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Ana-Maria Schweitzer

Mihaela Bogdan

Hepatitis C:
Perspectives on Chronic Care
in Constana, Romania

Constana, 2015
Hepatitis C:
Perspectives on Chronic Care
in Constana, Romania
Ana-Maria Schweitzer
Mihaela Bogdan

Hepatitis C:
Perspectives on
Chronic Care
in Constana, Romania
Desktop Publishing: Dan Crciun, Square Media
The qualitative assessment
Hepatitis C: Perspectives on Chronic Care
in Constanta, Romania has been prepared by:

The team is grateful for their generous support to:

5
Acknowledgments

The Baylor Black Sea Foundation is grateful to all people living with hep-
atitis C who have participated in the focus group discussions, as well as to
health care professionals who have shared their experiences, problems and
potential solutions to chronic care for people affected by this health condition.
We appreciate the participants willingness, honesty and true interest in
providing quality information about the subject.
A team of five young researchers, employed by the Baylor Black Sea
Foundation, has carried out the field activity and helped to collect the materi-
als analyzed in this report. The Baylor team appreciates their efforts.

6
About Baylor Black Sea Foundation

Baylor Black Sea Foundation is the only representative of the Baylor Col-
lege of Medicine International Pediatric AIDS Initiative (BIPAI) network in
Romania that offers medical and psychosocial services at the Center of Clin-
ical Excellence in Constana to people in Dobrogea region affected by infec-
tious diseases. Since 2001 Baylor Romania has added to the already existing
services (dentistry, infectious diseases, obstetrics-gynecology, pulmonology,
rapid testing and psychosocial) new ones: family planning and primary cardi-
ology services and most recently viral hepatitis care.
The hepatitis care program of Baylor Black Sea Foundation aims to give
hepatitis C patients and their families the power and courage to face the chang-
es happening in their lives due to their health problems and to prove that,
despite the chronic condition that they are fighting, there are structures that
encourage them to move forward and support them to improve their quality
of life. The Baylor Foundation also strives to develop among patients and their
families abilities to navigate within the medical system, and to catalyze and
stimulate the organization of patient-centred health systems.

Further information can be found at: www.baylor.ro and


www.bipai.org/romania

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Executive summary

Developing and strengthening the capacity of health systems to handle


hepatitis C in Romania is a public health priority.
This paper brings into focus the role of chronic care delivery design in
the management of hepatitis C.
The current organization of the Romanian health system and the current
level of organization of authorities response to the public health issue raised
by hepatitis C are presented in the first part of this report. Stress is laid on the
immediate need to structure an integrated approach that efficiently meets the
healthcare needs of hepatitis C patients. A future healthcare program should
be structured based on good practice and evidence.
In this context, Baylor foundation set to investigate what is the current
organizational model of care for patients with hepatitis C in a region of Roma-
nia, namely Constana County, in order to identify strengths, existent capacity
and areas of improvement.
The results of this qualitative assessment describe the chronic care de-
livery system for hepatitis C available in Constana, Romania, in the context
where the work of the public health system is complimented by the programs
and services of Baylor Foundation.
The research design is a qualitative investigation, using focus groups and
interviews, based on the Chronic Care Theoretical Model. This framework is
an evidence-based guide that indicates where the efforts of changing health
systems should be directed. Fifty six persons (patients with hepatitis C and
healthcare professionals) participated in this research. Thematic analysis was
used to interpret the data by matching the Chronic Care Model Assessment
tool categories.
Findings indicate that there is some existent local capacity, especially
regarding the organization of healthcare and delivery design, on which a more
chronic patient-centered approach can be built. The qualitative assessment
also reveals the importance of community linkages and civil society resources
in improving the quality of care, especially in supplementing self-management
interventions that state run programs do not usually incorporate. Special ca-
pacity building efforts need to be made and specific resources to be allocated
in order to compensate for the lack of development of important clinical deci-
sion support components and clinical information systems.
At the end of the qualitative assessment, specific recommendations are

8
suggested regarding interventions that can assist health planners in redesign-
ing the current care program for patients with hepatitis C in this region of
Romania.

9
Section A:
Delivery of Healthcare Services for
Hepatitis C in the Context of the Health
System in Romania

10
Chapter I. Characteristics of the
Romanian Health System

Health systems around the world face various challenges and critical sit-
uations for which they need to find a solution by developing coherent and inte-
grated actions. Efficient health systems have the capacity to deal promptly with
crises and immediate demands, and, moreover, they are capable of developing
proactive mechanisms by anticipating and planning population health programs.
Much of the burden of disease can be prevented or cured with known,
affordable technologies. The problem is getting drugs, vaccines, information and
other forms of prevention, care or treatment on time, reliably, in sufficient
quantity and at reasonable cost to those who need them1.

Stable
funding
mechanism
Sound
Adequate
and skilled risk
health ajustment
workforce methods
Resilient
health
systems
Adequate
costing Good
of health governance
services

Information
ows in the
system

Figure 1. Elements of a resilient health system, European Commission, 2014

Health systems are defined by the World Health Organization as a means


of organizing institutions, human resources and other types of resources (fi-
1 World Health Organization. (2007). Everybodys business: Strengthening health systems to improve
health outcomes: WHOs framework for action. Geneva: WHO Press. Available from htttp://www.who.
int/healthsystems/strategy/everybodys_business.pdf.

11
nancial, informational etc.) that meet the healthcare needs of a target group,
being responsible both for the actions aimed at influencing health determin-
ing factors, and for carrying out direct health improvement activities. The re-
silience of health systems is a new concept that has been defined by experts
as a result of unexpected challenges that health systems need to tackle under
such limitations as shortage of resources (economic crisis), unexpected surges
in demand (epidemics) etc. Resilience indicates the level of development of
the systems capacity to adapt effectively to changing environments by apply-
ing innovative solutions2.
The elements that make up a health system include services, human re-
sources, health-related informational issues, necessary products (drugs, vac-
cines, access to recent technologies), financial resources, and management-
and good governance-related issues.

Organization of health services in


Romania

The health system includes the sum of healthcare structures, public


and private organizations, institutions, and resources empowered to prevent,
maintain, improve and provide health to the population. In Romania, public
healthcare includes individual health services, health services that address the
population or certain population groups, and activities aimed at influencing
the policies and actions of other sectors that address the social-economic and
environmental determinants of health3.
Public healthcare is guaranteed by the state, and is financed from the
Ministry of Health budget, from the state budget or from own revenues, local
government budgets, health insurance budgets and other sources, as applica-
ble, pursuant to the law.
The public health system is managed and coordinated by the Ministry
of Health and its specialized structures, which are organized by competencies
and responsibilities at a national and regional level.

2 European Commission Communication from the Commission on effective, accessible and resilient
health systems, Brussels, 4.4.2014 COM (2014)215 final
3 Law regulating the organization and operation of the health system in Romania, Article 1, Public
Health

12
In Romania, the health system is built around the central administration
and, subsidiarily, around the medical staff, with the patient or their represen-
tatives having very few possibilities to influence the system for which they
pay. The single major change made in the past 30 years has been the imple-
mentation of the health insurance system whose organizational purpose was
to clarify and re-enforce the responsibility of the main buyer of health services
the National Health Insurance Agency (Casa Naional pentru Asigurri de
Sntate CNAS) through direct election of management structures at a
local level.
The bodies with a determining role in planning, coordinating and fi-
nancing the Romanian health system are the following: the Ministry of Health
and County Public Health Directorates; the National Health Insurance Agen-
cy, County Health Insurance Agencies and the Insurance Agencies of min-
istries that have their own network of healthcare units; the Romanian Col-
lege of Physicians and County Colleges of Physicians, as well as other similar
professional organizations; individual healthcare providers: healthcare offices,
hospitals, diagnosis and treatment centers, pharmacies and laboratories.
The Romanian health system supported by the EU Representation in
Bucharest, the World Bank, USAID, John Snow Institute, WHO, UNFPA,
UNICEF, and UNAIDS has made progress in the period 20002012, which
can be seen in the evolution of several health indicators for the said period:
increase in life expectancy from 71.25 to 73.83 years, reduction of infant mor-
tality from 18.63 to 9.79, of incidence of tuberculosis from 127.54 to
79.23%000, of syphilis from 55.96 to 10.85%000, and of hepatitis B from 12.2
to 2%0004.
The principles that define primary care family medicine as a specialty
with a separate profile show that it provides first contact care throughout the
patients life, at both family and community level, in direct relation with the
patients environment5. The family physician has complex duties. They include
delivery of prevention services: immunization, family planning, pregnancy
monitoring, home healthcare services, palliative care, directly observed thera-
py, social assistance, and also administrative and management activities.
The services delivered by family physicians include the management of
chronic diseases (high blood pressure, diabetes), short term treatments, immu-
nization, prenatal care, family planning, regular check-ups for neonates, basic
laboratory tests with the use of urine test strips, ECG devices and sometimes

4 Politici de Sntate magazine, July-August 2013, page 12


5 Clujul medical, 2010 Vol. LXXXIII - Supliment 1

13
ultrasound devices. The latter are highly required by patients, and many general
practitioners try to acquire competencies in imaging diagnosis6.
People who do not have health insurance benefit from three types of
health services from the family physician. These are: emergency healthcare,
consultations for infectious and contagious diseases, and check-ups for preg-
nant and lately confined women7.
The infectious and contagious diseases for which uninsured persons
may benefit from health services also include viral hepatitis (note should be
taken that the law does not clearly specify whether it refers to acute and/or
chronic viral hepatitis). However, uninsured patients will bear the costs of all
clinical and paraclinical investigations recommended, as well as of medica-
tions prescribed by family physicians. The only health service offered by the
family physician to uninsured chronic patients is a medical consultation and
referral to a specialist.
For insured patients, the duties of the family physician include referral to
screening services, complex medical investigations in the secondary system,
and registration of test results or of other recommendations made by the con-
sulting physician through medical letters sent with the patient.
In 2007, the competencies and responsibilities of family physicians were
reviewed and improved, which led to better outcomes through more consul-
tations and home visits, care for more registered patients and better coverage
for emergency healthcare8 .
Primary healthcare is insufficiently used. The referral rate is of 9% among
family physicians in the rural area, and of 12% among family physicians in the
urban area, which is the higher limit of the range compared to other countries.
Most of referrals are motivated by the legal obligation of referring patients to
consulting physicians with a view to obtaining permission to prescribe spe-
cific medicines. A report by NICE International for the Ministry of Health
shows that:
The relative underfunding inherent to the family medicine and outpatient
care sectors, combined with structural and financing anomalies, seem to have led
to an apparent underuse of family medicine, to an apparent overuse of inpatient
care and, as a result, to an extensive transfer of costs and occurrence of perverse

6 Strategy for primary healthcare 20122020, Oxford Policy Management/Problems with service provi-
sion/Quality of services
7http://www.economica.net/ce-servicii-primesti-gratuit-la-medic-daca-nu-esti-asigurat-la-sanata-
te_78527.html#ixzz3UXEF1jmR
8 NIVEL/CPSS. Evaluation of the structure and delivery of primary care services in Romania stu-
dy-based project. WHO Europe

14
incentives9.
The secondary healthcare level consists of healthcare units belonging to
the local public authorities, which deliver inpatient-specific healthcare ser-
vices. The tertiary healthcare level refers to services delivered by clinics and
specialized institutions (research and educational institutions).
The health services related to the secondary health level are delivered
through a network of healthcare units (hospitals, policlinics, health centers
and other institutions) belonging to the public and private sectors. In Roma-
nia, there are currently 360 public hospitals (decentralized to local authori-
ties, except for tertiary hospitals, which are still managed by the Ministry of
Health) from university hospitals delivering highest standard services (locat-
ed in Bucharest and other six university centers) to small hospitals with two
three specialties or even one.
The health system is still responding inefficiently to major health prob-
lems of the Romanian population, as the current design focuses on curative
and mainly inpatient care, laying stress on emergency services at the expense
of outpatient and primary care.
In the longer term, the risk that emergency care might replace regular
care should not be underestimated. Emergencies are becoming the de facto entry
point to the health system for most of the population, particularly the poor, and
after the planned cuts in hospital beds, emergency hospitals will contain about
three-quarters of all hospital beds10.
The connection between the two system sectors primary and tertia-
ry is not clear enough. The communication between family physicians and
consultants aimed at managing certain diseases (in particular, chronic dis-
eases) requires immediate integration. Poor development of guidelines for
family physicians, the lack of use of existing ones and the complete absence
of guidelines for nurses are aspects that contribute to an unclear distribution
of responsibilities within this category of professionals, and even to a lim-
itation of their role to auxiliary tasks, such as those related to bureaucracy11.
These barriers could be overcome because there are also facilitators. Thus, the
Strategy for primary healthcare 20122020 shows that Almost all family physi-
cians, except for those from remote areas, have a fast Internet connection and are
able to access evidence-based electronic resources and even share opinions online

9 Final report by NICE International for the Ministry of Health, January 2012http://www.ms.ro/
upload/ Ministerul%20Sanatatii%20NICE%20R0MANIA%20FINAL%20REP0RT.D0C
10 World Bank Functional review of the health sector in Romania - Final Report, 25 May 2011
11 Strategy for primary healthcare 20122020, Oxford Policy Management/Problems with service
provision/Quality of services

15
with their colleagues, if necessary12.

The tertiary sector consists of healthcare units that include research and
educational institutions that also deliver specialized and highly specialized
healthcare for the entire population.

Inpatient services

Specialized outpatient
care

Family medicine
services

Community
care
services

Figure 2. Performance of the health system according to


the national health strategy 20142020
Both public and private healthcare providers may be directly contracted
by National Health Insurance bodies for the delivery of medical services cov-
ered by the mandatory health insurance. A large number of parallel healthcare
services are also delivered through public medical institutions belonging to
other branches of the government, which are financed from the state budget
through their respective ministries, but they can also contract with the Na-
tional Health Insurance bodies.

12 Strategy for primary healthcare 20122020 prepared by Oxford Policy Management for the Ministry
of Health with funds from the World Bank, published on 23 March 2012

16
Health-Related Human Resources

The availability of a highly qualified and motivated health workforce of


adequate capacity and with the right skills is a component that has been facing
serious challenges in the past decade, a problem identified both in Romania,
and in other EU Member States.
Significant gaps have been identified in Member States capacity to plan
for future health workforce resource requirements, relating to both overall vol-
ume and required skills mixes, in order to meet expected healthcare needs effi-
ciently13.

Figure 3. Availability of physicians and nurses in 2009 in Europe,


source European Health for All Database. http://data.euro.who.int/hfadb/

13 European Commission Communication from the Commission on effective, accessible and resili-
ent health systems, Brussels, 4.4.2014 COM (2014)215 final

17
The issues related to health workforce concern both educational-quali-
tative aspects, and numerical-quantitative aspects. The numerical imbalance
occurs under various aspects in terms of specialties breakdown or regional
breakdown. Romania ranks among the last European countries (31 out of
33) in terms of professional density related to the number of inhabitants (1.9
physicians per 1,000 inhabitants), according to the statistical yearbook14. As
regards the geographic breakdown, an overcrowding of human resources is
noticed in the urban area at the expense of the rural area, where a vulnerable,
poor and uninsured population lives. In this context, the system is obsolete
and unable to adequately cover the specific needs of sub-groups or regions.
The staff training process could solve part of the human resources-re-
lated problem in the system. Unfortunately, it is characterized by many ex-
perts as being centered more on learning by heart and less on developing
evidence-based analytical skills15. This educational system discourages team
work, and is not centered on patients and their needs.
At least as discouraging as the process is the remuneration and promo-
tion system, as well as the working conditions.
Having an effective structure of incentives is vital to improving the per-
formance of health professionals and ensuring the focus on direct provision of
healthcare16.
The small number of healthcare employees in Romania following its ac-
cession to the EU is also the result of a massive migration of the workforce
to other Member States. According to the Romanian College of Physicians,
the demand for specialists was higher in family medicine, general practice,
surgery, anesthesiology, and intensive care. The number of people who have
chosen to work abroad is of almost 20,000. The migration of physicians has
continued through 2014 as well.
The College of Physicians has spoken about an exodus of physicians ever
since 2006. We issued warnings at least several times a year. However, nothing
has been done to prevent the collapse of the health system due to the lack of
qualified staff. Moreover, the decision to classify physicians as public servants
decision made by the Supreme Court without regard to the legislative and legal
framework is nothing but another reason for physicians to migrate. Especially
since there is no country in the European Union, in the European area, in Can-
ada or USA where the physician is a public servant17.
14 Report of the Presidential Commission A health system based on citizens needs
15 Report of the Presidential Commission A Health System Based on Citizens Needs
16 European Commission Communication from the Commission on effective, accessible and resili-
ent health systems, Brussels, 4.4.2014 COM (2014)215 final
17 http://www.cmr.ro/comunicat-de-presa-34/

18
Almost 2,500 physicians have requested professional certificates from
the Romanian College of Physicians in order to work abroad. Currently,
39,000 practitioners are registered with the Romanian College of Physicians,
and, according to the data submitted by the College, 3,000 physicians enter
the system and almost 3,500 leave the system (through migration, retirement
or death).18

Information and Research Systems

The systematic collection and dissemination of information within the


system (at various levels, from the patient history, needs, pathway, costs
to institution or types of health conditions) are vital elements for supporting
evidence-based decisions. E-health systems have been used on a larger scale in
Romania as well, due to pressures from the European Union, and an electronic
health card for insured people was introduced in 2015. In whole, the capacity
of the system used to collect, process, analyze and report data into existing IT or
information systems, and the capacity of using the data and information from
public policies are insufficient whilst communication/access to information that
is relevant for the patient and population is insufficiently developed19.
Furthermore, the most recent national strategy on population health
prepared by the Ministry of Health shows that in terms of its monitoring and
evaluation systems, Romania is still a beginner: we need to promote an orga-
nizational and system framework that is favorable to monitoring and evalua-
tion, that helps us achieve expected results through active co-participation from
the various relevant institutional stakeholders. Currently, the responsibility of
surveilling communicable diseases (including viral hepatitis) rests with the
National Centre for the Surveillance of Communicable Diseases, which cen-
tralizes data received from Public Health Directorates. The duties of County
Public Health Directorates, more precisely of the Department for the con-
trol of primary healthcare services, also include control of compliance with
the provisions regarding the reporting and monitoring of communicable and
chronic diseases by family physicians who carry out their activity in both pub-
lic offices, and private offices; control of management of primary healthcare
18 The Romanian College of Physicians http://www.cmr.ro/
19 http://www.ms.ro/upload/Anexa%201%20-%20Strategia%20Nationala%20de%20Sanatate%202014-
2020.pdf

19
records and medical information, including for the supply of data related to
county/regional/national vaccination and chronic disease records regulated
through implementing regulations20.
Besides improving data collection mechanisms, it is recommended to
immediately enhance the efforts for carrying out investigations, studies and
operational quality and quantity research in order to make sure that health
interventions have a measurable impact. The Ministry of Health states that:
In 2011, Romania spent 0.5% of the GDP for research and development
(Eurostat), the lowest percent among EU Member States (except for Cyprus).
There is no information available about health expenditure. Besides insufficient
funding, there are many other health research problems related to health visibil-
ity as a research priority, to the adequacy of defined research priorities, to the
transfer and efficient use of research results in medical practice, to the existing
research institutional capacity, and to the complexity of the accreditation process
for research, at least for non-public entities.

Existing Medical Products

Romania has a wide range of medicines, which is considered to be satis-


factory and permanently growing (e.g. there were more than 7,000 medicines
in 2009 on the Romanian market, and in 2013 their number reached 8,58221).
The authority that verifies and approves medicines and medical devic-
es in Romania is ANMDM (Agenia Naional a Medicamentului i Dispozi-
tivelor Medicale National Agency for Medicines and Medical Devices). It
was established 50 years ago, and reports directly to the Ministry of Health. Its
name has been changed several times, however its duties have remained the
same. Romania aligned to the European standards with respect to medicines
after 2007.
Medicines are sold to patients through a closed network of pharma-
cies (in hospitals), through a network of private community pharmacies or
through health centers. It is forbidden in Romania to sell prescription drugs
over the Internet. The growth seen by the private sector has led to an increase
in the number of pharmacies and pharmaceutical units; thus, in 2011, there
20 Organisational and Operational Rules, Public Health Division in Constana
21 Activity Report for 2013- National Agency for Medicines and Medical Devices http://www.anm.ro/
anmdm/_/RAPORT%20AcTlVlTATE/Raport_ANMDM_2013.pdf

20
were 8,240 units, 1,025 more than in 2008; approximately 15% of them are part
of the same chain. For medicines sold as part of national programs, prices are
regulated by the Government and do not allow for too large variations; how-
ever, among closed networks of pharmacies, the competition market is free22.
Access to pharmaceutical products is a problem for insured patients who live
in rural areas. According to the Health Law (Law no. 95/2006, Article 383 and
Article 788) and to the Pharmacy Law (Law no. 266/2008, Article 2), family
physicians are not allowed to sell medicines. Many rural areas lack pharma-
cies, and accreditation requirements for a pharmacy limit the possibility to
establish smaller rural pharmacies. Currently, several ideas are being issued
with respect to the funds owned for primary healthcare medicines. However,
a decision for authorizing physicians in remote areas to keep limited stocks of
pharmaceutical products has not been adopted yet (according to the Primary
Healthcare Strategy 2012-2020).
There is a complex process in place for establishing prices for prescrip-
tion drugs, and for reimbursing such prescriptions by Insurance Agencies.
Usually, the medicine inclusion process is considered by the population as
non-transparent, incoherent and seldom adapted to the actual needs of the
population23. There is widespread lack of confidence in generic drugs, which
is enhanced by physicians practice of prescribing new, top medicines promot-
ed by pharmaceutical companies, thus avoiding the obligation to prescribe
generic drugs. The Romanian legislation makes no reference as to the phar-
macists duty to inform patients about the cheapest medicine containing the
active ingredient prescribed by their physician. Requiring pharmacies to have
a permanent stock of generic drugs has also remained a mere intention24.
The European Union has imposed Romania to significantly increase the
volume of generic drugs on the free market, however its targets have not been
reached. The situation is due to investments made by pharmaceutical com-
panies, who have innovative products, in visiting physicians and pharmacists
directly to promote and advocate for the qualities of the original drug. For ex-
ample, in 2007, these investments accounted for half of the marketing budget
of pharmaceutical companies25.

22 Global Forum on Competition- Competition Issues in the Distribution of Pharmaceuticals Contri-


bution from Romania, 27-28 february 2014, DAF/CONP/GF/WD (2014)30
23 Romania Functional Review Health Sector Final Report May 25, 2011, The World Bank Europe
24 Central Asia Region, page 101
25 Global Forum on Competition- Competition Issues in the Distribution of Pharmaceuticals Contri-
bution from Romania, 27-28 February 2014, DAF/CONP/GF/WD (2014)30, pages 17-18

21
Sustainable Funding
and Social Protection

According to Law no. 145/1997 and to the Health Reform Law as of


2006, the Romanian health system is based on social health insurances that
include similar benefits for all tax payers (the basic package of health services
made available through a framework contract).
The funds are collected by a body of the Ministry of Finance, and coun-
ty insurance agencies collect taxes from freelancers. Insurance premiums are
mandatory (except for pupils, students and retirees), and they are dependent
on income and individual risks. Social health insurance contributions are paid
by both the employer (5.2% of the salary), and the employee (5.5% of the sal-
ary). The money for the health system come from the following sources: 60%
from social insurances mandatory contributions, 1015% from taxes and
specific fees, 10% from private insurances, and 1015% from payments made
by patients.
Almost half of the Romanian population does not contribute directly to
the public insurance budget26. Besides, the forecast on the ratio between active
people and socially assisted people in Romania is rather dark: in 2060 there
will be only two people aged between 15 and 64 for each person of more than
65. This ratio will have a visible negative impact on the budget of the national
health system.
The health system financing is still evaluated as inadequate and inef-
ficiently used. Compared to most European countries, Romania allocates a
significantly lower budget from the Gross National Product to health expen-
diture.

26 Romania Functional Review Health Sector Final Report May 25, 2011, The World Bank Europe and
Central Asia Region, pag 11

22
Figure 4. Income sources of the National Health Insurance Agency

12

10

4
2005 2006 2007 2008 2009 2010 2011 2012
Romania Germany France Hungary Bulgaria

Figure 5. Health-related expenditure, percentage from GDP,


source: World Bank (http://data.worldbank.org/indicator)

The monthly expenditure of the Romanian Government is of approx-


imately 27 Euro per capita compared to those of the German Government,
which allocates more than 230 Euro/month per capita27.

27 Forbes, Romania, 2012

23
Figure 6. Health-related expenditure correlated to the number of physicians available,
European Health for All Database

Apart from underfunding, an arbitrary use of resources among various


regions and types of services can also be noticed. There is limited access, char-
acterized by inequities, to high quality health services, with the main differ-
ences occurring between the rural and urban areas: the mortality rate in the
rural area is twice the rate recorded in the urban area, and the number of
physicians is three times smaller in the rural area than in the urban area, ac-
cording to a report of the presidential health commission28. Furthermore, the
current payment systems create financial incentives that are contrary to the gov-
ernments stated policy of reducing the use of inpatient services and increasing
the use of family medicine and specialized outpatient services29.
Financial barriers have a direct negative impact on patients. A survey
requested by the World Health Organization shows that most of respondents
complain about difficulties related to finding medicines, the lack of medicines,
costs and copayment. One fifth of the patients surveyed declared that they pay
for home medical visits, and one fifth that they pay to see a consultant after
they get a referral. 10% of the respondents declared that they refuse or post-
pone their visit in the primary care system for financial reasons30.
Informal payments are widespread in Romania, ranging from 63%

28 Report of the Presidential Commission A health system based on citizens needs, http://www.
presidency.ro/ static/ordine/COMISIASANATATE/UN_SISTEM_SANITAR_CENTRAT_PE_NEVOI-
LE_CETATEAN- ULUI.pdf
29 World Bank Functional review of the health sector in Romania - Final Report, 25 May 2011
30 World Health Organization: final report Evaluation of the structure and primary healthcare deli-
very in Romania; Primary healthcare in the European region of the WHO; WHO Europe; 2011

24
among the poor to 88% among families with a better financial condition31. The
data from the World Bank (see Figure 7) show that the level of out-of-pocket
payments has been high and steady in time.

100

80

60

40

2005 2006 2007 2008 2009 2010 2011 2012


Romania Germany France Hungary

Figure 7. Percentage of informal (out-of-pocket) payments,


source: World Bank (http://data.worldbank.org/indicator)
The poor have limited access to health services. Many of those who need
medical care do not seek health services. This is the case for almost 50% of the
poor. The gap between rich and poor is particularly large in the treatment of
chronic disease because 42% of the poor who suffer from a chronic disease
do not seek care compared to 17% of the rich. The actual gap is even larger as
many of the poor with chronic conditions are not aware of their need for care.
Simulations show that the need for chronic care is not similar among rich and
poor, and estimate that a whopping 85% of the poor who need chronic care are
not receiving it.32
Even the Ministry of Health states that, although the subsidies for health
services and the partial reimbursement of medicines are aimed at protecting
vulnerable populations, the financial protection fails to render the expected
outcomes as long as:
three out of four poor patients pay from their pocket for the medical care
they need,
62% of the poor who need medicines pay for them from their pocket,
average reimbursement rates are the same for the rich and the poor while
subsidized services are underused by the poor. Thus, the benefits of subsi-
31 Romania Functional Review Health Sector Final Report may 25, 2011, The World Bank Europe and
Central Asia Region, pag 45
32 Functional review of the health sector in Romania, World Bank, 2011

25
dies are directed more towards the rich or middle class33.
A survey conducted in 2014 at a national level by Asociaia pentru Im-
plementarea Democraiei (Association for Democracy Implementation), co-
ordinated by the Ministry of Health, shows that the phenomenon of corrup-
tion in the healthcare sector relates to healthcare service providers, and to the
management and administrative staff, and that patients also encourage this
phenomenon by offering gifts or money. More than a quarter of the people
who sought medical care in the public sector in the previous year admit that
they offered gifts or money to the medical staff. The same survey shows that
more than 50% of the patients have willfully offered gifts and money. Accord-
ing to the findings of the research, willfully offered or requested incentives
for the medical staff can be avoided through the implementation of an insur-
ance system that is able to provide comfort to the patient in the public health
system34.

Management and Good Governance

Good governance in the health sector is a process that was accelerated


in Romania following its integration into the European Union through the
development of common policies and common regulatory structures. The
transition from a centralized administration to a decentralized one, and the
development of the regionalization process are the most important changes
made in the past decade with respect to management in the health sector. The
decentralization process has been continuously amended and changed, which
is evidence for the lack of predictability and stability of the Romanian political
environment (the reform approved by Ordinance no. 162/2008 was amended
through emergency ordinances and decisions more than ten times by 2013).
The legislative and institutional framework propitious to the integration
of community healthcare services with the social services is still under devel-
opment, which deprives vulnerable groups of the support they need.
At least for chronic conditions, the prevalent design of healthcare is fo-
cused rather on treating flares than on managing the disease by detecting it as

33 Ministry of Health, Annex 1 to the National Health Strategy 20142020


34 The research was conducted on a three-stage sample, which is representative at a national level for
the Romanian adult population, made up of 1,076 respondents. The maximum error of the survey is of
+/-2.8% with a confidence index of 95%

26
early as possible and delivering intermittent, systematic and quality care in order
to reduce the risk of progress into more severe forms and complications35.
Ensuring continuous care is a priority for the national strategy, as the
Ministry of Health is going to prepare the methodology and treatment proce-
dures for the first 20 most frequent pathologies, including to define the service
plans for specialized outpatient care as part of the local health service plans.
The aspects related to monitoring quality, focusing on the physician-patient
relation and respecting patients rights will continue at the stage of intentions
and strategic action directions for now. All these aspects are included in a
program document, Strategy of the Ministry of Health 20142020. Until all
mentioned strategy plans are put into place, most of the policies are imple-
mented ad-hoc due to a lack of evidence and data which should underlie the
decisions made36.
The collection and analysis of health-related key indicators are not cen-
tralized at the level of a single agency/body, but duties are divided among sev-
eral institutions; some of the data are not available free of charge, and others
do not return into the system to change current practices.
The relation with the civil society is still weak and incoherent. Although
non-profit organizations have expertise in the medical field and they make
significant investments in the health sector (in the form of equipment, medi-
cines, continuing medical education or even healthcare service delivery), their
efforts are parallel to rather than integrated with the efforts of the Ministry
of Health. As a matter of fact, there are no non-governmental organizations
supported from public funds, which means they are self-supported. Patients
are organized into associations and coalitions, and they are approached and
involved by health authorities when required by law. The formal consultation
process requires continuity, and the partnership between public institutions
and the civil society needs to be improved. There are few good practice models
related to the delivery of prevention-testing-treatment services for patients in
public-private partnership with non-governmental organizations.

35 Ministry of Health, Annex 1 to the National Health Strategy 20152020, page 47


36 World Bank (October 15, 2010) Romania. Functional Review Center of Government. Final Report,
p. 7

27
Chapter II. Current Level
of Development of Care for Hepatitis C
Patients in Romania

There is a lack of knowledge and awareness about viral hepatitis among


at-risk populations, members of the public, and policy-makers; there is a lack of
knowledge and awareness about viral hepatitis even on the part of healthcare
and social-service providers.37

The Context of Health Policies


with Respect to Hepatitis C

No clear targets have been set at a global level with respect to HCV, that
is why the WHO is seeking to prompt a debate in 2015 over a Global Hepatitis
Strategy 20162021.
However, recent steps have been taken towards structuring the response
against hepatitis C, among which it is worth mentioning the Guidelines for
identifying, treating and managing people with HCV, published in April 2014,
and the Hepatitis C Resolution, in the World Health Assembly held in May
2014, signed by all member states.
Such guidelines should be adopted by all signatory states at a national
level; WHO states that only 37% of its member states reported the existence of
a national strategy that focuses on the control of hepatitis C, and almost half
of them also have clinical care guidelines38.
It is recommended that new testing strategies for identifying people with
HCV who are not aware of the infection be immediately developed, because
the number of infected people is continuously increasing39.
Referring reactive cases and taking them over for treatment and care
37 IOM (Institute of Medicine). Hepatitis and liver cancer: a national strategy for prevention and con-
trol of hepatitis B and C. Washington, DC: The National Academies Press; 2010.
38 Global policy report on the prevention and control of viral hepatitis. Geneva: World Health Organi-
zation; 2013
39 http://newsite.hiveurope.eu/Portals/0/Conference%202014/Press_release_HepHIV2014_UK.pdf

28
is the next step. Currently, the pathway of the hepatitis C patient within the
health system, if any, is poorly structured, most of the countries in the Eu-
ropean region reporting exclusive referral of the HCV patient to a hospital
or specialist40. In most European countries, patients access to treatment is
dependent on insurance41.
Since there are significant similarities between the HIV pandemia and
the one caused by HCV, in 2014 the World Health Organization (WHO) in-
cluded the Global Hepatitis Program alongside the HIV Department. The
optimization and standardization of the HIV care continuum (testing, treat-
ment, monitoring, adherence support etc.) are aspects that can also be used
when addressing HCV infection.

Epidemiological Facts about Hepatitis C


in Romania

The hepatitis C virus (HCV) was discovered more than twenty five years
ago (in 1989)42, however not earlier than in the past years has the infection
caused by this virus been acknowledged as a public health problem. Approx-
imately 3% of the world population (130170 million) is infected with HCV.
Due to an asymptomatic period of more than 23 decades, 75% of the people
infected with HCV are diagnosed late, when complications, such as cirrhosis
or hepatocellular carcinoma, are difficult to treat. Between 1996 and 2006,
cirrhosis prevalence has doubled, and that of hepatocellular carcinoma has
increased twenty times. These figures are not the peak of the endemia, as the
forecast for 2030 shows a three times increase in the number of people infect-
ed (and diagnosed) with HCV.
For a comparative understanding of the magnitude of the problem, we
outline that there are currently approximately 2.2 million people infected with
HIV and more than 28 million people affected by viral hepatitis in Europe43.
40 World Hepatitis Alliance, Viral hepatitis: Global policy, 2010, World Hepatitis Alliance. p. 1- 184
41 Central and Eastern European Harm Reduction Network, Hepatitis C Among Injecting Drug Users
in the New EU Member States and Neighboring Countries: Situation, Guidelines and Recommendations,
2007
42 UNITAID. Hepatitis C Medicines: Technology and Market Landscape. 2015; http://www.unitaid.eu/
images/marketdynamics/publications/HCV_Meds_Landscape_Feb2015.pdf
43 Global access to hepatitis drugs and diagnostics consultation with pharmaceutical and diagnostics
companies- 16 June 2014, Geneva, Switzerland, meeting report. World Health Organization/ HIV/2014.47

29
In Europe, most of the people infected with HCV are injection drug users,
whose prevalence ranges from 21% in Finland and over 90% in Estonia. The
World Health Organization (WHO) has identified injection drug users as the
main target group for HCV prevention and treatment programs44.
Many years ago, a website accredited by WHO (World Health Organi-
zation) Safe Injection Global Network drew attention to the persistence of
this problem in Romania: Romania An European home of hepatitis45. Most
probably exaggerated, the figures quoted estimated that 6 to 8% of the popu-
lation was infected with the B hepatitis virus (HBV), and 8 to 12% with the C
hepatitis virus (HCV). Most of the ill have been infected before 1990 due to
poor conditions in hospitals and policlinics, and to a lack of compliance with
the proper practices for parenteral treatments or transfusion security. In Ro-
mania, viral chronic hepatitis is the main cause for inpatient care.
The genetic heterogeneity of HCV is important because it has to do with
the differences among the effects of the disease, as well as with HCV infected
peoples response to treatment. In Europe, the most prevalent genotypes of
HCV are 1 and 3 (European Parliament 2014: 8). In Romania, 93% of people
living with hepatitis C are genotype 1b, which indicates that the HCV was
primarily transmitted through blood transfusion46.

Incidence:
According to the National Health Strategy 20142020, subject to non-ho-
mogenous national reports, in terms of incidence of the infection with the B
(HBV) and C (HCV) hepatitis viruses, Romania ranked second in Europe in
2011 and 2010, respectively, even if the incidence of infectious hepatitis has
decreased significantly between 2000 and 2010, reaching 1/5 of the hepatitis
B incidence for 2000 and 1/4 of the initial value for hepatitis C. However, the
burden of hepatic infection goes beyond the incident cases of clinically evident
diseases that are detected by healthcare providers. The hidden prevalence of
the viral infection in population is highly important, as the risk of infection
and transmission to the healthy population is actually dependent upon it.

44 World Health Organization (2010). Resolution A63/15: Viral hepatitis. 63rd World Health Assembly
45 http://www.ipsnews.net/2007/02/romania-a-european-home-to-hepatitis/
46 Gheorghe L, Csiki IE, Iacob S, Gheorghe C, Smira G, Regep L. The prevalence and risk factors of he-
patitis C virus infection in adult population in Romania: a nationwide survey 2006 - 2008. J Gastrointestin
Liver Dis. 2010 Dec;19(4):373-9. PubMed PMID: 21188327

30
7

1 000 000 population


number of cases / 5

0
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Year
Figure 8. Hepatitis C incidence in Romania, 2001-2010, according
to the National Centre for the Surveillance and Control of Communicable Diseases47

Data from the past four years about the incidence of viral hepatitis reveal
a steady trend in detecting and reporting new cases, and also a low level of
testing and diagnosis, according to epidemiologic studies:
2010 2011 2012 2013
Number of new cases reported by family physicians in 4518 3449 4469 4908
Source: INS SAN109B New cases of infected people

Prevalence:
Available prevalence studies show that Romania is a high risk country
for HBV and HCV infection (second highest prevalence in the EU for HVB
and highest prevalence for HCV). The problem posed by the disease among
the population is also amplified by a severe chronic secondary pathology (cir-
rhosis and liver cancer).
In Romania, the burden of the chronic disease is double48, due to both
high prevalence of noncommunicable diseases, and high interference rates of
infectious diseases. The Ministry of Health states that the prevalence of pres-
ent anti-HCV antibodies is of 4.3% in the overall population, and of 3.3% in
new blood donors49.
In the period of 20062008, a team of specialists from the Clinical In-

47 European Centre for Disease Prevention and Control, 2011, Country mission Romania: HIV, sexu-
ally transmitted infections, and hepatitis B and C, Stockholm, ECDC
48 Bygbjerg IC, Double burden of noncommunicable and infectious diseases in developing countries.
Science. 2012 Sep 21;337(6101):1499-501
49 National Health Strategy 20142020, Ministry of Health, Romania

31
stitute Fundeni conducted an epidemiologic50 study on more than 13,000
subjects, which revealed a national prevalence of 3.23%. Differences among
regions and/or counties were significant, and ranged from 0.56% to 7.19%.
The screening data of the Baylor Black Sea Foundation51, reveal annual
prevalence rates of approximately 3% for HCV in the period of 20102014 for
Constana and Tulcea Counties.

Findings of the screening program conducted in Dobrogea


on the overall population by the Baylor Foundation

3.30% year 2011, year 2013,


3.20% 3.16% 3.21%
3.10%
3.00%
year 2010 ,
2.90%
2.96%
2.80%
year 2012,
2.70%
2.85%
2.60% year 2014,
2.50% 2.77%
year 2010
year 2011
year 2012
year 2013
year 2014

Figure 9. Baylor Black Sea Foundation HCV Screening Program:


prevalence among overall population in Dobrogea

Transmission paths:
HCV transmission paths are similar to HIV, however, in terms of in-
fectiousness, HCV blood transmission is 10 times more efficient than HIV
transmission52. HCV transmission is associated with a set of behavioral prac-
tices, such as the use of drugs with non-sterile tools, re-use of medical tools
in the healthcare setting, performing tattoos and piercing with contaminated
tools, or incorrect transfusion practices. HCV can also be transmitted through
sexual contact, in particular among men who have sex with men. Unlike HIV,
50 Gheorghe L, Csiki IE, Iacob S, Gheorghe C, Smira G, Regep L. The prevalence and risk factors of he-
patitis C virus infection in adult population in Romania: a nationwide survey 2006 - 2008. J Gastrointestin
Liver Dis. 2010 Dec;19(4):373-9. PubMed PMID: 21188327.
51 De la lansarea sa n 2007, au fost testate peste 40.000 de persoane n cabinetele de testare i consiliere
gratuit din oraele Constana i Tulcea i de ctre echipa mobil. Surs: http://baylor.ro/wp-content/
uploads/2014/10/raport-anual-2013-ro-web.pdf
52 Taylor L, Swan T, Mayer K. HIV coinfection with hepatitis C virus: evolving epidemiology and
treatment paradigms. Clinical Infectious Diseases. 2012;55(Supp. 1):S33S42

32
sexual penilo-vaginal transmission seldom occurs, and mother-to-infant in-
fection is, also, less frequent53. HCV cannot be transmitted through breast-
feeding or daily shared activities.
HCV infects hepatic cells, with the acute infection stage occurring in a
period ranging from two weeks to six months after onset of the infection; only
20% of the persons in acute stage show symptoms, and less than half of in-
fected people develop natural immunity to the virus54. The remainder develop
chronic hepatitis, a long-term infection that leads to a severe condition of the
liver55 (liver cancer or cirrhosis).
HIV-HCV coinfection is quite frequent, which is due to a similarity
between transmission paths, and to a common behavioral context (approxi-
mately a quarter of HIV infected people are also infected with HCV56). IHIV
infection accelerates progression of hepatic disease57 and increases the risk of
monther-to-infant HCV transmission. Other conditions associated with dis-
ease progression include hepatitis B virus infection, alcohol consumption and
hepatic steatosis58.

Treatment:
Not treated, hepatitis can lead to cirrhosis and cancer, and it can cause
severe secondary conditions. Most of the patients are not aware of the in-
fection they have. Morbidity caused by chronic HCV infection goes beyond
hepatology, as it is also associated with autoimmune diseases, diabetes, lymph-
oproliferative diseases, depression and other cognitive distortions.
The scientific community has had a gradual response to this disease, as
interferon became available in 1991, and the double therapy with interferon
and ribavirin was first initiated in 1998. The therapies available in Romania
are free of charge for insured patients, and are based on a treatment scheme
consisting of two medicines (peginterferon alpha and ribavirin). Studies have
shown that achieving sustained viral response is greatly dependent on the vi-
ral genotype, not only on the treatment scheme. The genotype present in Ro-
manian patients (1b) guarantees therapy success in 4050% of them.
53 Guidelines for the screening, care and treatment of persons with hepatitis C infection. Geneva:
World Health Organization; 2014
54 Hepatitis C. Fact sheet No 164. Geneva: World Health Organization; 2014
55 Hepatitis C FAQs for the Public. Atlanta (GA): US Centers for Disease Control and Prevention;
2014.
56 HCV global prevalence 2013. HCV map. Louisville (CO): Center for Disease Analysis; 2013 (http://
www.centerforda.com/map.htm
57 Joshi D, OGrady J, Dieterich D, Gazzard B, Agarwal K. Increasing burden of liver disease in patients
with HIV infection. Lancet. 2011;377(9772):1198209
58 Mahajan R, Xing J, Liu SJ, Ly KN, Moorman AC, Rupp L, Xu F, Holmberg SD; Chronic Hepatitis
Cohort Study (CHeCS) Investigators. Mortality among persons in care with hepatitis C virus infection:
the Chronic Hepatitis Cohort Study (CHeCS), 2006-2010. Clin Infect Dis. 2014 Apr;58(8):1055-61.

33
Anti-VHC immunoenzymatic screening = positive result

Absent anti-VHC to be repeated

Risk factors assessment Present aminopherase

Normal aminopherase to be
Increased aminopherase - PCR
retested every 6 months

Normal aminopherase to be
Qualitative PCR Quantitative PCR retested every 6 months

Figure 10. Algorithm to diagnose HCV infectionC59

In 2011, more efficient medicines were launched, that lack interferon


and are able to eradicate this infection60. In January 2014, the European Com-
mission approved the first exclusively oral treatments against HCV with a cur-
ing rate during clinical tests of up to 98%61. The treatments received marketing
authorizations from the National Agency for Medicines in 2015.
Unfortunately, no promising vaccine against HCV was available as of the
date of this report.

59 Cernescu C. Actualiti n tratamentul hepatitelor virale Bi C, Editura Medical, Bucureti 2014, pg


158
60 Thomas DL. Global control of hepatitis C: where challenge meets opportunity. Nat Med. 2013
Jul;19(7):850-8.
61 European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) (2014). Perspectives on
Drugs: Hepatitis C Treatment for Injecting Drug Users.

34
Costs of Hepatitis C in Romania

The recently published study Burden of Hepatitis C in Romania the


Case of France and Romania62 determined that currently for around 580,000
persons with HCV Romania allocates about 5 billion Euro (these costs cover-
ing healthcare system costs, medication and indirect costs). Cases with little or
moderate symptomatology represent about 80% of the cases and the costs to
treat these patients raise up to 40% in Romania. The rest of the costs are cover-
ing expenses for patients with cirrhosis and liver cancer associated with HCV.
If the current conditions are to be maintained, it is estimated that the costs of
the health system will double by 2040 in the context of a decrease in preva-
lence; this is mainly due to complications associated with untreated hepatitis
C. For example, it is estimated that the number of patients with decompensat-
ed cirrhosis will increase from 20,000 to 40,000 by 2040; the number of liver
cancers is expected to increase from 2,000 to 4,500 and the annual mortality
is expected to increase from 1,200 to 3,500. The economic modeling has indi-
cated that in the context where the number of patients successfully treated for
HCV increases, the overall treatment costs are expected to decrease by 30%
until 2040 and the annual mortality rate is expected to decrease by 50%.

62 http://www.saptamanamedicala.ro/articole/Hepatita-C-poate-dubla-costurile-sistemului-sanitar-pa-
na-in-2040.html

35
The Level of Organization of the
Romanian Health Systems Response
to the Challenges Raised by Hepatitis C

Although Romania has more than 25 years of experience in assisting


chronic patients infected with HIV, and although progress has been made in
terms of programs to control this health condition which is quite similar to
hepatitis C, the lessons taken with HIV have not been learned and transferred
to the HCV AREA. Chronic hepatitis-related issues are posing serious chal-
lenges to the health system in terms of care integration plans, monitoring,
follow-up, communication between medical specialties involved etc. The re-
port of the presidential health commission63 outlines the lack of integration
of the health services with the system so that care is guaranteed on a continu-
ous basis. The sectors of the Romanian health system are operated separately.
Primary care has no functional connections with inpatient care, and health
promotion and disease prevention activities are not related with curative care.
According to the European hepatitis index, Romania ranks 25th out of
27, with 453 points out of 1,000 in terms of structuring its response to HCV
pandemia. The score refers to indicators such as prevention and screening, ac-
cess to treatment, and national programs. This classification ranks Romania as
the penultimate in HCV management within the global public health system.
Without funds from the government, it is difficult to perform HCV testing.
Under such conditions, great part of infections is detected late, which is why
prevention is not possible in small communities (couples, families etc.).
According to the same index, France and Scotland are in the front rank.
This is mainly due to their hepatitis patient management systems, which were
structured at an early stage by classifying hepatitis as a public health issue ever
since 1990 (France).
Romania is also behind with structuring a viral hepatitis prevention and
control strategy, and it has also failed to answer external fora with respect to
the stage of development of such strategy:

63 http://www.presidency.ro/static/ordine/COMISIASANATATE/UN_SISTEM_SANITAR_CEN-
TRAT_PE_NEVOILE_CETATEANULUI.pdf

36
Responses to the question, Is there a written national strategy or plan that focuses exclusively or primarily
on the prevention and control of viral hepatitis?

37
Figure 11. Existence/Absence of national strategies focused exclusively
on the prevention and control of viral hepatitis C, 2013

As shown in the chart of the World Health Organization, in the Global


policy report on the prevention and control of viral hepatitis C, conducted
in 2013 among the member states of WHO, Romania is in the No response
area, as there are no data about our country.
Concerning surveillance and notification, in 2011, the European Centre
for Disease Prevention and Control noted that the Romanian system for viral
hepatitis notification should be restructured because its current organization
does not enable understanding of the epidemiology of viral hepatitis, or con-
tinuous data monitoring64.
In the past two years, a series of steps have been taken in structuring re-
sponse to challenges raised by HCV. Thus, according to the order of the minis-
ter no. 657/2014, the National Hepatitis Registry was created in 2014, which
is subject to scientific coordination from the Infectious Disease Commission
of the Ministry of Health, and to technical coordination from the Infectious
Disease Institute Matei Bals in Bucharest. The same institute is in charge for
making the electronic data system available to professionals (infectious dis-
ease specialists, gastro-enterologists and hepatologists) who deliver healthcare
services to patients with viral etiology hepatitis, as the HepaReg. The order
regulates aspects related to software administration, data collection and man-
agement, reporting, frequency for reporting stages, and reported data analysis
and transfer to the Ministry of Health. The registry includes five important
components: screening which rests with the family physician. They will have
64 European Centre for Disease Prevention and Control, 2011, Country mission Romania: HIV,
sexually transmitted infections, and hepatitis B and C, Stockholm, ECDC, available at: http://www.ecdc.
europa.eu/en/publications/Publications/MER-Romania-2010-country-mission.pdf

38
a patient exposure risk assessment questionnaire which will help them to de-
cide whether they need detailed evaluations. The other components are: infec-
tion staging, therapeutic recommendations, monitoring and follow-up65.
The strategic directions of the Ministry of Health for the next seven years
are targeted exclusively towards strengthening prevention, early detection of
new cases, clinical and biologic monitoring and antiviral treatment in compli-
ance with national guidelines, minimizing occupational biologic risk for the
system staff, and researching the epidemiologic profile of chronic infections.
The treatment plan and active monitoring are not listed among indicators66,
as it is necessary to perform a subsequent review of the way services are deliv-
ered to patients with chronic conditions.
The national strategy is aimed at organizing public events and awareness
raising campaigns, testing people voluntarily and anonymously for HBV and
HCV, preparing and reviewing clinical guidelines, treating patients with spe-
cific antiviral treatment, and creating a functional registry for hepatitis B and
C. The costs for the national strategy 20142020 are estimated at 4,812,007.50
RON, and the available budget is of 3,347,957.50 RON.
The creation and implementation of national strategies that address cer-
tain public health issues have a measurable impact on the health level of the
population. For instance, as regards hepatitis C, the first country to develop
its own national strategy was Australia67, in 1994. The implementation of the
national strategy, together with all its proposals for improvement, has led to a
significant decrease in new infections (incidence reduction from 105 cases for
100,000 persons in 2000 to only 51 in 200968).
The success of such programs is however dependent upon the creation of
evidence-based implementation recommendations that have clear and mea-
surable targets staged in action calendars. Such an approach was chosen by
the Scottish authorities, who, in only three years (20072009), managed to
achieve a 34% increase in cases diagnosed with HCV, and to double the num-
ber of successfully treated persons69. Romania failed to prepare such a plan
despite being a WHO member, and a signatory of the World Health Assembly
since 2013.
65 Order no. 657/2014 to create and operate the national viral hepatitis registry, in force since
17.06.2014
66 http://www.ms.ro/documente/Anexa1, Strategia Naional de Sntate 2014-2020
67 National Centre in HIV Epidemiology and Clinical Research. HIV/AIDS, viral hepatitis and sexually
transmissible infections in Australia Annual Surveillance Report 2002. (Sydney, NSW: University of New
South Wales. 2002).
68 Australia, Commonwealth Government of. Third National Hepatitis C Strategy 2010 2013, Com-
monwealth of Australia, 2010. http://www.health.gov.au/internet/main/publishing.nsf/Content/ohp-nati-
onal-strategies-2010-hcv
69 Morris, K. Tackling hepatitis C: a tale of two countries. Lancet 337: 9973 (2011) 12271228

39
A strategic action plan for viral hepatitis was created by an international
coalition of patient associations (APAH, ELPA) in 2013. It was submitted to
the Romanian Government. Its provisions sum up the concerns of both pa-
tients and professionals, and refer in particular to the creation of an advisory
group for the Romanian decision making bodies, to the preparation and im-
plementation of a viral hepatitis surveillance system, and, not the least, to the
preparation of prevention policies. Unfortunately, the plan is still in the stage
of proposal. Neither this, nor other plans prepared by ministries or by the
Government have been adopted by now, although pressure is made from in-
ternational bodies, and warnings are issued internally by patient associations.
In Romania, there are general patient associations (such as COPAC -
Coaliia Organizaiilor Pacienilor cu Afeciuni Cronice Coalition of Pa-
tients with Chronic Diseases), as well as organizations that represent the in-
terests of patients with hepatitis (APAH, SANOHEP). Their actions are aimed
at informing and raising awareness among the general public through media
campaigns, online petitions, marches occasioned by various international
events, patient fora and, to a lower extent, lobby or advocacy.

40
The current pathway of patients
affected by HCV

According to statements made by the president of the National Health


Insurance Agency on the World Hepatitis Day in 2014, more than 32,000 pa-
tients benefited from hepatitis C treatment in 2013, the total value of the funds
allocated being of 387.7 million RON. For 2014, the National Health Insur-
ance Agency allocated for six months 86.7 million RON for the treatment of
approximately 10,000 patients with hepatitis C, and allocations of up to 470
million RON are estimated for the treatment of approximately 40,000 patients
for the entire year 2014, according to the same statements (press conference
organized in Bucharest by Mediafax)70.
The figures revealed are comparable to the level of access to treatment
for patients in the period of 20022012. For hepatitis C patients, the treatment
for insured persons is also made available by means of state-owned or private
pharmacies. Access to treatment is possible based on a record prepared by
the specialist physician, submitted to the County Health Insurance Agency
and approved by the National Health Insurance Agency. The investigations
required to prepare the record are partly reimbursed by the insurance system,
while the personal contribution of the patient is in most of the cases between
200 and 225 RON (antibody tests ~ 45 RON, fibrosis test contribution 90/120
RON, other tests ~ 70 RON). These are added transportation costs, given that
the specialists who treat these infections work in county hospitals, costs with
other approvals/investigations, if the treating physician asks them from other
specialists (psychiatrist, cardiologist, endocrinologist etc.) for cases when the
patient diagnosed with hepatitis has a history of conditions where interferon
is not indicated.
The process for referring patients for specialized diagnosis and treat-
ment services begins with a test whereby the level of anti-HCV antibodies is
detected. However, testing indications are missing for this infection, and the
family physician refers the patient based exclusively on their obligation to fill
in a risk sheet once every three years for people under 40 years of age, and
annually for those older than 40 years (see Framework Contract 20142015).
These provisions are however quite new, and hepatitis has been diagnosed

70 http://www.ghidcabinet.ro/2014/07/in-prezent-nu-exista-liste-de-asteptare-pentru-tratamentul-im-
potriva-hepatitei-potrivit-lui-vasile-ciurchea/

41
randomly so far. There are also situations of severe chronic disease when high
values of liver enzymes can trigger an alarm, and help the physician to recom-
mend tests for the presence of a virus.
Once antibodies are detected by the test, the patient is encouraged to
continue investigations, being known that part of infected people can go
through a spontaneous viral clearance, in which case the antibodies are still
present without a detectable viral activity.
According to the Surveillance and Control Guide, having all these re-
sults, the patient is eligible to receive treatment recommendations. To benefit
from free therapy, the patient will submit with the County Health Insurance
Agency a record with the above tests, a medical report and the informed con-
sent form signed by the patient.
The pathway of the record, which takes between 12 years (between
2010 and 2012) and a few months (less than six months since 20132014) is
between the approving commissions of CJAS and CNAS. CJAS sends its re-
sponse directly to the patient, who receives a letter from the agency regarding
its decision. If the record is approved, the patient submits the document to the
specialist physician, who issues monthly treatment prescriptions. Medicines
are obtained from the network of state-owned/private pharmacies based on
the prescription issued by the specialist.
The duration of a standard treatment is of 48 weeks, however recommen-
dations are highly dependent on the virus genotype. Thus, there is a possibility
to have a 6 months treatment (half the standard period) if the baseline viral
load (VL) is below 600,000 copies/mL, VL on first evaluation 4 weeks is un-
detectable, and is maintained through weeks 12 and 24. For persons with a VL
higher than 600,000 copies/mL, the first VL evaluation following the initiation
of treatment is performed after 12 weeks and, irrespective of the resulting val-
ue, the treatment continues up to week 48 if no adverse events render the use
of the medicine impossible. As a matter of fact, the VL is a test made four times
during the treatment as follows: week 12, 24, 48 and 6 months after the therapy
is completed. Week 54 VL (from baseline) is the control key to a successful
treatment. If it continues to be undetectable, it is deemed that the sustained
viral response has been achieved and the patient is declared cured.

42
Figure 12. HCV Patients Pathway in the Health System

If intermediary LV values (week 12, 24) are not detectable or do not de-
crease sufficiently (min. 2log10 compared to the reference value) this is an
indication that the therapy will fail, and the treatment is discontinued.
Throughout the therapy, the treating physician will periodically check
(every 2 weeks in the first month and monthly by the end of the third month)
the complete blood count and the transaminases in order to adjust on the way
the quantity of ribavirin and to avoid potential decreases in hemoglobin down
to the limit where hepatitis treatment can no longer be given.
The therapeutic protocol in assisting chronic hepatitis is a document
that regulates aspects related to patient inclusion criteria, medical monitoring
during treatment, therapy dosage etc. As part of its program entitled Surveil-
lance and control of communicable diseases, the Ministry of Health classified
acute viral hepatitis as a priority. The chronic viral hepatitis surveillance doc-
ument was prepared by the Ministry of Health and published in the Official
Gazette in 2010, and reviewed in 2014.

43
Section B:
Qualitative Research
Hepatitis C: Opinions of Patients and
Specialists on Chronic Care Delivery in
Constana, Romania

44
Part I. Research brief

Systems are perfectly designed to get the results they


achieve Don Berwick

Motivation and applicability of the


qualitative assessment

The importance of an effective care system for patients with hepatitis C is


becoming a priority in Romania during the past years. Thousands of patients
are being treated annually for HCV and thus a system of care is already set in
place. Baylor foundation set to investigate what is the current organizational
model of care for patients with hepatitis C in a region of Romania, namely
Constanta County.
The present evaluation describes the chronic care delivery system for
hepatitis C available in Constanta, Romania, in the context where the work
of the public health system is complimented by the programs and services of
Baylor Foundation. The current evaluation does not apply to other counties
in Romania; a separate study is needed to assess the situation in other coun-
ties, taking into consideration local availability of supplemental resources and
community linkages.
One of the most recognized and established theoretical maps that can
be used in this descriptive process is the Chronic Care Model. This model was
elected to analyze and understand the current format of delivering care for
patients with hepatitis C and to draw a series of recommendations. The model
offers the possibility of future comparing of our findings across systems and
across conditions by interested researchers and stakeholders.

45
Organization of the research related
reading material

The research paper describes the theoretical dimension of the assess-


ment in order to allow the reader to better understand the concepts of the
model and its interpretation. Several evidence based materials regarding the
relevance of the model are also presented in this section. After the theoretical
considerations, the paper presents the methodology, the content analysis and
the findings. Annexes offer supplemental materials to understand the proce-
dures and findings.

46
Part II. Chronic care model

Theoretical and conceptual aspects

During the past decades there has been an increasing pressure on im-
proving outcomes of chronic illness and finding the most effective disease
management approaches. In 2001 the Institute of Medicine published the re-
port Crossing the Quality Chasm: A New Health System for the 21st Century71
and it strongly recommended changing the current system of care so that it
incorporates the needs of patients with chronic illness, as doing the same over
and over again and trying harder will not work.
The relationship between chronic care and the actual organization of the
health care system is described as follows72:
The models that are most useful in caring for the chronically ill are very
different from our current delivery system models. Providing high-quality care
to chronically ill individuals requires well designed care processes focused on in-
formation that meets the self-management needs of patients and their families.
Patients with chronic illnesses require multidisciplinary care from teams of phy-
sicians, nurses, social workers, aides, and others. Team care is essential for high
quality care. Our current health care delivery system, which is organized around
professionals and types of institutions, grew out of a need to provide primarily
acute care rather than chronic care. This is one kind of chasm we have to cross.
The health care delivery system must be reorganized to meet the real needs of
patients.
Frameworks to guide efforts of changing the systems with the immediate
aim of improving chronic care systems have been developed and adopted by
various international Strategic Health Authorities, Quality Assurance Com-
missions and have also been embraced by the World Health Organization (see
WHO global report, Innovative Care for Chronic Conditions: Building Blocks
for Action, published in 2002).
71 IOM (Institute of Medicine) Washington, D.C: National Academy Press; 2001. Crossing the Quality
Chasm: A New Health System for the 21st Century
72 National Academy of Engineering (US) and Institute of Medicine (US) Committee on Engineering
and the Health Care System; Reid PP, Compton WD, Grossman JH, et al., editors. Building a Better De-
livery System: A New Engineering/Health Care Partnership. Washington (DC): National Academies Press
(US); 2005. Crossing the Quality Chasm.Available from: http://www.ncbi.nlm.nih.gov/books/NBK22857/

47
One of the best known broad frameworks was developed at the end of
the nineties by Edward Wagner and his team in U.S. and this model has been
adopted in many settings73 and for various diseases74. Currently, most chronic
care policies are based in various extents on the chronic care model (CCM) 75.
The theoretical model hypothesizes than an effective care for persons
with chronic issues involve creating a system that is able to76:
Mobilize the community resources to meet the needs of people with
long-term conditions
Create mechanisms that promote safe, high quality care
Actively prepare people to manage their health and healthcare,
Ensure efficient self-management support,
Promote care that is consistent with research evidence and patient pref-
erences,
Organize patient and population data to facilitate effective care.
Briefly, the model states that the delivery of services that improve the
clinical outcomes of chronic illness can only be assured if there are productive
interactions between the patients and the practice teams of health care profes-
sionals77. The productive interactions call on having the two parties involved
in these interactions in special states, called activated states. In other words,
patients need to be informed, motivated to act and prepared (have the health
related skills and confidence in their efficacy to use their skills), while practice
teams need to be prepared and proactive (with access to information, decision
support and all the resources needed to deliver care). The model clearly em-
phasizes that the healthcare system is not an isolated entity and that healthcare
delivery is not limited to various medical settings, rather a substantial part of
chronic care happens outside the formal health settings.
Productive interactions are defined as those that allow for the delivery
of evidenced-base disease care in a systematic care so that the patients needs
are met. They are described as being in contrast with the current interaction
model that is unsatisfactory for both the patient and the provider. Interactions
can be: face to face, phone interactions and/ or email communication.
73 Stroebel RJ, Gloor B, Freytag S et al. Adapting the chronic care model to treat chronic illness at a free
medical clinic. J Health Care Poor Underserved 2005; 16(2): 286-96,
74 Siminerio LM, Piatt G, Zgibor JC. Implementing the chronic care model for improvements in
diabetes
care and education in a rural primary care practice. Diabetes Educ 2005; 31(2): 225-34
75 Ham C, Singh D. Improving care for people with Long Term Conditions: a review of UK and Inter-
national framework.2006 ISBN 07044 2584X - HSMC, University of Birmingham.
76 Wagner EH. Chronic disease management: what will it take to improve care for chronic illness? Eff
Clin Pract 1998; 1: 2-4
77 Wagner EH, Davis C, Schaefer J, Von Korff M, Austin B. A Survey of Leading Chronic Dis-
ease Management Programs: Are They Consistent with the Literature?Managed Care Quarter-
ly.1999;7(3):5666.

48
Figure 13. The chronic care model. Apud Wagner, reproduced with permission
of the American College of Physicians (ACP)

The Chartbook of Chronic Care Model, developed by Improving Chron-


ic Illness Care group78 lists that the productive interactions can be operation-
alized in a system by the existence of the following elements:
Assessment of the self management skills and conficence, as well as clin-
ical status
Tailoring of clinical management by stepped care protocols
Collaborative goal-setting and problem solving resulting in a shared care
plan
Active and sustained follow-up
The productive interactions described by the chronic care model arise in
the context of changed practices that call for redesign of operations and pro-
cedures on four main areas: self-management support, delivery system design,
decision support and clinical information systems.
78 http://www.improvingchroniccare.org/index.php?p=Presentations_&_Slides&s=397

49
Self-management support emphasizes the central role of the patient in
the care relationship and it is supported by evidenced based recommenda-
tions stating that the likelihood of achieving optimal outcomes in chronic care
increase when the patients are partners in the process of managing the illness.
By providing self management support patients and families receive from the
health provider (and the larger system) the needed help in order to cope with
the challenges associated with the specific health problem they face79. The col-
laborative relationship involves patients involvement in setting the care goals,
choosing the treatment plans and identifying ways to solve problems that arise
while implementing the care plan. Self management support can be delivered
in the context where there are appropriate educational tools, programs for
skills training and services of psychosocial support, including behavioral in-
terventions. The system can incorporate such services by participatory pro-
cesses such as focus groups, advisory boards and expert panels. The results of
these processes are to be incorporated into the design of the support services
for patients and families.

Delivery system design refers to the structure of the care team and the
predefined pathways of interaction between the team and the patients; the de-
sign of the delivery system directly contributes to the effectiveness of the care
process (both clinical outcomes and the self management level). This compo-
nent of the model descibes the need for well defined tasks among team mem-
bers (clinical, non-clinical) and a clear intention for structured and planned
interactions. Unlike the acute care design, the chronic care delivery system is
more effective if they are based on a planned interaction80, that uses an agenda
and a structured communication plan (such as the SBAR81 communication
structure: situation- background- assessment-recommendation). The use of a
case manager (not necessarly the treating physician) that is able to intergrate
information about the patient and create a coherent care plan is of utmost im-
portance for a patient with longer term needs. It has been evidenced that the
use of a case manager and/or health educator is effective82 in several chronic
conditions especially when the plan is associated with follow-up83; creativity

79 Von Korff, M., et al. Collaborative Management of Chronic Illness. Annals of Internal Medi-
cine127, no. 12 (1997): 10971102
80 McCulloch et al. Effective Clinical Practice 1998; 1:12-22 and Disease Management 2000; 3(2):75-82
81 Dunsford, Jennifer (October 2009). Structured Communication: Improving Patient Safety with
SBAR. Nursing for Womens Health 13 (5): 384390.
82 Simon et al. Randomized trial of monitoring, feedback, and management of care by telephone to
improve treatment of depression in primary care. BMJ. 2000; 320:550.
83 Piette et al. Impact of automated phone calls and nurse calls on diabetes in the VA, Diabetes Care
2001

50
is required in order to implement follow up, and research has been suggesting
that planned group visits84 and telephone follow up85 are efficient and time
efficient methods.
Efficient case management involves the regular assessment of the follow-
ing elements:
Level of disease control/ symptoms, adherence and self-mangement sta-
tus
Immmediate action based on the results of the assessment: change treat-
ment, inform primary care providers about changed needs
Provide self-management support: reffer for psychosocial services, sup-
port group, educational sessions etc
Ensure temporary sustained follow up, until the problem is stabilised
Decrease barriers associated with navigating the healthcare system.

Decision support is a component of the chronic care model that refers


to assuring for the providers the access to the expertise necessary to offer ef-
fective care to the patients. In other words, the system needs to allow prac-
titioners to easily identify the best care that can be offered (as suggested by
guidelines and best practices) and to translate the guideline recommendations
into usual care in the chronic care system. Decision support allows to promote
clinical care that is consistent with scientific evidence and compatible with pa-
tient preferences. It is also suggested to share guidelines and information with
patietns, so that they can understand why a particular decision or procedure
is being performed.

Clinical information systems indicates to organize patients and popula-


tion data to facilitate efficient care. This imply to set up a disease registry that
describes performance and results of health care and allows to identify and
target specific interventions for populations that are at risk. For example, an
electronic medical record should provide reminders for providers, facilitate
individual patient care planning,share information on performance and so on.

Community resources and policies refers to taking into account the en-
tire offer of resources and services for patients that are not part of the medical
system, but can offer complementary support for the care goals of patients.
84 Beck, A., et al. A Randomized Trial of Group Outpatient Visits for Chronically Ill Older HMO
Members: The Cooperative Health Care Clinic. Journal of the American Geriatric Society45 (1997):
543549
85 Wasson, J., et al. Telephone Care as a Substitute for Routine Clinic Follow-up. Journal of the Amer-
ican Medical Association267, no. 13 (1992): 17881793

51
Examples include services offered by humanitarian organizations, exercise fa-
cilities, spiritual and faith based organizations etc. The model emphasizes the
importance of mapping community services, partnering with those (formally
and informally) and connecting patients with the auxiliary services in order
to ensure a continuum of care. The linkages with the community includes also
the common action, such as advocacy efforts to support patients and the elab-
oration of common strategies and workplans, with coordinated actions.

The health system organization component of the chronic care model


refers to the establishment of an organizational culture that is focused on qual-
ity care for patients with chronic issues and the organizational mechanisms
that allows to achieve the measurable care goals. The health system must have
in place the leadership, incentives and resources to help practices change to meet
the needs of chronically ill patients86.

To summarize the above components, the chronic care model involves


the existence of the following aspects87:
Self management support:
Patient education
Patient activation and psychosocial support
Self-management assessment
Self- management resources and tools
Collaborative decision making with patients
Guidelines available to patients
Delivery system design:
Care management roles
Team practice
Care delivery coordination
Proactive follow-up
Planned visit
Visit system change
Decision support:
Institutionalization of guidelines and use of prompts to use guideline
Provider education
Expert consultation support
86 Wagner EH, Davis C, Schaefer J, Von Korff M, Austin B. A Survey of Leading Chronic Dis-
ease Management Programs: Are They Consistent with the Literature?Managed Care Quarter-
ly.1999;7(3):5666
87 Tsai AC, Morton SC, Mangione CM, Keeler EB. A meta-analysis of interventions to improve care for
chronic illnesses. Am J Manag Care2005; 11(8): 478-88

52
Clinical information systems:
Patient registry system
Use of information for care management
Feedback on performance data
Community resources
For patients
For community
Health care organization:
Leadership support
Provider participation
Coherent system improvement and spread

The chronic care theoretical model (CCM) was tested and based on the
published evidence it was revised to include cultural competency, patient safe-
ty, care coordination, community policies, and case management (see below).

Figure 14. The care model, developed by the Maccoll Center

53
The published reviews88 have proven that the CCM improves the deliv-
ery of care and patient health outcomes when practices are designed in accor-
dance with its principles and recommendations. Moreover, the practice rede-
sign is efficient when it takes into account most or all of the components of the
model. Cochrane reviews regarding interventions that improve outcomes of
chronic care89 have proven that no single intervention seems to make a major
difference (ie: interventions to change the typical behaviour of the clinician,
interventions that were directed at the patient involvement, interventions tar-
geting the design of the practice or improvement of the clinical information
systems). However, as the number of interventions in different components of
the model increased, the effectiveness of the program increased. In contrast,
when looking at the studies of practice interventions that involved changes in
all four categories90, there was a positive impact on both process and outcome
measures, including reduced costs of health care delivery.
Canadian policy makers have adapted the CCM91, since their analysis
showed that the model was focused on clinically oriented systems, making
it difficult to apply to prevention and health promotion activities. The mod-
el was further enriched to include population health promotion components
such as the social determinants of health and enhanced community partici-
pation and it was renamed the Expanded Chronic Care Model (see below).
As defined by the World Health Organization health promotion is the
process of enabling people to increase control over, and to improve their health92,
changing the focus of responsibility from the health sector to the larger society.
By integrating the population health with the prevention and management of
chronic disease, the expanded model tackles simultaneously the determinants
of health as well as the delivery of high quality health services. While the clin-
ical outcomes result from productive interactions, the population health out-
comes result from productive interactions among community representatives.
The new model provides more details regarding the roles of the community
(building policies, creating supportive environments, initiating community
action) and also the influence of the community in shaping the main compo-
88 Coleman K, Austin BT, Brach C, Wagner EH. Evidence on the Chronic Care Model in the new
millennium. Health Aff (Millwood). 2009 Jan-Feb;28(1):75-85
89 Renders et al, Diabetes Care, 2001; 24:1821
90 Bodenheimer T, Wagner EH, Grumbach K. Improving Primary Care for Patients With Chronic
Illness: The Chronic Care Model, Part 2. JAMA. 2002;288(15):1909-1914.
91 Barr VJ, Robinson S, Marin-Link B et al. The expanded chronic care model: an integration of con-
cepts
and strategies from population health promotion and the chronic care model. Hosp Q2003; 7(1): 73-82.
92 World Health Organization, The Ottawa Charter for Health Promotion, 1986, http://www.who.int/
healthpromotion/conferences/previous/ottawa/en/

54
nents of the model (self-management, delivery system, decision support and
information systems). The model is useful for development of coordinated
and effective prevention and management of the chronic conditions, but cur-
rently the model is still to be tested in practice.

Figure 15. The expanded chronic care model, developed by Virgina Barr et al, 2003

55
Assessment of chronic illness care the
ACIC tool

The components of the CCM can be evaluated using a tool that was de-
veloped to measure current level of development of the six components as well
as tracking changes over time, by recording the progress made on any compo-
nent as a result of a redesign process93. The ACIC questionnaire has of 34 items
measuring strengths and weaknesses of the six areas of the CCM: health care
organization (6 items); community linkages (3); self-management support (4);
delivery system design (6); decision support (4); clinical information systems
(5). The ACIC also covers integrating the six components, such as linking pa-
tients self-management goals to information systems (6 items)94. A shorter 21
item version was recently developed by a Dutch research group95.
The items of the ACIC tool request from the respondent to score on a
scale from 1 to 10 the level of development in their organization/ health facil-
ity of the following elements:

Organization of the Healthcare Delivery System


1. Overall organizational leadership in chronic illness care
2. Organizational goals for chronic care
3. Improvement strategy for chronic illness care
4. Incentives and regulations for chronic illness care
5. Senior leaders
6. Benefits

Community linkages
7. Linking patients to outside resources
8. Partnership with community organizations
9. Regional health plans

Self-management support

93 Bonomi AE, Wagner EH, Glasgow RE, VonKorff M: Assessment of Chronic Illness Care (ACIC): A
Practical Tool to Measure Quality Improvement. BMC Health Serv Res2002,37(3):791-820
94 MacColl Center for Healthcare Innovation:Assessment of Chronic Illness Care Version 3.5.[http://
www.improvingchroniccare.org/downloads/ acic_v3.5a.pdf],
95 Cramm, Jane M., et al. Development and validation of a short version of the Assessment of Chronic
Illness Care (ACIC) in Dutch Disease Management Programs. Health Qual Life Outcomes 9.49 (2011):
1-10.

56
10. Assessment and documentation of self-management needs and ac-
tivities
11. Self-management support
12. Addressing concerns of patients and families
13. Effective behavior change interventions and peer support

Decision support
14. Evidence-based guidelines
15. Involvement of specialists in improving primary care
16. Providing education for chronic illness care
17. Informing patients about guidelines

Delivery system design


18. Practice team functioning
19. Practice team leadership
20. Appointment system
21. Follow-up
22. Planned visits for chronic illness care
23. Continuity of care

Clinical information systems


24. Registry (list of patients with specific conditions)
25. Reminders to providers
26. Feedback
27. Information about relevant subgroups of patients needing services
28. Patient treatment plans

Integration of chronic care components


29. Informing patients about guidelines
30. Information systems/registries
31. Community programs
32. Organizational planning for chronic illness care
33. Routine follow-up for appointments patient assessments and goal
planning
34. Guidelines for chronic illness care
ACIC is a tool that can be applied in various health-care systems, includ-
ing hospital based settings, community health centers or for profit medical
providers.

57
Recommendations to improve care
based on CCM

The Institute for Healthcare Improvement establishes a series of practical


recommendations and changes for improvement that are to be implemented
by systems interested to plan and implement a theoretically sound and evi-
denced based change process96. The recommendations are listed below, per
each CCM component:

Change recommendations regarding self-management:


Train Providers and Other Key Staff on How to Help Patients with
Self-Management Goals
Use Self-Management Tools That Are Based on Evidence of Effectiveness
Use Group Visits to Support Self-Management
Set and Document Self-Management Goals Collaboratively with Patients
Follow Up and Monitor Self-Management Goals

Change recommendations regarding delivery system design:


Use Planned Interactions to Support Evidence-Based Care
Ensure Regular Follow-Up by the Care Team
Define Roles and Distribute Tasks Among Team Members

Change recommendations regarding decision support:


Embed Evidence-Based Guidelines into Daily Clinical Practice
Integrate Specialist Expertise and Primary Care
Use Proven Provider Education Methods
Share Evidence-Based Guidelines and Information with Patients to En-
courage Their Participation

Change recommendations regarding clinical information systems:


Share Information with Patients and Providers to Coordinate Care
Provide Timely Reminders for Providers and Patients

Change recommendations regarding healthcare organization:


Make Sure the Senior Leaders and Staff Visibly Support and Promote the
96 http://www.ihi.org/resources/Pages/Changes/ChangestoImproveChronicCare.aspx

58
Effort to Improve Chronic Care
Encourage the senior leader to:
Visit the clinical team.
Speak about the improvement effort in all-staff meetings.
Participate in writing the aims and goals of the initiative and pro-
vide guidance for the clinical team.
Make monthly updates to the community.
Present local morbidity/mortality data to the Board of Directors
to make a compelling case for the need to change current practice.
Have the physician champion share tested tools and interventions at
provider meetings to engage interest and involvement.
Have team members present improvement activities at staff meetings.
Have the senior leader help identify the most enthusiastic and re-
spected clinician to be on the improvement team and test changes in
his/her practice.

Change recommendations regarding community support:


Encourage Patients to Participate in Effective Community Programs
Form Partnerships with Community Organizations to Support and De-
velop Interventions That Fill Gaps in Needed Services

Final comments regarding the CCM


usefulness and limitations

The CCM has been extensively researched in various observational stud-


ies and consistent evidence has been gathered about each component of the
model. There is evidence that single and multiple elements of the CCM leads
to better care, improved clinical outcomes and more effective resource use.
There is not enough evidence whether all components of the model are equal-
ly effective or essential for improving care. There is no comparative evidence
whether this framework is better than other frameworks, mainly because
there are no many other models formulated already97.

97 Ham C, Singh D. Improving care for people with Long Term Conditions: a review of UK and Inter-
national framework.2006 ISBN 07044 2584X - HSMC, University of Birmingham.

59
Part III. Qualitative assessment findings

Aim of the qualitative assessment

Baylor Foundation set up to evaluate the current structure of the care


available for patients affected by hepatitis C virus (HCV) in Constanta, Roma-
nia against the components of the Chronic Care Model, in order to identify
areas for improvement, gaps and possible recommendations for increasing the
quality of care. This was done in the context where services for HCV care are
provided by the public sector and by Baylor foundation. A secondary objec-
tive was to identify priority areas of service development and improvement for
Baylor Foundations HCV development strategy.

Methods

To collect the data for the evaluation, qualitative collection methods


were selected, in order to ensure enough information that will help under-
stand the current issues specific for the description of strengths and challenges
embedded in the structure of the current care for HCV. Qualitative evaluation
is also most appropriate where little is already known about the subject of
interest or where specific details are required from individual participants98.
The following methods were chosen by the team:
focus groups group interviews with people sharing similar characteris-
tics, led by 1 or 2 facilitators, based on a group interview guide99;
individual interviews to explore experiences, beliefs and attitudes of
the stakeholders in regard to the topic of the level organization of the
HCV care in the region.
Both methods were applied using semi-structured interviews, since this

98 Gill P, Stewart K, Treasure E, Chadwick B. Methods of data collection in qualitative research: inter-
views and focus groups. Br Dent J. 2008 Mar 22;204(6):291-5.
99 Barnett J. Focus Group Tips for Beginners. Texas Center for the Advancement of Literacy and
Learning. http://www-tcall.tamu.edu/orp/orp1.htm

60
type of guided data collection allows for the identification or elaboration of
information that is important to participants, but may not have previously
been anticipated of as relevant or important to include by the research team.
Focus groups and one to one interviews were carried out by an indepen-
dent organization commissioned by Baylor to conduct the fieldwork during
9-12 September 2014 in Constanta and 1-20 October in Bucharest. The aver-
age duration of focus groups and interviews was of ~90 minutes. All interviews
were recorded on an audio-recorder and were later transcripted verbatim.
The semi-structured interviews guides covered the following categories
of information:
Information systems: epidemiologic information, registries, informa-
tion about relevant subgroups of patients needing services
Examples of questions: What is the prevalence of hepatitis C in Ro-
mania? Is there a National Registry for people affected by hepatitis
C? How people at risk, insured and uninsured, are identified and di-
rected to testing services? To whom do you recommend testing for
hepatitis C? Are there any groups of population that systematically
are less likely to receive treatment in the public health system? Which
are these groups? Why are they less likely to receive treatment in the
public health system?
Decision support: information about modalities of taking clinical deci-
sions collaboration between practitioners, level of provider education,
informing patients about guidelines
Examples of questions: Who recommends and establishes the treat-
ment scheme? How do you collaborate with other specialists (infec-
tious, internists, psychiatrists, etc.)? Which are the categories of per-
sonnel involved in the detection, treatment and monitoring patients
with hepatitis C? Are they properly trained? What is the time interval
the patients (with and without treatment) are evaluated at? What does
the monitoring and evaluation imply? How long does this stage take?
How do you explain to the patients the results of the reactive rapid
test? How do you explain to the patients the positive results? What do
you recommend in each situation?
Delivery system design: use of an appointment system, follow-up,
planned visits, continuity of care
Examples of questions: How do you keep in touch with patients
(communication system)? Out of the total number of patients how
many follow the monitoring and evaluation program and visit you

61
periodically? What is the general practitioner role during this phase?
What support do you offer in putting together the treatment required
documents? Are there waiting lists? How many persons are on these
waiting lists?
Questions for patients: Please describe how was the interaction with
the health system (public and / or private) during the screening pro-
cess until monitoring (interaction with the system and medical staff
at different levels of the system) and the main barriers encountered
in accessing medical services; Please make the history of doctors and
places You went in the public or private sector? How long did it last
from identifying symptoms and diagnosis to getting treatment? How
often do you visit the doctor for check-ups? What does the check-up
implies?
Self-management support: addressing concerns of patients and fami-
lies, ensuring access to effective behavior change interventions and peer
support:
Examples of questions: Do you (patient) have a delegated person/ a
case manager/ medical staff (nurse, doctor, and specialist) that you
can talk to about the disease? What type of support provides you?
Which is the best source of support for you (patient)? How do you
(practitioner) support patients embracing a healthy lifestyle? Do you
(practitioner) think it would be useful to implement a personalized
plan for encouraging a healthy lifestyle for your patients?
Questions for patients: Did you received counseling before / after test-
ing? What information did you received about the disease (about the
widespread of hepatitis C, impact and evolution of the disease, possi-
ble treatments, where you can find more information and get support,
etc.)? Who gave you this information? How did you communicate
with the medical staff?
Organization of healthcare system: existence of organizational goals for
HCV care, regulations, incentives, leadership
Examples of questions: Which are the national priorities regarding
hepatitis C? Is there a national strategy to combat hepatitis C? What
is the legislative context? What is the budget allocated by the state to
cover the costs of treatment for hepatitis C? What should a national
program for hepatitis C include? Are there any prevention programs?
What should they include? During the lasts years, were there any na-
tional awareness/ information campaigns regarding hepatitis C? If so,

62
what was their impact? If not, would you consider them useful? How
should they be conducted? Which are the main recommendations to
improve the situation of patients with hepatitis C?
Community linkages: partnerships with community organizations, re-
gional health plans
Examples of questions: Are you (practitioner) aware if there are alter-
natives to state run services in the private / NGO sectors? Are there
any NGOs active in this field? What is the involvement of NGOs
working in the field, of patients associations etc.?

Participants

Convenience sampling was used to recruit participants. Phone calls were


made to invite participants and those were followed by written invitations ex-
plaining more about the purpose of the assessment, the time demands as well
as the facilitators of the data collection.
59 patients were invited to participate, 43 accepted to participate, finally,
36 did attend the focus groups. The reasons why the persons that had the
intention to participate, did not attend the meeting are not known; the
patients that declined the invitation were mainly not able to attend due
to schedule conflicts, including travelling.
16 family doctors were invited to participate in focus groups and all have
expressed their intention to attend the meeting; 10 have actually been
present, the reasons for those skipping the meeting are not known.
13 specialists and service providers were invited to participate in inter-
views; 3 specialists have declined the invitation (Ministry of Health, dia-
betes specialist and psychiatrist) for various reasons: not knowledgeable
about the hepatitis C issue or busy schedule.
A total of fifty-six persons (patients and professionals) accepted to be
part of the interviews/ focus groups and were included in the qualitative as-
sessment; the main groups targeted were:
patients with hepatitis C (in various stages of the disease), from Con-
stanta County, who have benefited of services provided by the Baylor
Foundation;
clinicians, including medical specialists and psychologists from public

63
hospitals and general practitioners (GPs), from Constanta and Bucharest;
specialists in the health policies sector, both at local and national levels;
representatives of civil society organizations active in the field, from
Constanta and Bucharest.
Data collection was based on semi-structured interviews with specialists
and organizations of patients and focus groups with patients and GPs. The
interviews and focus groups discussions followed five semi-structured guides,
which are included in Annexes.

No. of inter- No. of partic-


views/ ipants
Focus groups
Interviews, of which: 10 10
- Patient organizations 2 2
- Medical specialists 5 5
- Specialists in the health policies sector 3 3
Focus groups, of which: 7 46
- Patients 5 36
- General Practitioners 2 10
Table 13. Distribution of interviews / focus groups and respondents

service providers patients with


hepatitis C
Total number of interviewees, of which: 20 36
Medical professionals 15 -
Policy specialists 3 -
Patient organizations 2 -
Women 19 22
Men 1 14
Rural 3 5
Urban 17 31
Age: 18-45 years - 9
Age: 46-65 years - 16
Age: >65 years - 11
Table 14. Distribution of interviews / focus groups and respondents

64
Analysis of the qualitative data

Verbatim transcripts in Romanian were analyzed by two researchers


(AMS and MB) using thematic analysis100. Using the theoretical components
of the Chronic Care Model (CCM), the procedures of performing the qualita-
tive analysis of the verbatim transcripts were established.
A coding manual was elaborated using the items of the ACIC tool and
codes were established for all six components of the CCM. In order to pre-
cisely identify the constructs of each component of the model, the ACIC eval-
uation tool was examined and item content was associated with a specific sub-
theme. The code was also analyzed on wheatear it indicates the absence, the
relative development or the presence of the feature that was examined.
For example, a text coded for the domain community linkages could
be ranked as little support, basic support, good support or full support, thus
showing not only the existence of the theme, but also the level of development
of that specific feature. Codes for items in the ACIC tool that were not iden-
tified in the themes of the verbatim transcripts were also highlighted in the
final analysis.
The two researchers have individually coded the transcripts using the
coding manual. The codes allocated were afterwards compared; disagreements
were solved using consensus and comparative analysis was used re-iteratively.
Each summary table also groups the issues associated with the state-
ments from the participants as:
current needs (aspects that participants consider should be developed
in the future)
current capacity (aspects that are currently in place, on which services
can be built on, as suggested by participants)
proposed solutions and ideas generated by the participants during the
interviews and focus groups

100 Paill P:Qualitative par thorisation.In Dictionnaire des methods qualitatives en sciences humaines
et sociales.Edited by Mucchielli A. Paris: Armand Colin; 2009:214220

65
Results

The interviews and focus groups allowed for the collection of a wealth
of data that were organized on all six components of the CCM. Assessment
per each component is summarized below, together with general comments
regarding the integration of all the components.
Regarding the healthcare system organization among the issues that are
well defined the interviews revealed the following aspects:
financial resources mobilized for the treatment: the hepatitis C treat-
ment is completely subsidized by the National Insurance Fund, for all
patients that have a health insurance; however, there is not a fixed budget
allotted for HCV treatment, each countys Health Insurance Fund being
responsible for the level of prioritization of the disease and for the num-
ber of patients that can be treated per year.
good detection of hepatitis C among pregnant women thus making
it the most systematically implemented recommendation. This recom-
mendation is usually being made by family doctors or gynecologists.
However, testing for pregnant women is now always subsidized, but
most women in Constanta region are able to pay for their blood tests or
to use a community resource, such as Baylors free of charge rapid testing
program or other temporary free of charge campaigns.
partnership in place between various pharma companies and Roma-
nian Health Insurance Fund allows for subsidized detection of HCV
viral loads for patients with approval for treatment. This is managed ex-
clusively based on vouchers distributed by pharma to specialists.
The most prominent aspect that results from the qualitative analysis is
the fragmentation of healthcare. Patients have to understand, master and
manage the relationships between at least 3 different institutions/organiza-
tions:
1. the organization that provides the specialized HCV care ( where the
specialist is affiliated)
2. the National Insurance Fund (where the file for treatment is submit-
ted, the approval for treatment is obtained and the renewal of every
monthly prescription is requested)
3. the family physician office (who is supposed to integrate all informa-
tion about patients and ensure follow-up).
Starting from the file [for treatment approval]you start runningfirst

66
this doctorthan you go to the other doctor.than from that doctor, you run
to the other. Ok, I can accept that, but when you get the approval [to get free
treatment], every month you go to ask for the prescriptiongo hand over the
prescriptionstamp me this piece of paper, stamp me that
This experience [treatment approval files] is for the patients like Purga-
tory
There is insufficient coordination between the actions and interventions
developed between the 3 organizations listed above, and this creates disconti-
nuities in care. Interviews revealed the following issues that are listed from up
level of the system to the bottom one:

Current needs Statements


leadership in chronic HCV [physician] There has been more than 2 years since
care needs to be defined; we hear about promises about a national program;
there is no national pro- no one knows yet how it will actually look like
gram, nor national strategy
to support the prevention, [physician] There are no specific actions in this
treatment and care of persons direction, and this is my short answer regarding
affected by HCV, nor the the HCV policies
integration of these compo-
nents. Individual initiatives [physician] I am sorry, maybe one can consider
or isolated projects do exist, that I talk ill about my fellow doctors, but I believe
but efforts are not connected that we need to have a durable national program
with each other. to detect HCV; because now one detects it only by
chance and it is such a pity to die because of this
these days
goals and strategies for [ physician] Here at the hospital, we do not actively
hepatitis detection focused look for patients with HCV; not even when their
on patients with symptoms transaminases level is high, we still do not test for
that may flag the existence of the virus; we can order an echo graph or other in-
HCV need to be set vestigations, just to stay within the budget.there
is always the issue of funding
need to identify cases in a [physician] The majority of patients in my care has
more systematic way, instead been diagnosed completely by hazard, usually be-
of by chance cause they came to the hospital for other illnesses.

Were there HCV screening programs?


At the hospital where I work, never!
No?
Unfortunately, no

67
[Patient] I had no symptoms whatsoever I
simply saw the testing announcement on the street
[regarding Baylor free of charge screening pro-
gram] and I made an appointment and took the
test
need for timely detection of [ physician] As a specialist I see very many
new cases patients that are diagnosed at very advanced stages
of diseases progression.many are not diagnosed
at all.
need to expand the network [patient association representative] There are
of specialty doctors (gas- counties where there are very few doctors that are
tro-enterologists, infectious specialized in treating hepatitis, so patients have to
diseases specialists, hepa- travel to big cities or to university centers.
tologists, internal medicine
specialist)
[public health representative/] Family doctors have
need to develop incentives a very important role in prevention of HCV. When
and regulations to increase they encounter a situation of hepatic cytolysis,
HCV screening in the prima- they should immediately think about screening
ry care network that patient. And, again, when they identify risk
situations, he should recommend testing for HCV.
Screening everyone is not feasible, but one can
educate, sensitize the family of the patient. So, yes,
family doctors should play a very important role
need to allocate appropriate [ physician] I talk about the problems at the hos-
resources for timely follow- pital where I work: it has been more than a year
up of patients since we have not been able to detect the hepatitis
viruses B and C, due to technical and financial rea-
sons. Bio molecular and echo graphic tests suggest
hepatitis, but we cannot run the confirmatory tests.
need to decrease financial [patient association] For example, one is hospital-
burdens for hospitalized, ized for an affection. During the hospitalization
insured patients one does not receive any prescription from the
family doctor and he has to buy the medication
from the commercial pharmacies. The hospitals do
not provide the medication because the pharmacy
might not have the medication.

68
Current capacity Statements
free of charge testing is par- [patient] One gets tested for free [in the public sys-
tially available tem] if he goes to donate blood; it is free of charge
thenand here, at this foundation [Baylor]oth-
erwise, everywhere you go, to any other laboratory
you have to pay
easier referral process for [Baylor project manager] We encourage the pa-
those potentially exposed is tients with confirmed HCV to refer their families
available, but limited to the for testing as well. Our procedure allows to family
NGO community provider members of patients exposed to HCV to come at
our center and get tested without a prior appoint-
ment (no waiting time) .

Proposed solutions Statements


system organized around [HCV specialist] I believe that family doctors
specialty doctors needs to should be the ones that would gather all the infor-
include additional support, mation about the patient and manage it, make sure
such as by increasing the role to follow up on the patient and refer him to other
of family doctors in the HCV specialists, if necessary It is not the task of any
care specialist to integrate the HCV patient, even if we
are doing it many a times. I am aware that family
doctors also have very many patients and they
are very busy too, but in my mind this would be a
normal situation, to have a higher responsibility of
the family doctor in the management of the HCV
patients
prevention of hepatitis C [public health representative] It is the responsibil-
at the primary care level ity of the family doctor to explain to the patients
should be tailored, instead of about prevention of various affections, including
having a one measure fits all hepatitis C, when patients come for their annual
protocol visit. This is something new that has been intro-
duced into the contract [between the doctor and
the Health Fund]. Once a year, patients meet with
their doctor and he presents everything.

69
inter-disciplinary consults [Patient 1] I was not sent to the endocrinologist
need to become the norm [Patient 2] And they did not sent you also to the
cardiologist?
[Patient 1] No, noDid you?
[Patient 2] Yes, I was referred to the endocrinolo-
gist, I was also sent to check my heart

[endocrinologist] I always refer my [HCV] patients


to my colleagues that are specialized in this disease
Note: by December 2014, the Romanian authorities have released a doc-
ument regarding the surveillance procedure for the reporting of hepatitis cas-
es101, in order to be able to identify trends of hepatitis, vulnerable groups and
risk factors specific to Romania.
Regarding community linkages the general observation is that its devel-
opment is at an incipient stage and this makes sense with the situation where
the healthcare organization of HCV care as a chronic disease is also still at an
incipient stage. Community linkages domain requires a great deal of program
design and development regarding the prevention and chronic care of hepa-
titis C.
There are only two HCV patient organizations in Romania, who act es-
pecially on advocacy, policy development and general education; at the stage
of this report, their activities were not correlated and one patient organiza-
tion has been known to activate in Constanta, but only for specific, single
time events- such as sensitization days. NGOs that directly offer services are
limited in number and scattered. Community linkages are limited to Baylor
foundation- in the region, most partnerships being created ad-hoc, between
private practitioners and support organizations, out of the desire of helping
patients.

101 http://www.insp.gov.ro/cnscbt/index.php/metodologii/hepatite-virale-b-si-c/155-metodologia-de-
supraveghere-a-hepatitelor-virale-tip-b-si-c-actualizare-05-12-2014-pentru-anul-2015/file

70
Current needs Statements
need to ensure a supportive [public heath representative] First of all, those that
environment so that vulner- are uninsured would never go to the family doctor in
able groups can access health the first placethere are also costs associated with
care timely. going there, so this is a huge barrier.
need to create regional [public heath representative] The fact that an
health plans and more organization, such as Baylor, has become involved
coordination between key in this campaign, it is proof that the support of an
players, including NGOs and NGO is required, to support family doctors and the
patients associations population in general, because there are not national
programs right now.

[public heath representative] The only thing that


we truly need is the counseling part. To help the
patient understand what is going to happen to him,
to understand the risksand I think it is important
to discuss with Baylor and think about distributing
some first line information to the family doctors; also
some training are necessary, to help family doctors
do counselling about HCV. I think organizing some
discussion groups with Baylor about next steps in
counselling patients that are already diagnosed with
HCV give family doctors some tools, how to do
such a counseling in ten minutes or sothat will
make things easier for the doctors.

need for improved mapping Are you aware of any NGOs that are active in the
of community resources area of HCV? Do you work with any of those?
and easier ways to connect [physician] I do not collaborate with any organiza-
between the institutions tion.
But do you know about any organizations?
I dont even know they exist. This is the first time
when I hear. I am not sure there is anything they
can do about hepatitis

[ specialist] If my friend, who is a family doctor,


wants to refer someone to the foundation [Baylor, for
testing], how can the patient have access. I am asking
because I do not know. How does he send the pa-
tient? With a referral letter? Here, at the hospital, we
send to Baylor office [within the hospital] the patient,
with the nurse and his hospitalization document.
But, what is the procedure for the family doctor?

71
need to raise awareness How about the role of NGOs in offering coun-
regarding the added value of selling services?
community resources to the [specialist] I have to admit, I did not think about
healthcare process this before. Yes, we are always chased from one task
to another, we never have time, so many a times
the patient remains with less information then he
actually would needyes, counselling would be
quite helpful.

Current capacity Statements


once established, community How did you [patient] find out about the founda-
linkages create improved tion?
pathways for patients My doctor has sent me here. I went to the family
referral doctor, I asked for blood tests and she explained
how to come to the foundation.

[patient statement]: I think that private offices


should collaborate with [Baylor] foundation. I found
out about the foundation from another patient, my
doctor did not send me here, like the family doctors
of other persons did.
partnerships between public For me, personally, as a doctor, when patients come
health organizations and prepared by the foundation [i.e. counseled at Baylor]
NGOs compliments and it is a huge help. I am relieved when I hear them say
support the work of health- I know, I know about hepatitis, I know what to ex-
care specialists pect. They [the patients] come already sensitized,
educated and I am really grateful when I get such a
patient.
follow up support for vulner- [Public Health representative] If you are diagnosed
able patients is limited with HCV but uninsured you dont get care

[Baylor project manager] The treatment is free of


charge for those insured; when we have a patient
that is uninsured we teach him the steps he needs
to take to obtain an insurance he can pay an
insurance fee retroactively

Self-management component refers to a systems ability to perform rou-


tine assessment of patients needs and to provide to patients access to self-man-
agement and behavioral change programs. The analysis of the transcripts has
revealed that there are frustrations on both sides of the interactions:
On the one side, patients feel neglected, not heard and thrown away

72
from one unpleasant situation to another;
On the other side, the health care providers, are also frustrated as a result
of the interaction and they come to describe patients as coming forward
with stupid questions or as being at fault.
The behavioral results of these communication barriers lead to vari-
ous situations. For example, patients turn to self-education, and moreover to
self-medication, or they simply abandon treatment. Also, healthcare providers
turn to ultimata or to fear arousal strategies, thus risking to lose the relation-
ship with the patient and thus a chance for healing someone.
Both parties, patients and healthcare providers, acknowledge the im-
portance of education and emotional support, and this represents a posi-
tive foundation on which it can be built upon. The role of psychologists and
support persons is also being recognized, although since these type of practi-
tioners are not generally part of the traditional public health system, there is
more a theoretical desire to collaborate with this type of experts, than a prac-
tical, at hand option to include them in the team or referral network.
The concept of patient self-management per se was not identified during
the analysis of the transcripts; active building of patients skills regarding their
own health is still a concept to which the medical community that was inter-
viewed need to be introduced to. Shared decision making, collaborative goal
settings and planned behavioral change interventions are only incidentally
formulated as formal care objectives, the intuitive implementation of such
strategy being mostly reported by those included in this qualitative assessment.
Orientation tools, health literacy materials and educational support
were rarely mentioned and not routinely used.

Current needs Statements


need to increase patients knowl- [ Health Fund representative] Generally speak-
edge or skills to navigate the ing, everywhere one looks around in the medi-
healthcare system (to obtain and cal system, patients dont know what to do and
go through the entire treatment). their lack of knowledge is transformed into
aggressiveness against the medical personnel.

There are patients that come to the Health


Fund with their treatment file and then they
do not come back for one or two years; when
they return, and they have lost their turn to
get the medication, they are the ones that get
upset.

73
-So, getting the treatment is not an issue of
access to treatment?
- No, it is not! It is all about management!
To keep the pace with the system once you
entered it. To be perseverant. To be focused to
achieve your goal.

[Baylor project manager] The HCV screen-


ing program that we unfold make sense only
if we manage to help patients to access the
treatment. It is not enough to give him the bad
news [that he is infected], but it is important
to help him manage the new situation that he
is in.
clinicians perform alone all clini- So, one-two or three months after he [the pa-
cal functions: tient] starts the treatment he feels weak and he
The HCV specialist bears the ex- comes and tell me that he cant go on anymore.
clusive responsibility of the entire And I have to use all my convincing skills. This
management chain of the patient, is a hard work.
from the entry point until the And who is also in charge with this entire
exit point. This involves, poten- work of clarification with the patient?
tially being over-burdened taken Only I, as a specialist.
that he is the only one responsi- Always?
ble with all the self-management Yes, always.
issues, such as the assessment How about the family doctor?
and documentation of self-man- No, they rely on me too. I have no idea what
agement needs and activities, the family doctor actually tells to the patient.
providing self-management
support, addressing concerns
of patients and families and
implementing behavior change
interventions.

74
Current capacity Statements
patients who receive simple [patient] In March 2012 I have submitted my
interventions that ensure support file [to the Health Fund] and my approval
and follow up, better manage arrived in August. I managed to remember
their health process. because the ladies from Baylor telephoned me;
they asked me if I have called at Bucharest to
ask about the status of my approval. And I said
to myself: BINGO! Lets do that. So, without
their help, I wouldnt have remembered, I
would have expected for the approval to be
sent at my home.

[Baylor project manager] Because patients


need support to adhere to the treatment,
because it is important to accept the diagnosis
and go through the whole process, we have
initiated support groupsand other compli-
mentary services that are not offered by the
[public] system.
Proposed solutions Statements
emotional and peer support for [ specialist] I believe that sessions with persons
patients has potential to be effec- that are just diagnosed or are in the process [of
tive both in views of the patients being treated] would do them a lot of good.
themselves and of the health
providers. [ public health representative] Some kind of a
group, led by a foundation would be great
to share experiences, understand the steps that
are to be followed

[patient] Like there are abroad, some support


groups for people with similar diseases

[Baylor project manager] I would say that the


critical moment is when the person is commu-
nicated the diagnosis. At the point, the mad-
ness starts: why me? Where did I get it from?
How will I cope with the treatment?

75
patients need competent and [patient] The doctor will not explain anything
trusted self-education sources; to you. So youd better start reading right now!
when information provided in He is busy. If you do not start to read about
the healthcare setting is evaluat- your problem, you are up in the air
ed as non-satisfactory, patients
turn to other sources, mainly to You need a lot of patience to watch shows, read
the experience of other persons leaflets if you find any... If you come here [at
(neighbors, acquaintances, and Baylor], take one of the leaflets too, it should
relatives), internet forums and stick to your hand. This way you will eventual-
similar online sources. ly learn something.

I checked an online forum and I read that


there were others that have taken less pills. So
I did the same, Instead of taking 6 pills a day,
I was taking 5 pills a day. And I felt better.I
still have those pills at home

As described in the theoretical part of the chronic care model, the deci-
sion support component refers to identifying the best care that can be provid-
ed to patients and searching for modalities of translating those recommenda-
tion into routine, day to day standard operating procedures. Our assessment
aimed to evaluate the general perception among healthcare practitioners that
were interviewed, regarding the existence and usability of evidence based
guidelines and recommendations that support their clinical decision.
Guidelines and procedures were mainly mentioned as those who regu-
late the approval of dual treatment by the National Health Fund. There were
accounts with a lot of details regarding the criteria that the commission that
approves the file takes into consideration, thus focusing mainly on a bureau-
cratic process to access treatment. This is the most prominent and most
structured dimension regarding decision support. However, the HCV treat-
ment guideline published in the Official Monitor in 2010 describes in only 5
pages the therapeutic management of patients with hepatitis C (patients not
treated, patients with co-morbidities, relapses and the management of side
effects). It does not provide any guidance about the implementation proce-
dures, thus leaving at the latitude of the individual sub-systems to create their
own processes. For example, the guide briefly lists when various HCV related
blood tests should be performed, but in practice only some of the tests are re-
imbursed by the insurance. This leads to limited possibilities to implement
the guideline recommendations in real life; this leaves providers with hav-
ing to find ad-hoc solutions. Also, quality improvement cannot happen spon-

76
taneously in any settings, without a planned approach and eventually, with
external practice support. There was no information regarding the process of
revision/ amending the guidelines during the interviews from any participant.
No participant in the qualitative assessment has mentioned any best practices
that they are aware of regarding integrated chronic care. Most health providers
are creating their own set of rules, tweaking around the edges of an acute care
system not capable of handling needs of chronic illness102.

Current needs Statements


limited involvement of Do your patients have to come with a medical letter
specialists in primary care. from the family doctor?
[specialist] Yes, but I generally manage my patients
alone [without the involvement of the family doctor].
My patients can continue to keep in touch with their
primary carer, but I am a responsible doctor and I like
to do my job well. So, if I know that my patient will
come this Monday, I simply write down what tests he
needs to take [without referring for that to the family
doctor]

[specialist] I have not been talking with a family doc-


tor for a long time. I do not know if they can order
anti-HCV tests
need to improve patients [patient 1] So, is it easy to prepare the file or not?
understanding regarding [patient 2] The doctor does it, you just sign it!
guidelines and procedures [patient 3] oh, so you have to agree
[patient 2] many times they will not inform you.
need to improve training Do you have patients at your offices [with hepatitis C]
on the evidence behind that are not currently on treatment?
the care, especially among [family doctor] Yes, the majority of them,
the primary (family) Is this because they are not eligible?
doctors. [family doctor] Honestly, we do not know what is
going on in the mind of the specialist that evaluates
the case
need to increase guide- [HCV specialist] I, personally, prefer to ask my
line based practices, patients with low fibroses to return for an evaluation.
rather than those based I expect at some point to see increased fibrosis. Not
by preferences or ad-hoc everyone does it
practices.

102 http://www.improvingchroniccare.org/index.php?p=1:_Models&s=363

77
Proposed solutions statements
evidence based guideline [family doctor] Guidelines should state who the
for primary care could population at risk [in Romania] is, so we know it!
guide everyday practice Whether they want to be investigated or not, we
will find solutions somehow, we will convince them!
At least a temporary screening initiative might be
required.

outdated and limited [ specialist] Having the triple therapy would be in the
therapeutic options (at the advantage of the patient. There are less side effects to
date of the report, only manage.
interferon based dual ther-
apy available free of charge
in Romania for insured
patients).

Delivery design component details who is part of the health team and
what are the ways of interaction with patients (ideally based on planned vis-
its, follow up and continuity of care). The analysis revealed a general trend of
working separately (all heath providers in the interviews and focus groups):
each institution with its rules, each professional with his own practice habits,
with its own human and health resources etc.; thus it can be inferred that
multidisciplinary teams involved in the management of HCV patients are
rare, linkages between various professionals being more common. The lack of
such teams leads to the inadequate development of the delivery design, since
it is not focused on chronic care. The authors could not detect any indications
regarding planned visits, rather the majority of patients with chronic con-
ditions are assisted in a very similar way with those with acute conditions.
Moreover, continuity of care depends on the doctors interpersonal and hu-
man skills and on his availability to create communication bridges with other
specialties.

78
Current needs Statements
leadership regarding the [family doctors]
delivery design needs to Where is the leadership for the management of the
be clarified disease, in terms of talking with the patients about
what the treatment implications are, how it is going
to be
Ah! That is the job of the specialist
The infectious diseases doctor
No, we all do it. We do it and the hospital [infectious
diseases] does it too ..
appointment system with [patient] I would wait in front of the doctors door
specialists for patients from 8 AM just to get the prescription. If I insisted
with chronic health prob- to be seen, he would explain to me how busy he is,
lems in public hospitals that he has an entire ward with many patients with
settings is not common problems so around 4 PM I would actually get my
practice prescription.

[patient] When I go to renew my prescription, I never


see the doctor, only the residentif I want to ask him
something, he [the resident] doesnt know what to
say.
need to improve continui- Did you have any side effects [due to the treatment]?
ty of care Did you go to see another specialist?
- [patient] Oh, naturally, I did! I went to the neu-
rologist.
Did your doctor send you there?
[patient] No, I went there by my own decision.
Because I was fainting. I wanted to find out why I was
fainting so suddenly.

[endocrinologist] Generally speaking I have a good


relationship with my patients, and after they are seen
[by the HCV specialist], they came by themselves
to tell me if they started the treatment, how they are
feeling
very limited situations [ family doctor] It is hard to find a psychologist. Is
where teams include psy- there any working in both state policlinics here in
chosocial personnel Constanta?

[Baylor project manager] our team is made of doc-


tors, nurses, psychologists and counselors

79
limited awareness about [family doctor] What can a psychologist do for a pa-
the roles of some support tient? There is nothing he can say to change things for
team members him. Believe me! The only thing that matters is when
the patient sees his viral load result as undetectable

Proposed solutions statements


support personnel directly [Baylor project manager] Our case managers [psy-
involved in case manage- chologists] ensure patients follow-up, until they
ment are registered with a specialist and the diagnosis is
confirmed... we buffer the relationship between the
doctor and the patient

The final component, clinical information systems, covers the aspects


that encompass data management that allows for targeted interventions for
those in care. As stated above, at the date of the data collection there was no
official surveillance system available in Romania. At the end of the year 2014,
the surveillance forms and procedures of data collection were published by
the NATIONAL INSTITUTE OF PUBLIC HEALTH. However, in the spirit
of the CCM we were mainly interested to identify the clinical information
systems that are used for micro-management (for smaller clinics, offices, hos-
pitals), or for local/regional collaborations, and not specifically for the country
wide system. This part of the assessment is supposed to see if clinicians are
actively organizing their work using registries, reminders to perform specific
clinical tasks and if they use some specific technology to plan the treatment.
As a general comment, it can be observed that there was very little ev-
idence in the data collected regarding the organization of clinical infor-
mation systems for care management and treatment plans purposes. The
majority of reporting and data collection is being requested by higher order
institutions and feed-back is rarely integrated back into the current prac-
tice. Providers would need to make a special search effort to find out informa-
tion regarding subgroups of patients.

80
Current needs Statements
need to increase awareness [ physician] I am just a practicing doctor, so I do
about program impact and my job as a doctor, I am not a statistician. Prob-
results ably there is [somewhere] a situation, a report
about patients with HCV

We simply do what everybody else does: we just


report the data of the hospital. Now, if the data is
further centralized, that I wouldnt know to tell
you
key information regarding the [representative of Public Health Authority]
prevalence of HCV needs to be We do not collect data about the prevalence of
identified hepatitis, not at the country level and not at the
national level. Right now specialists are working
to create a national registry of patients with HCV.

-Can you tell us anything about at risk groups?


[representative of Public Health Authority] I
have no statistics at the level of the institution, to
be able to

Current capacity Statements


National database in prepara- [ patient association representative] Currently
tion the Matei Bals National Infectious Diseases
Institute is developing a national database of
patients [ever treated for hepatitis] more than
35 thousands persons are listed there

Proposed solutions Statements


Prompts and alerts relevant [patient] You know what? The doctor should
to the physicians need to be be alerted immediately. When he took all those
interpreted/ communicated to tests for my liver, he knew that my transaminases
the patient. where very high. He should have alerted me also!
I have had these result for over a year now. My
doctor should have alerted me and say Mister,
something is wrong with your liver.

81
Wrapping it up all together Mapping
the content analysis against the ACIC
assessment tool

The results of the qualitative assessment provide an evaluation of the


HCV chronic care delivery system available in Constanta, Romania, where
Baylor foundation runs its main operations as well.
The above results revealed by the content analysis have been further
mapped and summarized to draw the qualitative assessments conclusions. In
this respect, two researchers (AMS and MB) have classified the indications
revealed by the transcripts on the 4 level scale of the ACIC assessment form
(see table 3 below to understand the coding procedure). The scale classifies the
development of a key element of a component as having little support, basic
support, good support or full support. The sub-components for which the re-
searchers did not find any proof during the thematic analysis were not coded
(marked as blank, see legend).
The researchers have collected all the codes associated with qualitative
text data and analyzed the following elements:
presence or absence of codes related to the ACIC items
current level of development of the features identified among the themes.

82
coding Community resources Community Coordinated community
partnerships
Compo- Linking Patients to Partnerships with Regional HealthPlans
nents Outside Resources Community
Organizations
Little is not done system- do not exist. do not coordinate
support atically. chronic illness guidelines,
measures, or care resourc-
es at the practice level.
Basic is limited to a list of are being would consider some
support identified community considered but degree of coordination of
resources in an acces- have not yet been guidelines, measures or
sible format. implemented. care resources at the prac-
tice level but have not yet
implemented changes.
Good is accomplished are formed to currently coordinate
support through a designat- develop support- guidelines, measures, or
ed staff person or ive programs and care resources in one or
resource responsible policies. two chronic illness areas.
for ensuring providers
and patients make
maximum use of com-
munity resources.
Full is accomplished are actively currently coordinate
support through active co- sought to develop chronic illness guidelines,
ordination between formal supportive measures, and resources at
the health system, programs and the practice level for most
community service policies across the chronic illnesses.
agencies, and patients. entire system.
Table 15. Coding procedure based on the ACIC tool
Community Linkages Linkages between the health system and community
resources play important roles in chronic illness management.

It should be noted that maximum values at all scores, indicating an ex-


cellent level of development and integration of chronic care interventions, are
an ideal situation towards which health systems should strive for. In real life,
identifying current weaknesses of a system should guide the development of
interventions to improve the delivery of care for patients affected by chronic
conditions. The evaluation based on CCM can be used for strategic planning
of system change and/ or redesign. The findings are summarized on the next
table:

83
The observed strengths of the current HCV care system in Constanta
region refer to the existence of the evidence based guidelines, especially re-
garding the eligibility of patients for treatment and the treatment administra-
tion; the other components that have a good development refer to community
linkages and self-management support, this underscoring the importance of
increasing the community involvement during all the episodes of care, within

84
and between institutions and organizations.
There is existent capacity, especially regarding the organization of
health care and the delivery design on which a more chronic patient centered
approach can be built:
in Constanta region there are dedicated healthcare professionals, strug-
gling to find creative solutions to respond to their patients needs in spite
of severe limitations,
there are various partnerships with companies in order to decrease the
financial burden on patients,
the international context pushes towards an increased attention regard-
ing HCV care and this has echoes at the national level as well
Baylor foundations HCV program ensures alignment of own services
with various international initiatives ( such as the Word Hepatitis Alli-
ance) and with local institutions ( National Health Fund, Public Health
Authorities, local hospitals etc)
although the reach of Baylor support services for patients and families
with HCV is limited, there local expertise to increase the self-manage-
ment support delivered in the region
the specialists directly involved in the medical management of patients
with HCV work within a delivery design environment that ensures fol-
low up in accordance with guidelines and tend to plan visits only for
complicated cases
in order to ensure continuity of care, the preferred communication sys-
tem within the public health institutions remain the written referral and
medical letter
There is a long road ahead in terms of areas for improvement, some sug-
gestions and recommendations being listed below.

85
Part IV. Recommendations for
Interventions to Improve the Care of
Hepatitis C in Constana region

The recommendations formulated below suggest areas of improvement


that can be targeted by interventions to increase the quality of care delivered
in Constanta region to patients with chronic hepatitis C.
Systems cannot redesign and change all the components in the same
time, usually various practices having to choose only some areas of improve-
ment that are consider a priority.
There is growing body of evidence that isolated interventions to improve
only one element of the care system do not impact the overall quality of care.
However, interventions that tend to address several component at the same
time (not necessary all of them), do induce measurable results, both in terms
of patients clinical outcomes and self-management results.

Recommendations to improve the organization of healthcare system:


create a local body of stakeholders that is able to coordinate and plan the
improvement of care transitions of patients and the efficient transfer of
information between providers and institutions
develop formal agreements and partnerships that facilitate care coordi-
nation
align the coordination plan with strategic objectives as suggested by in-
ternational bodies and forums, such as World Health Organization, Eu-
ropean Liver Patient Association and World Hepatitis Alliance
advocate to find solutions in order to compensate for the insufficient
number of human resources with roles in the care of patients with HCV,
including the increased role of primary care practices
create procedures and practices that encourage the early detection and
enrollment of new cases
create and maintain screening programs for HCV, such as Baylors free of
charge, rapid testing screening program
increase the opportunities for testing in other primary care settings, in
order to actively detect new cases

86
Recommendations to improve the community linkages:
sensitize the health institutions about the importance of community
linkages
stimulate the health institutions to actively seek for community partner-
ships in order to expand the access to timely detection and the access to
healthcare of vulnerable populations, including those from underserved
areas
strengthen community action, by coordinating plans of NGOs with oth-
er local agencies
create simple, straight forward referral pathways between public health
institutions and community based organizations
educate health providers on the importance of increasing patients health
literacy level and give opportunities for trainings in this respect
increase the capacity of community linkages already in place, by actively
reviewing common chronic care goals
ensure access to external practice support programs to help practices
and health institutions to deliver more effective care

Recommendations to improve the patients self-management level:


disseminate evidence that recognizes the importance of assessing clini-
cal state in tandem in self-management status in the context of chronic
care
create local expertise on self-management and offer access to tools about
how patients self-management level can be assessed and developed as
part of the clinical care goals
develop locally relevant health literacy tools for providers and patients
help practices create health literacy friendly clinical environments
provide skills building opportunities for health care professionals re-
garding the development and implementation of simple self-manage-
ment interventions in the context of their own practice
create opportunities for exchanges regarding the successful implementa-
tion of self-management programs in the context of other health systems
and practices
assign and re-assign self-management tasks to other team members,
partner providers or support personnel
ensure consensus among providers and develop pathways for patients,
including designated contact persons at each key provider
tailor self-management interventions to match the patients needs in

87
each episode of care
create patients toolkits and workbooks to assist them with self-manage-
ment issues, such as lifestyle and health habits, adherence etc
make available to clinicians questionnaires, surveys and checklists that
can help them quickly asses self-management barriers and priorities for
action

Recommendations to improve decision support


create avenues for structured interactions of specialist with primary care
providers, to identify pathways for care transitions
create expert panels to develop consensus regarding locally relevant
strategies to identify appropriate patients for referral and follow up
make guidelines available to patients at an appropriate health literacy
level, to increase patients buy-in regarding treatment decisions
increase the access to the evidence behind the guidelines for primary
care providers in order to ease the understanding of patients treatment
plans
consider the possibility of comparing current practices against estab-
lished guidelines in specific settings and at the level of individual prac-
tices in order to determine local improvements that can be easily imple-
mented
make available to practicing professionals involved in the care of HCV,
easy to use standardized assessments and checklists to identify measures
to ensure disease control and risks for complications

Recommendations to improve delivery design:


make a public agenda about the importance of designing a chronic care
model, separate from the acute care system in place
coordinate the use registries to implement a planned visits approach (
special times allotted for consultations, use of agenda regarding the con-
tent of the planned visits etc)
assemble teams that can work together to implement the planned visits
system
use community resources to expand the staff capabilities ( interns, vol-
unteers, partner NGOs)

88
Recommendations to improve clinical information systems:
enable clinicians to use clinical information systems in order to guide
the delivery of planned care ( generate lists of high risk patients, patients
missing appointments or missing prescriptions etc)
advocate for the design of databases that are able to provide feedback
that indicates the needed services for specific categories of patients
invest in data-bases that use prompts and alerts that help to monitor
performance and stages in treatment plan
disseminate feedback regarding the results suggested by data gathered
through a network of interested providers

The above recommendations should be aligned with higher, national


level recommendations regarding hepatitis C policies that are to be drafted
and regulated by central agencies and Ministry of Health. The general recom-
mendations for Romania in the area of viral hepatitis policies and implemen-
tation include:
Drafting a national strategy to tackle viral hepatitis, incorporating the
existing prevention and treatment programs and, alongside this, en-
hancing screening, referral and treatment to prevent further infections.
Ensuring timely and continuous access to treatments, especially for pa-
tients facing the highest unmet need, and develop treatment protocols
that improve adherence to treatment.
Raising awareness especially among risk groups, socially excluded
groups, to test for viral hepatitis, and ensure easy access to diagnosis.
Developing diagnostic and therapeutic protocols and train general prac-
titioners and nurses to better detect and care for viral hepatitis.
Establishing Centers of Excellence for epidemiological surveillance,
treatment and research, as well as developing a national registry for viral
hepatitis to enable better management of patients.
Developing a national and regional network to better inform patients
and practitioners about epidemiological data and best strategies (bal-
kanhep.eu)

89
The qualitative assessments limitations

The research team recognizes a series of limitations regarding to the re-


sults of this qualitative assessment.
First of all, the geographical limitations should be stated. Secondly, the
partnership between Baylor foundation and the local health care providers
is not the norm in the rest of the country, and some of the results regarding
self-management and community linkages should be understood as describ-
ing a somehow atypical situation of Constanta Country compared with other
places in Romania.
The number of participants in the sample of health care professionals are
rather small, but this is also explainable due to the fact that there is a shortage
of specialists involved in the management of HCV prevention, treatment and
care. Regarding the characteristics of patients enrolled in this qualitative as-
sessment, in should be noted that the patients were exclusively persons that at
some point during their diagnosis and treatment pathway were beneficiaries
of services provided by Baylor Foundation. The research team did not have
access to patients that were outside this group (ie: patients that were exclu-
sively managed by the public health system). It is possible that the challenges
that the patients face when they are not at all supported by a community orga-
nization to be different or more intense, but this avenue was not investigated
comparatively in this qualitative assessment.
Some of the dimensions in the ACIC tool could not be ascertained, due
to the lack of information about the issues of the participants in the qualitative
assessment. It is possible that the cause it is not only the fact that participants
were not knowledgeable about some aspects, but also because the system does
not currently pay attention to those components.
The topic investigated in this qualitative assessment was very complex,
therefore in spite the fact that the researchers tried to have a comprehensive
approach it was rather discovered that not everything could be investigated
to the depth intended during the time framework that the participants had
available (for example, topics such as the management skills practices need to
run planned visits or topics about types of trainings that providers are inter-
ested to attend annually were insufficiently explored).
With the perspective of the availability of interferon free treatments that
offer very high cure rate in a short while, the importance of system redesign to
accommodate chronic care of patients with hepatitis C should also consider

90
the emergence of coordinated episodes of care. However long or short the
duration of treatments available in Romania, a system redesign is called upon
urgently.

91
Section C:
Annexes

92
The ACIC tool103

Organization of the Health Care Delivery System. Chronic illness


management programs can be more effective if the overall system (organiza-
tion) in which care is provided is oriented and led in a manner that allows for
a focus on chronic illness care.

Components Little support Basic support Good support Full support

OverallOrgani- does not exist is reflected in is reflected by is part of the


zationalLeader- or there is little vision statements senior leadership systems long term
ship in Chron- interest. and business and specific ded- planning strategy,
icIllness Care plans, but no icated resources receive necessary
resources are (dollars and resources, and
specifically ear- personnel). specific people are
marked to execute held accountable.
the work.
Organizational do not exist or exist but are are measurable are measur-
Goalsfor Chron- are limited to one not actively and reviewed. able, reviewed
ic Care condition. reviewed. routinely, and are
incorporated into
plans for improve-
ment.
Improvement are ad hoc and utilize ad hoc utilize a proven include a prov-
Strategies for not organized or approaches for improvement en improvement
ChronicIllness supported consis- targeted problems strategy for target- strategy and are
Care tently. as they emerge. ed problems. used proactively
in meeting organi-
zational goals.
Incentives are not used are used to are used to are used to
andRegulations to influence clin- influence utili- support patient motivate and em-
forChronic ical performance zation and costs care goals. power providers
Illness Care goals. of chronic illness to support patient
care. care goals.
Senior Leaders discourage do not make encourage im- visibly partici-
enrollment of the improvements to provement efforts pate in improve-
chronically ill. chronic illness in chronic care. ment efforts in
care a priority. chronic care.
Benefits discourage neither encourage are specifi-
patient self-man- encourage nor patient self-man- cally designed to
agement or system discourage patient agement or system promote better
changes. self-management changes. chronic illness
or system changes. care.

103 Adapted from The Assessment of Chronic Illness Care (ACIC), Copyright 2000 MacColl Institute
for Healthcare Innovation, Group Health Cooperative

93
Community Linkages. Linkages between the health system and com-
munity resources play important roles in chronic illness management.

Components Little support Basic support Good support Full support


Linking Patients is not done is limited to is accom- is accom-
toOutside Re- systematically. a list of identi- plished through plished through
sources fied community a designated staff active coordina-
resources in an person or resource tion between the
accessible format. responsible for en- health system,
suring providers community ser-
and patients make vice agencies, and
maximum use patients.
of community
resources.
Partnerships do not exist. are being are formed to are actively
withCommunity considered but develop support- sought to develop
Organizations have not yet been ive programs and formal supportive
implemented. policies. programs and
policies across the
entire system.
Regional do not coor- would consider currently coor- currently co-
HealthPlans dinate chronic some degree of dinate guidelines, ordinate chronic
illness guidelines, coordination measures, or care illness guidelines,
measures, or care of guidelines, resources in one measures, and
resources at the measures or care or two chronic resources at the
practice level. resources at the illness areas. practice level for
practice level most chronic
but have not yet illnesses.
implemented
changes.

94
Self-Management Support. Effective self-management support can
help patients and families cope with the challenges of living with and treating
chronic illness and reduce complications and symptoms.

Components Limited support Basic support Good support Full support


Assessment and are not done. are expected. are completed are regularly
Documentation in a standardized assessed and
ofSelf-Manage- manner. recorded in
mentNeeds and standardized
Activities form linked to a
treatment plan
available to prac-
tice and patients.
Self-Manage- is limited to is available is provided by is provided by
ment Support the distribution by referral to trained clinical clinical educators
of information self-management educators who affiliated with
(pamphlets, classes or educa- are designated to each practice,
booklets). tors. do self-manage- trained in patient
ment support, empowerment
are affiliated with and problem-solv-
each practice, and ing methodolo-
see patients on gies, and see most
referral. patients with
chronic illness.
Addressing Con- is not consis- is provided for is encouraged, is an integral
cernsof Patients tently done. specific patients and peer support, part of care and
andFamilies and families groups, and men- includes systemat-
through referral. toring programs ic assessment and
are available. routine involve-
ment in peer
support, groups,
or mentoring
programs.
Effective Be- are not avail- are limited to are available are readily
haviorChange able. the distribution only by referral to available and an
Interventionsand of pamphlets, specialized centers integral part of
Peer Support booklets, or other staffed by trained routine care.
written informa- personnel.
tion.

95
Decision Support. Effective chronic illness management programs as-
sure that providers have access to evidence-based information necessary to
care for patients decision support. This includes evidence-based practice
guidelines or protocols, specialty consultation, provider education, and acti-
vating patients to make provider teams aware of effective therapies.

Components Limited support Basic support Good support Full support


Evidence-Based are not avail- are available are available are available,
Guidelines able. but are not inte- and supported by supported by pro-
grated into care provider educa- vider education
delivery. tion. and integrated
into care through
reminders and
other proven
provider behavior
change methods.
Involvement is primarily is achieved includes spe- includes spe-
ofSpecialists through tradition- through specialist cialist leadership cialist leadership
inImproving al referral. leadership to and designated and specialist
PrimaryCare enhance the specialists who involvement in
capacity of the provide primary improving the
overall system to care team train- care of primary
routinely imple- ing. care patients.
ment guidelines.
Provider Educa- is provided is provided is provided includes train-
tionfor Chronic sporadically. systematically using optimal ing all practice
IllnessCare through tradition- methods (e.g. aca- teams in chronic
al methods. demic detailing). illness care
methods such as
population-based
management, and
self-management
support.
Informing is not done. happens on re- is done includes
Patientsabout quest or through through specific specific materials
Guidelines system publica- patient education developed for
tions. materials for each patients which de-
guideline. scribe their role in
achieving guide-
line adherence.

96
Delivery System Design. Evidence suggests that effective chronic illness
management involves more than simply adding additional interventions to a
current system focused on acute care. It may necessitate changes to the orga-
nization of practice that impact provision of care.
Components Limited sup- Basic support Good support Full support
port
Practice is not ad- is addressed is assured is assured by teams
TeamFunc- dressed. by assuring the by regular team who meet regularly and
tioning availability of meetings to have clearly defined
individuals with address guide- roles including patient
appropriate lines, roles and self-management educa-
training in key el- accountability, tion, proactive follow-up,
ements of chronic and problems in and resource coordina-
illness care. chronic illness tion and other skills in
care. chronic illness care.
Practice is not recog- is assumed by is assured by is guaranteed by the
TeamLeader- nized locally or the organization the appointment appointment of a team
ship by the system. to reside in specif- of a team leader leader who assures that
ic organizational but the role in roles and responsibilities
roles. chronic illness is for chronic illness care
not defined. are clearly defined
Appointment can be used assures sched- is flexible and includes organization
System to schedule uled follow-up can accommodate of care that facilitates the
acute care with chronically innovations such patient seeing multiple
visits, follow-up ill patients. as customized providers in a single
and preventive visit length or visit.
visits. group visits.
Follow-up is scheduled is scheduled is assured by is customized to
by patients or by the practice in the practice team patient needs, varies in
providers in an accordance with by monitoring intensity and methodol-
ad hoc fashion. guidelines. patient utilization. ogy (phone, in person,
e-mail) and assures
guideline follow-up.
Planned Visits are not used. are occasional- are an option are used for all
forChronic ly used for com- for interested patients and include reg-
Illness Care plicated patients. patients. ular assessment, preven-
tive interventions, and
attention to self-man-
agement support
Continuity of is not a depends on between is a high priority and
Care priority. written commu- primary care all chronic disease inter-
nication between providers and spe- ventions include active
primary care cialists and other coordination between
providers and relevant providers primary care, special-
specialists, case is a priority but ists, and other relevant
managers, or dis- not implemented groups.
ease management systematically.
companies.

97
Clinical Information Systems. Timely, useful information about indi-
vidual patients and populations of patients with chronic conditions is a critical
feature of effective programs, especially those that employ population-based
approaches.

Components Limited support Basic support Good support Full support


Registry (list is not available. includes name, allows queries is tied to
ofpatients with diagnosis, contact to sort sub-popu- guidelines which
specificcondi- information, and lations by clinical provide prompts
tions) date of last contact priorities. and reminders
either on paper about needed
or in a computer services.
database.
Reminders are not avail- include general include indi- include specific
toProviders able. notification of cations of needed information for
the existence service for popu- the team about
of a chronic lations of patients guideline adher-
illness, but do not through periodic ence at the time of
describe needed reporting. individual patient
services at time of encounters.
encounter.
Feedback is not available is provided occurs at fre- is timely, spe-
or is non-specific at infrequent quent enough in- cific to the team,
to the team. intervals and is tervals to monitor routine, and per-
delivered imper- performance and sonally delivered
sonally. is specific to the by a respected
teams population. opinion leader
to improve team
performance.
Information is not available. can only be can be is provided
aboutRelevant obtained with obtained upon routinely to
Subgroupsof special efforts request but is providers to help
Patients Need- or additional not routinely them deliver
ingServices programming. available. planned care.
Patient Treat- are not ex- are achieved are established are established
mentPlans pected. through a collaboratively collaboratively
standardized and include and include self
approach. self-management management as
as well as clinical well as clinical
goals. management.
Follow-up occurs
and guides care
at every point of
service

98
Interview guide for medical specialists

Assessing the needs of patients with chronic hepatitis C in order to inte-


grate them into medical and psychosocial services provided by Baylor Black
Sea Foundation.
Name: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Phone no: _ _ _ _ _ _ _ _ _ _ _
___________________________ _ _ __ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Function: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Email: _ _ _ _ _ _ _ _ _ _ _ _ _
___________________________ _________________
Institution: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Fax: _ _ _ _ _ _ _ _ _ _ _ _ _ _
___________________________ _________________
Interview date: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Hour: _ _ _ _ _ _ _ _ _ _ _ _ _
___________________________ _________________

1. Introductory discussion
Short presentation of the project and of the research team. What do you
know about Baylor?

2. General information about hepatitis C


Which is the prevalence of hepatitis C in Romania and globally?
Is there a National Registry of people affected by hepatitis C?
Is there a National Program for hepatitis C?
Which are the main groups with disproportionate risk of hepatitis C in
Romania?
Which are the main transmission paths?
Which are the main symptoms? How do they manifest?
What are the main causes of the disease? How does the disease progress-
es? What are the complications of the disease?
Which are the main prevention methods?
Which are the main problems of patients of hepatitis C (management of
the disease, access to treatment, poverty, discrimination, lack of help)?

3. Identification of persons at risk and diagnosis


How are people at risk, insured and uninsured, identified and directed
to testing services?
What do you think is the role of the general practitioner in identifying /
prevention / education / support for people at risk of hepatitis C?

99
Are there any screening programs?
How many hepatitis C patients do you have? How do patients get to you?
What types of services do you offer?
Are there any other medical specialities that can provide the same ser-
vices as you? Please name those.
How much do the tests needed to diagnose hepatitis C cost?
What is the route the patient has to follow in order to receive a diagnosis?
How long does it takes to establish the diagnosis and which are the costs
for the patient?

4. Treatment
Is hepatitis C treatment available in Romania? Does it complies with the
European standards?
Is the treatment accessible to everyone, free of major charges?
Are there waiting lists? How many persons are on these waiting lists?
Which are the latest treatment schemes available in Europe? Which are
the latest treatment schemes available in Romania?
Who recommends and establishes the treatment scheme?
How can the patient benefit of the treatment? Which is the procedure
(for example, how long does it take to prepare the necessary documents,
which are the costs)?
Are there any groups of population that systematically are less likely to
receive treatment in the public health system? Which are these groups? Why
are the less likely to receive treatment in the public health system?
Overall, how much does a patient (insured/uninsured) pays to receive
proper treatment?
What is the role of family practitioners and / or specialists in providing
care for the patients? What methods should be used to encourage patient ad-
herence to treatment and a corresponding lifestyle to slow the progression of
the disease?
How do you collaborate with other specialists (infectious, internists,
psychiatrists, etc.)? What support do you offer in putting together the treat-
ment required documents?

5. Monitoring and Evaluation


What is the time interval the patients (with and without treatment) are
evaluated at? What does the monitoring and evaluation imply?
Out of the total number of patients how many respect the monitoring

100
and evaluation program and visit you periodically? How do you support pa-
tients embracing a healthy lifestyle?

6. Development needs of the health services available / public


policies / priorities
Which are the main factors hampering the access to health services in
the public health system? Are there alternatives in the private / NGO sectors?
Which are the unmet needs of patients with hepatitis C?
Which are the categories of personnel involved in the detection, treat-
ment and monitoring patients with hepatitis C? Are they properly trained?
Which are the national priorities regarding hepatitis C? Is there a nation-
al strategy to combat hepatitis C?
What is the legislative context?
Is there a special budget allocated by the state to cover the costs of treat-
ment for hepatitis C? If yes, what is the budget?
What should a national program for hepatitis C include?
Are there any prevention programs? What should they include?
During the lasts years, were there any national awareness/ information
campaigns regarding hepatitis C? If so, what was their impact? If not, would
you consider them useful? How should they be conducted?
Are there any NGOs active in this field? What is the involvement of
NGOs working in the field, of patients associations etc.?
Which are the main recommendations to improve the situation of pa-
tients with hepatitis C? What do you think needs to be done? Who should be
involved?

101
Interview guide for policy makers

Assessing the needs of patients with chronic hepatitis C in order to inte-


grate them into medical and psychosocial services provided by Baylor Black
Sea Foundation.
Name: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Phone no: _ _ _ _ _ _ _ _ _ _ _
___________________________ _ _ __ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Function: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Email: _ _ _ _ _ _ _ _ _ _ _ _ _
___________________________ _________________
Institution: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Fax: _ _ _ _ _ _ _ _ _ _ _ _ _ _
___________________________ _________________
Interview date: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Hour: _ _ _ _ _ _ _ _ _ _ _ _ _
___________________________ _________________

1. Introductory discussion
Short presentation of the project and of the research team.

2. General information about hepatitis C


Which is the prevalence of hepatitis C in Romania and globally?
Is there a National Registry of people affected by hepatitis C?
Is there a National Program for hepatitis C?
Are there any screening programs? How are people at risk, insured and
uninsured, identified and directed to testing services?
Which are the main groups with disproportionate risk of hepatitis C in
Romania?

3. Problems of hepatitis C patients


Which are the main problems of hepatitis C patients?
What is the route the patient has to follow in order to receive a diagnosis?
How much does the diagnosis cost, how long does it take and who estab-
lishes the diagnosis.
What is the role of the general practitioner in identifying / prevention /
education / support for people at risk of hepatitis C?
Hepatitis C treatment is available in Romania? Is the treatment accessi-
ble to everyone, free of major charges?
Are there waiting lists? How many persons are on these waiting lists?
Which are the latest treatment schemes available in Europe? Which are

102
the latest treatment schemes available in Romania?
How can the patient benefit of the treatment? Which is the procedure
(for example, how long does it take to prepare the necessary documents,
which are the costs)?
Which are groups of population that systematically are less likely to re-
ceive treatment in the public health system? Why are they less likely to receive
treatment in the public health system?
Overall, how much does a patient (insured/uninsured) pays to receive
proper treatment?

4. Development needs of the health services available / public


policies / priorities
Which are the national priorities regarding hepatitis C? Is there a nation-
al strategy to combat hepatitis C?
What is the legislative context?
What is the budget allocated by the state to cover the costs of treatment
for hepatitis C?
What should a national program for hepatitis C include?
Are there any prevention programs? What should they include?
During the lasts years, were there any national awareness/ information
campaigns regarding hepatitis C? If so, what was their impact? If not, would
you consider them useful? How should they be conducted?
Which are the main recommendations to improve the situation of pa-
tients with hepatitis C?

103
Interview guide for patient organizations

Assessing the needs of patients with chronic hepatitis C in order to inte-


grate them into medical and psychosocial services provided by Baylor Black
Sea Foundation.
Name: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Phone no: _ _ _ _ _ _ _ _ _ _ _
___________________________ _ _ __ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Function: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Email: _ _ _ _ _ _ _ _ _ _ _ _ _
___________________________ _________________
Institution: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Fax: _ _ _ _ _ _ _ _ _ _ _ _ _ _
___________________________ _________________
Interview date: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Hour: _ _ _ _ _ _ _ _ _ _ _ _ _
___________________________ _________________

1. Introductory discussion
Short presentation of the project and of the research team. What do you
know about Baylor?

2. General information about hepatitis C


Which is the prevalence of hepatitis C in Romania and globally?
Is there a National Registry of people affected by hepatitis C?
Is there a National Program for hepatitis C?
Are there any screening programs? How are people at risk, insured and
uninsured, identified and directed to testing services?
Which are the main groups with disproportionate risk of hepatitis C in
Romania?

3. Problems of hepatitis C patients


Which are the main problems of hepatitis C patients regarding:
Management of the disease
Access to treatment
Keeping constant the income
Poverty
Discrimination
Lack of support etc.
What is the route the patient has to follow in order to receive a diagnosis?
How long does it takes to establish the diagnosis and which are the costs

104
for the patient?
What is the role of the general practitioner in identifying / prevention /
education / support for people at risk of hepatitis C?
Hepatitis C treatment is available in Romania? Is the treatment accessi-
ble to everyone, free of major charges?
Are there waiting lists? How many persons are on these waiting lists?
Which are the latest treatment schemes available in Europe? Which are
the latest treatment schemes available in Romania?
How can the patient benefit of the treatment? Which is the procedure
(for example, how long does it take to prepare the necessary documents,
which are the costs)?
Which are groups of population that systematically are less likely to re-
ceive treatment in the public health system? Why are they less likely to receive
treatment in the public health system?
Overall, how much does a patient (insured/uninsured) pays to receive
proper treatment?

4. Services
Which are the main factors hampering the access to health services in
the public health system? Are there alternatives in the private / NGO sectors?
Which are the unmet needs of patients with hepatitis C?
What services do you provide for hepatitis C patients? Do these services
cover their needs?
What type of support do you offer to encourage a healthy lifestyle?
Do you have trained personnel in managing hepatitis C (disseminating
information, diagnosis, treatment)?

5. Development needs of the health services available / public


policies / priorities
Which are the national priorities regarding hepatitis C? Is there a nation-
al strategy to combat hepatitis C?
What is the legislative context?
What is the budget allocated by the state to cover the costs of treatment
for hepatitis C?
What should a national program for hepatitis C include?
Are there any prevention programs? What should they include?
During the lasts years, were there any national awareness/ information
campaigns regarding hepatitis C? If so, what was their impact? If not, would

105
you consider them useful? How should they be conducted?
Which are the main recommendations to improve the situation of pa-
tients with hepatitis C?

106
Focus group guide for patients

Assessing the needs of patients with chronic hepatitis C in order to inte-


grate them into medical and psychosocial services provided by Baylor Black
Sea Foundation.
Participants: Total |__|__| Age 25-45 years |__|__|
Women |__|__| 46-65 years |__|__|
Men |__|__| > 65 years |__|__|
Date: Hour:

1. Introductory discussion
Short presentation of the project and of the research team.

2. Personal experience with hepatitis CTests and diagnosis


Tests and diagnosis
When did you first noticed symptoms and in what context? Which were
the symptoms?
Who did you talk first about the symptoms? (a family member, a general
practitioner, a specialist, other medical representative, another person)
How were you diagnosed? (for example: During a routine medical ex-
aminations, you felt ill one day and consulted a doctor, you felt ill for a period
of time and consulted a doctor, you got tested because another family member
was diagnosed)
How advanced was the disease when you got diagnosed?
How long did it take for you to get tested since you first thought about it?
How long did it take for you to consult a specialist for the first time?
How long did it take to receive a diagnosis?
Before you get ill, did you received any information or have taken any
preventive actions? What did you know about hepatitis C before being diag-
nosed?
Did you received counseling before / after testing? What information did
you received about the disease (about the widespread of hepatitis C, impact
and evolution of the disease, possible treatments, where you can find more
information and get support, etc.)? Who gave you this information? How did
you communicate with the medical staff?

107
Disclosing the disease
Who were the persons you spoke about the disease? From who did you
received support (any kind of support: emotional, information, financial, etc.)?
Have you encountered problems in disclosing that you have this disease?
What is the perception of family / friends / co-workers / neighbors /
community regarding this disease? Do you abstain in talking about the dis-
ease?
How did you overcome the detection of the disease?

Managing the disease


How did your life changed after diagnosis? Did the disease affected in
any way your professional life, family life, social life, diet, lifestyle, etc.?
To what extent do you have information about:
Transmission paths
Main symptoms and their manifestation
Effects of the disease (before and after treatment)
Causes and evolution of the disease
Prevention
Management of the disease what to do after being diagnosed
Treatment options in Romania and in Europe
Have you tried naturist treatments?
Please describe your experience during treatment: side effects, adverse
effects, how did you responded to treatment, who helped you during treat-
ment, if you completed the treatment, whether there was an alternative to
treatment (if advised of other treatment or research programs at certain insti-
tutions conducting research on patients).

3. Experiences with the healthcare system


Access to health services
Please describe how was the interaction with the health system (public
and / or private) during the screening process until monitoring (interaction
with the system and medical staff at different levels of the system) and the
main barriers encountered in accessing medical services.
Please make the history of doctors and places You went in the public or
private sector? How long did it last from identifying symptoms and diagnosis
to getting treatment?
Did you paid (formal or informal) for any necessary tests (for diagno-
sis)? How much did you pay? Have you been hospitalized for diagnosis? How

108
many days? And how much did it cost?
Did you asked for a second opinion?
Do you think that you have been diagnosed correctly and on time or,
incorrect and/ or late, fact that affected your health? Have you had time to ask
for clarification during the visit? Were you encouraged to ask questions? How
long was on average the interaction with the specialist?
After diagnosis, how much time did you spent in a hospital / public clin-
ic? Did you went to a private clinics or abroad? Health services received at the
clinic / hospital were free? Did you had to pay medical staff to receive proper
care? Did you had to pay for laboratory tests done at the clinic / hospital? Did
you had to pay for medication received at the clinic / hospital?

Access to treatment
What was the procedure for accessing treatment (for example, the elab-
oration of the application to receive treatment, duration, required documents,
costs)?
What type of treatment did you follow? Did you had access to treatment?
If not, why? Are you on the waiting list? Which are the treatment costs (formal
and informal)?

Monitoring
How often do you visit the doctor for check-ups? What does the check-
up implies? Is the distance from your home to the clinic / hospital acceptable?

4. Development needs of the health, social and support services


The need for information and education
How informed do you consider yourself about hepatitis C?
What type of information do you need?
Through what channels would you like to be informed?
Who would you like to provide you the information?
Which are the trustable sources of information?

Support services needs


Do you consider that you received adequate support to manage the dis-
ease? What type of support do you need? Who should provide it?
Who helped you in taking decisions on: changing the diet, ameliorating
symptoms, alternative therapies, treatment?
Do you use specialized sites to get information about hepatitis C?

109
Do you have a delegated person/ a case manager/ medical staff (nurse,
doctor, specialist) that you can talk to about the disease? What type of support
provides you? Which is the best source of support?
Are you a part of a support group?
If yes, What needs are covered by the support group? How useful is this
group in helping you tackling the disease? What are your expectations regard-
ing this group?
If not, why not? There are no such groups in your city? You dont want to
be part of such a group?

Medical services needs


What type of medical services do you need? What medical services do
you think should be improved?
Social and psychosocial services needs
What type of social/psychosocial services do you need? Did you benefit-
ed of any services provided by NGOs? Are there such NGOs in your city? Did
you ever heard of services provided by NGOs regarding hepatitis C? Do you
know anyone who benefited of such services?

110
Focus groups guide for GPs

Assessing the needs of patients with chronic hepatitis C in order to inte-


grate them into medical and psychosocial services provided by Baylor Black
Sea Foundation.
Participants: Total |__|__| Age 25-45 years |__|__|
Women |__|__| 46-65 years |__|__|
Men |__|__| > 65 years |__|__|
Date: Hour:

1. Introductory discussion
Short presentation of the project and of the research team.

2. General information about hepatitis C


What is the prevalence of hepatitis C in Romania and globally?
Is there a National Registry of people affected by hepatitis C?
Is there a National Program for hepatitis C?
Which are the main groups with disproportionate risk of hepatitis C in
Romania?
Which are the main transmission paths?
Which are the main symptoms? How do they manifest?
What are the main causes of the disease? How does the disease progress-
es? What are the complications of the disease?
Which are the main prevention methods?
Do you have patients with hepatitis C? If so, how many? At what stage
of the disease are they? How long after the first infection they discovered the
disease? From your experience, what percentage of patients: accidentally dis-
cover the infection; discover the infection after participation in a screening
program or discover it during the late stages?
Which are the main problems of patients of hepatitis C (management of
the disease, access to treatment, poverty, discrimination, lack of help)?
What are the main problems you face in relation to these patients?

111
3. Identification of persons at risk and diagnosis
How people at risk, insured and uninsured, are identified and directed to
testing services? To whom do you recommend testing for hepatitis C? Where
do you sent the patients to get tested?
How do you explain to the patients the results of the reactive rapid test?
How do you explain to the patients the positive results? What do you recom-
mend in each situation?
What do you think is the role of the general practitioner in identifying /
prevention / education / support for people at risk of hepatitis C?
Are there any screening programs? Do you think that they are necessary?
What is the route the patient has to follow in order to receive a diagno-
sis? Who establishes the diagnostic? Is hospitalization required in order to
establish a diagnosis? How long does it takes to establish the diagnosis?
How much do the tests needed to diagnose hepatitis C cost?

4. Treatment
Hepatitis C treatment is available in Romania? Does it complies with the
European standards?
Which are the latest treatment schemes available in Europe? Which are
the latest treatment schemes available in Romania?
Is the treatment accessible to everyone, free of major charges?
Are there waiting lists? How many persons are on these waiting lists?
Who recommends and establishes the treatment scheme?
How can the patient benefit of the treatment? Which is the procedure
(for example, how long does it take to prepare the necessary documents,
which are the costs)?
Are there any groups of population that systematically are less likely to
receive treatment in the public health system? Which are these groups? Why
are they less likely to receive treatment in the public health system?
Overall, how much does a patient (insured/uninsured) pays to receive
proper treatment?
Do you think that the liver-protective treatment is efficient? Should it be
financially supported by the state?
How can the general practitioner and/or the specialist to increase the
treatment compliance of patients? What methods should be used to encour-
age patient adherence to treatment and a corresponding lifestyle to slow the
progression of the disease?
How do you collaborate with other specialists (infectious, internists,

112
psychiatrists, etc.)? What support do you offer in putting together the treat-
ment required documents?

5. Monitoring and Evaluation


What is the time interval the patients (with and without treatment) are
evaluated at? What does the monitoring and evaluation imply? How long does
this stage take? How do you keep in touch with patients (communication sys-
tem)?
Out of the total number of patients how many respect the monitoring
and evaluation program and visit you periodically? What is the general prac-
titioner role during this phase? How do you support patients embracing a
healthy lifestyle? Do you think it would be useful to implement a personalized
plan for encouraging a healthy lifestyle?

6. Development needs of the health services available / public


policies / priorities
Which are the main factors hampering the access to health services in
the public health system? Are there alternatives in the private / NGO sectors?
Which are the unmet needs of patients with hepatitis C? Do you think there
is a fair territorial distribution of resources - rural patients have easy access to
resources?
Which are the categories of personnel involved in the detection, treat-
ment and monitoring patients with hepatitis C? Are they properly trained?
Which are the national priorities regarding hepatitis C? Is there a nation-
al strategy to combat hepatitis C?
What is the legislative context?
Is there a special budget allocated by the state to cover the costs of treat-
ment for hepatitis C? If yes, what is the budget?
What should a national program for hepatitis C include?
Are there any prevention programs? What should they include?
During the lasts years, were there any national awareness/ information
campaigns regarding hepatitis C? If so, what was their impact? If not, would
you consider them useful? How should they be conducted?
Are there any NGOs active in this field? What is the involvement of
NGOs working in the field, of patients associations etc.?
Which are the main recommendations to improve the situation of pa-
tients with hepatitis C? What do you think needs to be done? Who should be
involved?

113
Hepatitis C Lived Experiences as
revealed by focus groups

When have the interviewed patients been diagnosed?


The patients with hepatitis C who attended the group discussions fall
into five categories depending on the way in which they have been diagnosed
with hepatitis C. Most of them had no symptom whatsoever before being di-
agnosed.

1. They tested out of curiosity


The first category consists of the patients who tested out of curiosity at
the Baylor test centre or at the caravans with free testing.
So, no symptom, I just went there (Baylor Foundation), I saw the note
about rapid testing, went in and did it. (...)
You didnt feel bad, didnt have anything at all?
Nothing, nothing at all, I really dont know what it means to be ill, noth-
ing hurts me. (Focus Group Patients with Hepatitis C)
I had my mother at Fundeni (a hospital in Bucharest). It was a caravan
for the free HIV, B and C hepatitis tests. B and HIV were negative, C was
reactive. Then I started to move, I filed my medical record and so on.
(Focus Group Patients with Hepatitis C)

2. They tested because they need annual medical tests for their
job
Another category consists of the patients who work in areas which re-
quire blood counts annually. Since they monitor periodically their health
state, it is easier for them to realise how they got infected. Hence, many think
they were infected at the dentist.
Im in the army, I do a medical check every year, blood analyses and all.
I did it last year, in December, early December. I went to the dentist, me,
my daughter and my wife. Me and my daughter were treated for our
teeth, I had a small crown done, and at the blood test from May they
found me with C hepatitis. (Focus Group Patients with Hepatitis C)

114
3. They tested within the national health evaluation program
from 2007-2008
There are patients who tested positive for hepatitis C virus in 2007-2008,
when there was a national program for health state evaluation of the pop-
ulation, the so-called Nicolaescu program, by the name of the ministry of
health at that moment. Although the test for hepatitis C was not on the list of
compulsory tests within that program, some family doctors had their patients
checked because other medical indicators showed liver problems.
Accidentally, in 2008, it was that health check program started by minis-
ter Nicolaescu, and I tested positively for C.
Why did your family doctor ask you to make that test?
I was eating disorderly my lipid profile was busted and I did the trans-
aminases too, and with a cholesterol close to 400, she told me to try that
one too. And it tested positive in 2008. (Focus Group Patients with
Hepatitis C)

4. They tested because they felt sick or had other medical indi-
cators altered
Another category of patients positive for hepatitis C virus consists of the
people who had some symptoms or whose indicators for liver functions had
been repeatedly detected to be outside the normal ranges. Generally, for these
patients, the family doctors or the medical specialists considered it necessary
to run a test for the presence of the virus for hepatitis C.
I have diabetes and every six months I make analyses and TGP was high
each time. One day, the nutritionist sent me down to the hospital to do a
test. I asked, well, a month, one year, this year, next year, will they always
be higher? Not very high, but higher. And I went downstairs and I did
that test and this is how I discovered it, in spring. (Focus Group Patients
with Hepatitis C)

5. They tested during the pregnancy


Theoretically, all the pregnant women should do a test for virus C, so
even in the lack of symptoms, some had tested positive for hepatitis C on this
occasion.

115
Table of Contents

Acknowledgments ............................................................................. 6
About Baylor Black Sea Foundation ................................................. 7
Executive summary............................................................................ 8
Section A:
Delivery of Healthcare Services for Hepatitis C
in the Context of the Health System in Romania ........................... 10
Chapter I. Characteristics of the Romanian Health System....................11
Organization of health services in Romania............................................. 12
Health-Related Human Resources............................................................. 17
Information and Research Systems............................................................ 19
Existing Medical Products........................................................................... 20
Sustainable Funding and Social Protection............................................... 22
Management and Good Governance......................................................... 26
Chapter II. Current Level of Development of Care
for Hepatitis C Patients in Romania.........................................................28
The Context of Health Policies with Respect to Hepatitis C................... 28
Epidemiological Facts about Hepatitis C in Romania............................. 29
Incidence................................................................................................... 30
Prevalence................................................................................................. 31
Transmission paths.................................................................................. 32
Treatment.................................................................................................. 33
Costs of Hepatitis C in Romania................................................................ 35
The Level of Organization of the Romanian Health
Systems Response to the Challenges Raised by Hepatitis C................... 36
The current pathway of patients affected by HCV................................... 41
Section B:
Qualitative Research
Hepatitis C: Opinions of Patients and Specialists on Chronic Care De-
livery in Constana, Romania............................................................ 44
Part I. Research brief .................................................................................45
Motivation and applicability of the qualitative assessment..................... 45
Organization of the research related reading material ........................... 46
Part II. Chronic care model.......................................................................47
Theoretical and conceptual aspects ........................................................... 47
Assessment of chronic illness care the ACIC tool................................. 56

116
Recommendations to improve care based on CCM................................ 58
Final comments regarding the CCM usefulness and limitations........... 59
Part III. Qualitative assessment findings..................................................60
Aim of the qualitative assessment............................................................... 60
Methods......................................................................................................... 60
Participants.................................................................................................... 63
Analysis of the qualitative data................................................................... 65
Results............................................................................................................ 66
Wrapping it up all together Mapping the content analysis
against the ACIC assessment tool .............................................................. 82
Part IV. Recommendations for Interventions to Improve
the Care of Hepatitis C in Constana region............................................86
The qualitative assessments limitations..................................................... 90
Section C:
Annexes............................................................................................ 92
The ACIC tool............................................................................................... 93
Interview guide for medical specialists...................................................... 99
Interview guide for policy makers............................................................ 102
Interview guide for patient organizations............................................... 104
Focus group guide for patients.................................................................. 107
Focus groups guide for GPs....................................................................... 111
Hepatitis C Lived Experiences as revealed by focus groups.............. 114

117
118
Ana-Maria Schweitzer, senior clinical psychologist,
has been active in the healthcare area since 1999,
being part of the Baylor Black Sea Foundation that
has set up the multidisciplinary services at the Spitalul
Clinic de Boli Infecioase Constana Baylor College
of Medicine Texas Childrens Hospital Abbott Fund
Clinical Centre of Excellence in Constana, Romania.
Since 2005, she has been serving as the executive
director of the Baylor Black Sea Foundation that
focuses on developing prevention, testing and care
programs for people affected by chronic infectious
diseases, such as HIV infection or viral hepatitis.
Through her professional activity, she strives to
mitigate the psychological impact of chronic diseases and to develop patient
centered health projects.

Mihaela Bogdan has experience in healthcare


organizations of more than 15 years. She started her
career as a volunteer working in prevention projects.
She has progressively embraced different other
roles, such as health counselor, trainer and program
manager. In 2006 she joined the Baylor Black Sea
Foundation. At the Centre of Excellence she was a
key player in establishing the voluntary counselling
and testing project for HIV and viral hepatitis. As the
project director, Mihaela strives to ensure the teams
professional level and the alignment with the best
practices of service delivery for people affected by
chronic illnesses.

ISBN: 978-973-0-19453-1

9 789 730 19 4531