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Article history:
Received 25 March 2015
Received in revised form
1 July 2015
Accepted 4 July 2015
Objectives: Implement and test unit-wide patient-nurse assisted communication strategies (SPEACS).
Background: SPEACS improved nurse-patient communication outcomes; effects on patient care quality
and resource use are unknown.
Methods: Prospective, randomized stepped-wedge pragmatic trial of 1440 adults ventilated 2 days and
awake for at least one shift in 6 ICUs at 2 teaching hospitals 2009e2011 with blinded retrospective
medical record abstraction.
Main results: 323/383 (84%) nurses completed training; their communication knowledge (p < .001) and
satisfaction and comfort (p < .001) increased. ICU days with physical restraint use (p .44), heavy
sedation (p .73), pain score documentation (p .97), presence of ICU-acquired pressure ulcers
(p .78), coma-free days (p .76), ventilator-free days (p .83), ICU length of stay (p .77), hospital
length of stay (p .22), and median costs (p .07) did not change.
Conclusions: SPEACS improved ICU nurses knowledge, satisfaction and comfort in communicating with
nonvocal MV patients but did not impact patient care quality or resource use.
2015 Elsevier Inc. All rights reserved.
Keywords:
Augmentative and alternative
communications systems
Intubation
Endotracheal
Nurses
Education
Quality of health care
Abbreviations: ICU: intensive care unit; SPEACS: Study of PatienteNurse Effectiveness with Assisted Communication Strategies; MV: mechanical ventilation; SLP:
speech language pathologist; EMR: electronic medical record; APACHE: Acute Physiology and Chronic Health Evaluation; NCS: Nurse Communication Survey; ITT: intention to treat.
Author contributions: Study concept and design e M.B.H., A.E.B., J.A.T., S.M.S., D.C.
A.; Acquisition of data e J.B.S., A.S., J.V.P., J.A.T.; Statistical analysis e M.P.H., S.M.S.;
Analysis and interpretation of the data e M.B.H., A.E.B., J.A.T., J.B.S., S.M.S., D.C.A., E.
G.; Drafting of the manuscript e A.E.B., M.B.H., S.M.S., J.A.T., M.F.N., M.P.H.; Critical
revisions to the manuscript for important intellectual content e all authors;
Obtained funding e M.B.H, A.E.B., J.A.T., S.M.S, E.G., B.B., D.C.A.; Study supervision e
M.B.H., A.E.B., J.A.T., S.M.S, E.G., B.B., D.C.A.
0147-9563/$ e see front matter 2015 Elsevier Inc. All rights reserved.
http://dx.doi.org/10.1016/j.hrtlng.2015.07.001
409
Table 1
Components of the SPEACS-2 Intervention.
Intervention components
1. Six 10-min on-line educational modules involving narrated text slides and
video exemplars of communication assessment and techniques (60 min).
2. Reference manual, pocket reference cards, assessment e intervention
algorithm.
3. Communication cart in the ICU containing assistive communication tools and
materials.
4. Communication resource nurses (champions) e minimum of 2 per ICU.
5. Weekly teaching posters communication strategy of the week.
6. Weekly patient case conference with Speech Language Pathologist.
410
Neuro
Trauma
Unit
Medical
Cardiovascular
Transplant
Neuro Trauma
1
Included
n=30
Excluded
n=61
Included
n=30
Excluded
n=30
Included
n=30
Excluded
n=38
Included
n=30
Excluded
n=16
Included
n=30
Excluded
n=47
Included
n=34
Excluded
n=44
2
Included
n=30
Excluded
n=65
Included
n=30
Excluded
n=18
Included
n=30
Excluded
n=36
Included
n=30
Excluded
n=26
Included
n=30
Excluded
n=47
Included
n=32
Excluded
n=32
3
Included
n=30
Excluded
n=81
Included
n=30
Excluded
n=25
Included
n=30
Excluded
n=49
Included
n=30
Excluded
n=22
Included
n=30
Excluded
n=58
Included
n=23
Excluded
n=35
Quarter
4
5
Included
Included
n=30
n=30
Excluded Excluded
n=49
n=32
Included
Included
n=30
n=30
Excluded Excluded
n=19
n=19
Included
Included
n=30
n=30
Excluded Excluded
n=23
n=24
Included
Included
n=30
n=30
Excluded Excluded
n=15
n=15
Included
Included
n=30
n=30
Excluded Excluded
n=28
n=39
Included
Included
n=24
n=26
Excluded Excluded
n=28
n=24
6
Included
n=30
Excluded
n=56
Included
n=30
Excluded
n=20
Included
n=30
Excluded
n=41
Included
n=30
Excluded
n=23
Included
n=30
Excluded
n=43
Included
n=37
Excluded
n=21
7
Included
n=30
Excluded
n=38
Included
n=30
Excluded
n=21
Included
n=30
Excluded
n=30
Included
n=30
Excluded
n=21
Included
n=30
Excluded
n=44
Included
n=30
Excluded
n=36
8
Included
n=30
Excluded
n=51
Included
n=30
Excluded
n=18
Included
n=30
Excluded
n=44
Included
n=30
Excluded
n=19
Included
n=30
Excluded
n=45
Included
n=34
Excluded
n=31
Unshaded pre-intervention quarter; Light shading intervention deployment quarter; Dark shading post-intervention quarter. The total
number of randomly selected patients screened for abstraction eligibility in each quarter = included + excluded; the proportion of patients
meeting abstraction eligibility criteria = included/(included + excluded).
Fig. 1. [Box] Screening and Eligibility by Study Unit and Quarter. The unshaded section of the box represents pre-intervention quarters, the light-shaded section represents the
intervention deployment quarter, and dark shaded section represents post-intervention quarters. The total number of randomly selected patients screened for abstraction eligibility
in each quarter included excluded; the proportion of patients meeting abstraction eligibility criteria included/(included excluded).
Evaluation
Nurse outcomes
We assessed several process measures to evaluate the delity
of the intervention.15 Specically, we assessed training completion (intervention delivery) by dates of unit nurses completion
of the web-based training and post-test, with an a priori target
of 85% completion during the quarter of intervention deployment. We assessed nurse knowledge acquisition (intervention
receipt) by comparing nurses performance on a 10-item preand post-training test. Expert clinicians and nurse educators
vetted the tests after viewing all six training modules. We
recorded communication supply use during weekly restocking,
attendance at SLP bedside teaching rounds, and adherence
to training principles (intervention enactment) via bedside
observation.
We also assessed nurse satisfaction and comfort with communication with nonvocal patients using a 16-item Nurse Communication Survey (NCS) administered immediately before and 3
months after nurse training.16 This was adapted from a previously
validated 12-item NCS with 4 novel items drawn from our focus
group analysis from the original SPEACS study.9 The revised 16item NCS survey revealed 6 factors or subscales explaining 66% of
the item variance. We conned the outcome analysis to subscales
with internal consistency above a .70.
Patient outcomes
We selected quality of care measures proximately related to the
hypothesized mechanism of action of the communication skills
training, informed by video-analysis8 and focus group interviews
with participants in the original SPEACS trial.9 Specically, we
hypothesized that improved communication with nonvocal but
awake mechanically-ventilated ICU patients would: 1) increase
effectiveness of patient-nurse communication and thereby increase the frequency of pain score assessment and documentation,
and 2) decrease the frequency of patient frustration and agitation
and thereby decrease physical restraint and/or heavy sedation to
prevent device disruption and resultant ICU-acquired pressure
ulcers. We based these hypotheses on research linking communication difculty to feelings of anxiety and agitation during
MV,1,2,17 survey research indicating that patients perceived that
their frustration with communication would have been signicantly lower if communication tools had been offered during
MV,18 and our previous nding that seriously ill mechanically
ventilated patients communicated more often during periods of
non-restraint.19
We operationalized and measured these outcomes in the EMR
as follows: physical restraint (proportion of mechanically ventilated ICU days with one or more upper extremity restraint at any
point during the 24 h interval), heavy sedation (proportion of
mechanically ventilated ICU days in which the patient did not meet
awake criteria for 8 out of 12 h AM or PM as dened by Modied
Ramsay score 1e3, Glasgow Coma motor score of 6, nursing note
documentation of being alert, awake, arousable, responsive, or
communicative), coma-free days (number of days out of 28 in
which patients were assessed as awake or not in heavy sedation
state for at least 8/12 h of both AM and PM nursing shifts),20 pain
documentation (proportion of mechanically ventilated ICU days
with pain score documented, given documented presence of any
pain), any ICU-acquired pressure ulcer grade II or greater, and unplanned endotracheal or tracheal tube extubation (see Online
Supplement for greater detail).
Secondary patient outcomes included resource use. We
hypothesized that reductions in restraint and heavy sedation would
reduce length of MV, ICU and hospital stay, and costs. Specically,
we measured ventilator-free days,21 ICU and hospital length of stay,
and cost-adjusted charges.
Trained staff, blinded to intervention assignment, abstracted
clinical data (physical restraint, heavy sedation, coma-free days,
pain documentation, ICU-acquired pressure ulcers, unplanned
extubation, ventilator days) from the electronic medical record
(PowerChart, Cerner Corporation, Kansas City, MO) during the
incident ICU admission, for up to 28 days, using a standardized
abstraction instrument. From among the 1440 abstracted cases, 108
were randomly selected for co-abstraction by a single rater (10% for
quarters 1e4; 5% for quarters 5e8) with inter-rater reliability of
0.8e1.0 (near-perfect agreement)22 for all measures except the
presence of pressure ulcers (k 0.69). We report details of the
development and validation of the abstraction instrument elsewhere.23 We collected administrative data (ICU length of stay,
hospital length of stay, hospital charges) from billing records
(Medical Archival System, Pittsburgh, PA).
Statistical analyses
The study was appropriately powered and an adequate patient
sample was obtained to detect a small to medium effect size.
Specically, 30 patients per unit per quarter provided at least 80%
power to detect unit by quarter interactions as small as f 0.136
[small to medium effect size based on Cohen (1980)] using a
two-sided F-test from a two-way general linear model at a
411
412
Results
Nurse characteristics
A total of 323 of 383 eligible nurses completed the on-line
course. These study nurses were predominantly women (77%),
43% were bachelors-prepared, 5.5% were masters-prepared, and
17% were critical care certied.
Patient characteristics
From a sample of 5476 patients identied as potentially eligible
using administrative claims, we screened 3087 patient charts to
identify 1440 eligible patients for full chart abstraction (Fig. 1).
There were no statistically signicant differences in demographic
or clinical characteristics age, sex, race, APACHE III, or pre-hospital
functional status among abstracted patients admitted during
control and intervention quarters (Table 2). The distribution of
primary admission diagnoses classied by organ system differed
signicantly among control and intervention quarters due to the
order of crossover of subspecialty study ICUs. Subspecialty ICUs
that were randomized to cross-over earlier in the study period (e.g.,
Table 2
Demographic and clinical characteristics of abstracted eligible patients, by intervention period.
Pre-intervention
(N 626)
Age, mean (SD), y
59.97 (17.65)
Male sex, n (%)
326 (52.1)
b
Race (N 1435), n (%)
White
560 (89.7)
Black
57 (9.1)
Asian
2 (0.3)
Other
5 (0.8)
APACHE III score, mean (SD)
67.40 (27.8)
Primary admission diagnosis
classied by organ system, n (%)
Cardiovasculard
93 (14.9)
Respiratory
153 (24.4)
Neurological
54 (8.6)
Gastrointestinal
42 (6.7)
Trauma
105 (16.8)
Renal or liver
19 (3.0)
Transplant
23 (3.7)
Sepsis
31 (5.0)
Post-surgical
101 (16.1)
Othere
5 (0.8)
Pre-hospital functional dependence, n (%)b
Eating (N 1036)
25 (4.0)
Grooming (N 1033)
25 (4.0)
Bathing (N 1037)
30 (4.8)
Dressing (N 1031)
27 (4.3)
Transfers (N 1022)
34 (5.4)
Toileting (N 1221)
33 (5.3)
Intervention
groupa
(N 814)
p-value
62.06 (16.26)
428 (52.6)
0.07
0.85
0.33c
731
75
4
1
64.87
(90.1)
(9.2)
(0.5)
(0.1)
(27.41)
141
177
181
41
82
6
5
31
137
13
(17.3)
(21.7)
(22.2)
(5.0)
(10.1)
(0.7)
(0.6)
(3.8)
(16.8)
(1.6)
20
26
30
29
28
42
(2.5)
(3.2)
(3.7)
(3.6)
(3.4)
(5.2)
0.08
<0.01
0.10
0.42
0.30
0.47
0.07
0.93
SD e standard deviation; APACHE III e Acute Physiology Age and Chronic Health
Evaluation (APACHE) III score.
a
Includes 180 patients abstracted from a quarter of intervention deployment. In
our base-case analysis, we treated the unit as being partially exposed to the
intervention during the quarter in which the nurses received training. We assigned
a value between 0 and 1 corresponding to the median proportion of trained nurse
days in the unit. Units in which the nurses completed earlier in the quarter have
numbers closer to 1 than units in which the nurses completed training later in the
quarter (see Table 3).
b
The proportion reported is among patients with non-missing data; we report
the number of subjects with non-missing data in parenthesis.
c
p-value obtained from Fishers exact test.
d
Includes Cardio/thoracic/vascular surgery, cardiomyopathy, myocardial infarction, and arrhythmia.
e
Includes hematology/oncology.
Overall
Eligible nurses, n
383
Receipt
Completed training during quarter,a n (%)
323 (84)
Trained nurse days in quarter,a median proportion (IQR)
0.46 (0.52)
Nurse knowledge about strategies for communication with nonvocal patients
Nurses with both pre- and post-test data, n
273
Pre-test knowledge: % correct,b mean (SD)
49.0 (14.2)
Post-test knowledge: % correct,b mean (SD)
55.4 (14.4)
Change: % correct,b mean (SD)
6.3 (17.4)
p-value
<0.001
Nurse attitudes toward communication with nonvocal patients
Nurses with attitude data, n
264
Pre-training attitude score,c mean (SD)
3.21 (0.42)
Post-training attitude score,c mean (SD)
3.43 (0.42)
Change: mean item response, (SD)
0.22 (0.44)
p-value
<0.001
IQR e interquartile range (75th percentile value minus 25th percentile value); SD e
standard deviation.
a
Quarter during which the intervention was deployed.
b
Knowledge outcomes restricted to the 273/323 (84.5%) trained nurses who
competed both the pre- and post-test knowledge assessment tests.
c
Mean item response for the 16-item survey; each item had a possible range of
1e5 indicating strength of agreement.
p=.107
p=.122
p=.141
p=.268
Communication wall
cards/careplans
Algorithm use
Fig. 2. [Bar chart] Intervention Fidelity Monitoring (IFM). Direct observations during
the intervention implementation quarter (N 225) and during the rst postintervention implementation quarter (N 257) demonstrated no decreases in the
adherence to SPEACS-2 program components (written communication care plans, algorithm use, communication at all e with or without algorithm, and assistive and
augmentative communication tools in the patients room) over time.
413
Resource use
Overall, the sample had an average of 19.2 ventilator free days, a
median ICU length of stay of 9.0 days, a median hospital length of
stay of 15.0 days, and a median cost of $48,774. There were no
statistically signicant differences between intervention and control quarters in ventilator-free days (.15, p .83), ICU length of stay
(.20, p .77), hospital length of stay (1.22, p .22), and median
costs ($6,380, p .07) (Table 4).
These ndings were not qualitatively changed in analyses
adjusting for age, sex, race, admission APACHE III score, and
neurologic disorder as the admitting diagnosis (Table 4), or in
sensitivity analyses treating the intervention deployment quarter
as a control period (0) or a full intervention period (1), instead of a
fraction corresponding to the median proportion of trained nurse
days (data not shown). In post-hoc analyses stratied by units with
greater versus lesser nurse knowledge change, the intervention
was associated with an increase of $14,258 in per patient costs in
the 3 study units with less than 5% absolute increase in post-test
knowledge (p .03).
Discussion
Table 4
Nursing care quality and utilization outcomes, by intervention period.
Control
(N 626)
Interventiona
(N 814)
Unadjustedb intervention
effect b [95% CI]
p-value
Adjustedc intervention
effect b [95% CI]
p-value
47.9 (36.0)
50.1 (36.5)
37.9 (31.3)
32.3 (29.7)
Coma-free days, d
20.3 (10.2)
21.1 (9.9)
29.0 (30.1)
24.0 (27.2)
62 {9.9}
71 {8.7}
19.1 (7.5)
19.3 (7.3)
10.0 [12.0]
9.0 [11.0]
15.0 [15.0]
15.0 [13.0]
Cost, $d
45,876 [47,195]
50,458 [53,305]
Outcome
414
quantication of nursing care quality indicators in ICU to measure the effect of communication. The intervention demonstrated
modest improvements in nurse knowledge, and their comfort
and satisfaction with communication with nonvocal, intubated
ICU patients. Greater improvements in nurses knowledge
about communication using AAC tools and techniques may have
been achieved with formal educational follow-up or boosters
(e.g., webinar, simulation, role play, communication coaching).
Because we have no information on minimal clinically important
differences in scales measuring satisfaction and comfort with
communication, we are careful to not over-interpret the signicance. Although the gains were modest, the fact that the program
was able to change attitudes, particularly comfort with and
satisfaction in communicating with impaired patients is an
important step toward practice change. Program enactment
measures showed gradual increases over time from the deployment quarter to the post-implementation quarter, most notably,
in the use of AAC tools and techniques beyond simple yes/no
appropriate to the patients level of communication function, and
placement of AAC tools in the rooms of eligible mechanically
ventilated patients. Although program adherence and adoption
may not have reached levels necessary to show meaningful
change in quality indicators or patient outcomes, these achievements suggest that the program can produce measurable practice
change and that longer and more robust implementation may yield
better results.
Fourth, we powered the study to nd a small to moderate effect
size. If the effect size is considerably smaller, the null nding would
reect type II error.
Post-hoc sensitivity analysis indicating that units with low
gains in nurse knowledge experienced a substantive increase
in per patient costs in the post-intervention quarters are
difcult to interpret because other utilization outcomes that
typically track with costs, such as length of stay and ventilatorfree days, did differ between units with low and high gains in
nurse knowledge, and may reect Type I error (See Online
Supplement).
The stepped wedge design was chosen because individual level
randomization was not possible and to avoid threats to external
validity in a classic cluster randomized trial, particularly with
respect to heterogeneity of ICUs,26 and because the intervention
showed initial evidence of effectiveness in improving communication process measures.8 However, the protracted stepped
implementation extends trial duration while limiting the time
available for intervention implementation as well as the opportunity for follow-up measurement.37
Finally, more granular data collection on nurse dose and
implementation may have provided a more robust test of practice
change and the impact of that change on patient well-being. One
approach may be to quantify the proportion of days that the patients nurse(s) were SPEACS-2 trained. Nurses could be observed
for actual use of SPEACS-2 techniques and tools during patient
communication.
In conclusion, unit-wide implementation of a program of
nurse training in assistive communication skills, low-tech
communication tools and clinical resources (SPEACS-2) achieved
modest improvements in ICU nurses knowledge, satisfaction and
comfort in communicating with nonvocal mechanically ventilated patients but did not signicantly impact on nursing care
quality or clinical outcomes. Future studies should include longer
intervention periods, pragmatic clinical trial designs38 that
employ iterative intervention testing responsive to the ICU
setting, more granular intervention measurement, validation of
outcome measures, and consideration of patient and family
psychological outcomes.
Acknowledgments
Our thanks to research mentorship students, Rebecca Nock,
Anna Evans, Jin Lee, Ian Joel, Tiffany Behringer, Rachel Orler Reid,
Joe Ciampoli, Joe Kaye, Lauren Mancuso, Cassandra Delp, Hannah
Park, Alexandra Dreyzin, who worked on this project and to Melissa
Saul, MS and Elan Cohen, MS for database and programming
assistance.
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415.e1
Appendix Figure A1
Pre-Intervention
n=2,322
Intervention
n=3,154
Excluded:
n=714
Excluded:
n=933
Abstracted:
n=626
Abstracted:
n=814
Appendix Table A1
Quality indicator denitions
Quality indicator
Denition
Restraint use
All restraint devices used within the 24 h interval being evaluated including: soft extremity restraints (specify number of limbs restrained), vests,
waist belts, full side-rails, mitts, and enclosure beds.
Evidence of heavy sedation at any point during the 24 h interval as measured by:
Modied Ramsay score 4e6 or
Riker score of 1e2 or
Nursing note description of unresponsiveness to verbal or tactile stimulation, or being comatose or anesthetized.
Heavy sedation
Pain
ICU acquired
pressure ulcers
Awake for 8 out of 12 h for 12:00 ame11:59 am or 12:00 pme11:59 pm as dened by:
Modied Ramsay score 1e3.
GCS motor score of 6.
Nursing note documentation of being alert, awake, arousable, responsive, or communicative.
Presence of any pain during the 24 h period being evaluated (Y/N).
Highest pain score on a scale of 1e10 (including half scores) for the 24 h interval.
Any use of the descriptor unable to communicate in the pain assessment documentation during the 24 h interval (Y/N).
Any pressure ulcer, stage II or greater, occurring during the index ICU stay that was not documented on admission [cumulative for ICU stay].
415.e2
Appendix Table A2
Post hoc analysis of outcome variables by unit nurse knowledge gain
Low knowledge gain units
Intervention effect
Statistic
p value
2.63
8.32
1.22
3.36
0.66
t 0.38
t 1.43
t 0.63
t 0.65
Wald ChiSq 1.21
0.71
0.15
0.53
0.52
0.27
6.64
7.12
2.07
2.98
0.07
0.23
0.51
0.52
0.45
14,259
t
t
t
t
t
0.87
0.69
0.77
0.74
0.03
0.3
1.09
2.94
1.17
5913
0.17
0.4
0.29
0.33
2.15
Intervention effect
Statistic
p value
t 0.87
t 1.18
t 1.21
t 0.54
Wald ChiSq 0.01
0.38
0.24
0.23
0.60
0.93
t
t
t
t
t
0.23
0.84
1.77
0.88
0.86
0.82
0.40
0.08
0.38
0.39