Program, and
Joint National
Committee on
Prevention,
Detection,
Evaluation, and
Treatment of High
RCT=randomized controlled trial Blood Pressure

[68]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Glycosylated 3 years RCT None Not-for-profit The prevalence of


hemoglobin and staff-model health testing for
eye examinations maintenance glycosylated
organization hemoglobin and eye
examinations both
increased over the
3-year period after
implementation of the
program. Nearly
two-thirds of patients
with diabetes
received annual eye
examinations by the
end of the 3-year
period. In the first
year of the program,
half of all patients
with diabetes had a
foot examination
compared with
fewer than 20%
before program
implementation.
Microalbuminuria
screening also
increased markedly
after program
implementation. The
prevalence of smoking
decreased from 14% in
1994 to 10% in 1996.

Testing rates and 12 months RCT (1 yr before and None Hospital-based Testing of glycosylated
values for after intervention) clinic hemoglobin and LDL
glycosylated cholesterol and foot
Disease Management for Diabetes

hemoglobin, low- examinations increased and


density lipoprotein glycemic control improved
(LDL) cholesterol, in the intervention group.
and blood pressure;
eye and foot
examination rates

[69]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Nilasena DS, 31 Physicians Internal medicine Impact of a American Internal medicine Not specified
Lincoln MJ, resident physicians computer- Diabetes resident
et al., 1995 in their 3rd or 4th generated Association physicians
year reminder system in their 3rd or
on physician 4th year
compliance with
guidelines for
diabetes
preventive care;
residents in
intervention group
were provided with
a patient-specific
report listing
patient health
data and
upcoming or
overdue
preventive health
activities (e.g.,
physical
examinations,
laboratory tests,
referrals, patient
education)

Nine SL, 75 African Patients Exercise, medical Not specified Patients Registered nurse
Lakies CL, Americans with volunteered to nutrition therapy, or dietitian
et al., 2003 diabetes, participate support groups,
hypertension, cooking schools,
or both and service
coordination
Disease Management for Diabetes

RCT=randomized controlled trial

[70]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Compliance with 6 months RCT None Hospital The average compliance


guidelines for score 1 month after
preventive implementation of the
care reminder system was
significantly higher
compared with baseline in
the intervention group
(54.9% after 1 month
versus 38.0% at
baseline). The average
compliance score in the
control group also
increased significantly
over the same period
(51.0% after 1 month
versus 34.6% at baseline);
there was no significant
difference between the
two groups in the change
in compliance. The
highest compliance scores
were for laboratory tests
and referrals, and the
lowest scores were for
patient education. The use
of encounter forms
facilitated documentation of
clinical data and
compliance with guidelines
for diabetes preventive
care.

Blood pressure, 1 year Quasi-experimental None Community Glycosylated hemoglobin


glycosylated decreased significantly
hemoglobin, and in patients with elevated
quality of life initial values. Quality of life
improved but the change
was not significant.
Disease Management for Diabetes

[71]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Parker MT, Three long- A letter was sent Education American Registered Diabetes educators
Keggett-Frazier N, term-care to administrators program Association of nurses and
et al., 1995 facilities of 40 long-term- (7 biweekly Diabetes licensed practical
(LTCFs); two care facilities (the 20-minute Educators and nurses at long-
received method for sessions using American term care
intervention identifying these a lecture format Diabetes facilities
and one served facilities was not with slides and Association
as a control specified) in a question-and- guidelines were
group eastern North answer period on used to develop
Carolina that met medications, the diabetes
certain criteria for patient monitoring, knowledge test
number of beds managing
and number of hyperglycemia
patients with and hypoglycemia,
diabetes. diet, foot care,
illness care, and
exercise and
patient-family
education)

Piette JD, 248 English- Culled from Biweekly Self-care Patients Diabetes nurse
Weinberger M, or Spanish- medical automated education recorded educator
et al., 2000 speaking adult records of patients telephone messages were
patients with with scheduled assessment based on
diabetes appointments at (patient use of literature
managed by one of two general the touch-tone- published by the
medication medicine clinics of telephone keypad Centers for
a county health to enter blood Disease Control
care system glucose readings and Prevention
and other data and American
for review by a Diabetes
nurse) and Association
self-care
education calls
with nurse
follow-up
Disease Management for Diabetes

RCT=randomized controlled trial

[72]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Diabetes knowledge 3 months LTCFs were None Long-term-care The intervention


and diabetes care randomized to the facilities significantly improved
practices (providing intervention or control diabetes knowledge but
carbohydrates for group; pretests and did not affect diabetes care
patients with posttests were used practices.
hypoglycemia, to test diabetes
testing for knowledge and a
ketones and retrospective chart
contacting a review (randomly
physician for selected charts for
patients with LTCFs with more
hyperglycemia, than 20 residents
administering with diabetes and
insulin in the the entire
abdomen, and population of
having a podiatrist patients with
cut toenails) diabetes for LTCFs
with fewer residents
with diabetes) was
used to evaluate
diabetes care.

Self-monitoring of 12 months RCT None Home Self-monitoring of blood


blood glucose, glucose, foot inspection,
foot inspection, and weight monitoring were
and weight more frequent; problems
monitoring, with medication adherence
medication were less common; and
adherence, glycemic control was
glycemic control better in the intervention
(glycosylated group than in the control
hemoglobin, group, which received
serum glucose) usual care.

Disease Management for Diabetes

[73]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Piette JD, 248 English- or Culled from Biweekly Self-care Patients Diabetes nurse
Weinberger M, Spanish- medical automated education recorded educator
et al., 2000 speaking adult records of patients telephone messages
patients with with scheduled assessment were based on
diabetes appointments at (patient use of literature
managed by one of two the touch-tone- published by the
medication general medicine telephone Centers for
clinics of a county keypad to enter Disease Control
health care blood glucose and Prevention
system readings and and American
other data for Diabetes
review by a nurse) Association.
and self-care
education calls
with nurse
follow-up

Piette JD, 272 patients Recruited from Biweekly Not specified Patients Nurse
Weinberger M, with diabetes at three general automated
2001 a Veterans medicine clinics telephone
Affairs and one diabetes assessment
clinic specialty clinic (patient use of
within a the touch-tone-
university-affiliated telephone keypad
Veterans to enter blood
Administration glucose readings
health care system, and other data
using patient for review by a
medical records nurse) and
self-care education
calls with nurse
follow-up

Pijls LT, 125 patients Not specified Dietary European Patients Dietitians
de Vries H, et al., with type 2 (described counseling Association for the
2000 diabetes elsewhere in Study of Diabetes
and micro- published and American
albuminuria, literature) Diabetes
relatively high Association
Disease Management for Diabetes

albuminuria, or
diabetes for at
least 5 years
and high dietary
protein intake

RCT=randomized controlled trial

[74]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Depression, anxiety, 12 months RCT None Home Significantly fewer


self-efficacy symptoms of depression
(patients’ and days in bed because
confidence in of illness and significantly
participating in greater self-efficacy to
their own care), perform self-care activities
days in bed were associated with the
because of illness, intervention (automated
diabetes-specific telephone assessment and
health-related nurse follow-up) than with
quality of life, usual care (the control
general quality group). Anxiety and
of life quality of life were similar
in the two groups.

Self-care (self- 12 months RCT None Clinic Patients in the intervention


monitoring of blood group reported significantly
glucose, foot more frequent self-
inspections), monitoring of blood
symptoms, glucose and foot
satisfaction with inspections, fewer
care, and glycemic symptoms of poor
control glycemic control, and
greater satisfaction with
care. Among patients
with an elevated baseline
glycosylated hemoglobin,
the mean value after
12 months was significantly
lower in the intervention
group than in the control
group.

Protein intake 12 months RCT None Not specified Dietary protein intake was
estimated from significantly lower in the
urinary urea experimental group than in
excretion the control group after
6 months but the difference
was smaller and not
Disease Management for Diabetes

significant after 12 months.


Dietary counseling
resulted in only modest
protein restriction.

[75]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Pill R, 33 general Not specified Training (at least Not specified General A general
Stott NCH, practices with 3 hours divided practitioners and practitioner,
et al., 1998 252 patients into two sessions practice nurses research nurse,
with type 2 using discussions, and clinical
diabetes demonstrations, psychologist
and role-play) of
general
practitioners and
practice nurses
about an
unspecified
patient-centered
intervention
(“described
elsewhere”)
designed to
encourage
clinicians to
negotiate
individual care
plans based on
patients’
perceptions of
their disease and
readiness to
change their
lifestyles and to
work toward
realistic targets for
behavior change

Ridgeway NA, 28 adults Computerized Six 90-minute Not specified Patients Registered
Harvill DR, et al., audit identified education/behavior dietitians and
1999 diabetic patients modification registered nurses
who visited clinic sessions offered who were certified
in preceding year monthly, with a diabetes educators
and physicians follow-up session
recommended at 12 months
participation to
those patients
who met the
Disease Management for Diabetes

inclusion criteria
(i.e., diagnosis
of type 2 diabetes,
≥20% over ideal
weight, able to
participate in
monthly visits
and comprehend
presented material,
inadequate
RCT=randomized controlled trial glycemic control).

[76]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Change in 3 years RCT None General practice Although most clinicians


glycosylated had a moderate to good
hemoglobin, understanding of the
complications, underlying principles of the
patient satisfaction intervention, few routinely
with care, functional applied the principles in
health status, ability practice. An impact on
of health care patient outcomes and
professionals to health status was not
apply the intervention demonstrated.

Glycemic control During and RCT Cost of Primary care Significant but transient
(fasting blood 12 months educational clinic improvements in metabolic
glucose and after 6-month materials parameters as well as
glycosylated intervention and salaries body weight occurred in
hemoglobin), lipid for the program patients with type 2
profiles, body diabetes who participated
weight, knowledge in education/behavior
about diabetes, modification classes.
health-related Patients who took the
quality of life classes also improved
Disease Management for Diabetes

(HRQOL), their knowledge of


medication diabetes and
requirements demonstrated significantly
more knowledge than
controls post-intervention.

[77]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Rothman R, 138 adults General internal Diabetes American Patients Pharmacists


Malone R, with poorly medicine practice education, Diabetes
et al., 2003 controlled limited physical Association
type 2 diabetes examination,
initial treatment
recommendations,
the use of
medication
algorithms, and
frequent patient
follow-up

Schmidt SO, 231 patients Random selection Use of a diabetes American Diabetes Physicians Not specified
Burns C, et al., with diabetes of charts management Association (ADA)
2003 at six clinics flow sheet, with or
without provider
feedback on
performance

Smith DE, 22 older obese Advertisements Three Not specified Patients Psychologists
Heckemeyer CM, women with and a patient individualized experienced in the
et al., 1997 type 2 diabetes letter motivational intervention
interviewing technique
sessions (to
assess attitude
toward change,
solve problems,
assess objective
data on health
and behavior,
delineate
discrepancies
between
current status
and goals, and
develop realistic
and objective
goals)
Disease Management for Diabetes

RCT=randomized controlled trial

[78]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Glycosylated 6 months Retrospective, not None University-based Glycosylated hemoglobin


hemoglobin controlled clinic decreased significantly,
especially in patients with
high baseline levels or a
recent diagnosis.

Compliance with 2 months Quasi-experimental None Clinic Both interventions


ADA recommended significantly improved the
frequencies for performance of foot exams
various tests and but had little impact on
exams and patient other tests and patient
outcomes outcomes.

Body weight, 16 weeks RCT None Home with Treatment adherence


glycosylated intermittent and blood glucose control
hemoglobin, meetings in were significantly better in
treatment unspecified the motivational
adherence (group setting (intervention) group than in
meeting attendance, the standard (control)
maintaining and group. Both groups lost a
submitting diaries significant amount of
of eating, exercise, weight but the two groups
and home blood did not differ in the
glucose monitoring) amount of weight loss.

Disease Management for Diabetes

[79]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Smith L, 30 women with Letters were Program using None Female patients Certified diabetes
Weinert C, 2000 type 1 or 2 sent to certified computer-based with diabetes educator
diabetes living diabetes educators, telecommunications
in rural areas and flyers about technology to
the program for provide support,
distribution to information, and
patients were education
enclosed; the
mailing list for the
state chapter of
the American
Diabetes
Association was
also used to
identify potential
participants who
then received
flyers.

Stott NC, 30 primary Identified family Introduction of Not specified Doctors and Not specified who
Rees M, care doctors, practices with visual agenda- nurses; patients managed
et al., 1996 33 nurses, and doctors and nurses setting technology secondarily intervention for
200 patients who are (charts, diaries, involved as doctors and
“interested and readiness-to- recipients of nurses; nurses
active in diabetes change ruler), as technique and doctors
care” (e.g., attend well as applied techniques
continuing techniques in to patients
education sessions) negotiation and
motivational
interviewing that
health
professionals can
use to facilitate
clinician-patient
interactions,
patient lifestyle
changes, and
compliance
Disease Management for Diabetes

RCT=randomized controlled trial

[80]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Measures of 10 months RCT None Patient homes, Quality of life scores were
social support, many of which higher for women in both
quality of life, were far from the groups who had more
psychosocial nearest source of education and improving
adaptation to health care health. Attitudes toward
illness, attitudes the use of
about the telecommunications
impact of the technology were positive,
computer and 77% of subjects
intervention recommended its use “very
highly.” The program
provided a great deal of
support to 77% of women
in the computer group.

Uptake of training, 3 years RCT None 29 family A high percentage of family


use of the method, practices in practice-based clinicians
attendance/ Wales reported frequent (71%) or
participation in occasional (22%) use of
group discussions, agenda-setting technology
willingness to in their interactions with
have consultations type 2 diabetics following
tape-recorded an intervention directed at
introducing and
promoting this technique.
While levels of engagement
were higher among
nurses, doctors also
reported benefits of
using visual charts and
techniques, negotiation,
and motivational
interviewing to encourage
patient compliance
and lifestyle changes.
Disease Management for Diabetes

[81]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Tan ASL, Yong LS, 278 patients Recruited as they Diabetes Not specified Patients Nurse trained in
et al., 1997 with diabetes came to the clinic education program counseling
(183 for the for treatment (at least six techniques
intervention) out (first 100 individual or
of a total assigned to small-group
population of control group, counseling
about 2,500 subsequent sessions using
with diabetes patients to the patient booklets
served by the intervention group) and four group
clinic sessions, with
lectures,
videotaped
presentations,
group
discussions,
and food displays)

Teufel NI, Not specified Not specified Establishment of Not specified Zuni high school Collaboration
Ritenbaugh (it is unclear supportive social students in New between public
CK, 1998 how many networks, Mexico, a school district
patients development of a population with and university
participated for wellness (exercise) a high prevalence department of
the first facility, incorporation of type 2 diabetes family and
2 years of of diabetes and an early community
this 4-year education into the age at diagnosis medicine
study and high school
provided curriculum, and
longitudinal modification of the
data for that food supply to
period) reduce fat content
and consumption
of sugary
beverages and
increase fiber
content
Disease Management for Diabetes

RCT=randomized controlled trial

[82]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Diabetes 1.5 years Controlled, but not None Government The intervention (diabetes
knowledge (disease, randomized primary education program)
complications, health care clinic significantly improved
management, and diabetes knowledge, dietary
self-care), dietary practices, medication
practices, medication compliance, and glycemic
compliance, self- control in patients with
monitoring of blood diabetes.
or urine glucose,
glycosylated
hemoglobin

Body mass index, 4 years (results Not controlled None Two high schools Within 2 years after the
dietary intake of available only for (community) intervention, the
fiber and sugary first 2 years) consumption of sugary
beverages, heart beverages, body mass
rate, fasting and index, and heart rate had
postprandial decreased (a decreased
glucose and heart rate suggests
insulin levels improved cardiovascular
fitness), and dietary fiber
intake and glucose-to-
insulin ratios had
increased (an increase in
the glucose-to-insulin ratio
suggests a reduced
prevalence of
hyperinsulinemia and risk
for type 2 diabetes). Only
the changes in sugary
beverage consumption
and insulin levels were
significant, but the other
changes suggest the
adoption of healthy
behaviors that might
Disease Management for Diabetes

reduce the prevalence of


risk factors for type 2
disease as the study
continues.

[83]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Uusitupa MIJ, 1996 86 obese Not specified Intervention group Not specified Patients Not specified
Finnish patients made six visits to
an outpatient
clinic at 2-month
intervals for
intensive therapy
with (1) a
restricted dietary
intake of calories,
total fat (<30%),
saturated fats
(<10%), and
cholesterol
(<300 mg/day),
which was
monitored by
examining food
records and
measuring
serum lipids,
and (2) exercise
training (30–60
minutes three to
four times per
week), which was
monitored by
analyzing daily
exercise records.
Disease Management for Diabetes

RCT=randomized controlled trial

[84]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Dietary intake of 1 year and RCT None Outpatient clinic The intervention led to a
calories via food 3 months reduction in intake of
records, serum saturated fats and calories.
lipids, and Weight loss and beneficial
exercise training changes in metabolic
control (fasting blood
glucose) and lipid profile
(e.g., high-density
lipoprotein cholesterol,
triglycerides) were
observed during the
intervention period only in
the intervention group.
Follow-up assessment
1 year after the
completion of the
intervention period
revealed that glycemic
control was maintained
by a significantly larger
percentage of patients
in the intervention
group than in the
conventional
treatment group.

Disease Management for Diabetes

[85]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

van den Arend IJ, 243 patients All eligible Four structured Guidelines on Patients General
Stolk RP, et al., with type 2 patients were programs for type 2 diabetes practitioners,
2000 diabetes included or some patient care, of the Dutch dietitians,
were selected including (1) care College of diabetes nurses,
randomly or based guided by General ophthalmologists,
on poor glycemic protocol, with oral Practitioners podiatrists
control (depending and written
on the program) patient information,
(2) care with
computerized
support and a
diabetes nurse
available to answer
patient questions,
(3) a special
educational
program focusing
on blood glucose
monitoring for a
subset of patients
with poor glycemic
control, and (4) an
integrated care
program with an
educational
program with
didactic elements
and interactive
group discussion
on basic self-care
skills and diabetes
pathophysiology
and complications
Disease Management for Diabetes

RCT=randomized controlled trial

[86]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Disease knowledge, 12 months Randomized, but None Primary care Disease knowledge
self-care behavior not controlled setting and self-care behavior
(dietary adherence, increased in all four
self-monitoring of programs and was
blood glucose, maintained at follow-up.
physical exercise, The increases were
and foot inspection), significantly greater
and disease in programs with an
perception educational component
(programs 3 and 4)
than in those without
an educational
component (programs 1
and 2).

Disease Management for Diabetes

[87]
Appendix C.
(continued)
Method of
Identifying
Population for
Size of Whom Data Are Intervention Guideline Audience for Primary Manager
Author(s) Population Evaluated Strategy Based? Intervention of Intervention

Weinberger M, 275 adults Computerized Nurse-initiated Not specified Patients Nurses


Kirkman S, receiving care audit identified telephone contacts
et al., 1995 at Veterans patients who between clinic
Affairs medical had ever filled visits to primary
clinic a prescription for care physicians to
insulin or an oral provide education,
hypoglycemic reinforce
agent at the compliance,
pharmacy and had monitor health
visited the clinic in status, solve
the preceding year. problems, and
Patients who met facilitate access
the inclusion criteria to primary care
(i.e., diagnosis of
type 2 diabetes,
currently using
insulin or oral
hypoglycemic
agent, receiving
regular care at
clinic, access to
phone) were
invited to
participate by letter,
phone, or clinic visit.

Whitlock WL, 28 adult Recruited based Weekly home American Patients Nurse case
Brown A, et al., patients with on glycosylated telemedicine Diabetes manager under
2000 type 2 diabetes hemoglobin value (voice and video Association direction of
and from internal interaction) visits primary care
glycosylated medicine, family with patient by physician
hemoglobin practice, and nurse case
>8% primary care manager to review
clinics using blood glucose
hospital levels, body
information weight, blood
systems at an pressure,
Army medical hypoglycemic
center episodes,
exercise and
nutrition goals,
and well-being,
and monthly
physician
telemedicine
Disease Management for Diabetes

visits

Wing RR, 154 non-diabetic Newspaper Group meetings Not specified Non-diabetic Behavior therapist,
Venditti E, et al., individuals at advertisement for about diet, individuals registered dietitian,
1998 risk for diabetes overweight exercise, or both; exercise
because of individuals restricted diet with physiologist
overweight and with a parent who structured meal
a parental has diabetes plans; group
history of the exercise sessions
disease plus individual
exercise

RCT=randomized controlled trial


[88]
Economic
Outcomes Time Period Study/Evaluation Effects
Measured Studied Design Assessed Setting Key Results

Glycosolated 1 year RCT None Veterans Affairs The intervention modestly


hemoglobin, general medical improved glycemic control
fasting blood sugar clinic but not HRQOL or
health-related diabetes-related
quality of symptoms.
life (HRQOL),
and symptoms

Laboratory tests 3 months RCT None Home There were significant


(glycosylated reductions in glycosylated
hemoglobin, hemoglobin and total
lipid values), body weight in the
total body weight, telemedicine group but not
quality of life in the control group.

Disease Management for Diabetes

Body weight, oral 2 years RCT None Not specified Diet and diet plus exercise
glucose tolerance produced significant weight
test, fasting glucose loss and improvement in
and insulin, cardiovascular risk factors
glycosylated (lipid profile, blood
hemoglobin, lipid pressure) initially but these
profile, blood improvements were not
pressure maintained on a long-term
basis. The risk for type 2
diabetes was significantly
reduced by even a modest
weight loss.
[89]
Appendix D.
Diabetes Disease Management Programs

Group Health Cooperative of Puget Sound U.S. Public Health Service


Seattle, Washington Carville, Louisiana

Group Health Cooperative of Puget Sound, a Seattle-based HMO, Reducing lower-extremity amputations in patients with diabetes by
is developing a “clinical road map” for members with diabetes that 40% is an objective of a project called the Lower Extremity
includes a sophisticated, individualized method of patient education Amputation Prevention (LEAP) Program, which is headquartered at
and empowerment and a restructuring of clinic operations. A ran- the Gill W. Long Hansen’s Disease Center in Carville, Louisiana.
domized, controlled trial is under way to compare outcomes in Annual foot screenings, patient education, proper footwear selec-
three groups: one using a new educational model in conjunction tion, daily self-inspection of the feet, and management of simple
with a diabetes clinic, another incorporating the model into primary foot problems are components of the LEAP program. A 25%
care practices, and a control group receiving usual care with no reduction in lower-extremity amputations has already been report-
educational intervention. The educational model is based on the ed, although additional progress is sought. A study of a patient
transtheoretical model of behavior change. Intervention guidelines empowerment program in which patients self-screen for loss of
have been developed for each of five stages of behavior change sensation in the feet is under way at 40 sites in 18 states.
(precontemplation, contemplation, preparation, action, mainte-
nance).
Texas A&M School of Rural Public Health
Bryan, Texas
Baylor College of Medicine
Houston, Texas A 3-year study by researchers at Texas A&M’s School of Rural
Public Health is under way to explore cost-effective strategies for
Improving the health of Mexican Americans, who have high rates of bringing disease management to rural populations. A model devel-
obesity and are at high risk for type 2 diabetes, was the objective oped at Mahomet, Illinois–based Carle Health Systems Research
of Unidos en Salud (United in Health), a 5-year research project Center was used. This model involves branch clinics to improve
conducted by Baylor College of Medicine. The researchers patient access to health care in rural areas, a care team made up
focused on a population of 40,000 people who were primarily of a registered nurse partnered with 5–10 primary care providers,
(97%) Hispanic and poor in Starr County, which borders northern and the use of authoritative clinical guidelines. Another model of
Mexico. The project was built on the results of Cuidando el care under study by the Texas A&M researchers is the St. Elizabeth
Corazon (Caring for Your Heart), an earlier research project that of Hungary Clinic in Tucson, Arizona, which takes care of many
involved culturally sensitive approaches to reducing dietary fat uninsured patients with diabetes. A diabetes clinical flow sheet is
intake and other dietary modifications. used to track clinical assessments, laboratory test results, interven-
tions, physician exams, and self-care activities for each patient.
A randomized, controlled study was undertaken to determine Diabetes day group visits are used to make care more accessible
whether 6 months of professional nutrition, lifestyle management, or convenient for patients and to improve compliance (patients can
and exercise interventions followed by 6 months of social support obtain all needed services in a single visit instead of multiple visits).
and peer support as maintenance would result in an individual The average glycosylated hemoglobin measurement decreased
weight loss of at least 10 pounds in 300 women. Other outcome from 8.9% to 8.2% over a 2-year period as a result of the interven-
measures include body mass index, serum glucose, insulin, glyco- tion. Glycemic control improved over the course of 1 year in nearly
sylated hemoglobin, lipids, and blood pressure. Women were ran- half of patients with diabetes who were considered at high risk.
domized to the intervention or a wait-listed group (the latter served Plans are under way to use telemedicine for patients with diabetes
as a control group). in rural areas and to implement preventive initiatives (e.g., nutrition
counseling) for patients at risk for developing diabetes (i.e., patients
Many women did not reach the goal of losing at least 10 pounds with prediabetes). See: The new frontier: delivering cost-effective
during the intervention period, although some women achieved DM to rural populations. Dis Manag Advis. 2003;9:122–26.
Disease Management for Diabetes

success during the maintenance period. Peer support provided


significant benefits. Women with the least education and income
appeared to benefit most from the social support.

[90]
Appendix D.
Diabetes Disease Management Programs (continued)

Gottleib Memorial Hospital UnitedHealthcare Diabetes Management Program


Melrose Park, Illinois Minneapolis, Minnesota

Gottlieb Memorial Hospital offers a subcapitated disease manage- Visions for Diabetes was a UnitedHealthcare program designed to
ment program for diabetes to the 200 physician members of its help members with diabetes take better care of themselves and
physician/hospital organization. The program uses a multidiscipli- prevent serious complications. It sought to promote physician com-
nary approach to manage diabetes and reduce the incidence of pliance with guidelines established by the American Diabetes
complications. About 100 patients have been enrolled. Dramatic Association, improve quality of care and clinical outcomes, and
improvements in glycemic control have been observed with the modify member and physician behaviors. The company delivered a
program. There were no hospital admissions because of uncon- comprehensive diabetes health management program in collabora-
trolled diabetes in the first 6 months of the program. Annual cost tion with Merck-Medco Managed Care, LLC. The International
savings of $750,000 are projected, based on 50% reductions in Diabetes Center, a world leader in the development of education
both hospital admissions and hospital days for diabetes. and treatment models to improve the health and lives of people
with diabetes, provided continuing medical education credits for
provider “rollout” and case management training. UnitedHealthcare
also has a disease management program for asthma and a well-
ness program for pregnancy. (For additional information, go to
http://www.unitedhealthcare.com.)

Disease Management for Diabetes

[91]
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The National Pharmaceutical Council
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Phone: 703-620-6390
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