COMPASS: A Novel Transition Program to Reduce Disability After Stroke
Phase: NA
Conditions: Ischemic Stroke, Hemorrhagic Stroke
Sponsor: Washington University School of Medicine

 
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COMPASS: A Novel Transition Program to Reduce Disability after Stroke 
 
Study Protocol 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Version: 8.3 
Original: October 26, 2017 
Last Updated: August 7, 2023 
 
 
 
 
 
 

 
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Principal 
Investigator: 
 
Co-Investigators: 
 
 
Biostatistician:  
 
 
Study Site:  
 
Susan Stark, PhD, OTR/L 
Program in Occupational Therapy 
Washington University School of Medicine 
St. Louis, Missouri 
 
Alexandre Carter, MD 
Department of Neurology  
Washington University School of Medicine 
St. Louis, Missouri 
 
 
Yan Yan, MD, PhD 
Division of Biostatistics 
Washington University School of Medicine 
St. Louis, Missouri 
 
 
Washington University School of Medicine 
4444 Forest Park Avenue 
St. Louis, MO  63110 
 
 
 
 
 
 

 
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Table of Contents 
Key Abbreviations ............................................................................................................................................................. 5 
Glossary of Terms .............................................................................................................................................................. 6 
Version Updates ................................................................................................................................................................. 7 
World Health Organization Data Set .......................................................................................................................... 8 
Organizational Structure and Responsibilities .................................................................................................... 12 
Abstract ............................................................................................................................................................................. 13 
Methods ............................................................................................................................................................................. 15 
Research Design Overview ...................................................................................................................................................... 15 
Study Participants ................................................................................................................................................................................................................ 15 
Recruitment .................................................................................................................................................................................. 16 
Informed Consent ....................................................................................................................................................................... 16 
Baseline Home Visit (T1) for All Participants ................................................................................................................... 17 
Randomization and Blinding .................................................................................................................................................. 18 
Phone Assessment T1b ............................................................................................................................................................. 18 
Primary Intervention ................................................................................................................................................................ 18 
Defining the Treatment (Table 1) ................................................................................................................................................................................. 19 
Attention Control Group ................................................................................................................................................................................................... 19 
Follow-up Period for All Participants .................................................................................................................................. 20 
Data Collection ................................................................................................................................................................ 21 
Outcome Assessments for Baseline & Follow-up Home Visits .................................................................................... 21 
Demographic Assessments ...................................................................................................................................................... 22 
Statistical Analyses ........................................................................................................................................................ 23 
Intention-to-Treat Analysis ..................................................................................................................................................... 23 
Baseline Analyses........................................................................................................................................................................ 23 
Missing Data .................................................................................................................................................................................. 23 
Primary Analysis ......................................................................................................................................................................... 23 
Secondary Analyses .................................................................................................................................................................... 24 
Safety ............................................................................................................................................................................................... 24 
Process Outcomes ....................................................................................................................................................................... 24 
Sample Size Calculations .......................................................................................................................................................... 24 
Strengths and Limitations ........................................................................................................................................... 25 
Potential Benefits, Risks, and Alternatives ............................................................................................................ 25 
Benefits ........................................................................................................................................................................................... 25 
Risks ................................................................................................................................................................................................. 25 
Minimization of Risks and Confidentiality ............................................................................................................. 25 
Adverse Event Reporting and Safety Monitoring ................................................................................................. 26 

 
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Premature Study Termination ................................................................................................................................... 27 
Indemnity ......................................................................................................................................................................... 27 
Ethics and Dissemination ............................................................................................................................................ 27 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Key Abbreviations 
 
 
AC  
 
 
 
Attention Control 
ADLs   
 
 
Activities of Daily Living 
AE  
 
 
 
Adverse Event 
BI 
 
 
 
Barthel Index 
BJH   
 
 
Barnes Jewish Hospital 
CGI 
 
 
 
Caregiver Interview 
COMPASS   
 
Community Participation Transition after Stroke 
FIM 
 
 
 
Functional Independence Measure 
HIPAA 
 
 
Health Information Portability and Accountability Act  
HRPO  
 
 
Human Research Protection Office 
IADLs  
 
 
Instrumental Activities of Daily Living 
ICF  
 
 
 
International Classification of Function, Disability and Health  
ICH   
 
 
Intracranial Hemorrhage  
I-HOPE  
 
 
In-Home Occupational Therapy Evaluation 
IR  
 
 
 
In-patient rehabilitation 
IRB   
 
 
Institutional Review Board 
IS  
 
 
 
Ischemic Stroke 
NIH   
 
 
National Institutes of Health 
NIHSS  
 
 
National Institute of Health Stroke Scale 
OT  
 
 
 
Occupational Therapy 
PROMIS  
 
 
Patient Reported Outcomes Measurement Information System 
PSS  
 
 
Perceived Stress Scale 
RNLI   
 
 
Reintegration to Normal Living Index 
RCT   
 
 
Randomized Controlled Trial 
SBT  
 
 
Short Blessed Test 
SAS  
 
 
Statistical Analysis System 
SIS  
 
 
 
Stroke Impact Scale 
SPSS  
 
 
Statistical Package for the Social Sciences 
TRISL  
 
 
The Rehabilitation Institute of St. Louis 
 
 
 

 
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Glossary of Terms 
 
Environmental barriers 
Features of the built environment which makes activity performance 
difficult or unsafe (e.g. lack of hand support by toilet to hold onto while 
transferring) 
 
Environmental modifications 
Changes to the built environment which remove the barrier and 
compensate for loss in function that a person might experience after a 
stroke (e.g. installing grab bars on each side of the toilet to give individual 
hand hold while transferring). 
 
Strategy training 
Strategy training is an iterative rehabilitation intervention that promotes 
goal setting, planning and self-monitoring used to help individuals identity 
and overcome difficulties on their own.  
 
Tailoring 
Tailoring is the process the interventionist uses to adapt the treatment 
intervention to match and compensate for each participant’s pattern of 
functional loss and unique home and community environments. 
 
Motivational interviewing 
Motivational interviewing is a method used to help individuals resolve 
ambivalent feelings and insecurities to find the internal motivation needed 
to change behavior. It is a practical empathetic process that takes into 
consideration the difficulty people face when making life changes, 
especially after a significant health event like a stroke. 
 
Booster Visit 
A visit which occurs months after the initial intervention that is completed 
to reinforce the strategies learned during the intervention as well as help 
the participant problem solve any new performance problems which might 
have arisen after the initial intervention was completed.  
 
Community participation 
An individual’s involvement his/her own community, as the individual sees 
fit and meets his/her individual desires and needs. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 

 
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Version Updates 
 
 
Date 
Version Description  
3/23/18 
1.0 
Added phone call system, caregiver and therapist participant recruitment and 
measures, removed Lily Hu and changed Emily Somerville to study coordinator 
4/9/2018 
2.0 
Changed inclusion criteria to include intracranial hemorrhagic stroke as well, per 
discussion with study neurologist, Dr. Alex Carter.  
6/14/2018 3.0 
Changed time points caregivers are assessed  
10/18/18 
4.0 
Added transportation option to home visit as staff vehicle. This has been ok’d by 
Wash U insurance group 
11/30/18 
5.0 
If a person has an extended hospital stay or goes to a SNF for the short term, we will 
push back their T3 based on the extra days of stay. Normal LOS is considered 3 
days.   
3/8/19 
6.0 
Changed our n to 180, based on retention rates 
1/2/20 
7.0 
Decided if T3 is missed by more than 3 months, we will skip T3 and go to T4 
3/31/20 
7.1 
Because of the stay-at-home orders our primary endpoint will be impacted 
(community participation). In addition, because we can’t go into people’s homes, we 
will need to do follow up via phone and won’t be able to do the I-HOPE barriers. We 
will add repeat of the follow-up time points to collect data in the home when we can 
go back in. Those timepoints will be T2COVID, booster 1&2COVID,T3COVID, 
T4COVID. At this point, those are 60 days after their original time point (30 days for 
SAH orders and 30 more days to allow the person to get back into the community 
after the SAH orders are lifted). 
4/1/20 
7.2 
We will ask our participants if they have access to technology needed for telehealth 
and are willing to participate in visits remotely using telehealth. 
4/9/20 
7.3 
In order to better understand the impact the COVID-19 pandemic is having on our 
participants, we will add additional measures to ask all participants, both those who 
have finished and those are still in follow up. Measures will include: RNLI, SIS, GDS, 
PROMIS SF Anxiety, NIH Instrumental Support, Pittsburgh Sleep Quality Index, 
PROMIS SF Social Isolation, 3-Item UCLA Loneliness Scale, and the Connor 
Davidson Resilience Scale. 
6/26/20 
7.4 
In order to reduce physical contact with participants during the COVID-19 pandemic, 
we will switch to electronic consenting when at all possible. 
7/10/20 
7.5 
Added that we will continue with e-consenting even after COVID-19 is over 
11/11/20 
8.0 
Added the option for modified assessment process during COVID when participant is 
not able to leave TRISL for home assessment. 
1/6/22 
8.1 
Added question about participants’ COVID-19 vaccination status. 
6/22/2023 8.2 
Updated contact information for study personnel  
8/28/23 
8.3 
Added statement about waiver of consent to collect chart review data as a follow up 
metric to identify patient outcomes and for safety monitoring. 
 
 
 
 
 
 
 
 
 
 

 
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World Health Organization Data Set 
 
Primary Registry 
and Trial 
Identifying Number 
ClinicalTrials.gov: NCT03485820 
 
Date of 
Registration  
April 2, 2018 
Secondary 
Identifying 
Numbers 
IRB ID#: 201705047  
Source(s) of 
Monetary Support 
 
Funding for the COMPASS trial is through the National Center for Medical 
Rehabilitation Research (NCMRR), 1R01HD092398-01 
 
Primary Sponsor 
 
Program in Occupational Therapy—Washington University School of 
Medicine in St. Louis, MO 
Secondary 
Sponsor(s) 
 
N/A 
Contact for Public 
Queries 
 
Susan Stark, PhD, OTR/L 
sstark@wustl.edu 
314-273-4114 
Program in Occupational Therapy 
Washington University School of Medicine 
5232 Oakland Ave 
St. Louis, MO 63110 
United States  
 
Contact for 
Scientific Queries 
Susan Stark, PhD, OTR/L 
sstark@wustl.edu 
314-273-4114 
Program in Occupational Therapy 
Washington University School of Medicine 
5232 Oakland Ave 
St. Louis, MO 63110 
United States  
 
 
Public Title 
 
COMPASS: A Novel Transition Program to Reduce Disability after Stroke 
 
Scientific Title 
 
COMPASS: A Novel Transition Program to Reduce Disability after Stroke 
 
Countries of 
Recruitment 
United States 

 
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Health Condition(s) 
or Problem(s) 
 
Stroke in adults 
Intervention(s) 
 
Study arm 1: Home Modifications  
 
Study arm 2: Attention Control 
 
 
Key Inclusion and 
Exclusion Criteria 
 
Participants with Stroke 
Inclusion criteria:  
(1) aged ≥50 years 
(2) acute ischemic stroke (IS) or focal intracranial hemorrhagic (ICH) stroke 
diagnosis verified by study neurologist Dr. Alexandre Carter 
(3) independent in activities of daily living (ADLs) prior to stroke (premorbid 
Modified Rankin Scale Score ≤2) 
(4) plan to discharge to home  
 
Exclusion criteria:  
(1) severe terminal systemic disease that limits life expectancy to < 6 
months 
(2) previous disorder (e.g., dementia) that makes interpretation of the self-
rated scales difficult or Short Blessed Test (SBT) score of 10 or less 
(indicating significant cognitive impairment) 
(3) moderate-to-severe aphasia as determined by the National Institutes of 
Health Stroke Scale (NIHSS) Best Language rating of 2 or more 
(4) reside in congregate living facility 
 
Caregivers 
Inclusion criteria: (1) primary informal (family or friend) caregiver of a 
stroke patient enrolled in the COMPASS II study, (2) aged ≥18 years 
Exclusion criteria: (1) non-English speaking 
 
Study Type 
 
Interventional/Randomized Controlled Trial phase: IIb 
Allocation: Randomized 
Intervention model: Parallel assignment 
Masking: Interventionist not blinded to group, participant not blinded to 
group, primary outcome assessor blinded to group. PI, rehabilitation 
staff at The Rehabilitation Institute of St. Louis (TRISL) blinded to 
participant group assignment.   
 
Primary purpose: Community reintegration  
 
Date of First 
Enrollment 
 
January 19, 2018 
 
Target Sample Size 
 
180 
 
 

 
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Recruitment Status 
 
Closed to Enrollment 
Primary 
Outcome(s) 
 
Specific Aim 1 (Primary): We will compare the efficacy of a novel 
enhanced rehabilitation transition program (COMPASS) and an equivalent 
dose of attentional control for significant improvements in community 
participation and ADL performance and a reduction in environmental 
barriers in the home and community after stroke. 
 
Specific Aim 2 (Secondary): We will evaluate alternative primary outcome 
measures of participation, function, patient-reported quality of life, and 
caregiver burden that permit comparison to other stroke clinical trials and 
confirm the safety of COMPASS. 
 
Specific Aim 3 (Secondary): We will evaluate process outcomes such as 
reach, cost, fidelity, and adherence to aid interpretability of the trial and 
future implementation. 
 
Primary Endpoint: Reintegration to Normal Living Index (RNLI). The 
RNLI measures the extent to which a person is able to resume normal 
life activities after illness or injury.1 The 11-item questionnaire quantifies 
participation (basic self-care, functional mobility, avocational and 
productive pursuits, travel in the community), with a higher score 
indicating higher attainment of normal levels of living. The RNLI is a 
valid and reliable2 measure that is well-aligned with the primary aim of 
this trial. The scale demonstrated excellent internal consistency,3 
construct and content validity,2,3 and interrater reliability.2 The RNLI is 
brief and can be administered in person or by telephone.  
 
Secondary endpoints: Stroke Impact Scale (SIS) ADL Domain. The 
SIS is a stroke-specific assessment of health-related quality of life 
(participation, ADLs, mobility, hand function, strength, memory, 
communication, emotion). It has demonstrated high content validity4 and 
construct validity.5 The SIS domains have excellent internal consistency 
(Cronbach α = 0.83–0.90)6 and test–retest reliability (Interclass 
correlation range 0.7–0.92),6 and discriminate across four Rankin levels 
of stroke severity (P ≤ 0.01).6 The SIS ADL domain demonstrated a 
moderate (0.44) effect size in our pilot. 
 
The In-Home Occupational Performance Evaluation (I-HOPE) to 
measure ADL performance and magnitude of environmental barriers in 
the home. The I-HOPE is a performance-based, multistep, client-
centered assessment that evaluates the performance of older adults 
doing 44 activities in the home. Four subscales measure limitations in 
daily activities, self-reported performance and satisfaction with 
performance of problematic activities, and the magnitude of 
environmental barriers that influence performance. I-HOPE assessment 
is commonly used in occupational therapy (OT) to provide home 
modification interventions. The instrument yields four subscales with 
high internal reliability (α = 0.77–0.78) and interrater reliability (α = 0.94–
1.0)7 and is sensitive to change in environmental support.  
 
Exploratory endpoints: Our goal is to optimize the design of a phase III 
multicenter trial; therefore, we will examine additional endpoint 
measures to evaluate their utility in the trial setting. These measures 

 
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include the Caregiver Inventory8 (CGI; caregiver burden), Perceived 
Stress Scale,9 Barthel Index10 (BI; ADL performance), and Patient-
Reported Outcomes Measurement Information System (PROMIS) 
Physical and Mental Health Scales11 (health-related quality of life).  
 
Time Points of 
Interest: 
Baseline, immediately post-intervention, 6 and 12 months post-stroke 
 
 
 
 

 
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Organizational Structure and Responsibilities  
Principal Investigator:  
Susan Stark, PhD, OTR/L 
 
Responsibilities include: Managing the operations of the study, ensuring tasks are completed, ensuring 
compliance with quality assurance requirements (e.g., human participant protection), preparing interim 
reports and publication of study reports. 
 
Study Coordinator(s): 
 
Brianna Holden, MS, OTR/L and Emily Somerville, OTD, OTR/L 
Responsibilities include: Developing all study materials including the Manual of Procedures and study 
forms; verifying informed consent from each participant; reporting adverse events (AEs) and serious 
adverse events (SAEs); recruiting, screening, enrolling, and randomizing participants; following and 
scheduling participants through study completion; protecting participants’ rights; submitting documents to 
regulatory bodies; developing and implementing quality control procedures, liaison with community 
partners. 
 
 
Data Management 
Missy Krauss, MPH 
Clinical Research Supervisor 
Dana Sutter, MSOT 
Occupational Therapy Practitioners 
Brianna Holden, MS, OTR/L 
Meghan Haxton, COTA/L 
Becky Bollinger, OTD, OTR/L 
Responsibilities include: managing delivery of the intervention in accordance with the study protocol. 
OTPs will document all visits and data collection. 
Data Management Committee:  
Susan Stark, PhD, OTR/L 
Yan Yan, MD 
 
Responsibilities include: Statistical design of study data verification, developing and implementing data 
management procedures including the data flow and procedures for data entry, error identification and 
correction, and preparing quarterly reports on enrollment, participant status (e.g., withdrawals), AEs, and 
independent safety monitoring body reports. 
 
Data and Safety Monitoring Committee: 
Susan Stark, PhD, OTR/L 
 
Responsibilities include: reviewing and evaluating the study data to ensure participant safety, study 
conduct, progress, and efficacy, and making recommendations regarding the continuation, modification, 
and termination of the trial. 

 
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Abstract  
 
Stroke is a leading cause of disability in the US. Most stroke survivors have difficulty performing daily activities 
and participating in the community. Efficacy of interventions that address the chronic needs of stroke survivors 
has been identified as a high priority for stroke research. A gap in care exists at the point of transition from 
inpatient rehabilitation (IR) to home, when survivors encounter new environmental barriers due to the cognitive 
and sensorimotor sequelae of stroke. Resolving these barriers and improving independence in the community 
have potential to significantly improve stroke survivors’ long-term morbidity. The proposed study investigates 
the efficacy and safety of a novel, enhanced rehabilitation transition program to reduce environmental barriers 
and improve daily activity performance and community participation. Community Participation Transition after 
Stroke (COMPASS) uses two complementary evidence-based interventions: home modifications and strategy 
training delivered in the home. Home modifications provide environmental support to compensate for 
impairments. Strategy training enables patients to identify and prioritize ADL problems, identify barriers to 
performance, and develop strategies to resolve barriers. The complementary effects of these therapies at a 
novel point of care offer a robust intervention for a current service gap. The primary aim of this phase IIb, 
single-blind, parallel-group, randomized controlled trial is to investigate the efficacy of COMPASS during the 
transition from IR to home. Participants will be randomized to receive either COMPASS or attentional control. 
We hypothesize that COMPASS participants will demonstrate significant improvements in community 
participation and ADL performance and a significant reduction in environmental barriers versus control. In 
preparation for a phase III multicenter trial, we will explore additional candidate study endpoints and establish 
intervention safety by examining the rates of falls and hospital readmissions. Finally, we will conduct a process 
evaluation examining outcomes such as reach, cost, fidelity, and adherence to aid interpretability of the trial 
and implementation. The aims fill critical gaps in stroke rehabilitation evidence by investigating the efficacy, 
safety, and implementation of an intervention targeting the transition from an acute to a chronic condition. The 
results of this trial will provide important information about the long-term participation and environmental 
barriers of stroke survivors. The project has the potential to resolve the significant unmet need of disability after 
stroke.  
 

 
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Background 
 
Stroke is highly prevalent, costly, and disabling. Stroke is a leading cause of serious long-term disability in 
the US.12 Half of stroke survivors are dependent on caregivers to perform their ADLs.13,14 Unless a solution is 
identified to improve the long-term outcome of stroke survivors, annual US costs attributed to stroke are 
projected to increase to $240.67 billion by 2030.15 Patients report “waiting” at home 6–12 months after 
discharge for “recovery” before attempting to resume participation in daily activities.16 The transition from IR to 
home is an important window of opportunity for intervention.17,18 Resumption of previous activities immediately 
after discharge,19 at a time when people with stroke report struggling to reestablish daily routines,18 can 
improve immediate and long-term community reintegration. 
 
Transition home from inpatient rehabilitation (IR) is understudied, but face validity exists for 
treatments that reduce environmental barriers and improve daily activity performance. A paucity of 
evidence exists for interventions targeting the transition period from IR to home. In a systematic analysis of the 
Guidelines for Adult Stroke Rehabilitation and Recovery,20 we mapped COMPASS elements to the evidence 
recommendations. Transition interventions including environmental modifications (provision of adaptive 
equipment) and problem-solving approaches like those proposed in COMPASS are rated as having high face 
validity and low risk but lack rigorous evidence of efficacy. COMPASS also directly addresses goals in the NIH 
Plan for Rehabilitation Research.21 The plan has prioritized research that provides an understanding of 
environmental barriers and individual participation outcomes in real-world settings and specifically calls for 
research using self-management strategies like strategy training that can be implemented in community 
settings to achieve patient independence and improve caregiver outcomes.  
 
Reducing environmental barriers improves daily activity performance but is unproven among stroke 
survivors. Providing environmental support is a potent and immediate strategy to improve daily activity 
performance. In our systematic review22 and home modification practice guideline23 (including 35 articles with 
levels I–III evidence), strong evidence shows that home modifications improve daily activity performance24-36 
and reduce falls37-43 among adults and older adults with disabling conditions. Notably, during this review, we 
did not discover a study of the efficacy of environmental modifications for stroke. That may explain why 
environmental modification programs are not part of IR, despite face validity that environmental interventions 
might be an effective approach to reduce excess disability for this population. 
 
Strategy training shows promise in acute IR for stroke but is unproven at the point of transition home. 
Strategy training enables patients to identify and prioritize daily activity problems and to identify barriers to 
performance and strategies to resolve the barriers. The approach leads to generalization and learning rather 
than skill attainment.44,45 OT scientists have demonstrated the efficacy of guided strategy training interventions 
for patients with neurological impairments, including acute stroke.46-52 Strategy training is consistent with new 
models of inpatient stroke care such as those tested by Skidmore46-48 but is unproven in transition programs for 
stroke survivors. 
 
We will provide evidence of the efficacy and safety of a transition program designed to increase the 
independence of stroke survivors. COMPASS is a manualized intervention that includes pre- and post-
discharge visits in the home to remove barriers through home modification and strategy training. The 
intervention targets community reintegration, or the ability to resume daily activities in the home and 
community. Our preliminary data provide evidence of acceptability and feasibility for delivery during IR (versus 
home health, for which regulatory policies and practice patterns preclude a focus on community 
participation).53,54 If effective, this program will reduce disability in daily activity performance and improve 
participation outcomes. We will explore anticipated downstream effects of the intervention including 
rehospitalization rates and caregiver burden. 
 
 
 
 
 
 

 
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The conceptual model of this intervention (Figure 1) is the World Health Organization’s International 
Classification of Functioning, Disability and Health (ICF).55 The ICF describes the mechanism of COMPASS. 
Survivors of IS experience decreased cognitive, sensory-motor, and emotional function. After stroke, the home 
and community environments of survivors pose barriers that prevent successful performance of daily activities 
and participation. Intervening to remove barriers and enable survivors to use problem-solving strategies to 
overcome barriers will improve daily activity performance and participation outcomes. This intervention is 
designed to augment current rehabilitation practice focused at the body structure and function domains. This 
conceptual model is empirically supported by our recent work exploring the role of environmental barriers in 
function.56  
Methods 
Research Design Overview  
The objective of this phase IIb RCT is to determine the efficacy and safety of a compensatory intervention 
designed to improve daily activity performance and participation outcomes in preparation for a definitive trial. 
We will test the hypothesis that a manualized, theoretically grounded, and empirically supported transition 
intervention (COMPASS) is superior to an equivalent dose of attentional control (AC) for daily activity 
performance and participation outcomes with high adherence. The hypothesis is based on our previous 
work,35,36 the work of others,27,57,58 and our preliminary data. We will recruit 180 patients currently undergoing 
IR for IS or focal ICH and randomize them to receive five in-home sessions (one pre-discharge visit and four 
post-discharge visits) and two booster contacts of the enhanced rehabilitation transition program or AC. Our 
primary endpoint of participation and secondary outcome of ADL performance will be assessed by certified 
blinded raters at baseline, immediately after intervention, and at 6 and 12 months after stroke. Measures of 
mobility, cognition, and depression, will be used to characterize the clinical phenotype or body structure and 
function of the participants as important covariates. We will also examine important process outcomes such as 
cost, satisfaction, adherence, safety, and caregiver burden. 
 
Study Participants 
Stroke patient inclusion criteria: (1) aged ≥50 years, (2) acute IS or focal ICH diagnosis, (3) independent ADLs 
prior to stroke (premorbid Modified Rankin Scale Score ≤2), (4) plan to discharge to home.  
Stroke patient exclusion criteria: (1) severe terminal systemic disease that limits life expectancy to < 6 months, 
Figure 1. COMPASS conceptual model adapted from the International Classification of Functioning, Disability and Health. 
Blue boxes represent intervention. Blue lines and green boxes represent the hypothesized mechanism of action. By 
reducing environmental barriers, activity and participation outcomes will improve. We will measure covariates in the 
domains of body function, personal factors, and health condition. 

 
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(2) previous disorder (e.g., dementia) that makes interpretation of the self-rated scales difficult or SBT score of 
10 or less (indicating significant cognitive impairment), (3) moderate-to-severe aphasia as determined by the 
NIHSS Best Language rating of 2 or more, (4) reside in congregate living facility.  
Caregiver inclusion criteria: (1) primary informal (family or friend) caregiver of a stroke patient enrolled in the 
COMPASS II study, (2) aged ≥18 years 
Caregiver exclusion criteria: (1) non-English speaking 
TRISL staff:  
Inclusion criteria: (1) occupational therapist, physical therapist, or case manager at TRISL, (2) provided 
treatment to stroke patient enrolled in the COMPASS II study 
Exclusion criteria: (1) Non-English speaking 
Recruitment 
We will recruit participants through Barnes Jewish Hospital (BJH) and TRISL.  
 
At BJH, potential participants will be screened and referred to the study by the Stroke Patient Access Core. At 
TRISL, rehabilitation staff and physicians will identify potential participants daily and, with permission, refer to 
the study team. We will target survivors of IS and focal ICH but not subarachnoid hemorrhage. Outcomes for 
IS and focal ICH are generally better, but those with subarachnoid hemorrhage are associated with 
considerably increased mortality and decreased function after stroke.59 
Informed Consent 
Stroke Survivors: A study team member will call all patients/caregivers who meet the inclusion criteria and 
invite them to participate in the study. The informed consent form will be explained over the phone to all 
patients interested in participating in the study. For potential participants who have computer access and 
capability, the formal study consent process will be conducted using a REDCap-based electronic consent form. 
The consent form has been developed in REDCap, a secure, web-based HIPAA-compliant, data collection 
platform with a user management system allowing the PI to grant and control varying levels of access to study 
staff. Potential participants would receive an email with a unique link to review the informed consent form 
online. After the research team explains the study and answers any question, the potential participants can 
electronically fill in an "Agree" button, followed by their electronic signature. Upon completion of the consent, 
participants are presented with the option to download a copy of the executed form. The research team will 
also e-mail a copy of the executed form to the participant. E-consent versioning will be managed using the e-
consent Framework in REDCap. Within the e-consent survey options, we have designated the e-consent 
version number in this application as e-consent version 1. The PDF's of completed responses will have the 
timestamp, participant name, and e-consent version number inserted in the footer. Future versions of the e-
consent will be created by making a copy of the REDCap form and revising it. The old version would be de-
activated upon receiving IRB approval for the new version.  
 
If a participant does not have access to a computer or smart device at the time of consent potential participants 
will be provided with a copy of the informed consent in person or via email.  Once the potential participant has 
had time to look over the consent form, a study team member will talk with the participant by phone to review 
the study information and answer any questions. If they choose to continue their participation, they will be 
asked to sign the consent and return to us either by email (scan or photo). The signed consent form will then 
be downloaded and retained by research staff. We will instruct participants to keep a copy for themselves. 
 
We will continue to use the electronic consent process even after COVID restrictions have been lifted. All 
procedures will be the same as described above but with an option for signing in person using the electronic 
consent on a study provided iPad. This will happen as follows: Once the potential participant has had time to 
look over the consent form provided to them either via email or paper copy, a study team member will talk with 
the participant in person to review the study information and answer any questions. If they decide to 
participate, they will be asked to sign the electronic version of the consent using a study provided iPad. We will 

 
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email a copy of the consent form if the participant has a valid email address, otherwise we will download a 
copy and provide it to the participant. 
 
The following privacy protections will be enacted for all patient communication via email: 1) a test email will be 
sent to the participant to verify their identify (confirm correct recipient) and that this email will be sent in a secure 
manner (i.e., [secure] in subject line); 2) The body of the email will instruct the participant to send all information as 
a response to this thread and to not remove the "[secure]" from the subject line; 3) we will document in our research 
records that the participant agreed to provide information over email.  
 
In the event participants who consented using the REDCap e-consent would need to be re-consented, we will send 
the participant a link to the new version to discuss, sign electronically, download, and receive vie email as described 
above. 
 
During the consent process, participants will: (1) have what the study is about and what is expected of them 
explained in detail either over the phone or in person when remote is not possible, (2) discuss potential 
problems that could interfere with participation either over the phone or in person when remote is not possible, 
(3) have their questions answered either over the phone or in person when remote is not possible, and (4) 
receive a summary of the study and contact information for the PI and study coordinator. Informed consent to 
participate in the study will be obtained before any test or measurements are performed. The consent form will 
be signed by a witness and will be stored in REDCap or paper copies will be stored the office of the PI under 
double locks. Participants will be advised in the consent form that there is a possibility that their medical 
research record, including identifying information, may be inspected and photocopied by officials of federal or 
state government agencies and the Washington University Human Research Protection Office (HRPO). 
 
Caregivers: Primary caregivers of stroke patients will be provided with information on the research study via 
phone or in person. All procedures mentioned above will be followed for the caregivers as well.  
 
Baseline Home Visit (T1) for All Participants 
Prior to randomization, baseline activity assessment will be conducted in the home before discharge by an OT 
using methods established in our pilot study. The intervention is designed to augment rather than replace usual 
care, so both groups will receive the in-home assessment (considered best practice). Medically stable 
participants who are eligible for a therapeutic pass will participate in the home visit. The OT provider will meet 
the participant and their family at TRISL for car transfer training before departing for the participant’s home. 
The visit will be scheduled to avoid disrupting ongoing inpatient therapy and to accommodate family schedules. 
Transportation will be provided via study staff vehicle, family vehicle or taxi cab. If the participant is not able to 
transfer safely into a family vehicle or if no family or vehicle is available, we will charter a wheelchair-accessible 
taxi. If the entrance to the home is not accessible, a temporary ramp will be installed. We were able to install 
ramps within 48 hours of request in our pilot trial. Onsite, we will use I-HOPE to identify environmental barriers 
in the home and to establish baseline activity levels. Results of the T1 home assessment (for participants in 
each arm) will be shared with the rehabilitation health care team, because home assessment is considered 
best practice for patients whose disposition is home.60  
 
During COVID, we will have the option to complete a modified initial evaluation if the participant is not allowed 
to leave TRISL, as indicated by the circumstances (e.g. number of cases in the community, orders issued by 
the Health Department, or current policies at The Rehabilitation Institute of St. Louis). After the participant 
consents, the study therapist will use the “Participant Intake Form” to gather information from the TRISL 
therapists about the current level of functioning of the participant as well as the participant’s concerns about 
going home. The study therapist will then arrange with a family member or friend to meet at the participant’s 
home to complete the modified home visit. During the home visit, the therapist will complete a home safety 
assessment to evaluate the home environment and will also look specifically at the six therapist priority 
activities from the I-HOPE (getting in/out house, moving around the house, getting on/off toilet, getting in/out of 
the shower, getting on/off toilet, and getting in/out of the bed) and identify environmental barriers that will 
impede the participant’s performance of those activities. The therapist will take pictures of the home, including 
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therapist will review the home evaluation with the participant and will share the results of the evaluation with 
the TRISL therapist team.  
 
If the home evaluation is completed during COVID using the procedures described above, the therapist will 
meet with the study participants in the treatment group before they discharge from TRISL and review 
recommendations for home modifications and adaptive equipment. The therapist will facilitate implementing 
the agreed upon modifications/adaptive equipment prior to discharge from IR following normal study 
procedures. 
 
Randomization and Blinding 
Age is a negative marker for functional recovery after stroke, and functional status is a strong predictor of 
recovery.61,62 The Functional Independence Measure (FIM) will be used to determine functional status post-
stroke. Randomization will be balanced using the participant’s age and FIM score.  
Participants will be allocated using a 1:1 ratio via adapted randomization sequences generated a priori by the 
study statistician, Dr. Yan, using a computerized formal probability model. The allocation ratio will be 
maintained at periodic intervals. Randomization sequence concealment will be achieved by query of the 
REDCap (Research Electronic Data Capture) system.63 After baseline assessment (T1) is securely uploaded 
and locked and stratification variables are entered, the interventionist will elicit the treatment assignment in 
the field in real time using a secure data connection to REDCap. This will permit prioritization of problems for 
participants assigned to the treatment group.  
Upon randomization, participants will be assigned to an interventionist by the treatment coordinator. Although 
the results of the home assessments will be shared with the rehabilitation staff, IR staff will be blinded to the 
group placement so that they do not modify their inpatient or discharge treatment plan. All outcomes will be 
assessed by a blinded rater. 
Phone Assessment T1b 
To allow time for participants to adjust and personally assess their participation, T1 participation 
assessments will be conducted for both groups by telephone 2 days after discharge from IR. A rater who is 
blinded to allocation will conduct the baseline assessment for the primary, secondary, and exploratory 
endpoints. 
Upon completion of T1b phone assessment, the participant will receive visits 2–6 over an 8-week period. The 
home modification group will progress from daily activity performance to community participation. 
Primary Intervention  
COMPASS is a complex intervention that combines two evidence-based treatment strategies at a new point of  
care (transition from IR; Table 1). The objective of home visits by an OT interventionist is to remediate barriers 
in the home and community that influence daily activities and community participation. The COMPASS manual 
fully defines and justifies each element of the intervention and has been iteratively revised during the pilot 
phase. The treatment will include a set of one pre-discharge64,65 and four 75-minute post-discharge66 visits 
(Table 1). The intervention is followed by two booster sessions. Data from the T1 home barrier assessment, 
demographic assessments, and rehabilitation staff assessment of functional abilities (e.g., transfers) will be 
used by the OT interventionist to develop an environmental modification intervention plan. Environmental 
modifications will be installed before discharge if possible. The intervention (not reimbursable) will be provided 
at no cost to the participant. Problem areas addressed are participant-specific (tailored), but the process to 
identify and address the target area is systematic. All participants will receive identical intervention 
components. The standardized components include assessment, identification of five problematic activities 
(and environmental barriers), identification of three solutions (for each problem), implementation of a solution 
set selected by the participant, training, and active practice of daily activities in one’s own home and 
community.  
 

 
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During COVID, if the modified home assessment procedures were used, the I-HOPE will be completed with the 
participant during the first post-discharge home visit, allowing the participant time to experience life in his/her 
home after the stroke. Priority activities identified during the I-HOPE will then be addressed during the 
remaining treatment sessions. 
 
Defining the Treatment (Table 1) 
The treatment theory guiding the intervention is a competence-press model that posits that removing 
environmental barriers (e.g., grab bars near the toilet, using accessible transportation) matched with the 
patient’s pattern of functional loss will improve the outcomes of daily activity performance and participation.67  
The two essential components68 of COMPASS are (1) home modification and (2) strategy training. Both 
address barriers in the participant’s own home and community environment.69 The intervention is tailored70-72 
by the interventionist to each participant’s pattern of functional loss and unique home and community 
environments. Tailoring is necessary, given the heterogeneity of environments.22 The participant will engage in  
active practice with the OT provider. Home modifications coupled with active practice of daily activities 
improves functional performance of persons with disabilities.8,25,27,69,73  
 
Timing: Pre-discharge Environmental Modification Intervention. Using standardized assessment and 
manualized procedures, environmental modifications will be installed before discharge. The intervention (not 
reimbursable) will be provided at no cost to the participant. Post-discharge Activity and Participation 
Intervention. On completion of T1b phone assessment, the participant will receive visits 2–5 over an 8-week 
period. Interventions will progress in complexity from daily activities to community participation based on the 
participant’s goals. A booster session will be provided at 4 and 5 months after intervention over the phone; 
participants may request a home visit.  
 
Attention Control Group 
The control group will experience the same effects of time and attention in the home but no effect on the 
outcome of interest.74 Because this study examines the efficacy of a new intervention, there is no opportunity 
for a usual care arm with dose equivalency. Because 75% of stroke survivors and 78% of caregivers report 
that their informational needs were not met in the hospital,75 we developed and piloted a tailored stroke 
Table 1. Experimental Compass Treatment 
Dosage and timing 
(1) Assessment session (prior to d/c), four 75-minute visits in the home with 
OT (over 8 weeks); (2) booster sessions (4 & 5 months) 
Model/theory 
ICF model; Competence-Press Theory 
Two components (evidence-based 
strategies) 
 
Home modifications  
• Assessment  
• Participants ID problems in the home 
• Tailored home modifications; shared decision making to select solutions 
• Active Practice in context  
 
 Strategy training 
• Active problem-solving to ID problems participating in the community 
• Guided discovery to ID barriers and solutions, and implementation 
• Evaluation of process 
Approach 
• Dose of home modification begins high and tapers; dose of strategy training 
begins low and increases 
• Clinician as partner; caregivers included 
Standardized elements of tailored 
approach 
• ID up to 10 in-home problematic activities 
• ID three solutions (for each in-home problem) 
• Implement selected solutions in home 
• In-context training, active practice 
• ID two problematic community activities 
• Strategy training to resolve community barriers 
• Two booster sessions (phone or in person)  
d/c=discharge; ICF=International Classification of Functioning Disability, and Health; ID=identify; OT=occupational 
therapy. 
 

 
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education program for AC. An OT practitioner will deliver the program in accordance with “Evidence-Based 
Educational Guidelines for Stroke Survivors after Discharge Home.”76 Topic order is determined by 
participants. Four 75-minute sessions will be provided. Topics include stroke symptoms, risk factors and 
preventing stroke recurrence, nutrition, managing emotions, sleep, fatigue, pain, social support, and sexuality. 
Written materials from the National Stroke Association and the American Stroke Association are provided. 
Environmental barriers will not be addressed in the educational sessions. 
 
Follow-up Period for All Participants 
Stroke and caregivers: Home visits T2 (immediately after intervention), T3 (6 months after stroke), and T4 (12 
months after stroke). The follow-up activity, participation, and process assessments will be conducted in the 
home. All follow-up assessments will be completed by a blinded rater who did not conduct the T1 evaluation, 
as new home modifications could reveal group assignment. Distal time points will explore the permanency of 
any treatment effect on participation. If the participant is not available for in-home assessment, the primary 
endpoint will be collected by phone. Falls and healthcare utilization are collected monthly by phone (using an 
automated system). 
 
For participants who experience a delay in the study timeline (such as hospital admission, travel, short-term 
admission to a skilled nursing facility, etc.), the timeline will be adjusted accordingly. For example, if someone 
returns to the hospital during the intervention period and is in the hospital for 4 weeks, their T2 follow-up will be 
pushed back 4 weeks. If we can’t schedule the T3 for three months past the normal time point for the T3, we 
will skip the T3 and schedule the T4. 
 
Our primary outcome of the study is community participation. This has been severely limited by the current 
COVID-19 pandemic stay-at-home orders. We will adjust some of our follow up timepoints for data collection to 
reflect the SAH orders and allow people a chance to get back into the community before collecting community 
participation data. Our original timepoints are as follows: T2 (immediate post treatment), T3 (six months post 
stroke) and T4 (12 months post stroke). We will collect data at those timepoints but we are adding an 
additional collection time for each of those. Our T2COVID, T3COVID, T4COVID are all 60 days after the 
original T2/T3/T4 time point to allow for the SAH orders to lift and the participant to resume normal community 
participation. We will adjust these timepoints if the SAH orders continue longer than anticipated at this point. 
 
Waiver of Consent: Retrospective Chart Review 
 
 
At this time, we have consent to review medical charts during the enrollment and treatment process. However, 
we do not have permission to review the record after treatment was completed. Because we have ceased 
recruiting and all of our participants are finished with their participation in the study intervention and control 
groups, we no longer have contact with the majority of study participants. We would like to review medical 
charts (Wash U BJH medical records only) from participants who signed the Wash U COMPASS II consent 
form. We will collect limited data points, including date of death, hospitalizations, emergency room visits, and 
SNF/IPR admissions between their date of enrollment in this study and date of final study contact. For the 
waiver of consent, we will recruit participants already enrolled in this study. 
 
The data collected from this retrospective chart review will be saved in Excel as a limited dataset (with no 
direct identifiers) on Box in a folder only accessible to the research team and separate from the full REDCap 
database) to protect the participant’s information from a breach of confidentiality. The results of the research 
will not affect the clinical care of the individuals because the information is being collected retrospectively after 
the participant’s completion of the study intervention. 
 
Adherence to the conditions required for an IRB Waiver of Consent are as follows: 
1) The research involves minimal risk, as the review of the participant’s medical records is for limited 
information. The likelihood of any adverse effects on the subject’s status, employment, or insurability is 
exceedingly low.  Stringent measures have been implemented to restrict the record review to specific 
data to minimize the risk of a breach of confidentiality. One research team member trained in EPIC and 

 
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HIPAA compliance will access medical records and will only search for and document the above 
mentioned data.  A limited dataset including only an ID number, stroke date, rehab discharge date, date 
of last visit/last study contact, and dates of death, hospitalization, ER visit, and SNF admission will be 
saved in an Excel file separate from the REDCap database which contains full study data. No direct 
identifiers such as names, birth dates, address, phone numbers etc will be saved in this Excel file. Only 
research team members will have access to look up the ID number in REDCap to view other research 
data. The Excel file will be stored on a Box folder only accessible by the study team. Data will be 
retained for six years following project close-out and then will be destroyed.  It should be noted that 
reaching out to subjects for their consent may potentially be seen as an intrusion on their privacy and 
could lead to undue anxiety or emotional pain amongst participants or their families.   
2) The rights and welfare of the individual would not be adversely affected because the indicated 
events have already occurred and been documented in the patient’s medical record regardless of the 
research.  The retrospective review of this information takes place after the participant’s involvement in 
the study intervention and therefore does not have any bearing on treatment decisions.  Therefore, 
participants are not denied standard care they are entitled to receive under any circumstances.   
3) The research could not be practicably carried out without a waiver. Due to the retrospective nature 
of this data collection, it is not possible to contact all study participants for a complete review of these 
variables as a follow-up metric. Some participants may be uncontactable due to death, 
institutionalization, or changes in cognitive status after completing the study intervention. 
4) It would not be appropriate to provide these subjects with information about the results of the 
research as the results would have no effect on the participants. The events have already occurred for 
the participants and they are aware of their occurrence independent of the study. There is no 
anticipated benefit to the participants that would alter what has already taken place.  
Participants who are still enrolled will be re-consented. 
 
Data Collection 
 
Outcome Assessments for Baseline & Follow-up Home Visits 
 
In-Home Occupational Performance Evaluation (I-HOPE). The I-HOPE will be used to measure current activity 
patterns of participants, identify activities that are difficult but important to them, and identify the environmental 
barriers that influence those activities (person–environment fit). The I-HOPE is a multi-step assessment that 
evaluates the performance of older adults doing 42 activities in the home. Using labeled pictures of each home 
activity (e.g., washing dishes, getting in and out of bed), older adults identify activities difficult for them to 
perform and self-rate their performance and satisfaction with performing each of the activities. A trained rater 
(e.g., OT interventionist) observes the older adult performing the activity and quantifies the person–
environment fit (or misfit). The instrument yields four subscales: the activity subscale (α = 0.78; 6 items); the 
performance subscale (α = 0.85; 38 items); the satisfaction subscale (α = 0.77; 8 items); and the environmental 
barrier subscale (α = 0.77; 6 items). Intraclass correlation coefficients were calculated for the I-HOPE 
subscales on a sample of 10 participants, and scores ranged from 0.94 to 1.0 for raters.77  
 
Barthel Index (BI). The BI is a reliable and valid assessment that will be used to assess a person's ability to 
complete 10 ADLs (feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair 
transfer, ambulation, and stair climbing) and the amount of assistance they need to complete these activities. 
We will use this information to examine changes in participants' functional performance in this study. There is 
excellent correlation and agreement for stroke patients between the FIM motor and 10-item Barthel at 
admission and discharge (r > 0.92; ICC > 0.83).78  
 
Stroke Impact Scale (SIS). The SIS is a health-related quality of life measure that quantifies the impact of 
stroke on a participant’s life, via questionnaire. Fifty-nine items are measured across eight domains: strength, 
hand function, mobility, ADLs and instrumental activities of daily living (IADLs), emotion, memory, 
communication, and participation. Performance is self-reported based on the difficulty the participant 

 
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experiences with each rater. Each item is scored on a five-point scale, and total domain scores are based on a 
scale from 0 (poorest outcome) to 100 (best outcome). A final question asks the participant’s perception of 
their recovery post-stroke on a visual analog scale from 0 (no recovery) to 100 (full recovery). Rasch analysis, 
which is widely used to validate self-report outcome measures, established the SIS’s validity and reliability and 
concluded that it has good psychometric characteristics.79 
 
Reintegration to Normal Living Index (RNLI). The RNLI is a disability-related quality of life instrument that will 
be used to measure participants’ satisfaction with their home and community participation and has been 
validated on a population of community-dwelling individuals with chronic conditions.2 Participants will read 11 
statements related to their monthly activity patterns and assign each one a score based on a 10-point ordinal 
scale with 1 indicating “does not describe my situation at all” and 10 indicating “fully describes my situation.”  
 
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical and Mental Health Scales11 
will be used to measure health-related quality of life. PROMIS is a publicly available system of highly reliable, 
precise measures of patient-reported health status for physical, mental, and social well-being.   
 
Perceived Stress Scale (PSS).9 The PSS will be used to measure perceived stress in the caregiver 
participants. The PSS is a global measure of perceived stress designed for use in community samples. The 
participant rates feelings and thoughts during the past month using a Likert scale from 0 (never) to 4 (fairly 
often). The items on the PSS were designed to assess the degree to which respondents find their lives 
unpredictable, uncontrollable, and overloading. 
 
Caregiver Inventory (CGI)80. The CGI will be used to measure self-efficacy in caregiving. The CGI is a valid 
and reliable measure consisting of four subscales—managing medical information (three items), caring for the 
care recipient (seven items), caring for oneself (five items), and managing difficult interactions and emotions 
(six items)—and will be collected at all follow-up study visits to examine whether the study had an impact on 
caregiver burden.  
Demographic Assessments 
Demographics. Questions such as living situation, education level, and employment status will be used to 
gather demographic information from the participant. Participants (newly enrolled and those still receiving any 
in-person study-related visits) will be asked their COVID vaccination status. 
 
Geriatric Depression Scale, Short Form (GDS-SF). The GDS-SF will be used to assess depression levels in 
stoke participants.81 The GDS-SF is a 15-item self-report questionnaire specifically designed and validated with 
the older population and correlates highly with the original 30-item GDS (r=.84).81 Participants answer yes-or-
no questions about their feelings in the past week. Total scores range from 0 to 15, and scores of 5 or more 
indicate probable depression. 
COVID-19 Assessments 
In response to the COVID-19 pandemic, we will add additional measures to ask our participants. We will ask 
current participants these additional measures monthly during the pandemic. If this monthly phone call 
corresponds with one of their other follow up timepoints, we will ask them at the same time. For participants 
who have completed the study, we will call them and ask if they are willing to complete the assessments for us 
as well, so that we can determine if the study intervention has a protective effect during this pandemic and if it 
allows people to get back to normal life after this pandemic is over. For participants who have completed the 
study, we will ask them the following measures and also the GDS, SIS and RNLI (described above). 
 
PROMIS Social Isolation. The PROMIS Social Isolation item bank assesses perceptions of being avoided, 
excluded, detached, disconnected from, or unknown by, others. It is a 4-item short form scored on 1-5 scale; 
yields a sum score, with lower score indicating less social isolation 
 
3-Item Loneliness Scale. The 3-item loneliness scale is brief, easily administered remotely and the questions 
have been simplified so people at all education levels can complete it accurately. It is reliable and valid and 

 
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take less than a minute to administer. Can be completed remotely. Items are scored on a 3-point likert scale, 
higher scores indicate more loneliness. 
 
PROMIS Anxiety. PROMIS Anxiety measures anxiety participants are currently experiencing. It is a 4-item 
scale; measures anxiety participants currently experience on a 1-5 scale; generates a sum score of anxiety 
with a higher scoring indicating more anxiety. 
 
NIH Toolbox Instrumental Support Scale measures the availability of support for an individual to assist with 
completing daily tasks; 8-item scale, uses a 5-point likert scale response, scores are summed with higher 
score indicating more instrumental support. 
 
10-Item Connor-Davidson Resilience Scale will measure resilience or ability to adjust to a stressful situation; 
consists of 10 items, all answered used a 5-point likert scale; total scores range from 0-40, with higher scores 
indicating greater resilience. 
 
Healthcare Utilization and Mortality  
 
Retrospective review of the medical records of all randomized participants to collect date of death, 
hospitalizations, emergency room visits, and skilled nursing facility (SNF)/Inpatient Rehabilitation (IPR) 
admissions between participants’ date of enrollment until date of final study contact as a follow up metric to 
identify patient outcomes (see waiver of consent). 
 
Statistical Analyses 
 
Intention-to-Treat Analysis 
We will perform our analyses using an intention-to-treat paradigm. We will perform exploratory data analysis 
looking for extreme or otherwise unusual values. Non-normal and heteroscedastic data will be transformed as 
necessary.  
 
Baseline Analyses 
We will use unpaired t tests and chi-square tests to compare TØ and baseline characteristics in the two groups 
for descriptive information (except when statistical assumptions are not met, in which case we may use 
Wilcoxon or Fisher exact tests).  
 
Missing Data 
We expect missing values in outcome measures because of dropout, death, missed assessment, or 
nonresponse. Our main analysis, a linear mixed-effects model, accommodates missingness due to treatment, 
prior outcome, or baseline covariates missing at random.82 Assuming that missing data occur at random, 
inferences will be valid even if we have differential dropout by intervention arm. If the missing data mechanism 
is not ignorable (ie, missing is not at random), then mixed-effects selection models or pattern-mixture models 
will be used.
83  
 
Primary Analysis  
Our primary analysis (testing primary hypothesis) will be based on a linear mixed model using baseline and 12-
month RNLI s, accounting for the correlation between a participant’s repeated measurements over time. The 
fixed-effect portion of the model will have the form Yit = β0 + β1 × 12 months + β2Group + β3Group × 12month, 
in which Yit is the RNLI score for participant i at baseline (time 0) and 12 months (time 1), and Group indicates 
study arm. In this model, the baseline RNLI is modeled as a dependent variable.27 For improved precision, the 
model will be adjusted for baseline covariates including race, sex, depression, and length of hospital stay if an 
imbalance in covariates between arms is observed in baseline analyses. In this model, β0 is the mean RNLI 
score for the control arm at time 0, and β1 is the change in the mean RNLI from baseline to time 1 for the control 

 
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arm; β2 is the mean RNLI score for the treatment arm at time 0, and β3 is the change in mean RNLI from time 
0 to time 1 for the treatment arm. The primary hypothesis is that the difference in the change in RNLI scores 
from time 0 to time 1 between arms will be tested by examining β3, which estimates the difference.  
 
 
Secondary Analyses  
For the secondary analyses of the change in SIS score at 1 year and the change in I-HOPE at 1 year, we will 
use the same approach as for the primary analysis because these two outcomes are also continuous. We have 
overall type I error control for testing the 1-year change in these three analyses at the design stage. The 
significance level for testing is 0.016. In addition to comparison of 1-year change, we will extend the model by 
including scores immediately after intervention and at 6 months to see whether the difference in outcomes is 
achieved at those time points. Depending on the form of time variable in the model, we will use appropriate 
regression coefficients or a linear combination of the regression coefficients to determine the difference in 
change of these scores between arms at certain time points. Interpretation of these results should be cautious 
because we do not have the type I error controlled for these analyses. Because it is possible that severity of 
functional impairment after stroke may impact response to treatment, we will analyze impact of functional 
impairment on response to treatment. We will examine functional impairment by group interaction to examine 
possible differential intervention effects of functional impairment on community participation and performance 
of daily activities.  
 
Safety 
To determine whether the intervention poses no greater risk than AC, we will examine the differences in 
numbers of falls and rehospitalizations between groups. The statistical models for count data will be used for 
analyses of these two outcomes. Using the number of falls as an example, we will fit a Poisson regression 
model (with overdispersion adjustment if necessary), in which a dummy variable for the intervention arm is 
used. The regression parameter estimate for this dummy variable is the log of rate ratio of falls for COMPASS 
versus control arm, and exponentiation of the regression parameter estimate is rate ratio. Using the parameter 
estimate and its standard error, we can construct a two-sided 95% CI for the rate ratio. We expect the 
confidence interval for rate ratio will include 1, indicating no significant difference in the fall rate between the 
two groups. 
 
Process Outcomes 
Evaluate acceptability and feasibility to aid in the interpretability of the trial. COMPASS will have high 
acceptability (80% retention), high fidelity by therapists (95% of elements and 90% of dose delivered), low 
safety risk (no increased rate of falls or health care use compared with the AC group), and high adherence 
(80% of modifications in use) at 12 months. We will conduct between-group comparisons of process endpoints 
collected at each time point (time to first fall, number of injurious falls, health care utilization rate, dosage 
delivered, and adherence rate) using unpaired t tests or chi-square tests. We will compare the characteristics 
of patients who complete the assigned intervention with those who do not for differences in stroke severity and 
comorbidities. Descriptive statistics will be used for costs per participant and adherence.  
Sample Size Calculations  
The study is designed to have 80% of power to reject three null hypotheses of equal mean changes in the 
primary and secondary endpoints (RNLI, SIS, and I-HOPE) using a two-sided, two-sample, unequal-variance t 
test with overall type I error <0.05. Three alternative mean changes (standard deviation [SD] of change) in 
intervention and control populations are 15.3 (SD 22.6) versus 1.3 (SD 23.4) for RNLI, 15.7 (SD 16.1) versus 
5.6 (SD 9.1) for the SIS ADL domain, and 62.1 (SD 26.1) versus 46.2 (SD 18.8) for I-HOPE. With a 1:1 
allocation ratio, 130 patients (65 in each group) are needed for the RNLI outcome, 84 are needed for the SIS 
outcome, and 100 are needed for the I-HOPE outcome. We will enroll 180 patients to account for a 30% 
attrition rate. This magnitude of between-group difference is considered clinically meaningful based on prior 
relevant literature and is achievable based on our pilot study. Sample size calculation includes correlation 
between baseline and follow-up measures and is based on analysis of change scores, which is equivalent in 
efficiency to the proposed analytic model. Based on the number of stroke patient participants, we will enroll an 
equivalent number of caregivers.  

 
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Strengths and Limitations 
 
The COMPASS study has important strengths. The intervention is grounded in sound theory and evidence. 
The intervention has made a significant impact on the ability of people with disability to improve their ability to 
complete daily activities. The intervention will now be tested as part of a community transition program to help 
stroke survivors complete daily activities at home, as well as transition back into the community.  
 
The research proposed in this application is innovative because it represents a departure from the status quo 
by delivering a transition program targeting environmental barriers and providing skill training in the “real world” 
at the point of discharge from IR. Our preliminary studies suggest that this approach will be highly effective in 
improving the performance of daily activities and participation outcomes, which could lead to reduced 
readmission and improved safety.  
 
An additional strength of this study is that it is being conducted in partnership with TRISL, which is managed by 
HealthSouth, a national health care organization that specializes in providing rehabilitation services for 
individuals. If this trial is feasible, it can be rolled out nationally with HealthSouth because that partnership 
already exists and the mechanisms are already in place for a national, multisite trial. 
 
There are a few limitations that exist for this study. The first is low generalizability of findings with only a single 
site. However, participants at TRISL are comparable nationally regarding demographics, length of stay, and 
treatment; the only exception is that our sample has a higher percentage of Black patients. In addition, TRISL 
and HealthSouth have policies in place that limit the amount of contact outside study staff can have with 
individuals prior to recruitment. In some cases, the policies are even stricter than institutional review board 
(IRB) policy and make recruitment difficult.   
Potential Benefits, Risks, and Alternatives 
Benefits 
There will be considerable benefits to the participants enrolled in the proposed study. All participants will 
receive a complete home evaluation provided by a registered and licensed OT interventionist. In addition, 
participants in the active treatment group will receive free home modifications, while participants in the AC 
group will have a trained research assistant deliver stroke education. 
 
Risks 
Potential risks of research participation—physical, psychological, financial, and legal risks, among others—are 
considered minimal (45CFR46.404). In-home evaluations and assessments of barriers may result in fatigue or 
aggravation. In addition, some questions may touch on emotionally sensitive issues that could cause anxiety or 
other forms of emotional stress. The performance-based testing involves observation of everyday activities, 
which may result in fatigue or embarrassment. In rare instances, the evaluation protocol could result in a fall. 
Participants will be told that their involvement in this research study is voluntary and that they may choose not 
to participate or to withdraw their consent at any time. Withdrawal from the study will not at any time affect the 
commitment of the clinician to administer care, and there will be no penalty or loss of benefits to which 
participants are otherwise entitled. Participants who undergo the study visits will be given the option to 
reschedule the visit or take a break at any time during the study if necessary. There is little legal risk to 
participating in this research. All research-related information will be kept confidential and accessible only to 
authorized members of the research team. 
 
Minimization of Risks and Confidentiality 
 
To protect against and minimize potential risks, participants will be carefully screened and evaluated for 
eligibility by the research coordinator. To avoid or minimize symptoms of fatigue, agitation, or emotional 
distress due to testing, participants will be instructed to notify the rater or interventionist if they experience any 

 
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discomfort. They will also be periodically questioned about their tolerance for the tests/intervention. Testing 
and interviews will be terminated if participants develop fatigue, agitation, or emotional distress. Participants 
will be trained in the use of all modifications by a licensed and registered occupational therapist. When 
photographing the home, only environmental barriers and changes will be collected. Images of participants will 
not be collected. An ID number will be assigned to each participant. All data collected from a participant will be 
labeled with the ID number. All participant electronic and hard-copy data will be kept under double-lock 
protection. All hard-copy forms that contain personal identifiers (e.g., name, address, phone number) will be 
stored in a separate, locked file drawer under double-lock protection. No publication or presentation of the 
study data will uniquely identify or provide sufficient information to uniquely identify participants. 
 
Risks during the home visit will be minimized by having licensed and trained interventionists available to 
monitor safety during the home assessment. If needed, an additional trained assistant will accompany the 
interventionist and family on the home visit. Gait belts will be used at all times while in the home. If needed, 
temporary ramps will be installed to facilitate entry 
 
To guard against unauthorized data access, all shared-use computer systems at the Washington University 
School of Medicine are protected with passwords, which are changed at 4-month intervals. Only individuals 
with a particular "need to know" status are given access, and system privileges are carefully restricted. All 
personal computers to be used in the Administrative Unit are located within a secure area, and the system is 
locked when not in use. SAS and SPSS software packages will be used for data management and analysis. 
Datasets generated from these programs will be password protected, which will make accessing study data 
difficult even in the event that unauthorized computer access occurs. Systems connected to the Ethernet are 
carefully controlled, and all systems without Ethernet access control are insulated from the backbone by 
bridges or routers. The Ethernet cable itself is routed only through secure passageways. 
 
Data are directly entered into a REDCap database. REDCap servers are securely housed in an onsite, limited-
access data center managed by the Division of Biostatistics at Washington University. All Web-based 
information transmission is encrypted. All data are stored on a private, firewall-protected network. All users are 
given individual user IDs and passwords, and their access is restricted on a role-specific basis. REDCap was 
developed specifically around HIPAA security guidelines and is implemented and maintained according to 
Washington University guidelines. Study data will be collected via tablet in the field and managed using 
REDCap electronic data-capture tools hosted at Washington University. REDCap is a secure, Web-based 
application designed to support data capture for research studies.  
 
In order to complete the automated phone calls, first names and phone numbers will be shared with Twilio, an 
online communication software designed to make automated phone call surveys. To complete the call, Twilio 
will access first names and phone numbers via REDCap. Survey responses will be temporarily stored by 
Twilio, transferred into Washington University’s secure databases (REDCap), and deleted from Twlilio as soon 
as possible.  
 
Adverse Event Reporting and Safety Monitoring 
 
All SAEs will be reported to the HRPO in the following time frames: (a) death–immediately, (b) life-threatening–
within 7 calendar days, (c) all other SAEs–within 15 calendar days using the Electronic Serious Adverse Event 
Reporting System. Should an SAE occur that increases the risk to the participants, the study will be stopped, 
an investigation will be conducted, and a findings report will be generated before the study is resumed. 
 
Dr. Stark will be responsible for reviewing study progress and outcomes including recruitment, data quality, 
safety, and efficacy. Quarterly reports will be reviewed by the study investigators. Because risk in the proposed 
study is considered minimal, the data monitoring plan will include continuous, close monitoring by the study 
investigator with prompt reporting of any AEs. Given the small number of subjects undergoing treatment, 
problems will become more readily apparent through close monitoring of individual participants. In this study, 
Dr. Stark will monitor the study for AEs, adherence to the protocol, and safety. 
 

 
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Premature Study Termination 
 
Preliminary study data will be monitored by the data management team for any potentially harmful outcomes. If 
interim data raise significant safety concerns, the trial will be ended early.  
 
Indemnity 
 
Washington University School of Medicine is responsible for any non-negligent damage incurred as a result of 
participating in the COMPASS Trial. The indemnity is renewed on an annual basis. Washington University 
School of Medicine assures that it will continue renewal of the indemnity for the duration of the trial.  
 
Ethics and Dissemination 
 
This protocol and the template informed consent forms will be reviewed and approved by the Washington 
University IRB with respect to scientific content and compliance with applicable research and human subjects 
regulations. All study personnel involved in the conduct of this research will receive the required education on 
the protection of human participant rights.  
 
On publication of the study results, participants will be invited to attend a community meeting, during which the 
results of the study will be reported. The information will be repeated during three community sessions to be 
held during daylight hours. Participants will receive a mailing announcing the meetings and summarizing the 
study findings. The location of the meetings will be in a fully accessible auditorium with accessible parking and 
access to public transportation. A written report will be distributed, and the results will be presented by the 
study investigators, followed by a question-and-answer period. Refreshments will be served, and participants 
and their family members will be thanked for their generous support of the project. 
 
 

 
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