Early Supported Discharge for Improving Functional Outcomes After Stroke
Phase: NA
Conditions: Stroke, Transient Ischemic Attack
Sponsor: Wake Forest University Health Sciences

March 19, 2021 
Application - IRB00035998 
1 
 
COMprehensive Post-Acute Stroke Services (COMPASS) Study 
 
 
Principal-Investigator:  
 
Pamela Duncan, PhD, PT 
 
Co-Investigators:  
Wake Forest 
 
Cheryl Bushnell, MD, MHS (Co-PI) 
 
Walter Ambrosius, PhD 
 
Ralph D`Agostino, PhD 
 
Sabina Gesell, PhD 
 
Allison Brashear, MD, MBA 
 
Brian Wells, MD, PhD 
UNC Chapel Hill  
 
Wayne Rosamond, PhD (Co-PI) 
 
Janet Freburger, PhD, MS  
 
Jacqueline Halladay, MD, MPH  
 
Anna Kucharska-Newton, PhD, MPH, MS 
UNC Wilmington 
 
Barbara Lutz, PhD, RN 
East Carolina University  
 
Doyle “Skip” Cummings, PharmD  
Duke University 
 
Janet Prvu Bettger, ScD 
 
Amy Pastva, PhD, PT 
 
 
Sponsor: 
Patient-Centered Outcomes Research Institute (PCORI) 
 
 
 

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Contents 
COMprehensive Post-Acute Stroke Services (COMPASS) Study ................................................................. 1 
Background ..................................................................................................................................................... 5 
Objectives & Specific Aims ............................................................................................................................ 6 
Primary Study Question: ....................................................................................................................... 6 
Primary Aim: ........................................................................................................................................ 6 
Secondary Aims: ................................................................................................................................... 6 
Exploratory Aims: ................................................................................................................................. 6 
Methods and Measures.................................................................................................................................... 8 
Study Design ......................................................................................................................................... 8 
Study Setting ......................................................................................................................................... 8 
Study Population ................................................................................................................................... 8 
Randomization ...................................................................................................................................... 8 
Subjects Selection Criteria .............................................................................................................................. 9 
Inclusion Criteria: ................................................................................................................................. 9 
Exclusion Criteria: ................................................................................................................................ 9 
Sample Size: .......................................................................................................................................... 9 
Intervention and Interactions ........................................................................................................................ 10 
Phase 1: Patients in Control Hospitals ................................................................................................ 10 
Phase 1: Patients in COMPASS-Intervention Hospitals ..................................................................... 11 
Phase 2: COMPASS-Intervention & COMPASS-Sustain Hospitals .................................................. 13 
Phase 1 Only: Caregivers Outcomes Survey ...................................................................................... 15 
Phase 1 & Phase 2: Community-Engagement .................................................................................... 15 
Outcome Measures ........................................................................................................................................ 17 
Patient Participant Study Outcomes (Phase 1 and 2): ......................................................................... 17 
Caregiver Participant Study Outcomes (Phase 1 only): ...................................................................... 20 
Study outcomes collected and linked to insurance claims data (Phase 1 & Phase 2): ........................ 21 
Clinical Data collection: ...................................................................................................................... 22 
Analytical Plan .............................................................................................................................................. 24 
Human Subjects Protection ........................................................................................................................... 26 
Informed Consent .......................................................................................................................................... 28 
Confidentiality and Privacy .......................................................................................................................... 30 
Overview ............................................................................................................................................. 30 
COMPASS Analytic Database at EMSPIC ........................................................................................ 30 
Electronic Care (eCare) Plan Informatics Database ............................................................................ 30 
Carolina Survey Research Lab Database and Security ....................................................................... 31 
Sheps Center Data Security ................................................................................................................. 32 
Description of the Secure Data Transfers ........................................................................................... 33 

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Data Access for Analysis .................................................................................................................... 34 
REDCap (Research Electronic Data Capture) .................................................................................... 34 
Data and Safety Monitoring .......................................................................................................................... 35 
Responsibilities ................................................................................................................................... 35 
Frequency of Meetings and Communication between DSMB and COMPASS ................................. 35 
Membership ........................................................................................................................................ 35 
Reporting of Unanticipated Problems or Deviations .................................................................................... 36 
References ..................................................................................................................................................... 37 
Appendices .................................................................................................................................................... 39 
Appendix 1 - COMPASS Hospital Characteristics ........................................................................................................... 40 
Appendix 2 - COMPASS Hospital Survey ....................................................................................................................... 44 
Appendix 3 - Eligibility Screening Form .......................................................................................................................... 56 
Appendix 4 - Enrollment Form ......................................................................................................................................... 58 
Appendix 5 - Control-Arm Patient Handout –COMPASS Study ..................................................................................... 63 
Appendix 6 - Letter to the Patient at 30 Days and Magnet ............................................................................................... 64 
Appendix 7 - Letter to the Patient at 60 Days ................................................................................................................... 66 
Appendix 8 - Letter to the Patient at 80 Days ................................................................................................................... 67 
Appendix 9 - NCSCC Stroke Care Card ........................................................................................................................... 69 
Appendix 10 - Screener and Consent (At 90 Days) .......................................................................................................... 71 
Appendix 11 – Sustain-Arm Patient Handout –COMPASS Study Brochure ................................................................... 83 
Appendix 12 - Intervention-Arm Patient Handout –COMPASS Study Brochure ............................................................ 84 
Appendix 13 - Intervention- Arm Patient Handout –COMPASS Roadmap ..................................................................... 85 
Appendix 14 - COMPASS Blood Pressure Log ............................................................................................................... 86 
Appendix 15 - COMPASS Blood Pressure Educational Handout .................................................................................... 89 
Appendix 16 - Two-Day Post-Discharge Follow-up ........................................................................................................ 94 
Appendix 17 - Post-stroke Functional Assessment ......................................................................................................... 100 
Appendix 18 - Caregiver Assessment ............................................................................................................................. 108 
Appendix 19 - Post-stroke Advanced Practice Assessment ............................................................................................ 110 
Appendix 20 - Individualized Patient Care Plan (eCare Plan) ........................................................................................ 112 
Appendix 21 - Consent and HIPAA Authorization for Clinical Data ............................................................................. 122 
Appendix 22 - 30 and 60 Day Call Forms (60 Day Call Form is Identical) ................................................................... 124 
Appendix 23 – 90d Patient Survey (CATI/ Phone Format) ............................................................................................ 126 
Appendix 24 - 90d Patient Survey (Full Survey Mailed with the 80 day letter) ............................................................. 154 
Appendix 25 – 90d Patient Non-Responder Survey and Letter (Mailed if unable to reach over phone) ....................... 166 
Appendix 26 - Caregiver Letter (First Attempt) ............................................................................................................. 169 
Appendix 27 - Caregiver Survey .................................................................................................................................... 170 
Appendix 28 - Proxy SIS-16 ........................................................................................................................................... 173 
Appendix 29 - Caregiver Letter (Second Attempt) ......................................................................................................... 174 

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Appendix 30 - Caregiver Thank You Note ..................................................................................................................... 175 
Appendix 31 - IRB Approval Letter for PCORI Stakeholder Interviews ....................................................................... 176 
Appendix 32 - DSMB Template Sections ....................................................................................................................... 177 
Appendix 33 – CTSI Supplemental Proposal (Implementation of COMPASS)............................................................. 178 
Appendix 34 – 2Day Disposition Form .......................................................................................................................... 181 
Appendix 35 – Clinic Disposition Form ......................................................................................................................... 182 
Appendix 36 – Phase 2 Patient Brochure for Sustaining COMPASS Hospitals ............................................................ 186 
Appendix 37 – Phase 2 Patient Brochure for Intervention Sites (formerly Usual Care) ................................................ 187 
Appendix 38 – Phase 2Enrollent Form ........................................................................................................................... 188 
Appendix 39 – Consent Matrix ....................................................................................................................................... 193 
 
 
 

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Background 
  
Stroke is the fifth-leading cause of death in the United States (US) and a major cause of long-term disability.1 North 
Carolina (NC) is in the Stroke Belt, a region of the US with a very high stroke incidence. Eastern NC is the “buckle” of 
the Stroke Belt, where stroke mortality is 40% higher than the US average and hospital admission rates are the highest in 
NC.2 African Americans, over 20% of the population in NC, are more likely than their white counterparts to die of stroke 
at relatively young ages.2 There is also evidence that African-Americans are more likely to be readmitted after stroke.3 
 
Stroke exemplifies a complex co-morbidity condition, with 85% of Medicare beneficiaries with stroke having four or 
more other chronic health conditions,4 and their health care is costly. Stroke patients with congestive heart failure have per 
capita costs that are about five times higher than the average spending for Medicare fee-for-service beneficiaries.4 In 
addition, stroke patients are frequently readmitted to the hospital.5,6 A PCORI-funded study shows that 25% of stroke 
patients discharged home without post-acute care are readmitted within 90 days7.  These data align with what stroke 
survivors and caregiver advocates from across NC have said that stroke patients need. One of our patient partners who 
started a support group for other stroke survivors stated:  
“You can’t just place an individual back in their home with a bottle of pills and a follow-up visit…There is a real need for 
assistance when patients get home…What is in place for the patient? Nothing… No visiting nurse, no one to answer 
questions, or help them get what they need. That is why people end up back in the hospital.” 
 
Roughly half of stroke patients in NC are discharged directly home, often with new disability. Around 44% cannot walk 
independently at discharge.8 Complications from immobility account for up to 51% of deaths in the first 30 days after 
ischemic stroke.9,10 Other complications are common early after stroke and include falls and fractures, aspiration 
pneumonia, deep vein thrombosis, infections, depression, and adverse events associated with warfarin therapy.11–16 Even 
those with mild post-stroke disability can have physical and cognitive deficits which often go undetected during acute 
hospitalization.  These mild disabilities interfere with function, and management of risk factors and medication.17,18 
 
Fewer than 50% of individuals with stroke have their risk factors assessed, treated, or controlled. Of those overweight at 
initial evaluation, 90% remain overweight. Nearly half of hypertensive individuals do not have blood pressure controlled. 
Smokers do not quit and few participate in exercise programs.19 At three months post-discharge, only 75% of stroke 
patients are still taking their preventive medications.20 About 40% remain dependent on others.20,21 Stroke also affects 
caregivers. Caregivers have poorer mental health, less social contact and activity, and are at increased risk for 
depression.20,21  
 
Comprehensive post-acute services for stroke require bridging hospital-based acute care with expanded care teams for 
rehabilitation, primary care management, access to community resources, and caregiver support. Evidence-based reviews 
have concluded that stroke morbidity and mortality could be reduced through effective transitional care,22–24 secondary 
prevention,25 and rehabilitation early post-stroke.26 Involvement with a stroke liaison worker or case manager is associated 
with more knowledge about stroke and satisfaction with services.27,28 Caregiver-oriented, individualized discharge 
planning for stroke patients going home improves caregiver preparedness.29  
 
Given the significant impact of stroke on public health, the high risk and complexity of these patients early after 
discharge, and the strain on caregivers, an effective post-acute care model is needed. A pragmatic trial is the ideal method 
to test a care model that can be readily disseminated and implemented. 
 
 
 

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Objectives & Specific Aims 
 
The COMprehensive Post-Acute Stroke Services (COMPASS) Study will determine the effectiveness of a post-acute 
comprehensive intervention.   
 
Primary Study Question:  
Does implementation of the COMPASS for stroke patients discharged directly home, improve functional outcomes 
(measured by the Stroke Impact Scale-16) at 90 days post-stroke? Intention-to-treat principles will be used to determine 
all primary and secondary outcomes. 
 
Primary Aim:  
Comparative effectiveness of COMPASS verses usual care (Control) on stroke survivor functional status (measured by 
the Stroke Impact Scale) at 90 days post-stroke. 
 
Secondary Aims:  
1) Using responses from the 90 day caregiver survey, determine if the COMPASS intervention reduces caregiver 
strain (measured by the Modified Caregiver Strain Index) at 90 days post-stroke. 
2) Using responses from the 90 day survey, we will measure self-rated general health; medication adherence 
(MMAS-4); self-monitoring of blood pressure; global disability; physical activity; depression (PHQ2); cognition 
(Mini MOCA); falls; fatigue; and satisfaction of care. 
3) Using claims data from multiple payer sources up to 12 months after stroke hospitalization, we will measure 
effectiveness of COMPASS vs usual care for all-cause readmissions at 30 and 90 days and 1-year post-discharge. 
4) Comparative effectiveness of the COMPASS vs usual care on: mortality; health care utilization; (emergency 
department visits, admissions to skilled nursing facilities/inpatient rehabilitation facilities); and use of transitional 
care management billing codes. We will use claims data from multiple payer sources up to 12 months after stroke 
hospitalization. 
5) For all outcomes we will adjust analyses to account for race, sex, age, stroke severity, and insurance status. 
 
Exploratory Aims: 
1)  Phase 2: The implementation sustainability objectives for Phase 2 of the COMPASS Study are to characterize 
whether rates of transitional care management (TCM) delivery and eCare plan delivery are sustained, worsen, or 
improve during the sustainability period of the COMPASS study for hospitals randomized to the intervention 
during Phase 1.  
2)  Phase 2: The effectiveness sustainability objective for Phase 2 of the COMPASS Study is to characterize whether 
patient outcomes are sustained, worsen, or improve during the sustainability period of the COMPASS study for 
hospitals randomized to the intervention during Phase 1.  
3) Phase 2: The primary comparative effectiveness objective for Phase 2 of the COMPASS Study is to evaluate 
whether Stroke Impact Scale 16 (SIS-16) scores are improved during Phase 2 (i.e., the intervention phase) for 
hospitals randomized to usual care in Phase 1.  
4)  Phase 2: Using Claims, the Pre-Post analyses compared outcomes in hospitals randomized to provide UC in Phase 
1 with outcomes among those that crossed over and delivered the INV in Phase 2 for mortality; health care 
utilization; (emergency department visits, admissions to skilled nursing facilities/inpatient rehabilitation 
facilities); and use of transitional care management billing codes. We will use claims data from multiple payer 
sources up to 12 months after stroke hospitalization. 
5).  Phase 2: Using Claims, the Sustainability analyses compared outcomes in hospitals randomized to deliver the 
INV in Phase 1 with outcomes among those that sustained the intervention (SUS) in Phase 2 for mortality; health 
care utilization; (emergency department visits, admissions to skilled nursing facilities/inpatient rehabilitation 

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facilities); and use of transitional care management billing codes. We will use claims data from multiple payer 
sources up to 12 months after stroke hospitalization. 
 
 
Data Collected for Ancillary Studies: 
1) Analysis of individual, organizational, and community factors affecting implementation of COMPASS through 
supplemental funding (CTSI Award lead by Co-I Dr. Gesell). This pilot project will contribute to a process 
evaluation of our Phase1, intervention-randomized health systems adopting COMPASS. 
2) An exploratory analysis that compares patient clinic return rate and use of services to physical locations of 
patients and services (i.e. distance and drive times to/from clinics and community resources). 
3) At the 90 day survey, we will also use the PROMIS Global-10 instrument that assesses general domains of health 
and functioning including overall physical health, mental health, social health, pain, fatigue, and perceived quality 
of life. These are similar in nature to our primary outcome, the SIS-16. 
Hospital Performance Metrics (to support participating sites in delivery of the intervention):  
1) Evaluate compliance with the new model of post-acute stroke care by exploring quality indicators among 
intervention hospitals, (e.g., proportion of patients called within 2 days after hospital discharge; proportion of patients 
seen by an advanced practice provider [MD/NP/PA] within 7 to 14 days from hospital discharge; and proportion of 
eligible patients  receiving  home or outpatient rehabilitation therapy). 
 
 
 

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Methods and Measures 
Study Design  
The COMPASS Study is a pragmatic, cluster-randomized trial of 41 hospitals in North Carolina designed to determine the 
effectiveness of a model of post-acute stroke care (i.e. the COMPASS Intervention) compared with usual care (Control).   
 
 
Study Setting  
The COMPASS intervention will be implemented in hospitals and communities in 2 phases over a 5-year period.  We will 
recruit 41 hospitals that represent diverse geographic locations (i.e. rural vs urban), primary stroke center certification 
status, and stroke patient volumes.  Included in this IRB Application (Appendix 1) is an attachment (Titled: COMPASS 
Hospital Characteristics) which provides a side-by-side comparison of hospitals expected to participate in the COMPASS 
trial with All North Carolina Hospitals.  A list of our COMPASS Hospitals is also included.  The data used to make the 
comparison is from CMS Hospital Compare30. COMPASS will ask participating hospitals to fill out a Hospital Survey 
(Appendix 2) at the start of the study to better understand the current state of transitional care at each hospital.  
Study Population 
In 2013, data from hospitals in the North Carolina Stroke Care Collaborative (NCSCC) indicated that 46% of patients 
were discharged directly home from the hospital after a stroke (our proposed study population).  Using this data we 
anticipate an estimated sample of approximately 6,000 potentially eligible participants.  In that population, the mean age 
was 65.0 years (SD 14.4), 25% were African American, and 48% were women. Stroke severity, measured by the NIH 
Stroke Severity score and ranging from 0 (no deficit) to 42 (maximum deficits), was on average 3.2 for those discharged 
home. 
 
Randomization 
Since individual stroke patients cannot easily be 
randomized to receive the COMPASS intervention, 
we determined that the optimal statistical design for 
this pragmatic trial utilizes a cluster randomized 
approach. Thus, 41 individual hospitals will be 
randomized to either receive the COMPASS 
intervention at the beginning of the study (Phase 1) 
or in Phase 2 (see Figure 1).  Two of the 
participating 41 hospitals were randomized 
together, therefor we have 40 randomized units.  
Hospitals randomized to receive the intervention in 
Phase 2 will be referred to as the control group. 
Randomization per hospital will be stratified by 
volume of stroke patients and primary stroke center 
status. In this intention-to-treat design, all stroke 
patients who are discharged directly home from 
randomized acute care hospitals will be included in 
analyses. The analyses will be performed at the individual level with adjustment for lack of independence 
between hospitals. The primary analysis of patient-centered outcomes will occur at the end of Phase 1.     
Figure 1: Hospital Randomization to the COMPASS 
Intervention in Phase 1 and Phase 2 

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Subjects Selection Criteria 
 
Inclusion Criteria: 
 
Patients aged 18 years or older, discharged home from a participating COMPASS Study hospital with 
a diagnosis of ischemic or hemorrhagic stroke or transient ischemic attack (TIA). 
Exclusion Criteria: 
 
Patients transferred to another short-term acute care hospital, skilled nursing facility, inpatient 
rehabilitation facility, or hospice. 
 
Patients with a diagnosis of subdural or aneurysmal subarachnoid hemorrhage. 
 
Patients who speak neither English nor Spanish. 
 
Sample Size: 
 
Approximately 6,000 potentially eligible participants during Phase 1  
 
Approximately 6,000 potentially eligible participants during Phase 2 
 
 
 

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Intervention and Interactions 
 
As described in the Methods section above, the trial has two Phases (see 
Figure 1).   
 
Phase 1: Patient enrollment for Phase 1 of the trial will run from June 
2016 to March 2018.  Phase 1 includes a control arm (Control Hospital) 
and an intervention arm (COMPASS-Intervention Hospitals).  Details 
of these arms and interactions are described below.  Figure 2 depicts the 
patient flow of activities for Phase 1 when there is a control arm and 
COMPASS intervention arm.   
 
Phase 2: Patient enrollment for Phase 2 of the trial will run from 
November 2017 – January 2019.  Phase 2 includes an intervention arm 
(COMPASS-Intervention hospital) and the other arm is COMPASS 
Hospitals who will sustain the COMPASS intervention using their own 
hospital resources (COMPASS-Sustain hospital).  Detail of these arms 
and interactions are described below.   
 
Note, that there is some overlap between Phases 1 and 2.  The 
overlap is due to differences in the timing of hospital recruitment and 
enrollment (i.e. larger hospitals enrolled patients faster). 
 
COMPASS will support hospitals in implementing structured post-acute 
stroke services consistent with CMS transitional care codes and management.  
Hospitals which participate are implementing COMPASS as the new 
standard of care. The goal of COMPASS is to structure and organize the 
processes of post-acute care to optimize patient recovery function, reduce 
caregiver stress, improve risk factor management, and facilitate self-
management of risk factors.  
 
Phase 1: Patients in Control Hospitals 
Prior to hospital discharge, the Post-Acute Coordinator (PAC) will identify 
stroke and TIA patients for eligibility using the Eligibility Screening Form 
(Appendix 3).  Determining eligibly will involve daily review of stroke 
admissions to the hospital by screening the electronic medical records.  This 
will be done under Limited HIPAA Waiver. 
 
If eligible, the patient will be enrolled, a COMPASS ID is assigned and the 
PAC will fill out the Enrollment Form (Appendix 4).  For those not eligible, 
no further information is collected and a COMPASS Identification number is 
not assigned.  Enrollment will be done under a Full HIPAA Waiver. 
 
The PAC will visit eligible patients in the hospital, notify the patient that the 
hospital is participating in the COMPASS Study, and give the patient a 
handout with information on the COMPASS Study (Appendix 5). The 
information informs the patient that their hospital is participating in a state-
wide study to evaluate best models of post-stroke care.  The patient will be 
informed if their hospital is in the usual care group or in the COMPASS 
intervention group.  The handout that patients receive in the control arm is 
tailored to the hospital.  Each control arm hospital brochure will include the PAC name, the PAC contact information and 
a tailored description of the post-acute “standard care” that the patient will receive at that hospital.  This information will 
equip patients with information to fully inform them of the COMPASS Study and how this will impact them and what to 
expect from the hospital.  The PAC will also explain that the patient will get a phone call in about three months asking 
Figure 2: Flow of Intervention Activities for 
Phase 1, Control and COMPASS Participants 

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them to participate in a telephone survey and that they will get three reminder letters in the mail to remind them about the 
survey (Appendix 6-8).  The PAC will record patient and caregiver contact information on the COMPASS enrollment 
form.  In the COMPASS analytical database, the PAC will record the date, time and method (i.e. in person or over the 
phone) of informing the patient of the COMPASS Study, and confirm that the patient was given the brochure.  As a 
pragmatic study, we anticipate that PACs may miss a patient (for example a patient may be missed on the weekends) and 
the patient will need to be enrolled retrospectively and notified of the study and mailed the brochure.  The PAC will 
attempt to reach the patient over the phone to follow-up on the mailed brochure.  The brochure also has contact 
information for the patient to call the study if they would like additional information. 
 
As part of case ascertainment and consistent with the North Carolina Stroke Care Collaborative (NCSCC) methodologies 
to characterize all stroke admissions and processes of acute stroke care the PAC will complete the NCSCC Stroke Care 
Card (Appendix 9).   
 
Patients will receive three letters in the mail to remind them about the 90 day survey and to provide educational 
information and resources from the American Stroke Association (Appendix 6-8).  Although the 90 day phone survey will 
be relying on a Full HIPAA Authorization Waiver, the letter mailed to the patient at 80 days includes a statement on 
HIPAA to inform the patient on how they have been identified for the study and that agreeing to participate in the phone 
survey will be authorizing the use of identifiable health information and how that information will be used in the study.  
The 80 day letter will also include $10 cash as a thank you gift for considering participation in the phone survey.    
 
At 90 Days, stroke survivors will receive a phone call from the Carolina Survey Research Lab (CSRL).  CSRL will follow 
a telephone script which includes consent (Appendix 10) and conduct blinded assessments (Appendix 23 and 24).  If the 
patient prefers s/he can request that a proxy answer questions and provide verbal consent and HIPAA Authorization on 
her/his behalf.  In the event contact is never made with the patient by phone or connection is lost (e.g. the number is not in 
service, no one answers the phone calls, call is answered but is disconnected prior to the researcher sharing the reason for 
calling, or there is loss of connection during the call) we will mail an abbreviated version of the survey with a letter 
explaining the survey purpose (Attachment 25).  We will also include a self-addressed envelope with prepaid postage to 
the patient to gather responses via paper survey.  This abbreviated survey contains the SIS-16, global health rating scale 
and blood pressure questions.   
 
Approximately one year later the study will acquire claims data from Medicare, Medicaid, State Insurance Plan, and Blue 
Cross Blue Shield.  We plan to use a HIPAA Waiver to acquire the data sets and along with this application we are asking 
for a waiver of signed consent to link all enrolled patients to the claims data sets.   
 
Phase 1: Patients in COMPASS-Intervention Hospitals  
In addition to the activities outlined in the Control Hospitals section above, patients who enter the study through a 
COMPASS Intervention hospital will receive: (1) a follow-up phone call 2 days after being discharged from the hospital, 
(2) a 7-14 day Advanced Practice Provider visit, (3) a follow-up 30 day phone call, and (4) a follow-up 60 day phone call. 
The structure and processes of this COMPASS intervention are consistent with the Center for Medicare and Medicaid 
(CMS) Transitional Care Management Codes. In essence the COMPASS study is an evaluation of the implementation of 
CMS recommendations for post hospital care coordination.  
 
The process for determining Eligibility for COMPASS patients is identical to that of Control patients.   
 
If the patient is eligible, they will be enrolled in a similar manner to that of the Control patients:  The PAC will visit each 
patient in the hospital and give the patient a tailored handout about the COMPASS Study (Appendix 12).  The information 
informs the patient that their hospital is participating in a state-wide study to evaluate best models of post stroke care.  The 
patient will be informed if their hospital is in the usual care group or in the COMPASS intervention group.  This brochure 
is tailored to the hospital.  The PAC name and the PAC contact information will be provided on an appointment card.  
This information will equip patients with information to fully inform them of the COMPASS Study and how this will 
impact them and what to expect from the hospital.  The PAC will also give an additional handout about COMPASS 

March 19, 2021 
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intervention activities (Appendix 13), a Blood Pressure Log (Appendix 14) and Blood Pressure Handout (Appendix 15).  
The PAC will work with the patient to schedule follow-up visits with the patients Primary Care Physician (PCP) and the 
Advanced Practice Provider (APP) for the 7-14 day follow-up visit.  The PAC will let the patient know they will be 
calling them in a couple of days for the 2-day follow-up phone call.  The PAC will record patient and caregiver contact 
information on the COMPASS enrollment form.  In the COMPASS analytical database, the PAC will record the date, 
time and method (i.e. in person or over the phone) of informing the patient of the COMPASS Study, and confirm that the 
patient was given the brochure.  As a pragmatic study, we anticipate that PACs may miss a patient (for example a patient 
may be missed on the weekends) and the patient will need to be enrolled retrospectively and notified of the study and 
mailed the brochure. The PAC will attempt to reach the patient over the phone to follow-up on the mailed brochure.  The 
brochure also has contact information for the patient to call the study if they would like additional information. 
 
As part of case ascertainment and consistent with the North Carolina Stroke Care Collaborative methodologies to 
characterize all stroke admissions and processes of acute stroke care the PAC will complete the NC Stroke Care Card 
(Appendix 9).   (Note:  this is identical to the Control group).   
 
At 2 days post- hospital discharge, the PAC will call the patient and discuss medication use, symptoms, and confirm 
(or schedule) follow-up appointments with the patients Primary Care Physician and the Advanced Practice Provider.  The 
PAC will provide patient education to ensure they know about signs of a subsequent stroke.  The script for the 2 day 
follow-up call is in Appendix 16.   
 
Following the 2day call, the PAC will complete a disposition form (Appendix 34) to record if the call took place (yes/no) 
and if the call did not take place a categorical reason why the call did not take place.  These questions are similar to what 
is acquired in claims data research.  Use of data from this form will be done under a request for Full HIPAA Waiver for 
all patients who are enrolled in an intervention hospital. 
 
Between 7 and 14 days, the patient will attend a follow-up visit with the advanced practice provider (APP).  The 
PAC will also attend this visit.  The goal of this visit is to create an individualized patient Care Plan and, if needed, make 
additional referrals for the patient.  At this visit, the PAC will clinically assess the patient using the Post-stroke Functional 
Assessment (Appendix 17).  Based on responses from this assessment, the PAC may also conduct the Caregiver 
Assessment (Appendix 18) with the patient's caregiver if the caregiver is present.  The provider will assess the patient 
using the Post-stroke Advanced Practice Assessment (Appendix 19).  Responses to these assessments will be used by the 
provider to develop an individualized patient Care Plan.  These three assessments have been programmed into an 
electronic platform (eCare Application) to ease administration, assessments, data capture and development of the 
individualized patient Care Plan (eCare Plan) which will be conducted on an iPad.  The tool will summarize the three 
assessments and make suggestions for the provider in creation of the individualized patient Care Plan (Appendix 20 is an 
example; the provider customizes these recommendations).  As the decision-making authority in patient care, the final 
individualized patient Care Plan and any referrals are given by the provider. The PAC will review the Care Plan with the 
patient, establish preferences for care and coordinate referrals for services.  A copy of the Care Plan will go forward to the 
patient’s primary care provider and rehabilitation providers.  The APP will send a summary of the visit and the Care Plan 
to the patient’s primary care provider and rehabilitation providers.  During this visit the patient will be asked for consent 
and HIPAA Authorization to use clinical data for future analyses (Appendix 21).     
 
Following this clinic visit, the PAC will complete a clinic visit disposition form (Appendix 35) which records if the clinic 
visit was conducted (yes/no) and date of visit.  This form also records which clinic forms were completed during the visit 
to determine to what extent the COMPASS intervention was implemented for quality improvement on processes and 
delivery of care.  This form also summarizes care and community service recommendations, which were made for patient 
care and to record for quality improvement initiatives.  This form includes yes/no and categorical responses similar to 
what is acquired in claims data.  Use of data from this form will be done under a request for Full HIPAA Waiver for all 
patients who are enrolled in an intervention hospital. 
 

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At 30 and 60 days, patients will be called by the PAC to follow-up on their Care Plan.  The PAC will ask the patient 
if they are having any challenges with implementing the care and treatment plans that their health providers have given 
them (Appendix 22). 
 
Patients will also receive three letters in the mail to remind them about the 90 day survey and to provide educational 
information and resources from the American Stroke Association (Appendix 6-8).  Although the 90 day phone survey will 
be relying on a Full HIPAA Authorization Waiver, the letter mailed to the patient at 80 days includes a statement on 
HIPAA to inform the patient on how they have been identified for the study and that agreeing to participate in the phone 
survey will be authorizing the use of identifiable health information and how that information will be used in the study.   
The 80 day letter will also include $10 cash as a thank you gift for considering participation in the phone survey.   (Note:  
this is identical to the Control group).   
 
At 90 Days, stroke survivors will receive a phone call from the Carolina Survey Research Lab (CSRL).  CSRL will follow 
a telephone script which includes consent (Appendix 10) and conduct blinded assessments (Appendix 23 and 24).  If the 
patient prefers s/he can request that a proxy answer questions and provide verbal consent and HIPAA Authorization on 
her/his behalf.  In the event contact is never made with the patient by phone or connection is lost (e.g. the number is not in 
service, no one answers the phone calls, call is answered but is disconnected prior to the researcher sharing the reason for 
calling, or there is loss of connection during the call) we will mail an abbreviated version of the survey with a letter 
explaining the survey purpose (Attachment 25). We will also include a self-addressed envelope with prepaid postage to 
the patient to gather responses via paper survey.  This abbreviated survey contains the SIS-16, global health rating scale 
and blood pressure questions.  (Note:  this is identical to the Control group) 
 
Approximately one year later the study will acquire claims data from Medicare, Medicaid, State Insurance Plan, and Blue 
Cross Blue Shield.  We plan to use a HIPAA Waiver to acquire the data sets and along with this application we are asking 
for a waiver of signed consent to link all enrolled patients to the claims data sets.  (Note:  this is identical to the Control 
group).   
 
Phase 2: COMPASS-Intervention & COMPASS-Sustain Hospitals 
 
Hospitals which were randomized to the control-arm in Phase 1 of the study will be encouraged to cross over to provide 
the COMPASS Intervention during Phase 2 of the study.  Hospitals that were randomized to the COMPASS Intervention-
arm during Phase 1 of the study will be encouraged to continue providing all of the COMPASS Intervention to eligible 
patients (Sustain Sites).  Both the Intervention and the Sustain Sites will provide the same intervention as described in this 
section.  This intervention is nearly identical to the Phase 1 Intervention.  Minor changes were made in order to streamline 
some of the intervention activities based on lessons-learned from Phase 1.  The structure, however, remains unchanged: 
Patients who enter the study through a participating hospital will receive: (1) a follow-up phone call 2 days after being 
discharged from the hospital, (2) a 7-14 day Advanced Practice Provider visit, (3) a follow-up 30 day phone call, and (4) a 
follow-up 60 day phone call.  
 
The process for determining Eligibility for patients is identical to Phase 1 of the study:  Prior to hospital discharge, the 
Post-Acute Coordinator (PAC) will identify stroke and TIA patients for eligibility using the Eligibility Screening Form to 
assist in determining eligibility (Appendix 3).  Determining eligibly will involve daily review of stroke admissions to the 
hospital by screening the electronic medical records.  This will be done under Limited HIPAA Waiver. 
 
If eligible, the patient will be enrolled, a COMPASS ID is assigned and the PAC will fill out the Enrollment Form which 
has been streamlined for Phase 2 of the study (Appendix 38).  For those not eligible, no further information is collected 
and a COMPASS Identification number is not assigned.  Enrollment will be done under a Full HIPAA Waiver. 
 
Once the patient is enrolled, the patient will be notified of the study.  The PAC will visit each patient in the hospital and 
give the patient a tailored, Phase 2 handout about the COMPASS Study (Appendix 36 & Appendix 37).  Like Phase 1 of 
the study, the information informs the patient that their hospital is participating in a state-wide study to evaluate best 

March 19, 2021 
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models of post stroke care.  The patient will be informed their hospital is providing the COMPASS intervention.  The 
PAC name and the PAC contact information will be provided on an appointment card.  This information will equip 
patients with information to fully inform them of the COMPASS Study and how this will impact them and what to expect 
from the hospital.  The PAC will also give an additional handout about COMPASS intervention activities (Appendix 13), 
a Blood Pressure Handout and Log (Appendix 14).  The PAC will work with the patient to schedule follow-up visits with 
the patients Primary Care Physician (PCP) and the Advanced Practice Provider (APP) for the 7-14 day follow-up visit.  
The PAC will let the patient know they will be calling them in a couple of days for the 2-day follow-up phone call.  In the 
COMPASS data application, the PAC will record the date, time and method (i.e. in person or over the phone) of 
informing the patient of the COMPASS Study, and confirm that the patient was given the brochure.  As a pragmatic study, 
we anticipate that PACs may miss a patient (for example a patient may be missed on the weekends) and the patient will 
need to be enrolled retrospectively and notified of the study and mailed the brochure. PACs are encouraged to notify 
patients over the phone as follow-up on the mailed brochure.  The brochure also has a toll-free study phone number for 
patients to call the study if they would like additional information or to opt-out of the study. 
 
In Phase 2, hospitals will not be required to complete the North Carolina Stroke Care card (Appendix 9), however, this 
card will be made available to hospitals if they find it beneficial. 
 
At 2 days post- hospital discharge, the PAC will call the patient and discuss medication use, symptoms, and confirm 
(or schedule) follow-up appointments with the patients Primary Care Physician and the Advanced Practice Provider.  The 
PAC will provide patient education to ensure they know about signs of a subsequent stroke.  The script for the 2 day 
follow-up call is in Appendix 16.  (Note this is identical to Phase 1 Intervention) 
 
Following the 2day call, the PAC will complete a disposition form (Appendix 34) to record if the call took place (yes/no) 
and if the call did not take place a categorical reason why the call did not take place.  These questions are similar to what 
is acquired in claims data research.  Use of data from this form will be done under a request for Full HIPAA Waiver for 
all patients who are enrolled in an intervention hospital. (Note this is identical to Phase 1 Intervention) 
 
Between 7 and 14 days, the patient will attend a follow-up visit with the advanced practice provider (APP).  The 
PAC will also attend this visit.  The goal of this visit is to create an individualized patient Care Plan and, if needed, make 
additional referrals for the patient.  At this visit, the PAC will clinically assess the patient using the Post-stroke Functional 
Assessment (Appendix 17).  Based on responses from this assessment, the PAC may also conduct the Caregiver 
Assessment (Appendix 18) with the patient's caregiver if the caregiver is present.  The provider will assess the patient 
using the Post-stroke Advanced Practice Assessment (Appendix 19).  Responses to these assessments will be used by the 
provider to develop an individualized patient Care Plan.  These three assessments have been programmed into an 
electronic platform (eCare Application) to ease administration, assessments, data capture and development of the 
individualized patient Care Plan (eCare Plan) which will be conducted on an iPad.  The tool will summarize the three 
assessments and make suggestions for the provider in creation of the individualized patient Care Plan (Appendix 20 is an 
example; the provider customizes these recommendations).  As the decision-making authority in patient care, the final 
individualized patient Care Plan and any referrals are given by the provider.  The PAC will review the Care Plan with the 
patient, establish preferences for care and coordinate referrals for services.  A copy of the Care Plan will go forward to the 
patient’s primary care provider and rehabilitation providers.  The APP will send a summary of the visit and the Care Plan 
to the patient’s primary care provider and rehabilitation providers.  During this visit the patient will be asked for consent 
and HIPAA Authorization to use clinical data for future analyses (Appendix 21).  (Note this is identical to Phase 1 
Intervention) 
 
Following this clinic visit, the PAC will complete a clinic visit disposition form (Appendix 35) which records if the clinic 
visit was conducted (yes/no) and date of visit.  This form also records which clinic forms were completed during the visit 
to determine to what extent the COMPASS intervention was implemented for quality improvement on processes and 
delivery of care.  This form also summarizes care and community service recommendations, which were made for patient 
care and to record for quality improvement initiatives.  This form includes yes/no and categorical responses similar to 
what is acquired in claims data.  Use of data from this form will be done under a request for Full HIPAA Waiver for all 
patients who are enrolled in an intervention hospital.  (Note this is identical to Phase 1 Intervention) 

March 19, 2021 
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At 30 and 60 days, patients will be called by the PAC to follow-up on their Care Plan.  The PAC will ask the patient 
if they are having any challenges with implementing the care and treatment plans that their health providers have given 
them (Appendix 22).  (Note this is identical to Phase 1 Intervention) 
 
Patients will also receive three letters in the mail to remind them about the 90 day survey and to provide educational 
information and resources from the American Stroke Association (Appendix 6-8).  Although the 90 day phone survey will 
be relying on a Full HIPAA Authorization Waiver, the letter mailed to the patient at 80 days includes a statement on 
HIPAA to inform the patient on how they have been identified for the study and that agreeing to participate in the phone 
survey will be authorizing the use of identifiable health information and how that information will be used in the study.   
The 80 day letter will also include $10 cash as a thank you gift for considering participation in the phone survey.  (Note 
this is identical to Phase 1) 
 
At 90 Days, stroke survivors will receive a phone call from the Carolina Survey Research Lab (CSRL).  CSRL will follow 
a telephone script which includes consent (Appendix 10) and conduct blinded assessments (Appendix 23 and 24).  If the 
patient prefers s/he can request that a proxy answer questions and provide verbal consent and HIPAA Authorization on 
her/his behalf.  In the event contact is never made with the patient by phone or connection is lost (e.g. the number is not in 
service, no one answers the phone calls, call is answered but is disconnected prior to the researcher sharing the reason for 
calling, or there is loss of connection during the call) we will mail an abbreviated version of the survey with a letter 
explaining the survey purpose (Attachment 25). We will also include a self-addressed envelope with prepaid postage to 
the patient to gather responses via paper survey.  This abbreviated survey contains the SIS-16, global health rating scale 
and blood pressure questions.  (Note this is identical to Phase 1) 
 
Approximately 6-months later the study will acquire claims data from Medicare, Medicaid, State Insurance Plan, and Blue 
Cross Blue Shield.  We plan to use a HIPAA Waiver to acquire the data sets and along with this application we are asking 
for a waiver of signed consent to link all enrolled patients to the claims data sets.  (Note, this is identical to Phase 1 with 
the exception we are doing 6 months of claims data follow-up in Phase 2.  As a reminder, in Phase 1, the study is 
doing 12 months of follow-up.) 
 
Phase 1 Only: Caregivers Outcomes Survey 
COMPASS Study team will mail the patient’s caregiver a letter (Appendix 26), and the Caregiver Survey (Appendix 27).  
Non-respondents will be mailed a second letter (Appendix 29) with the survey (Appendix 27).  If the caregiver still does 
not respond they will receive a reminder telephone call from UNC Carolina Survey Research Lab.  (Note, Phase 2 will 
not include a Caregiver Outcomes Survey) 
 
Phase 1 & Phase 2: Community-Engagement 
This is a community-engaged study. Patients, family caregivers, and others stakeholders will be involved in all phases of 
the research process. These community members will be engaged in non-research activities (e.g., revising study materials 
for clarity) as well as research activities (e.g., participating in focus groups). By design, community-engaged research 
requires decision making by many stakeholders and frequent IRB amendments. For clarity and oversight purposes we 
have submitted a separate IRB (PCORI Stakeholder Interviews: IRB00028495; Appendix 31) for research activities 
involving stakeholders.  
 
 
Phase 1 Only: Implementation Analysis 
We will be asking participating staff at implementing sites (approximately 20 PACs and COMPASS team members) to 
agree to have their responses on the Bi-weekly Implementation Calls and surveys recorded and transcribed and analyzed 
to better understand the process of implementing the COMPASS Care Model.  We will be asking participating staff at 
implementing sites (approximately 40 therapy care providers and COMPASS team members) to agree to have their 
responses on the Bi-weekly Home Health and Outpatient Calls and surveys recorded and transcribed and analyzed to 

March 19, 2021 
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better understand the process of implementing the COMPASS Care Model.  We will also be asking study staff 
COMPASS Director of Implementation and members of the Implementation Committee for individual semi-structured 
interviews.  Additional detail to this study activity is provided in Appendix 33. 
 
 
 

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Data Collection and Outcome Measures 
Patient Participant Study Outcomes (Phase 1 and 2):  
 
Measure 
Assessment(s) 
When Collected 
Appendix  
Primary 
Outcome 
Physical Function 
Stroke Impact Scale 
(SIS-16)  
@90 days, 
consenting patients 
asked by CSRL  
23 
 
 
 
 
 
Secondary 
Outcome 
Self-rated General Health 
A question rating 
health on a 5-point 
scale & a question on 
perception of health 
improvement  
@90 days, 
consenting patients 
asked by CSRL 
24 
Secondary 
Outcome 
Disability and 
Dependence 
Modified Rankin Scale 
@90 days, 
consenting patients 
asked by CSRL 
24 
Secondary 
Outcome 
Physical Activity 
Three questions which 
ask about time spent 
walking 
@90 days, 
consenting patients 
asked by CSRL 
24 
Secondary 
Outcome 
Depression 
Patient Health 
Questionnaire (PHQ-2) 
Note: these items do 
not ask about suicidal 
thoughts or actions 
@90 days, 
consenting patients 
asked by CSRL 
24 
Secondary 
Outcome 
Cognition 
MOntreal Cognitive 
Assessment (MOCA) 
Mini 
@90 days, 
consenting patients 
asked by CSRL 
24 
Secondary 
Outcome 
Medication Adherence 
 4-item Morisky 
Green-Levine Scale 
@90 days, 
consenting patients 
asked by CSRL 
24 
Secondary 
Outcome 
Secondary Prevention 
Self-Monitoring of BP 
By asking: “Do you 
check your blood 
pressure at home?” 
@90 days, 
consenting patients 
asked by CSRL 
24 
Secondary 
Outcome 
Blood Pressure 
Management 
Effectiveness 
For those who check 
BP at home, we ask: 
“Is your blood pressure 
less than 140/90 most 
of the time?”  
@90 days, 
consenting patients 
asked by CSRL 
24 
Secondary 
Outcome 
Falls and Hospitalization* 
Questions to capture: 
Number of falls, 
injuries, and 
hospitalizations   
*Note: Note: Outcome 
is binary variable of 
Fall either Yes or No.  
Hospitalizations, 
injuries and number of 
falls were collected but 
were not used in the 
analyses   
@90 days, 
consenting patients 
asked by CSRL 
24 

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Secondary 
Outcome 
Fatigue 
PROMIS Fatigue 
Instrument – Adult 
Short Form 4A 
@90 days, 
consenting patients 
asked by CSRL 
24 
Secondary 
Outcome 
Satisfaction with care 
Questions on how the 
patient felt about care 
and treatment from 
health care providers. 
@90 days, 
consenting patients 
asked by CSRL 
24 
Exploratory Aim 
Use of Community 
Resources 
By asking: “Since 
discharge from the 
hospital, have you used 
services such as Senior 
Services, Meals on 
Wheels, in-home aides, 
or stroke survivor or 
caregiver support 
groups?”  
@90 days, 
consenting patients 
asked by CSRL 
24 
Data collected to 
support the 
operations of the 
trial.  
Initial Presentation Data 
Hospital arrival and 
Mode of arrival, 
Ambulatory status 
prior to admission, 
Diagnosis at 
admission, NIHSS, 
Imaging performed, 
etc. 
Entered into the 
COMPASS 
Database by the 
hospital 
9 
Data collected to 
support the 
operations of the 
trial.  
 
Demographic Data 
DOB, Race, Gender, 
Insurance, Medical 
History, Medication , 
etc.  
Entered into the 
COMPASS 
Database by the 
hospital  
9 
Data collected to 
support the 
operations of the 
trial.  
t-PA Data 
Time t-PA was 
initiated, BP and 
Glucose levels, 
bleeding 
complications, etc.  
Entered into the 
COMPASS 
Database by the 
hospital 
9 
Data collected to 
support the 
operations of the 
trial.  
In-hospital Data 
Admission data, 
secondary prevention 
counseling, treatment, 
lipid profile, 
medications, 
treatments, etc. 
Entered into the 
COMPASS 
Database by the 
hospital 
9 
Data collected to 
support the 
operations of the 
trial.  
Discharge Data 
Resources and stroke 
education materials, 
assess for 
rehabilitation, 
ambulatory status, 
Rankin Score, final 
diagnosis, discharge 
disposition, ICD-10 
data, etc.  
Entered into the 
COMPASS 
Database by the 
hospital 
9 
 
 

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Patient Participant Study Outcomes (Phase 2):  
 
Measure 
Assessment(s) 
When Collected 
Appendix  
Ancillary Study  
General Heath and 
Function 
PROMIS Global-10   
@90 days, consenting 
patients asked by 
CSRL  
23 
 
 
 
 
 
 
 
 

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Caregiver Participant Study Outcomes (Phase 1 only): 
 
Measure 
Assessment(s) 
When Collected 
Appendix  
Secondary 
Outcome 
Caregiver Burden 
Modified Caregiver 
Strain Index 
@95 days, mailed to 
the caregiver   
27 
Data collected to 
support the 
operations of the 
trial. 
Relation to stroke 
patient 
Relation to stroke 
patient 
@95 days, mailed to 
the caregiver   
27 
Data collected to 
support the 
operations of the 
trial. 
Demographics 
Age, Gender, Race 
@95 days, mailed to 
the caregiver   
27 
Data collected to 
support the 
operations of the 
trial. 
Primary Caregiver 
Are you the primary 
caregiver 
@95 days, mailed to 
the caregiver   
27 
Data collected to 
support the 
operations of the 
trial. 
Length of Caregiving 
service 
How long have you 
been providing care? 
How many hours per 
day do you spend 
providing care? 
Do others help provide 
care? 
@95 days, mailed to 
the caregiver   
27 
Data collected to 
support the 
operations of the 
trial. 
Type of caregiving 
activities 
Type of caregiving 
activities 
@95 days, mailed to 
the caregiver   
27 
Data collected to 
support the 
operations of the 
trial. 
Awareness and use of 
Community Resources 
Awareness and use of 
Community Resources 
@95 days, mailed to 
the caregiver   
27 
Data collected to 
support the 
operations of the 
trial. 
Self-rated General 
Health 
Compared to others 
your age, how would 
you rate your health 
using a scale of 1 to 5, 
with 1 being “Poor” 
and 5 being 
“Excellent?” 
@95 days, mailed to 
the caregiver   
27 
Data collected to 
support the 
operations of the 
trial. 
Accessed the 
COMPASS Website 
Have you explored the 
information on the 
COMPASS website 
@95 days, mailed to 
the caregiver   
27 
 
 
 

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Study outcomes collected and linked to insurance claims data (Phase 1 & Phase 2): 
 
Measure 
Assessment(s) 
When Collected 
Appendix  
Secondary 
Outcome 
Readmissions 
30-day, 90-day and 1-
year all-cause 
readmission 
Approximately 1 year 
post-stroke in Phase 1  
This will be collected 
via Administrative 
Claims Data sets from 
Medicare, Medicaid,  
and Blue Cross Blue 
Shield 
Secondary 
Outcome 
Mortality 
Mortality 
Approximately 1 year 
post-stroke in Phase 1  
This will be collected 
via Administrative 
Claims Data sets from 
Medicare, Medicaid, 
and Blue Cross Blue 
Shield 
Secondary 
Outcome 
Emergency 
Department (ED) 
Visits 
Number of patient 
emergency department 
visits 
Approximately 1 year 
post-stroke in Phase 1  
This will be collected 
via Administrative 
Claims Data sets from 
Medicare, Medicaid, 
and Blue Cross Blue 
Shield 
Secondary 
Outcome 
Admissions to skilled 
nursing facilities and 
inpatient rehabilitation 
facilities  
Number of patient 
admissions and 
number of days in to 
skilled nursing 
facilities, and number 
of patient admissions 
to inpatient 
rehabilitation facilities 
Approximately 1 year 
post-stroke in Phase 1  
This will be collected 
via Administrative 
Claims Data sets from 
Medicare, Medicaid, 
and Blue Cross Blue 
Shield 
Secondary 
Outcome 
Use of transitional 
billing codes 
Use of Transitional 
Care Management 
(TCM) billing codes 
and Chronic Care 
Management (CCM) 
billing codes   
Approximately 1 year 
post-stroke in Phase 1  
This will be collected 
via Administrative 
Claims Data sets from 
Medicare, Medicaid,  
and Blue Cross Blue 
Shield 
 
 
 

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Clinical Data collection: 
 
We will collect clinical data to inform the patient’s individualized care plan that will be routine for implementing 
transitional care, and would like to keep this data for future analyses: 
 
Measure 
Assessment(s) 
When Collected 
Appendix  
Data collected to 
support the 
operations of the 
trial. 
Neurological Status and 
Deficits 
Post Stroke Advanced 
Practice Assessment  
 
7-14 Day Visit 
19 
Data collected to 
support the 
operations of the 
trial. 
Stroke Complications 
Post Stroke Advanced 
Practice Assessment  
7-14 Day Visit 
19 
Data collected to 
support the 
operations of the 
trial. 
Stroke Risk Factor 
Management 
Post Stroke Advanced 
Practice Assessment  
7-14 Day Visit 
19 
Data collected to 
support the 
operations of the 
trial. 
Lifestyle Coaching 
Post Stroke Advanced 
Practice Assessment  
7-14 Day Visit 
19 
Data collected to 
support the 
operations of the 
trial. 
Medication Access and 
Use 
Post Stroke Functional 
Assessment  
7-14 Day Visit 
17 
Data collected to 
support the 
operations of the 
trial. 
Knowledge of Stroke 
Risk Factors 
Post Stroke Functional 
Assessment  
7-14 Day Visit 
17 
Data collected to 
support the 
operations of the 
trial. 
Self-rated General 
Health 
Post Stroke Functional 
Assessment  
7-14 Day Visit 
17 
Data collected to 
support the 
operations of the 
trial. 
Mobility  
Post Stroke Functional 
Assessment  
7-14 Day Visit 
17 
Data collected to 
support the 
operations of the 
trial. 
Falls and 
Hospitalizations 
Post Stroke Functional 
Assessment  
7-14 Day Visit 
17 
Data collected to 
support the 
operations of the 
trial. 
Social and Caregiver 
Support 
Post Stroke Functional 
Assessment  
7-14 Day Visit 
17 
Data collected to 
support the 
operations of the 
trial. 
Activities of Daily 
Living 
Post Stroke Functional 
Assessment  
7-14 Day Visit 
17 
Data collected to 
support the 
operations of the 
trial. 
Home Health, 
Outpatient services 
Post Stroke Functional 
Assessment  
7-14 Day Visit 
17 

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Data collected to 
support the 
operations of the 
trial. 
Durable Medical 
Equipment 
Post Stroke Functional 
Assessment  
7-14 Day Visit 
17 
Data collected to 
support the 
operations of the 
trial. 
Living Will  
Post Stroke Functional 
Assessment  
7-14 Day Visit 
17 
Data collected to 
support the 
operations of the 
trial. 
Relation 
Caregiver Assessment 
7-14 Day Visit 
18 
Data collected to 
support the 
operations of the 
trial. 
Demographics 
Caregiver Assessment 
7-14 Day Visit 
18 
Data collected to 
support the 
operations of the 
trial. 
Caregiving activities 
Caregiver Assessment 
7-14 Day Visit 
18 
Data collected to 
support the 
operations of the 
trial. 
Self-rated General 
Health 
Caregiver Assessment 
7-14 Day Visit 
18 
Data collected to 
support the 
operations of the 
trial. 
Stress 
Caregiver Assessment 
7-14 Day Visit 
18 
Data collected to 
support the 
operations of the 
trial. 
Signs of a stroke 
Caregiver Assessment 
7-14 Day Visit 
18 
 
 
 

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Analytical Plan  
 
As described above, this pragmatic trial utilizes a cluster randomized design with 41 hospitals being randomized to 
receive the COMPASS intervention (N=20) or control (N=20) in Phase 1.  In Phase 2, the control group hospitals will be 
rolled into the intervention (Figure 1).  All stroke patients who are discharged directly home from one of the randomized 
hospitals will be included in the intention-to-treat analyses.  Analyses will be performed at the individual (patient) level, 
with adjustments for hospital and/or patient level characteristics to control for possible correlations of patients within 
hospitals. 
 
We used two stratification factors in randomization: annual stroke patient volume per hospital (3 levels: <100, 100-299, 
300+ patients) and whether the hospital is a primary stroke center (Yes/No).  Thus, there will be a total of 6 strata. We 
will use a random permuted block design with block size of two; within each stratum we will randomize an even number 
of hospitals.  This will allow us to maintain balance between the treatment groups while also protecting the validity of the 
randomization process. Study team involved with site selection will not have access to the randomization schedule which 
will be held by Dr. Walter Ambrosius.  Likewise, Dr. Ambrosius will not be involved in site selection. Although patients 
in the intervention cannot be blinded to their group assignment, interviewers gathering outcome data will be blinded.  Our 
estimated sample size will permit pre-specified subgroup analyses by race, gender, age, stroke severity and insurance 
status. 
 
For the primary aim, the primary endpoint is the Stroke Impact Scale (SIS-16) measured 90 days post-stroke. The 
secondary aims include the Modified Caregiver Strain Index at 90 days; 30- and 90-day all-cause readmissions; and 
mortality, health care utilization, continuity of care, utilization of transitional care, and medication adherence, all 
measured 1 year after index discharge. In addition, analyses by race, gender, age, stroke severity and insurance status will 
determine if there is evidence of heterogeneity of the intervention effect across any subgroups. Finally, for the two 
exploratory aims, we will (1) examine hospital-level measures of stroke care quality indicators in the COMPASS 
hospitals, and (2) compare administrative claims outcomes and post-acute stroke performance outcomes between 
COMPASS patients in Phase 1 (intervention phase) and Phase 2 (sustainability phase). 
 
Since the primary endpoint (SIS-16) is measured on a continuous scale, we will use a mixed model to compare the 
COMPASS and control groups. Although the stratified randomization of hospitals should balance most important 
hospital-level characteristics between groups, since imbalances may exist between groups on patient-level characteristics, 
we propose to include both fixed and random effects in this mixed model. The first model will include two fixed effects: 
stratum (1 to 6) and the intervention effect (COMPASS vs. control) and one random effect: hospital. This additive model 
can be written as: Yijk = μ + γk+αj + βk(j) + εi(jk),where Yijk is the outcome (i.e. SIS at 90 days) measured on the ith patient, 
under the jth intervention (j=1 (COMPASS), 2(Control) in the kth hospital; μ is the grand mean; γk is the stratum (1 to 6) 
for hospital k; αj is the fixed treatment effect for group j (COMPASS/CNT); βk(j) is the random effect of the kth hospital 
nested within the exposure group; and εi(jk) is the error term for the ith patient nested within the treatment group and 
hospital. Other fixed effects can be added at the patient level (e.g. age, gender, race, stroke severity, or SES) for sensitivity 
analyses. The random hospital effect allows the possibility of correlated observations (patients) within hospitals. Of 
primary interest is the treatment effect (αj), which indicates difference in the dependent variable (SIS-16) between groups. 
 
After we fit our primary model, we will consider other models that may include more patient-level and hospital-level 
characteristics. For instance, since some patients may be transferred to a different hospital before being discharged home, 
we can include a yes/no variable on that point. Although hospitals will be stratified pre-randomization based on stroke 
volume, we can include a hospital-level covariate for the total number of stroke patients discharged home for each 
hospital. With 40 clusters (of the 41 hospitals, 2 were randomized together) included, we will be able to add other cluster-
level covariates to the model if needed. 
 
For secondary aims and outcomes measured on a continuous scale, we will use a similar approach as above (i.e. for the 
Modified CSI). For binary outcomes such as whether a patient is readmitted within 30 or 90 days (Secondary Aim 2), we 
will use mixed logit models to fit the relationship between the intervention and outcome measures. The mixed logit model 
is similar to the mixed model presented above but uses a logit link in a generalized linear mixed model. Software is 

March 19, 2021 
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readily available (e.g., SAS PROC GLIMMIX) that can fit these models. The mixed logit model approach will also allow 
a mixture of fixed and random effects to be included as in the mixed model above. Other Secondary Aim 2 variables will 
be analyzed using a mixed model or alternatively generalized linear mixed models (e.g., Poisson regression [with 
overdispersion] for the number of inpatient days). 
 
We will examine 1-year mortality rates as a binary outcome and use the methods described above to compare groups, but 
we will also consider mortality as a time-to-event outcome and compare groups using Cox proportional hazards models. 
In these survival analysis models, the treatment indicator will be included as the primary independent variable and the 
stratum included as stratification factor. 
 
 
 

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Human Subjects Protection 
 
COMPASS is implementation of CMS recommendations for post hospital care coordination.  COMPASS is using a 
pragmatic, randomized controlled trial approach because it facilitates consistent delivery in post-acute stroke care 
management.  Hospitals are being asked to implement the COMPASS Intervention as a new standard of care for all stroke 
patients.  Because specific informed consent would not typically be sought in a clinical setting, stroke patients at the 
participating hospitals will not have the option to consent to (or opt out of) the site intervention.  It is unlikely that our 
study can seamlessly implement the new models of transitional care in routine clinical care delivery if the traditional 
informed-consent process for research participation is required.  COMPASS will incorporate an Integrated Consent Model 
for Pragmatic Trials.31 In this model, the “consent” will inform the patient that they are seeking care in a hospital that has 
been randomized to provide their usual standard of post hospital care or a hospital that is going to incorporate the 
COMPASS model of post hospital care.  This integrated consent model simply incorporates information about the hospital 
randomization process and whether their hospital is randomized to usual standard of care or the COMPASS intervention.   
 
A stroke coordinator (PAC), who is a hospital employee, will visit patients in the control sites and in the intervention sites 
prior to hospital discharge and provide patients with a tailored study brochure. The PAC will review the content of the 
informational brochure (Appendix 5 and Appendix 12) and inform patients that the hospital is participating in a statewide 
study to evaluate the best way to provide post-acute services after hospitalization for a stroke. The PAC will also inform 
the patient that there are many ways to care for patients after they leave the hospital and we are not sure which model is 
best. 
 
The PAC can answer any questions that the patient has regarding this conversation and provide their contact information, 
the COMPASS toll-free phone number and website as a reference for additional information.  For additional assurance, 
the study will ask PACs to document into the COMPASS Study data portal the date and time the patient was informed. 
The goal of this study is to capture all patients discharged directly home. In the event that a patient is discharged on a 
weekend or before the PAC is able to visit the patient, the PAC will make a call attempt to the patient to inform them of 
the hospital study and then the PAC will mail the brochure to the patient’s preferred mailing address. The PAC will also 
document in the COMPASS Study data portal that the patient was called and the brochure was mailed to the patient.   
 
Our protocol and process for consent reflects this integrated model. All enrolled stroke patients will be told that the 
hospital is enrolled in a state-wide initiative to evaluate and improve post-acute stroke care: 
 
Phase 1 & 2 - Consent for the Clinical Data (COMPASS Intervention Patients only at 7-14 Day APP Visit): A 
signed consent and HIPAA Authorization (collected on the iPad eCare Application or, if the PAC prefers, this can 
be conducted on paper) to use data collected from patient during clinical care for research purposes (i.e., to better 
understand recovery and factors that might influence response to the COMPASS intervention). 
 
Phase 1 & 2 - Consent for the 90 day phone survey for patients: A verbal consent over the phone, performed by 
the UNC Carolina Survey Research Laboratory.  COMPASS will rely on the Full HIPAA Waiver for this phone 
survey, however we have included in the 80 day reminder letter, information on HIPAA for the patient to make an 
informed decision on if they would like to participating in the phone survey. 
 
Phase 1 only - Consent for the 95 day paper survey mailed to caregivers: A returned, completed survey constitutes 
consent.  
 
Phase 1 & 2 - Consent for the Claims Data Analysis: A waiver of consent is requested as this activity (1) is low 
risk, (2) does not affect the right and welfare of patients, and (3) cannot be practically carried out without this 
waiver.   
 
Minimal/No Risk Intervention: Participation in the COMPASS study does not expose patients to any additional risks 
and therefor it is a minimal-risk or no-risk intervention.  The COMPASS model and intervention activities are not 
experimental.  COMPASS is evidence-based, and considered best practice for management of post-acute care.  CMS 
supports the delivery of these types of post-acute services and has implemented billing codes (TCM and CCM) to 
actualize implementation of these services.  Hospitals which participate in the COMPASS Study will be asked to 
implement at the hospital-level these evidence-based services into the systematic delivery of post-acute care to all stroke 
patients.  The COMPASS Study will determine effectiveness of this model on self-reported functional outcomes. 

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In order to minimize potential differences in loss to follow-up between the control and intervention groups we will send 
reminder letters (as described in the intervention section) to both control and intervention groups.  These letters will 
include resources from the American Stroke Association (ASA).  We will include a refrigerator magnet to remind them 
that we will call stroke survivors and survey caregivers at 90 days to assess outcomes.  
 
 
 

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Informed Consent 
 
As a pragmatic trial, our eligibility and outcomes assessment will 
include all patients discharged home from participating hospitals 
who are adopting the non-experimental, evidence-based 
intervention as the new model of care.  Our approach has been to 
minimize patient risk and maximize participation by providing an 
informational brochure to patients and their families during the 
hospital stay (or informing by mail), and allow them to opt out of 
the follow-up phone call at 90 days.   
 
Patients will not be asked for consent to participate at the hospital.  
It is unlikely that our study can seamlessly implement the new 
models of transitional care in routine clinical care delivery if the 
traditional informed-consent process for research participation is 
required.  COMPASS will incorporate an Integrated Consent Model 
for Pragmatic Trials.31  In addition, during focus groups, patient 
stakeholders informed us that this would not be the optimal time for 
informed consent.  Patients are often overwhelmed during the 
hospital stay as they are introduced to a large amount of new 
information in addition to processing the recent health event 
(stroke).  This was described during the focus group as an 
emotional and difficult time.  Patient stakeholders reported that they 
are asked to sign a lot of paperwork during the stay and at 
discharge.  According to our stakeholders, the process can be 
confusing.  The COMPASS Study team did not want to add 
additional burden on the patients and study staff to gain informed 
consent at the hospital for this low/no risk study.    
 
Figure 3 depicts the flow of Control (left and during Phase 1 only) 
and COMPASS Intervention (right during Phase 1 and 2) activities 
and how research activities are covered at each step (center). 
 
A HIPAA Waiver which is included as a part of this application is 
used to confirm eligibility, enrollment, and collect NCSCC Registry 
Stroke Card data, contact the participants with letters and surveys. 
 
Consent for the Clinical Data (COMPASS Intervention Arm 
only): At the 7-14 day APP visit, COMPASS participants will be 
asked for written informed consent and HIPAA Authorization for 
the study to keep clinical data (2 day phone call, 7-14 day visit, 30 
day phone call and 60 day phone call) for future analyses (e.g. 
follow-up with recommendations for care, demographic and clinical 
factors that predict follow up and outcomes in the intervention 
arm).  The post-acute coordinator will ask for informed consent and 
will use the eCare Application on the iPad to capture signature. The 
abbreviated consent and HIPAA Authorization contains the 
following elements of informed consent: the purpose of the study; 
the types of clinical data that will be captured and analyzed; 
explaining how information the patient provides will be used; data 
will be kept confidential and secure and will abide to HIPAA regulations; a reminder that providing consent is voluntary; 
identification of funding agency, study PI, and institution; contact information should the patient want to withdraw 
Figure 3: HIPAA Waiver and Consent of COMPASS  

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(Appendix 21).  Patient will use his/her finger to sign and date on the iPad for capture of written signature.  (A paper 
version of the consent form is also available.) The PAC who will be conducting the consent process will also sign and 
date.  A hard copy of consent script will be printed out for the patient to take with them.  If the patient declines consent, 
this will also be noted.  In order to not disrupt the clinical work-flow, consent will be collected during the visit either in-
between assessments or at the end of the visit. 
 
Consent for the 90 Day Phone Survey for Patients (All Patients): All stroke patients (or representing proxies) will 
consent to (or decline) participation in the survey of outcomes. COMPASS will rely on the Full HIPAA Waiver for this 
phone survey, however we have included in the 80 day reminder letter, information on HIPAA for the patient to make an 
informed decision on if they would like to participating in the phone survey. Verbal consent at the introduction of the 
telephone survey should adequately protect the individuals’ rights of patient participants.  Study-eligible patients are 
discharged home, and thus proxy support is unlikely to be needed.  If the patient prefers a proxy to complete the survey, 
the patient can ask the proxy to support them in responding.  We will record whether the data are provided by the proxy or 
the patient. 
 
Consent for the 95 Day Paper Survey Mailed to Caregivers (All Caregivers): Caregivers will be asked to respond to a 
paper survey questionnaire.  This questionnaire does not have any questions about the patient, therefore we are not asking 
for permission from patients to send this survey to caregivers.  Response to the questionnaire will be considered consent 
and HIPAA Authorization to participate in the study.   
 
Consent for the Claims Data Analysis (All Patients): We will acquire claims data sets using a HIPAA waiver.  We will 
link patient data collected at study enrollment (this data collected is under a HIPAA Waiver) to the claims data.  A waiver 
of consent is requested and included in this application as this activity (1) is low risk, (2) does not affect the right and 
welfare of patients, and (3) cannot be practically carried out without this waiver.  
 
Consent for Engagement Activities:  Consent for research-related engagement activities (i.e. focus groups) will be 
covered under separate IRBs (PCORI Stakeholder Interviews: IRB00028495; Appendix 31). 
 
Consent for Implementation Analysis (Phase 1 only):  Additional detail to this study activity is provided in Appendix 
33. 
We will be asking participating staff at implementing sites (approximately 20 PACs, 40 therapy providers and COMPASS 
team members) to agree to have their responses on the Bi-weekly Implementation Calls and surveys recorded and 
transcribed and analyzed to better understand the process of implementing the COMPASS Care Model:   
 
Some of these calls and surveys have been previously recorded because our sites started launching in June 2016 
and the funding for the CTSI Implementation Analysis will not start until April 2017.  Retrospective recordings of 
the calls will be covered under a Waiver of Consent granted by the IRB as this is low-risk to the call participants, 
this data is needed to run this research analysis and because gaining consent would be difficult considering that 
there has been some staff turnover at some of our participating sites.  
 
For any future calls and surveys we will gain consent of participants by informing them that the (1) the call/survey 
is being recorded and (2) responses may be used for research to analyze implementation of COMPASS program, 
and (3) responses will be aggregated to maintain confidentiality (meaning any identifying information will be 
removed prior to publicly using any responses/data).  This will re quire Waiver of Signature since by participating 
they are providing implicit consent.  
We will also be asking study staff COMPASS Director of Implementation and members of the Implementation 
Committee for individual semi-structured interviews for which we will gain verbal approval.  We estimate that we will 
interview her for 3 hours.  For her time, we will offer compensation of $200 for her participation in this research.  
 
 
 
 
 

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Confidentiality and Privacy 
Overview  
The Principal Investigators and Co-Investigators will ensure the privacy and confidentiality of all study data. All 
COMPASS Study Investigators and team members are required to complete a yearly HIPAA training and will have 
research training from CITI (or its equivalent research training).   
 
High-levels of security have been put in place to ensure confidential and secure collection, storage and transfer of data.  
Patient-level data will be stored on secure servers in four different locations, three of which are at UNC-CH and one at 
Wake Forest Baptist Health:   
1. COMPASS Analytic Database housed by (UNC-CH) EMS Performance and Improvement Center (EMSPIC)   
2. COMPASS eCare Plan Informatics Database housed by Wake Forest Baptist Medical Center (WFBMC)  
3. Carolina Survey Research Lab (UNC-CH) will temporarily store data that is needed to conduct the phone surveys 
and send reminder letters.   
4. Sheps Center (UNC-CH) will support COMPASS and house claims data.   
 
The sections below describe the information technology protections put in place to ensure security of all patient-level data 
at all times in each database. 
 
COMPASS Analytic Database at EMSPIC  
All COMPASS participants will be assigned a unique participant ID that will be used to link participant records and 
identify participants within the database.  Only key study investigators, team members and clinicians will have access to 
the identity of participants.  
 
A comprehensive Data Use Agreement governs the use of the data collected and stored by the UNC EMS Performance 
and Improvement Center (EMSPIC) for research purposes.  
 
Data security is achieved through storage in a secure data center (Peak10), data inspection and monitoring (StillSecure), 
and complex application security.  Access to COMPASS data will require three levels of security: a badge and security 
code to enter EMSPIC, a badge and fingerprint scan to access the data center, and a security code for each data rack. All 
outside access to servers and databases must be accomplished through a Virtual Private Network (VPN). All EMSPIC 
applications use a strong and sophisticated security module, which restricts access based on entity assignments, and 
security rights monitored by EMSPIC staff. All applications are only accessible via Hypertext Transfer Protocol Secure 
(HTTPS). HTTPS is a layering of the standard internet protocol (HTTP) onto an SSL (Secure Sockets Layer) protocol. 
This results in bidirectional encryption of communications between the client and server and serves as reasonable security 
against eavesdropping on or tampering with the contents of that communication. The HTTPS protocol will be used for all 
application through SSL hardware encryption and signed by an accepted root certificate authority.  
 
EMSPIC does not allow the use of portable storage devices and unencrypted data will never be stored on flash drives, 
external hard disks, or laptops. All applications developed at the EMSPIC prevent SQL Injection attacks from occurring 
by isolating all form data by escaping incoming string data. 
 
Electronic Care (eCare) Plan Informatics Database  
The COMPASS eCare Plan Application is a secure web-based application created by a HIPAA-trained programming team 
at Wake Forest Baptist Medical Center to capture intervention-related data.  As described in the intervention section, the 
eCare Plan Application supports health care providers in efficiently and systematically evaluating patients and identifying 
next steps for referrals.  Data collected into this application will be used to support providers in creation of an 
individualized care plan (eCare Plan) for patients and generate referral note(s) to other providers (if needed).   
 

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The eCare Plan Application is a secure application utilizing TLS level security (a more secure version of SSL).  
Communication and data transfer between the user's device (iPad, Desktop, Laptop) and eCare Plan Application are 
encrypted at all times.  To access the eCare Plan Application, health care providers must user-authenticate into the 
COMPASS portal.  The eCare Plan Application will employ role-based security which will limit users access to only 
information they were authorized to access. .  Users will be asked to change their password regularly.  Data will not be 
stored locally on any devices to minimize the risk associated with any lost or stolen devices.  
 
The eCare Plan Informatics Database is part of a SQL Server relational data warehouse which is housed in the Wake 
Forest Health Sciences A1a data center on 3rd Street in Winston-Salem, NC.  The webserver hosting the eCare Plan 
Application is also hosted in the A1a data center.  The webserver is a virtual server so in the event of disaster or 
unexpected significant and lengthy interruption, we can migrate the server into a second data center on Miller St in 
Winston-Salem, NC.  The servers are contained within a secure data center with environmental controls which detect 
abnormal conditions such as power outages, high heat or humidity, and loud sound.  The A1a data center has several 
secure access points that are accessible only by a badge reader.  Only authorized staff will have access to these areas.  The 
building is surrounded by a 10-foot fence with a gate access through badge control.  The outside building door is accessed 
through badge control.  The data center room is housed in a locked computer room that is accessed through badge control.  
Each of these access controls is in place 24 hours a day and seven days a week.  All servers have uninterruptible power 
supplies (UPS).  The building has a backup generator that will automatically initiate in the event of a power failure.  The 
computer room is equipped with fire suppression equipment.  This equipment is tested on a scheduled timetable by the 
institution.  The entire Data Center is fire- protected by a clean agent system which is backed up by a dry-pipe pre-action 
sprinkler system.  The Data Center room is located on the second floor of the building in an area with no windows and has 
a raised floor to protect against flooding. 
 
Carolina Survey Research Lab Database and Security 
Staff at the CSRL must complete training on Human Subjects Protection, Conflict of Interest, and sign a Confidentiality 
Agreement.  The team is provided a wide variety of computing resources for data collection, statistical computing, and 
office automation.  Staff members and research assistants are provided with a Pentium class microcomputer running 
Windows 7 and Microsoft Office Professional, as well as SAS 9.3 and SUDAAN 10.0 for statistical analysis, virus 
detection software, and a wide variety of other standard microcomputer software.   
 
CSRL computers communicate securely through the UNC- ITS systems for Internet communications and for access to 
secure files which have automatic back-up.  All sensitive information is hosted on a server that meets the University 
Information Security policy (http://its.unc.edu/files/2014/08/Information-Security-Policy.pdf).  This policy includes, but is 
not limited to, the following configurations: host based and network based firewalls, least functionality, least privileged, 
weekly vulnerability scans, secure backup (located in a separate location on campus), secured physical access, password 
enforcement policy, warning banner, incident management plan, monitored malware protection, and patch management. 
 
CSRL manages information in a variety of forms including paper, diskettes, and electronic databases.  The CSRL 
maintains a secure file room in an interior room within a suite for the storage of original paper forms and sensitive data on 
diskettes.  This room is locked at all times and only select staff have access to it.  For electronic databases, the CSRL 
employs two servers: (1) data collection machines, which may collect personal identifiers, are protected on a server 
behind a physical firewall that is cut-off from the Internet; and (2) data analysis machines have access to a server that 
stores de-identified data; that is, data collected through the calling room machines that have been stripped of any potential 
identifiers. 
 
To facilitate surveys, patient and caregiver names, phone numbers and addresses, date of hospital discharge, preferred day 
and time of contact, as well as PAC information will be exported as a CSV file from the Analytic Database.  This file will 
be stored on a secure server (\\cecil.schsr.unc.edu) and accessed by staff at CSRL for pre-loading into their phone system 
once per week. All access to this secure server will only be granted through UNC secure VPN. 
 

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Trained and approved staff at CSRL will have access to COMPASS Analytic Database to record responses and avoid 
storing patient level-data in a database outside of the primary COMPASS database.   
 
Sheps Center Data Security 
The Sheps Center will be housing administrative claims data and the server to which EMSPIC and CSRL will post their 
shared files. Claims data files at the Sheps Center are placed on a secure dataset server configured specifically to handle 
large-scale health utilization data.  Each data file has access restricted to those users authorized by the relevant DUA.  The 
primary dataset directories on the dataset server provide one inventory of our current claims data files.  Disk-to-disk 
backups of claims data files on our dedicated dataset server are made nightly to two separate backup servers at two 
different Data Center locations on the UNC campus.   
 
Claims data files are housed on a dedicated secure dataset server configured specifically for sensitive health utilization 
data. The server is physically located in a Tier II data center at 440 W Franklin St, Chapel Hill as part of the UNC 
campus. These facilities have 24x7 surveillance, multiple power sources and backup power sources, climate control, etc. 
Our systems administrators get access via electronic pass cards. Each card entry gets recorded with time/date stamps in 
facility access logs. The dataset server is behind a firewall, accessible only to Sheps Center IP addresses and UNC Secure 
VPN addresses. There is no printer attached to the dataset server.  Only aggregated (anonymized) data and SAS output are 
taken off the server and onto local computers. 
 
The server is a Linux (RedHat enterprise) server with all unneeded services disabled. Access to the claims data on the 
Sheps Dataset Server will be restricted to users authorized by the PI. The server is routinely patched with system updates 
and receives twice-weekly vulnerability scans using Qualys. Identified vulnerabilities are addressed according to UNC 
Security Policy. Access to the server is via SSH. Off campus access is restricted to UNC VPN connections requiring a 
user to authenticate with VPN before server login. VPN also provides an encrypted tunnel. SAS and Stata are typical data 
programs used.  
 
The Sheps Center makes two daily disk-to-disk backups of the secure dataset server.  One backup goes to a dedicated 
backup server within the same Tier II data center at 440 W Franklin.  The second goes to a second dedicated backup 
server at a second Tier II data center located across town at 211 Manning Drive, Chapel Hill.  The backup data travel via 
an SSH tunnel over the same VLAN within the UNC campus firewalls.  Both backup servers are behind a firewall 
denying the ability of other computers or servers to initiate a connection to the backup servers.  Instead, the backup 
servers reach out to the secure dataset server and “pull” the backup data over.   
 
The hard drives and CDs on which data have been delivered will be stored in a locked cabinet at the Sheps Center. Only 
authorized staff will have keys to the cabinet.  The office will be locked when not occupied. In addition, the Sheps Center 
is locked 24 hours a day.   
 
User level access to claims data files is restricted based on authorized roles. Unix groups are leveraged to provide layered 
controls.  Users may access the data in the following ways:  
1. Using a computer that is on the UNC Active Directory domain and is managed by UNC ITS security tools that 
perform required scans for viruses and malware and force updated software and operating system patches. Users 
with this type of computer (desktop or laptop) can access the server directly from campus or via a remote VPN 
using SSH.  
2. Using a computer not managed by UNC ITS security tools via a specifically designated secured UNC Virtual 
Computer (virtual computing lab), which connects to the server.  This virtual desktop is setup, maintained, and 
managed by Sheps Center sys admins.  At the end of a working session, the virtual computer is destroyed along 
with any data that may have been used locally in the virtual computer instance. 
 
Logical access is safeguarded at multiple levels: 
1. The claims data files will be housed on a dedicated secure dataset server configured specifically for sensitive 
health utilization data. The server is physically located in a Tier II data center at 440 W Franklin St, Chapel Hill, 

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an extension of the UNC campus. These facilities are governed by the UNC ITS Data Center Operations policies 
and procedures.  They have 24x7 surveillance, required visitor sign-in with escorts, multiple power sources and 
backup power sources, climate control, etc. Our systems administrators get access via electronic pass cards. Each 
card entry gets recorded with time/date stamps in facility access logs.  While other sys admins of ITS have access 
to the same physical space where our server racks are housed, these are trusted people governed by central 
campus ITS policies and procedures.  Also, the Data Center space has logged entry of individuals and is under 
constant surveillance where any unauthorized physical access would be monitored and recorded.  Significant 
sanctions are known and apply, up to and including job termination and possible criminal prosecution. 
2. The designated server is firewalled allowing only SSH port 22 to be open. All unnecessary ports are closed and all 
unnecessary services are disabled. User level access to files is restricted based on authorized roles. SSH 
connections are limited to UNC subnets and UNC VPN addresses. Access to the designated secure dataset server 
is restricted to computers within the UNC network domain.  Connections originating outside the UNC network 
are restricted to UNC VPN authentication first and then system-level user/pw authentication. Users may only 
connect using SSH and Kerberos authentication leveraging the UNC Single Sign-on policies and procedures. 
3. Nightly secure backups are performed to two dedicated backup servers – one backup within the same data center 
within the firewalled subnet and the second backup in another data center across town via the same VLAN.  The 
original CMS data is not backed up to tape but instead the delivery media is kept for backup, if needed. In case of 
(a) data center disaster, or (b) backup failure, a second backup computer is housed in a second campus data center. 
Two system administrator computers are allowed to connect to backup servers to control them. Firewall prevents 
all other computers from reaching backup servers. Backup computers initiate the network connections to the 
server. It is not possible for any user to initiate a connection to a backup server from the main server or from any 
other computer except for those owned by two system administrators. All network connections are encrypted. 
4. The designated server is kept up-to-date with recommended operating system patches and patches for 
applications. The server is scanned twice weekly for vulnerabilities using the UNC licensed QualysGuard SaaS 
software. System administrators monitor event logs, security logs, and system logs.  UNC uses Snort for intrusion 
detection and Tipping Point for intrusion prevention.  These systems/appliances are monitored and handled 
centrally by the UNC ITS Security Office.  Suspicious activity is reported to the Sheps Center’s Security Liaison 
for investigation and handling with assistance from the central ITS Security Office.  If these data will be delivered 
via CD or hard drive, the media will be kept in a locked storage location provided by the project, with key access 
only to research team members.  
5. Project staff at the Sheps Center will access the secure dataset server via SSH using computers physically in the 
Sheps Center Building.  The Sheps Center Building’s exterior doors are locked 24x7.  Individual offices inside the 
Sheps Center are also locked.  Staff enter using an authorized key.  Visitors must be buzzed in using a video 
intercom system and then must report to the receptionist and sign in.  There are no servers physically located in 
the Sheps Center Building.   
 
 
Description of the Secure Data Transfers  
Secure Data Transfer between the COMPASS DB and eCare Plan Informatics (eCPI) DB 
Data transfer between the COMPASS Database and the eCPI Database will be via RESTful web services designed 
specifically for the limited datasets being exchanged. Secure data transfer protocols will be in place to provide fully 
encrypted transmissions.  The eCare Application may retrieve and update patient data from the COMPASS Database (the 
database of record for patient data) for use during a patient visit in order to foster the use of that data in creating an eCare 
Plan.  Patient data is requested based on key identifiers and the resulting match reflected in the eCare application.  The 
web service will allow for the transmission of data stored in the eCPI database to the COMPASS Database for use in 
analysis as well as patient status updates and notifications to appropriate study personnel.  The eCare database remains the 
database of record for those intervention data while making the COMPASS DB and associated application aware of the 
analytical data needed for the study.  The eCare application will contain the logic necessary during the flow of its data 
collection to validate data with the patient as well as prevent implausible and/or out-of-range responses. 
 
 

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Secure Data Transfer between COMPASS DB and CSRL 
As described above, to facilitate surveys, patient and caregiver names, phone numbers and addresses, date of hospital 
discharge, preferred day and time of contact, as well as PAC information will be exported as a CSV file from the Analytic 
Database.  This file will be stored on a secure server (\\cecil.schsr.unc.edu) and accessed by staff at CSRL for pre-loading 
into their phone system once per week. 
 
 
Data Access for Analysis 
We have in place secure operations for sharing SAS datasets between investigators to ensure safety and confidentiality of 
patients.  Datasets will be stored on a secure server that is accessed through a virtual network.  Study investigators will be 
granted access to this server for running data reports and analyses of the study data.  These internal datasets will contain 
the COMPASS Unique participant IDs to link data in different files together.  PHI (including date of birth, medical record 
number, names, addresses, phone numbers, and email addresses) will be removed from datasets prior to export of these 
SAS datasets from the COMPASS Database.   Data sharing with investigators outside of UNC will occur through data 
transfers using secure File Transfer Protocols. 
 
 
REDCap (Research Electronic Data Capture) 
COMPASS Study will use REDCap at Wake Forest Baptist Medical Center to store responses from hospital stakeholders 
and track stakeholder engagement activities.   
 
Vanderbilt University, with collaboration from a consortium of institutional partners, has developed a software toolset and 
workflow methodology for electronic collection and management of research and clinical trial data.  REDCap (Research 
Electronic Data Capture) is hosted at Wake Forest Baptist Medical Center through the Biomedical Informatics program of 
the Translational Science Institute.  REDCap servers are located within the Wake Forest Baptist Health firewall and all 
web-based information transmission is SSL (Secure Socket Layer) encrypted; the databases are backed up nightly through 
the institution’s enterprise backup system.  Users are granted access to the system using their unique medical center 
username and password with specific access rights setup for each study.  REDCap was developed specifically around 
HIPAA-Security guidelines and is used by 1,000+ academic/non-profit consortium partners on six continents with over 
195,000 research end-users (www.project-redcap.org). 
 
 
 
 
 

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Data and Safety Monitoring 
The COMPASS Data and Safety Monitoring Board (DSMB) will serve to support as an independent review board of the 
study and study activities to protect patients.  Adverse events among this patient population are likely; however because 
COMPASS is a minimal/no risk study, COMPASS will not be tracking adverse events.  Therefore the COMPASS DSMB 
will provide thrice-annual review of study activities providing external review and assurance on the performance of the 
study.  This thrice-annual review will include case ascertainment and enrollment; expected versus observed outcomes; 
review of percentage of participants in the intervention receiving the 2-day call, the 7-14 day visit, the eCare Plan; and 
review of protocol deviations.   
 
To avoid any appearance of conflict of interest, it is critical that DSMB members not be involved in the study, have no 
vested interest in its outcome, have no ties to the study investigators (e.g., not from the same institution and no history of 
extensive collaboration), and have no financial ties to any commercial concerns likely to be affected by the study's 
outcome. If at any time a DSMB member perceives that he/she or another member of the Board has a potential conflict of 
interest, he/she is obligated to bring the issue to the attention of the full DSMB for open discussion and resolution. 
Responsibilities 
1. COMPASS DSMB members will be responsible for assuring study participants are not exposed to unnecessary, 
unreasonable or unexpected risk, and is charged with ensuring that the study is conducted according to the highest 
scientific and ethical standards.  
2. Specifically, oversight will include the following areas:  
 
Review of the COMPASS Manual of Operations and Procedures (MOP), the analysis plan, and 
implementation of the study procedures at the first DSMB meeting. 
 
Review of study protocol including our informed consent processes. 
 
The DSMB may recommend modifications or request clarifications of the protocol. 
 
Review of the study outcomes and their clear definition, study procedures, informed consent documents, data 
security, and investigator responsibilities. 
 
In subsequent meetings, the DSMB will focus on case ascertainment and enrollment; expected versus 
observed outcomes; review of percentage of participants in the intervention receiving the 2-day call, the 7-14 
day visit, the eCare Plan; and review of protocol deviations.   
 
Any other areas the DSMB considers oversight to be necessary. 
Frequency of Meetings and Communication between DSMB and COMPASS 
COMPASS DSMB members will meet annually.  The first meeting will take place in person, in early 2016.  Subsequent 
meetings will take place remotely over webinar. Meetings will be closed to the public.  Only DSMB members and 
members of the COMPASS Executive Leadership Committee will attend.  ELC members will prepare in advance a 
DSMB report for review (Appendix 32). Each meeting will start with discussion between COMPASS Executive 
Leadership Team and DSMB and then the DSMB will meet privately without study personnel.   
 
At the end of each annual meeting, the DSMB will provide a verbal report to the Executive Leadership Team noting any 
areas of concern in study performance and/or operations. Care will be exercised to ensure no information will be 
conveyed that could compromise the study or its outcomes. Within two weeks, the DSMB Chair will provide a written 
report to PCORI and the Executive Leadership Team, which includes the DSMB recommendation for continuing, 
discontinuing, amending, or suspending the study.  This written report will cover data reviewed, recommendations, and 
date of the next scheduled review. This report will be forwarded by the PIs to the Central IRB at Wake Forest Medical 
Center and the Data Coordination IRB at the University of North Carolina and PCORI. 
 
Membership 
The process for identifying the DSMB included feedback from PCORI, recommendations from the Steering Committee 
and vetting by the Executive Leadership Committee (ELC). The ELC reviewed each recommendation and consulted with 
PCORI for additional guidance and input on the final selection of DSMB members.  Once DSBM members were 

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approved by the ELC, the Project Manager sent out a formal letter to the proposed DSMB members inviting them to 
serve.  COMPASS DSMB members include: 
DSMB Chair: 
1. Jason Conner, PhD – Director and Senior Statistical Scientist for Berry Consultants.  Dr. Connor has expertise in 
Bayesian statistics and designing adaptive clinical trials.  He serves on the Clinical Trials Advisory Panel (CTAP) for 
PCORI.  Dr. Connor has accepted to serve as a DSMB member.   
DSMB Members: 
2. Judy Lichtman, PhD, MPH – Chair, Chronic Disease Epidemiology, Yale University.  Dr. Lichtman focuses on stroke 
research and is experienced in outcomes research, quality improvement and CMS data linkage.  Dr. Lichtman has 
accepted to serve as a DSMB member.   
3. Brett Kissela, MD – Chair of Department of Neurology and Rehabilitation Medicine at the University of Cincinnati 
(UC) College of Medicine and UC Health.  Dr. Kissela is a stroke neurologist and stroke researcher.  Dr. Kissela has 
accepted to serve as a DSMB member.   
4. Theresa Damush, PhD – Associate Research Professor of Medicine, Indiana University School of Medicine.  Dr. 
Damush is a research health psychologist focusing on implementing evidence-based practices for stroke survivors and 
caregivers.  She specializes in the design and evaluation of patient centered programs. Dr. Damush has accepted to 
serve as a DSMB member.   
 
Reporting of Unanticipated Problems or Deviations 
Any unanticipated problems, deviations or protocol changes will be promptly (within 10 days) reported by the principal 
investigator or designated member of the research team to the IRB and sponsor or appropriate government agency if 
appropriate. 
 
This study is not collecting or reporting adverse events.  
 
System-Level Protocol Deviations include:  
 
Loss of participating site (i.e. a hospital drops out of the study). 
 
Change of personnel or study staff at the hospital without notifying the COMPASS Team of change of study 
personnel.   
 
Patient-level Protocol Deviations include: 
 
Not notifying enrolled patients that the hospital is participating in the COMPASS Study by either (1) providing 
the COMPASS brochure packet to the patient prior to discharge or (2) mailing the patient brochure (if the patient 
is discharged before study staff can inform the patient). 
 
For Intervention-randomized sites conducting the consent:  Consent needs to be conducted by research trained 
study staff or clinicians. 
 
Study-Level Deviations include:  
 
Including any patient participants in analysis (for research purposes) if they have not provided consent and 
authorization according to our outlined protocols and our “consent matrix” (Appendix 39). 
 
 
 
 

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References 
 
1. American Heart Assosiation. Heart Disease and Stroke Statistics—2015 Update. Circulation. 2015;131:e29–e322. 
2. Bertoni AG, Ensley D, Goff DC. 30,000 fewer heart attacks and strokes in North Carolina: a challenge to 
prioritize prevention. N. C. Med. J. 2012;73:449–456. 
3. Kennedy BS. Does race predict stroke readmission? An analysis using the truncated negative binomial model. J. 
Natl. Med. Assoc. 2005;97:699–713. 
4. Centers for Medicare and Medicaid Services. Chronic Conditions among Medicare Beneficiaries. Baltimore, MD: 
2012. 
5. Olson DM, Cox M, Pan W, Sacco RL, Fonarow GC, Zorowitz R, LaBresh KA, Schwamm LH, Williams L, 
Goldstein LB, Bushnell CD, Peterson ED. Death and Rehospitalization after Transient Ischemic Attack or Acute 
Ischemic Stroke: One-year Outcomes from the Adherence Evaluation of Acute Ischemic Stroke–Longitudinal 
Registry. J. Stroke Cerebrovasc. Dis. 2013;22:e181–e188. 
6. Fonarow G, Smith E, Reeves M, Pan W, Olson D, Hernandez A, Peterson E, Schwamm L. Hospital-level 
variation in mortality and rehospitalization for Medicare beneficiaries with acute ischemic stroke. Stroke. 
2011;42:159–166. 
7. Rosamond W, Johnson A, Bennett P, O’Brien E, Mettam L, Jones S, Coleman S. Monitoring and improving acute 
stroke care: The North Carolina Stroke Care Collaborative. N. C. Med. J. 2012;73:494–498. 
8. Bernhardt J, Dewey H, Thrift A, Donnan G. Inactive and Alone Physical Activity Within the First 14 Days of 
Acute Stroke Unit Care. Stroke. 2004;35:1005–1009. 
9. Bamford J, Dennis M, Sandercock P, Burn J, Warlow C. The frequency, causes and timing of death within 30 
days of a first stroke: the Oxfordshire Community Stroke Project. J. Neurol. Neurosurg. Psychiatry. 1990;53:824–
829. 
10. Johnston KC, Li JY, Lyden PD, Hanson SK, Feasby TE, Adams RJ, Faught RE, Haley EC. Medical and 
Neurological Complications of Ischemic Stroke Experience From the RANTTAS Trial. Stroke. 1998;29:447–453. 
11. Whitson HE, Pieper CF, Sanders L, Horner RD, Duncan PW, Lyles KW. Adding injury to insult: fracture risk 
after stroke in veterans. J. Am. Geriatr. Soc. 2006;54:1082–1088. 
12. Davenport RJ, Dennis MS, Wellwood I, Warlow CP. Complications after acute stroke. Stroke J. Cereb. Circ. 
1996;27:415–420. 
13. White JH, Attia J, Sturm J, Carter G, Magin P. Predictors of depression and anxiety in community dwelling stroke 
survivors: a cohort study. Disabil. Rehabil. 2014;:1–8. 
14. Husseini NE, Goldstein LB, Peterson ED, Zhao X, Pan W, Olson DM, Zimmer LO, Williams JW, Bushnell C, 
Laskowitz DT. Depression and Antidepressant Use After Stroke and Transient Ischemic Attack. Stroke. 
2012;43:1609–1616. 
15. Kelly J, Rudd A, Lewis RR, Coshall C, Moody A, Hunt BJ. Venous Thromboembolism After Acute Ischemic 
Stroke A Prospective Study Using Magnetic Resonance Direct Thrombus Imaging. Stroke. 2004;35:2320–2325. 
16. Lai S-M, Studenski S, Duncan PW, Perera S. Persisting Consequences of Stroke Measured by the Stroke Impact 
Scale. Stroke. 2002;33:1840–1844. 
17. Bushnell CD, Zimmer LO, Pan W, et al. Persistence with stroke prevention medications 3 months after 
hospitalization. Arch. Neurol. 2010;67:1456–1463. 
18. Kopunek SP, Michael KM, Shaughnessy M, Resnick B, Nahm E-S, Whitall J, Goldberg A, Macko RF. 
Cardiovascular Risk in Survivors of Stroke. Am. J. Prev. Med. 2007;32:408–412. 
19. Rigby H, Gubitz G, Eskes G, Reidy Y, Christian C, Grover V, Phillips S. Caring for stroke survivors: baseline 
and 1-year determinants of caregiver burden. Int. J. Stroke Off. J. Int. Stroke Soc. 2009;4:152–158. 
20. Rigby H, Gubitz G, Phillips S. A systematic review of caregiver burden following stroke. Int. J. Stroke. 
2009;4:285–292. 
21. Prvu Bettger J, Alexander KP, Dolor RJ, Olson DM, Kendrick AS, Wing L, Coeytaux RR, Graffagnino C, 
Duncan PW. Transitional Care After Hospitalization for Acute Stroke or Myocardial InfarctionA Systematic 
Review. Ann. Intern. Med. 2012;157:407–416. 
22. Fearon P, Langhorne P, Early Supported Discharge Trialists. Services for reducing duration of hospital care for 
acute stroke patients. Cochrane Database Syst. Rev. 2012;9:CD000443. 

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23. Langhorne P, Taylor G, Murray G, Dennis M, Anderson C, Bautz-Holter E, Dey P, Indredavik B, Mayo N, Power 
M, Rodgers H, Morten Ronning O, Rudd A, Suwanwela N, Widen-Holmqvist L, Wolfe C. Early supported 
discharge services for stroke patients: a meta-analysis of individual patients’ data. Lancet. 2005;365:501–506. 
24. Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, Fang MC, Fisher M, Furie 
KL, Heck DV, Johnston SC (Clay), Kasner SE, Kittner SJ, Mitchell PH, Rich MW, Richardson D, Schwamm LH, 
Wilson JA. Guidelines for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack A 
Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. 
Stroke. 2014;:STR.0000000000000024. 
25. Teasell R. Evidence-Based Review of Stroke Rehabilitation [Internet]. [cited 2014 Jun 14];Available from: 
http://www.ebrsr.com/ 
26. Legg LA, Quinn TJ, Mahmood F, Weir CJ, Tierney J, Stott DJ, Smith LN, Langhorne P. Non-pharmacological 
interventions for caregivers of stroke survivors. Cochrane Database Syst. Rev. 2011;:CD008179. 
27. Forster A, Brown L, Smith J, House A, Knapp P, Wright JJ, Young J. Information provision for stroke patients 
and their caregivers. Cochrane Database Syst. Rev. 2012;11:CD001919. 
28. Salter K, Allen L, Richardson M, Teasell R. Community Reintegration [Internet]. EBRSR.COM; 2013. Available 
from: http://www.ebrsr.com/sites/default/files/Chapter19_Community-reintegration_FINAL_16ed.pdf  
29. Tu J, Willison D, Silver F, Fang J, Richards J, Laupacis A, Kapral M. Impracticability of informed consent in the 
Registry of the Canadian Stroke Network. New Engl J Med. 2004;350:1414–1421. 
30. Centers for Medicare & Medicaid Services. Hospital Compare Datasets. [https://data.medicare.gov/data/hospital-
compare] 
31. Kim, SYH and Miller FG. Informed Consent for Pragmatic Trials — The Integrated Consent Model. N Engl J 
Med 2014; 370:769-772 
 
 

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Appendices 
 
 

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Appendix 1 - COMPASS Hospital Characteristics  
In order to provide additional details on hospitals that the COMPASS Study is recruiting to participate, we have prepared 
a side-by-side comparison of the COMPASS Hospitals we expect to randomize with All North Carolina Hospitals (Table 
1).  We gathered the comparison data from the publicly reported CMS Hospital Compare Information (CMS. Hospital 
Compare Datasets: https://data.medicare.gov/data/hospital-compare). 
 
For each of the hospitals that we expect to randomize, we have generated Table 2 which provides additional details on the 
percentage of hospitals that are a Primary Stroke Center (PSC) or a Certified Stroke Center (CSC) and annual stroke 
volume.  This data comes from our North Carolina Stroke Care Collaborative (NCSCC) Data. 
 
Table 3, is the list of hospitals participating in the study.  This list was updated in December 2016.   
 
 
 
**Table 1. Comparison of Anticipated Participating Hospitals with All NC Hospitals ** 
  
COMPASS 
(N=47*) 
All NC Hospitals 
(N=85) 
30-day Mortality Rate for Stroke Patients 
15.6 (14.2 - 16.7) 
15.4 (14.1 - 16.6) 
30-day Unplanned Readmission Rate for Stroke Patients 
12.6 (11.8 - 13.4) 
12.8 (12.1 - 13.6) 
CMS HCAHPS 5-Star Quality Rating, median score  
Overall summary score 
3 (3 - 4) 
3 (3 - 4) 
Care transition score 
3 (3 - 4) 
3 (2 - 4) 
Stroke quality measures, % of patients that received measure  
Venous Thromboembolism (VTE) Prophylaxis 
98 (96 - 100) 
99 (96 - 100) 
Discharged on Antithrombotic Therapy 
100 ( 99 - 100) 
100 ( 99 - 100) 
Anticoagulation Therapy for Atrial Fibrillation/Flutter 
100 (96 - 100) 
100 (96 - 100) 
Thrombolytic Therapy 
95 (91 - 100) 
93 (84 - 99) 
Antithrombotic Therapy by End of Hospital Day 2 
100 (98 - 100) 
100 (98 - 100) 
Discharged on Statin Medication 
98 (96 - 100) 
99 (96 - 100) 
Stroke Education 
97 (92 - 100) 
97 (90 - 100) 
Assessed for Rehabilitation 
100 (99 - 100) 
100 (98 - 100) 
*Data from Murphy Medical Center are not available from Hospital Compare.   
Notes: Values are presented as median (25th, 75th percentile).  HCAHPS represents Hospital Consumer Assessment of Healthcare 
Providers and Systems. 
**This Table was last Updated in Jan 2016 
 
 
 
 

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**Table 2. Characteristics of Anticipated Hospitals (N=48) 
N 
Percent 
Teaching hospital 
2 
4% 
Joint Commission stroke certified sites (PSC or 
CSC) 
22 46% 
Geographic region  
Piedmont 
26 54% 
Western 
11 23% 
Eastern 
11 23% 
Annual stroke volume 
<100 discharges 
12 25% 
100-299 discharges 
23 48% 
300+ discharges 
13 27% 
**This Table was last Updated in Jan 2016 
 
 
 

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Table 3.  List of Participating Hospitals (Table Updated December 2016)   
# 
Hospital 
Wave Arm 
Stroke 
Center  
2013 Stroke 
Discharges 
1 
Cape Fear Valley Medical Center 
1 
Usual Care 
PSC 
300+ 
2 
FirstHealth Moore Regional 
1 
Intervention PSC 
300+ 
3 
Onslow Memorial Hospital 
1 
Usual Care 
PSC 
100-299 
4 
Carteret County General Hospital 
1 
Intervention PSC 
100-299 
5 
WFBH Lexington Medical Center 
1 
Usual Care 
PSC 
100-299 
6 
Hugh Chatham Memorial Hospital 
1 
Intervention PSC 
100-299 
7 
Pardee Health 
1 
Usual Care 
No 
100-299 
8 
Lenoir Memorial Hospital  
1 
Intervention No 
100-299 
9 
CHS NorthEast 
2 
Intervention PSC 
300+ 
10 
Novant Health Presbyterian Medical Center 
2 
Usual Care 
PSC 
300+ 
11 
New Hanover Regional MC 
2 
Usual Care 
PSC 
300+ 
12 
Mission Hospital 
2 
Intervention PSC 
300+ 
13 
Novant Health Huntersville Medical Center 
2 
Intervention PSC 
100-299 
14 
Novant Health Matthews Medical Center 
2 
Usual Care 
PSC 
100-299 
15 
CHS University  
2 
Intervention No 
100-299 
16 
CHS Blue Ridge 
2 
Usual Care 
No 
100-299 
17 
CHS Union  
2 
Intervention PSC 
100-299 
18 
CHS Cleveland  
2 
Usual Care 
PSC 
100-299 
19 
CHS Kings Mountain  
2 
Usual Care 
No 
<100 
20 
Wilkes Regional Medical Center  
2 
Intervention No 
100-299 
21 
Northern Hospital of Surry County 
2 
Usual Care 
PSC 
<100 
22 
Frye Regional Medical Center 
2 
Intervention PSC 
300+ 
23
a 
Carolinas Medical Center 
3 
Intervention PSC 
300+ 
23
b 
CHS Mercy (randomized with CMC as a single 
unit) 
3 
Intervention PSC 
<100 
24 
WakeMed Health & Hospitals  
3 
Usual Care 
PSC 
300+ 
25 
Duke Raleigh Hospital 
3 
Usual Care 
PSC 
100-299 
26 
CHS Stanly 
3 
Intervention PSC 
100-299 
27 
Ashe Memorial Hospital 
3 
Intervention No 
<100 
28 
Alleghany 
3 
Usual Care 
No 
<100 
29 
Betsy Johnson Hospital 
3 
Usual Care 
No 
100-299 
30 
Morehead Memorial Hospital 
3 
Intervention No 
<100 
31 
UNC Hospital 
3 
Usual Care 
CSC 
300+ 
32 
Rex Healthcare  
3 
Intervention PSC 
300+ 
33 
CHS Lincoln  
3 
Usual Care 
No 
<100 
34 
Caldwell Memorial Hospital 
3 
Intervention No 
100-299 
35 
Vidant Duplin Hospital 
3 
Intervention PSC 
<100 
36 
Blue Ridge Regional  
3 
Usual Care 
No 
<100 
37 
Vidant Edgecombe Hospital 
3 
Usual Care 
No 
100-299 
38 
Angel Medical Center 
3 
Intervention No 
<100 
39 
Washington County Hospital 
3 
Intervention No 
<100 
40 
SouthEastern Regional Medical Center 
3 
TBD 
No 
300+ 
 

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Appendix 2 - COMPASS Hospital Survey 
 
 
 

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Appendix 3 - Eligibility Screening Form 
 
 
 

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Appendix 4 - Enrollment Form 
 
 
 
 

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Appendix 5 - Control-Arm Patient Handout –COMPASS Study 
 
 
 

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Appendix 6 - Letter to the Patient at 30 Days and Magnet 
 
Dear <NAME>, 
 
 
 
 
 
 
 
 
 
<DATE> 
Greetings from the COMPASS Study!  We are contacting you on behalf of <HOSPITAL>, which is 
participating in our study.  You may remember your nurse gave you a brochure about our study 
purpose while in the hospital.  As a reminder, our goal is to improve healthcare and the lives of 
North Carolinians who had a transient ischemic attack (TIA), mini-stroke, stroke, or related 
episode. 
What to expect: 
In a couple months you will receive a call from a team member at the Carolina Survey Research 
Lab to ask you to take part in a phone survey.  During this call, we would like to talk with you 
about how you have been doing since your hospital visit.  The survey is brief, and is completely 
voluntary and confidential.  Your participation will be very valuable in helping other patients 
and their families find their way forward to recovery. 
How you can participate:  
[-] Your call is tentatively scheduled for the week of <DATE > 
 
[-] We will call you at <PHONE #> 
 
[-] We have enclosed a COMPASS Study refrigerator magnet and will send a 
gift to you in a future letter so be sure to open it!  
If the phone number above is incorrect or if you would like to opt-out of this call and future 
letters, please contact us as soon as you can at the toll-free number: 1-844-501-7668.   
Find out more about the COMPASS Study:  
[-] To learn more about the COMPASS Study please visit our website:                  
www.nccompass-study.org 
[-] If you would like to speak with a team member about the study, call us at:                     
1-844-501-7668 
 
Thank you very much for your time and we look forward to speaking with you soon! 
Best regards, 
The COMPASS Study Team 
P.S Don’t forget to mark your calendar.  Your response matters! 
 
 

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Appendix 7 - Letter to the Patient at 60 Days 
 
 
Dear <NAME>, 
 
 
 
 
 
 
 
 
 
<DATE> 
 
Greetings from the COMPASS Study team!  This is another reminder that you will be receiving a 
call from a team member at the UNC Carolina Survey Research Lab.  They will ask you to take 
part in a phone survey.  The survey is brief, completely voluntary and confidential.  Your 
participation will be very valuable in helping other North Carolinians and their families.   
 
How you can participate:  
[-] Your call is tentatively scheduled for the week of <DATE> 
[-] We will call you at <PHONE #> 
[-] We will send you one more reminder letter a week before the call.  That letter will include a 
copy of the survey questions and our thank you gift – so be sure to open it!  
 
Please contact us at the toll-free number 1-844-501-7668 if any of the information above is 
incorrect or you would like to opt out of the phone call and future letters.  
 
We encourage you to explore resources provided by the American Heart/ American Stroke 
Associations.  The free Stroke Family Warmline connects you to other individuals and their 
families who have had experiences similar to yours (1-888-4-STROKE).  The Stroke 
Connection Magazine is also an excellent resource.  You can read a digital copy and subscribe 
by visiting: http://strokeconnection.strokeassociaton.org  
 
Find out more about the COMPASS Study:  
[-] To learn more about the COMPASS Study and to find other useful information about care after stroke or 
mini-stroke, please visit our website: www.nccompass-study.org 
[-] If you would like to speak with a team member about the study, call us at:                         1-844-501-
7668 
 
 
Best regards, 
The COMPASS Study Team 
 
 
 
 

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Appendix 8 - Letter to the Patient at 80 Days 
 
 
Dear <NAME>, 
 
 
 
 
 
 
 
 
 
<DATE> 
 
Greetings from the COMPASS Study team!  As you know, we are working to determine the best 
ways to care for individuals after they go home from the hospital.  <HOSPITAL NAME> and your 
doctor have identified you as a participant in this study.  
 
A team member at the UNC Carolina Survey Research Lab is planning to call.  We want to hear 
how you’ve been doing since your hospital visit a few months ago.  Attached is a copy of the 
survey questions if you would like to review them before the call.  We appreciate your help in 
improving healthcare in North Carolina!  
How you can participate:  
[-] We have enclosed $10 to say THANK YOU in advance!  
[-] Your call is scheduled for the week of <DATE > 
 
[-] We will call you at <PHONE #> 
 
[-] Our records show your preferred call window is: <BEST TIME TO CALL> 
Please contact us as soon as you can at the toll-free number 1-844-501-7668 if any of the 
information above has changed.   
At the beginning of the call, you will be asked if you wish to participate.  Participation is 
completely voluntary and confidential and any information you provide will be held securely.  
We hope that you will provide your input. 
 
Find out more about the COMPASS Study:  
[-] To learn more about the COMPASS Study please visit our website:                      
www.nccompass-study.org 
[-] If you would like to speak with a team member about the study, call us at:                          
1-844-501-7668 
 
We look forward to speaking with you soon! 
 
Best regards, 
The COMPASS Study Team 
 

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[pg 2]  
HIPAA Authorization Note:  The COMPASS Study team has worked with your hospital and 
doctor to identify you as a potential participant for this research study.  The Carolina Survey 
Research Lab (CSRL) will ask for your consent to participate when they call you next week.  We 
do hope that you will agree to participate in the survey but this is voluntary and optional.  Any 
responses you provide will be held confidential and securely.  
 
By agreeing to participate in the phone survey, you will be giving permission to CSRL to use or 
disclose your identifiable health information for the COMPASS research study.  The health 
information that we may use or disclose for this research includes information from your recent 
hospital visit, visits to your doctor, medications, and other information about your insurance 
claims.  The health information listed above may be used by and/or disclosed to the study 
investigators at this site and others, study management centers, the study sponsor, and other 
groups, including federal agencies, which have a responsibility to assist in the oversight and 
management of the research study.   
 
Please note that <HOSPITAL NAME> may not refuse to treat you if you do not provide consent 
for this Authorization and phone survey.  Once you have agreed, you may change your mind and 
take back the Authorization at any time.  Even if you take back this Authorization, the 
organization may still use information that was previously collected about you.  To take back 
the Authorization, you must call 1-844-501-7668 or email thecompassstudy@gmail.com.  
Authorization does not have an expiration date. 
 
 
 
 
 

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Appendix 9 - NCSCC Stroke Care Card 
 

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Appendix 10 - Screener and Consent (At 90 Days) 
CONSENT LANGUAGE PULLED OUT OF THE SCREENER 
 
PURPOSE:  
We are calling to follow up on his/her/your recent hospital stay at [HOSPITAL]. This hospital is 
participating in the COMPASS study which is a research study looking at how patients are doing after 
their stroke. 
 
EXPLAIN [IF IRB_MON=1]:  
[….] During this survey, you have the right to refuse to answer any questions you don’t want to 
answer and you can stop participating at any time. [….] 
 
SECURITY:   
We wanted to also let you know that by participating you are giving us permission to keep a 
record of your responses to the survey. All of your responses and data will be strictly 
confidential and will be kept in a secure location. 
 
RISKBENEFIT:  
We do not anticipate that participation in this survey involves any risks. There is also no direct 
benefit to you for participating. 
 
 
PARTICIPATE/CONSENT:  
Do I have your permission to continue with the survey?  
 
 
THANK YOU:  
Thank you for agreeing to participate in the COMPASS Study.  
 
 
IF IRB_OFFER NUM: 
If you have any additional questions about the study, I can provide the numbers of the Wake Forest and 
UNC Chapel Hill Institutional Review Boards. Their job is to protect your rights and welfare as a research 
participant. They have reviewed and approved this study.  Would you like those numbers?  
 
The survey also has a link to the COMPASS website. 
 
 
IRB_PI NUMBER [IF [IF IRB_OFFER NUM=1]: 
If you have any questions, comments or concerns about the study, please contact, anonymously 
if you wish, the Wake Forest IRB at 336-716-4542 or the UNC Chapel Hill Institution Review Board.   
You can reach them at 919-966-3113 or by email to IRB_subjects@unc.edu. This information is 
also at the bottom of the survey that was mailed to you. 
 
Information about how to reach the COMPASS project manager, the UNC Institutional Review Board, as 
well as the link to the COMPASS website, are at the bottom of the survey that was mailed to you. 

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Screener  
 
LABEL 
VALUE 
TEXT 
INSTRUCTIONS 
 
DID ANSWER 
0-1 
0=NO 
1=YES  
 
INTERVIEWER: DIAL 
###-###-####. DID A 
PERSON ANSWER? 
 
IF NO, HANG UP AFTER 
12 RINGS. 
 
UNKNOWN HELLO 
[IF DID ANSWER=1] 
1=PERSON NAMED ON 
PHONE OR COMING 
TO PHONE (GO TO 
SEL_HELLO) 
2= PERSON NAMED 
NOT AVAILABLE (GO 
TO SCHEDULE_CB1) 
3= PERSON NAMED ON 
PHONE IS IN THE 
HOSPITAL, INPATIENT 
REHAB OR A NURSING 
HOME(GO TO 
IN_FACILITY) 
4= PATIENT UNABLE 
TO TALK ON PHONE 
DUE TO THEIR 
STROKE (GO TO 
MED_SPECIFY) 
5= PERSON NAMED ON 
PHONE IS DECEASED 
(GO TO DECEASED) 
6= PERSON NAMED NO 
LONGER AT THIS 
NUMBER, BUT NOT IN 
A FACILITY (GO TO 
ASK_NEW#)  
7=NO ONE BY THAT 
NAME KNOWN (GO TO 
MISMATCH) 
99=HANG UP OR 
PERSON NAMED 
REFUSES TO COME TO 
PHONE 
Hello, my name is [FULL 
NAME] and I’m calling on 
behalf of [HOSPITAL 
NAME] and the 
COMPASS STUDY. 
 
 
May I please speak with 
[FIRST NAME LAST 
NAME]? 
 
 
 
PRELOAD NAME 
 
 
ASK_NEW# 
0=NO, GK WILL NOT 
PROVIDE NUMBER 
(GO TO END 
INTERVIEW AND 
CODE REV1 
1=YES, GK WILL 
PROVIDE NUMBER 
(GO TO GET_NEW#) 
 
Does [Mr/Ms LAST 
NAME] have a new 
personal or residential 
number where I could reach 
[him/her] regarding this 
study? 
 
IN: IF GK SAYS R IS 
DECEASED, IN A 
 

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FACILITY OR 
MEDICALLY 
INCAPABLE, GO BACK 
TO UNKNOWN_HELLO 
AND CHOOSE 
APPROPRIATE 
RESPONSE. 
 
IF NEEDED: For the 
purposes of this study, we 
are not able to speak with 
those in nursing homes or 
other facilities, but we 
might be able to speak with 
a family member or friend. 
GET_NEW# 
ENTER NUMBER 
 
Thank you.  What is that 
number? 
 
GET_ALT# 
ENTER NUMBER (GO 
TO END_INTERVIEW, 
THEN APPOINTMENT 
TAB) 
Is there another number in 
case we don’t reach 
[him/her] at that number?  
 
IN: IF NO OTHER 
NUMBER, LEAVE 
EMPTY AND HIT ENTER 
TO CONTINUE 
 
SCHEDULE_CB1 
1=PREFERRED CB 
TIME PROVIDED (GO 
TO THANK_CB) 
2= PERSON NAMED ON 
PHONE IS IN THE 
HOSPITAL, INPATIENT 
REHAB OR A NURSING 
HOME (GO TO 
IN_FACILITY) 
3= PATIENT UNABLE 
TO TALK ON PHONE 
DUE TO THEIR 
STROKE (GO TO 
MED_SPECIFY) 
4= PERSON NAMED ON 
PHONE IS DECEASED 
(GO TO DECEASED) 
 
9=REFUSE (GO TO 
RESP_REF) 
I am calling in regard to a 
phone survey we would like 
you/[MR/MS LAST 
NAME] to complete.  
You/she/he should have 
received some letters about 
this survey. When would be 
a good time to call back? 
 
IN: IF R IS NO LONGER 
AT THIS NUMBER BUT 
NOT IN A FACILITY, GO 
BACK TO 
UNKNOWN_HELLO 
AND CHOOSE #6 
 
 
 
IN_FACILITY 
0=NO (GO TO 
FACILITY_SPECIFY) 
1=YES (GO TO 
SCHEDULE_CB2) 
 
8=DON’T KNOW (GO 
TO SCHEDULE_CB2) 
Do you think s/he will be 
available and able to do a 
phone survey before 
[EXPIRATION DATE 
MINUS 2DAYS?] 
 
IF ‘DON’T KNOW’: 
PRELOAD 
EXPIRATION 
DATE 
 
 

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9=REFUSE (GO TO 
FACILITY_SPECIFY) 
OK, I’ll plan to try to call 
back before then to see if 
they are available. 
FACILITY_SPECIFY 
1=the hospital (GO TO 
PROXY) 
2=an in-patient 
rehabilitation facility, or 
(GO TO PROXY) 
3=a nursing home? (GO 
TO PROXY) 
4=OTHER (GO TO 
SPEC_OTHER) 
Could you please tell me, is 
s/he currently in . . . 
 
IN: IF GK HAS 
ALREADY SPECIFIED 
FACILITY, CONFIRM 
INFORMATION HERE 
 
SPEC_OTHER 
OPEN TEXT  
(250 CHARACTERS) 
SPECIFY OTHER 
 
MED_SPECIFY 
1=DIFFICULTY 
TALKING 
2=DIFFICULTY 
UNDERSTANDING 
3=TOO SICK 
4=OTHER (GO TO 
OTHER_MED) 
 
8=DON’T KNOW (GO 
TO PROXY) 
9=REFUSE (GO TO 
PROXY) 
For our records, would you 
mind telling me:  Is 
[Mr./Ms. LAST NAME] 
unable to do the survey 
because [he/she] has 
difficulty talking, difficulty 
understanding, is too sick 
or is there some other 
reason [he/she] is unable to 
do the survey? 
 
IN: IF GK INFORMS YOU 
THAT R IS IN A 
FACILITY, GO BACK TO 
UNKNOWN_HELLO 
AND CODE 
APPROPRIATELY 
BEFORE CONTINUING 
ALL GO TO 
PROXY 
OTHER_MED 
OPEN TEXT 
50 CHARACTERS 
What other reason is that? 
 
PROXY 
1= YES, WILLING 
PROXY ON PHONE (GO 
TO RCV_INFO, THEN 
PROXY NAME, THEN 
PROXY_REL, THEN 
EXPLAIN) 
2= YES, WILLING 
PROXY COMING TO 
PHONE (GO TO 
SELECTED_HELLO, 
RCV INFO, PROXY 
NAME, PROXY REL) 
3= YES, PROXY IS 
UNAVAILABLE (GO TO 
PROXY NAME, THEN  
SCHEDULE_CB2)  
4= NO, THERE IS NO 
PROXY (GO TO INEL) 
I’m sorry to hear that.  I 
would like to complete the 
survey with someone else if 
possible. 
Does Mr/Ms [LAST 
NAME] have an adult 
relative or health care 
power of attorney who can 
be reached at this number 
and who has regular contact 
with him/her and knows 
about his/her health and 
could take the survey on 
his/her behalf?  
IF 
UNK_HELLO=3,4 
OR 5 OR 
SCHEDULE_CB1=2
,3 OR 4AND 
IN_FACILITY=0 
AND PROXY=0, GO 
TO INEL AND 
CODE PRE1 (IN 
FACILITY) 
 
 
IF UNK_HELLO=6 
OR 
SCHEDULE_CB1=5 
AND PROXY=0, GO 
TO INEL AND 
CODE MEDX 

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5= PROXY REFUSAL 
(GO TO RESP_REF) 
 
SEL_HELLO 
[IF UNKNOWN 
HELLO=1] 
0-3 
0=NO 
1=YES (GO TO 
RCV_INFO AND/OR 
PROXY_NAME, THEN 
EXPLAIN) 
2=UNKNOWN 
UNAVAILABLE 
3=UNKNOWN 
REFUSAL (GO TO 
RESP_REF) 
 
IF PARTICIPANT OR 
PROXY IS ALREADY 
ON THE PHONE, 
ENTER "YES" 
 
IF PARTICIPANT JUST 
CAME TO THE PHONE, 
SAY: 
Hello, my name is [FULL 
NAME]. I’m calling on 
behalf of the COMPASS 
study.  
 
Am I speaking with [FILL 
IF PROXY=1 OR 2:  an 
adult relative or health care 
power of attorney for ] 
[FIRST NAME LAST 
NAME]? 
 
 
IF PROXY=3 OR 4, 
GO TO RCV_INFO 
THEN PROXY 
NAME  
RCV_INFO 
[IF SELECTED HELLO = 
1] 
0-3 
1=CONTINUE (GO TO 
EXPLAIN) 
2=R UNAVAILABLE 
(GO TO 
SCHEDULE_CB2) 
3=R REFUSAL (GO TO 
RESP_REF) 
 
We are calling to follow up 
on his/her/your recent 
hospital stay at 
[HOSPITAL]. This hospital 
is participating in the 
COMPASS study which is 
a research study looking at 
how patients are doing after 
their stroke. 
 
We recently sent 
him/her/you a description 
of   the study and some 
reminder letters about this 
call. . 
 
Today I’m calling to ask 
you some questions about 
how you are feeling and 
about your health in 
general. 
 
 
IF PROXY=2: We were 
informed earlier that 
Mr./Ms. [LAST NAME] 
would be unable to 
participate in a phone 
survey due to his/her health 
PRELOAD 
GENDER 

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but that you would be able 
to answer our questions on 
his/her behalf. 
 
INTERVIEWER: IF R 
CLAIMS HE IS 
UNAWARE OF THE 
STUDY, PROMPT BY 
DESCRIBING.  IF 
STILL UNFAMILIAR, 
CODE FINAL 
REFUSAL. 
IN: THE LETTER IS 
NOT REQUIRED TO 
DO THE PHONE 
SURVEY 
PROXY_NAME 
OPEN TEXT 
(10 CHARACTERS) 
 
GO TO PROXY 
RELATION 
Could you please tell me 
your first name so that I can 
refer to you personally? 
IN: THIS IS A REQUIRED 
FIELD.  IF PROXY IS 
UNWILLING TO 
PROVIDE A NAME, 
EXPLAIN THAT YOU 
NEED INITIALS OR A 
NICKNAME SO THAT IF 
YOU MUST CALL BACK 
YOU CAN BE SURE TO 
REACH THEM AND NOT 
SOME OTHER FRIEND 
OR FAMILY MEMBER. 
PROGRAMMING: 
THIS IS  A 
REQUIRED 
FIELD 
PROXY_RELATION 
1=Legal guardian? 
2=Health care agent named 
under a health care power 
of attorney? 
3=Spouse? 
4=Adult son and/or 
daughter? 
5=Parent? 
6=Adult brother and/or 
sister? 
7=Uncle and/or aunt? 
8=Other adult relative (GO 
TO OTHER_REL)? 
 
88=DON’T KNOW (GO 
TO  
99=REFUSED (GO TO 
RESP REF 
 
For our records, can you 
tell us your relationship to 
[R NAME]? 
 
IN: IF NOT ONE OF 
THESE 
RELATIONSHIPS, R 
MUST COMPLETE 
ELIGIBILITY AND 
CONSENT 
HIM/HERSELF BEFORE 
ALLOWING PROXY TO 
COMPLETE; GO BACK 
TO UNK_HELLO AND 
CHOOSE APPROPRIATE 
RESPONSE TO SPEAK 
TO R OR GO BACK TO 
PROXY AND CHOOSE 
#4, NO PROXY 
 
OTHER_REL 
OPEN TEXT 
50 CHARACTERS 
SPECIFY OTHER 
RELATIONSHIP 
 

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PROXY_AGE 
1=YES (GO TO 
HOSP_INFO) 
And I need to confirm, are 
you at least 18 years old? 
 
IN: IF NO, GO BACK 
AND RE-ASK PROXY 
AND CODE 
APPROPRIATELY.  
DON’T ALLOW 
REF OR DK 
MISMATCH 
[IF UNKNOWN 
HELLO=8] 
 
0-2 
0=NO 
1=YES 
2=HANG UP BEFORE 
NUMBER 
VERIFICATION 
 
Let me just confirm that I 
dialed correctly.  Did I 
reach you at ###-###-####? 
 
MISDIAL 
[IF MISMATCH=0] 
EMPTY 
I’m sorry. I must have 
misdialed.  Thank you for 
your time. 
 
REDIAL 
DECEASED 
ENTER DATE (GO TO 
END INTERVIEW AND 
CODE DECX) 
DON’T KNOW(GO TO 
END INTERVIEW AND 
CODE DECX) 
REFUSE(GO TO END 
INTERVIEW AND 
CODE DECX) 
I’m very sorry to hear that. 
Would you mind telling me 
when s/he passed away so 
that I can record that 
information and we do not 
call again?.. 
END CALL AND 
CODE DECX 
END INTERVIEW 
[IF  ASK_NEW#=0 OR 1 
OR MISMATCH=1] 
 
EMPTY 
Thank you for your time. 
END CALL  
 
 
 
 
 

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HOSP_INFO 
[IF IRB_CONF=1] 
1=INFO ON RECORD IS 
CORRECT (GO TO 
EXPLAIN) 
2=HOSPITAL IS 
WRONG (GO TO NEW 
HOSP) 
3=DISCHARGE DATE 
IS WRONG (GO TO 
NEW DISCHARGE) 
4=R SAYS NOT 
HOSPITALIZED FOR 
STROKE (GO TO NEW 
ADMIT) 
 
8=DON’T KNOW (GO 
TO EXPLAIN) 
9=REFUSE (GO TO 
EXPLAIN) 
 
Our records show that 
he/she/you was/were 
hospitalized for a stroke or 
TIA at [HOSPITAL] and 
that he/she/you was/were 
sent home on [DschrgD].  
 
Is that correct? 
 
IF NEEDED: TIA stands 
for transient ischemic 
attack and is sometimes 
referred to as a mini-stroke 
or warning stroke. 
 
IN: R MAY HAVE BEEN 
HOSPITALIZED ON 
OTHER DATES, BUT WE 
ARE NOT ASKING 
ABOUT THOSE.  
IT IS OKAY TO 
CONTINUE EVEN IF R 
DOES NOT REMEMBER 
HOSPITAL AND DATE 
INFORMATION.  
 
 
 
PRELOAD 
HOSPITAL AND 
DISCHARGE DATE 
NEW_HOSP 
OPEN TEXT 
What was the name of the 
hospital where you were 
hospitalized for your 
stroke? 
 
NEW DISCHARGE 
MM/DD/YYYY 
What was the date of your 
discharge? 
 
NEW ADMIT 
OPEN TEXT 
What were you hospitalized 
for? 
 
EXPLAIN 
[IF IRB_MON=1] 
1-3 
1=CONTINUE (GO TO 
HOSP_INFO) 
2=R UNAVAILABLE 
3=R REFUSAL (GO TO 
RESP_REF) 
 
Before I continue, I need to 
let you know that for quality 
control purposes, this call 
may be monitored by my 
supervisor. 
During this survey, you have 
the right to refuse to answer 
any questions you don’t want
to answer and you can stop 
participating at any time. 
 
 
INELIGIBLE 
 
 
I’m sorry, but that means we 
won’t be able to do the 
survey. Thank you very 
much for your time. I 
 

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appreciate your talking with 
me. 
ELIGIBLE 
 
1-3 
1=CONTINUE (GO TO 
PURPOSE) 
 
 
INTERVIEWER: CASE IS 
NOW ELIGIBLE, ENTER 1 
TO CONTINUE 
 
 
 
 
 
LENGTH 
 
1-3 
1=CONTINUE (GO TO 
SECURITY) 
2=R UNAVAILABLE 
3=R REFUSAL (GO TO 
RESP_REF) 
The survey should take 
about 20 minutes to 
complete.  
 
 
SECURITY  
1-3 
1=CONTINUE (GO TO 
RISKBENEFIT) 
2=R UNAVAILABLE 
3=R REFUSAL (GO TO 
RESP_REF) 
We wanted to also let you 
know that by participating 
you are giving us 
permission to keep a 
record of your responses to 
the survey. All of your 
responses and data will be 
strictly confidential and will 
be kept in a secure 
location.  
 
RISKBENEFIT 
 
1-3 
1=CONTINUE (GO TO 
INCENTIVE) 
2=R UNAVAILABLE 
3=R REFUSAL (GO TO 
RESP_REF) 
We do not anticipate that 
participation in this 
research survey involves 
any risks. There is also no 
direct benefit to you for 
participating.  
 
 
 
 
 
IRB_OFFER NUM 
 
0-1 
0=NO 
1=YES (GO TO IRB_PI 
NUMBER) 
If you have any additional 
questions about the study, 
I can provide the numbers 
of the Wake Forest and 
UNC Chapel Hill 
Institutional Review 
Boards. Their job is to 
protect your rights and 
welfare as a research 
participant. They have 
reviewed and approved 
this study.  Would you 
like those numbers?  
The survey also has a link 
to the COMPASS website. 
 
IRB_PI NUMBER 
[IF [IF IRB_OFFER 
NUM=1] 
EMPTY 
If you have any 
questions, comments or 
concerns about the study, 
please contact, 
 

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anonymously if you 
wish, the Wake Forest 
IRB at 336-716-4542or 
the UNC Chapel Hill 
Institutional Review 
Board. You can reach 
them at 919-966-3113 or 
by email to 
IRB_subjects@unc.edu.  
 
Information about how to 
reach the COMPASS project 
manager, the UNC 
Institutional Review Board, 
as well as the link to the 
COMPASS website, are at 
the bottom of the survey that 
was mailed to you. 
BEGIN SURVEY 
[IF IRB MON=1] 
1-3 
1=YES, CONTINUE  
2=YES, RESPONDENT 
UNAVAILABLE 
3=NO, RESPONDENT 
REFUSAL 
 
Do I have your permission 
to continue with the 
survey? 
 
INTERVIEWER: ANSWER 
ANY RESPONDENT 
QUESTIONS, AND THEN 
CONTINUE. 
 
THANK_YOU 
GO TO INTRO 
Thank you for agreeing to 
participate in the 
COMPASS study. 
 
 
 
WHO_DO 
1=PATIENT 
2=PROXY, WITH 
PATIENT CONSENT 
(GO TO NON-LAR 
NAME) 
3=PROXY AS LEGAL 
AUTHORIZED 
REPRESENTATIVE 
WHO IS COMPLETING 
THIS SURVEY? 
 
IN: A NON-LAR PROXY 
IS ALLOWED ONLY IF 
THE PATIENT 
CONSENTED 
HIM/HERSELF. 
 
PROXIES MUST BE AT 
LEAST 18 YEARS OLD. 
 
NON-LAR NAME 
OPEN TEXT  
ENTER NON-LAR NAME 
ONCE NON-LAR PROXY 
IS ON THE PHONE: 
 
Hello, my name is [FULL 
NAME] and I’m calling 
regarding the COMPASS 
Study, which is a research 
study looking at how 
patients are doing after their 
stroke. 
 

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Mr./Ms. [LAST NAME] 
has already given his/her 
consent to participate in the 
study but would like for 
you to answer the questions 
on his/her behalf. 
 
Could you please tell me 
your first name so that I can 
refer to you personally? 
 
 
NON-LAR AGE 
1=YES (GO TO SURVEY 
INTRO) 
Are you at least 18 years 
old?  
IN: IF NO, GO BACK TO 
BEGIN_SURVEY AND 
CODE APPROPRIATELY. 
 
SCHEDULE CB_2 
[] 
OPEN TEXT  
[200 CHAR] 
When would be a better 
time for me to speak with 
him/her/you? 
 
SCHEDULE 
CALLBACK THEN 
END CALL 
RESP REF 
 
OPEN TEXT  
[200 CHAR] 
To help us understand how 
to improve our study, may I 
ask why you don't want to 
participate? 
END CALL 
 
REF SPEC 
 
OPEN TEXT  
[200 CHAR] 
ENTER SPECIFICALLY 
WHAT WAS SAID 
ABOUT REASON FOR 
REFUSAL 
 
ONLY COMES UP 
IF REFUSAL IS 
FINAL (2ND SOFT 
REFUSAL OR 1ST 
HARD REFUSAL) 
THANK_CB 
 
Thank you.  We will try 
back another time. 
 
ANSWERING 
MACHINE MESSAGE 
[IF DID ANSWER=0 AND 
ANSWERING MACHINE 
PICKS UP] 
EMPTY 
Hello, my name is (FULL 
NAME) and I am calling 
from the University of 
North Carolina on behalf of 
[HOSPITAL NAME]. We 
are trying to get in touch 
with [PARTICIPANT 
FIRST AND LAST 
NAME]. We’ll try you 
back again later or you may 
also call us, toll-free, at 1-
866-862-4636 and leave a 
message letting us know the 
best time to call. 
LEAVE A MESSAGE 
THE FIRST TIME 
AN ANSWERING 
MACHINE IS 
REACHED.  WAIT 
UNTIL THE 4TH 
CALL ATTEMPT TO 
LEAVE A SECOND 
MESSAGE. 
 
 
 

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Appendix 11 – Sustain-Arm Patient Handout –COMPASS Study Brochure 
 
 
 
 
 

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Appendix 12 - Intervention-Arm Patient Handout –COMPASS Study Brochure 
 
 
 

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Appendix 13 - Intervention- Arm Patient Handout –COMPASS Roadmap 
 
 

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Appendix 14 - COMPASS Blood Pressure Log 
 
 
 
 

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Appendix 15 - COMPASS Blood Pressure Educational Handout 
 

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Appendix 16 - Two-Day Post-Discharge Follow-up 
 
 
 
 
 

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Appendix 17 - Post-stroke Functional Assessment 
 
 
 

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Appendix 18 - Caregiver Assessment 
 
 
 
 

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Appendix 19 - Post-stroke Advanced Practice Assessment  
 
 
 

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Appendix 20 - Individualized Patient Care Plan (eCare Plan)   
 
 
 
 
 

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Appendix 21 - Consent and HIPAA Authorization for Clinical Data 
 
 

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Appendix 22 - 30 and 60 Day Call Forms (60 Day Call Form is Identical) 
 
 
 
 

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Appendix 23 – 90d Patient Survey (CATI/ Phone Format) 
COMPASS 90 Day Patient Survey 
 
LABEL 
VALUE 
TEXT 
INSTRUCTIONS 
 
INTRO 
0=R DOES NOT HAVE 
Q’NAIRE FOR REFERENCE 
1=R DOES HAVE Q’NAIRE 
FOR REFERENCE 
 
8=DON’T KNOW  
I’m going to be asking you a 
series of questions about [IF 
NO PROXY: your] [IF 
PROXY=1 OR 2: FILL R 
NAME]’s health and 
activities since NO PROXY: 
you were PROXY: he/she 
was hospitalized for stroke 
or TIA. Most of the 
questions are on the 
questionnaire we mailed 
[NO PROXY: to you] about a 
week ago. Do you have that 
in front of you or would you 
like to go get it?  
 
IN: GIVE THE R TIME TO GO 
GET IT, BUT IF THEY DON’T 
HAVE OR CAN’T FIND 
PAPER Q’NAIRE: That’s OK, 
we can complete the call 
without it.  
 
IF NEEDED:  TIA stands for 
transient ischemic attack 
and is sometimes referred 
to as a mini-stroke or 
warning stroke. 
 
 
SIS_INTRO 
EMPTY 
I’d like to start by asking 
you about the physical 
problems NO PROXY: you 
PROXY: he/she may have 
because of your/his/her 
stroke (or TIA). I want to 
know NO PROXY: [from 
YOUR POINT OF VIEW] how 
stroke has affected 
your/his/her physical 
 

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function in the past two 
weeks.  
 
I’m going to read a list of 
tasks and for each one, I’d 
like you to tell me whether 
it is not difficult at all, a 
little difficult, somewhat 
difficult, very difficult or if 
the task can’t be done at 
all. 
 
IF NEEDED: I’m required to 
ask all the questions, but 
please just answer to the 
best of your ability. 
 
 
SIS1 
1=Not difficult at all  
2=A little difficult  
3=Somewhat difficult  
4=Very difficult  
5=Or you could not do this 
activity at all? 
8=DON’T KNOW 
9=REFUSE 
In the past two weeks how 
difficult was it PROXY: for 
him/her to dress the top 
part of your/his/her body? 
Would you say . . . 
 
SIS2 
1 =Not difficult at all  
2=A little difficult  
3=Somewhat difficult  
4=Very difficult  
5=Or you could not do this 
activity at all? 
8=DON’T KNOW 
9=REFUSE 
In the past two weeks, how 
difficult was it [for 
him/her]to bathe 
yourself/himself/herself? 
Would you say… 
 
INTERVIEWER NOTE: 
Bathing oneself does not 
include getting into the tub. 
 
SIS3 
1 =Not difficult at all  
2=A little difficult  
3=Somewhat difficult  
4=Very difficult  
5=Or you could not do this 
activity at all? 
8=DON’T KNOW 
9=REFUSE 
In the past two weeks, how 
difficult has it been [for 
him/her] to get to the toilet 
on time? 
 
(Would you say…) 
 
INTERVIEWER NOTE: For 
this question we are 
interested in how quickly 
 

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you/he/she can get to the 
bathroom. 
SIS4 
1=NOT (DIFFICULT) AT ALL  
2=A LITTLE (DIFFICULT)  
3=SOMEWHAT (DIFFICULT)  
4=VERY (DIFFICULT)  
5=OR YOU COULD NOT DO 
THIS ACTIVITY AT ALL? 
8=DON’T KNOW 
9=REFUSE 
In the past two weeks how 
difficult has it been [for 
him/her] to control 
your/his/her bladder, that 
is, not have an accident? 
 
(Would you say . . .) 
 
IN: OKAY TO DROP 
“DIFFICULT” WHEN 
READING RESPONSE 
OPTIONS 
 
IN NOTE: LOSING A 
LITTLE 
URINE/DRIBBLING IS 
CONSIDERED AN 
ACCIDENT. IF PERSON 
HAS INTERMITTENT 
CATHETER AND IS 
HAVING NO LEAKING 
PROBLEMS CODE THEM 
AS PER REPORT. IF 
PERSON HAS AN IN-
DWELLING FOLEY 
CATHETER, CODE AS 
CANNOT DO AT ALL. 
 
SIS5 
1=NOT (DIFFICULT) AT ALL  
2=A LITTLE (DIFFICULT)  
3=SOMEWHAT (DIFFICULT)  
4=VERY (DIFFICULT)  
5=OR YOU COULD NOT DO 
THIS ACTIVITY AT ALL? 
8=DON’T KNOW 
9=REFUSE 
In the past two weeks how 
difficult has it been [for 
him/her] to control 
your/his/her bowels, that 
is, not have an accident? 
 
(Would you say…)  
 
IN NOTE: CONSTIPATION 
IS NOT COUNTED HERE. 
THE PERSON HAS TO 
HAVE AN ACCIDENT. 
 
SIS6 
1=NOT (DIFFICULT) AT ALL  
2=A LITTLE (DIFFICULT)  
3=SOMEWHAT (DIFFICULT)  
4=VERY (DIFFICULT)  
(In the past two weeks, how 
difficult has it been [for 
him/her] to) Stand without 
losing balance? 
 
 

March 19, 2021 
Application - IRB00035998 
129 
 
5=OR YOU COULD NOT DO 
THIS ACTIVITY AT ALL? 
8=DON’T KNOW 
9=REFUSE 
(Would you say. . .) 
SIS7 
1=NOT (DIFFICULT) AT ALL  
2=A LITTLE (DIFFICULT)  
3=SOMEWHAT (DIFFICULT)  
4=VERY (DIFFICULT)  
5=OR YOU COULD NOT DO 
THIS ACTIVITY AT ALL? 
8=DON’T KNOW 
9=REFUSE 
(In the past two weeks, how 
difficult has it been [for 
him/her] to) Go shopping? 
 
(Would you say…) 
 
IN NOTE:  THIS CAN BE 
SHOPPING ALONE OR WITH 
SOMEONE. 
 
SIS8 
1=NOT (DIFFICULT) AT ALL  
2=A LITTLE (DIFFICULT)  
3=SOMEWHAT (DIFFICULT)  
4=VERY (DIFFICULT)  
5=OR YOU COULD NOT DO 
THIS ACTIVITY AT ALL? 
8=DON’T KNOW 
9=REFUSE 
(In the past two weeks, how 
difficult has it been [for 
him/her] to) Do heavy 
household chores, for 
example, vacuum, laundry 
or yard work? 
 
(Would you say…) 
 
SIS9 
1=NOT (DIFFICULT) AT ALL  
2=A LITTLE (DIFFICULT)  
3=SOMEWHAT (DIFFICULT)  
4=VERY (DIFFICULT)  
5=OR YOU COULD NOT DO 
THIS ACTIVITY AT ALL? 
8=DON’T KNOW 
9=REFUSE 
(In the past two weeks, how 
difficult has it been[for 
him/her]  to) Stay sitting 
without losing your/his/her 
balance? 
 
(Would you say…) 
 
SIS10 
1=NOT (DIFFICULT) AT ALL  
2=A LITTLE (DIFFICULT)  
3=SOMEWHAT (DIFFICULT)  
4=VERY (DIFFICULT)  
5=OR YOU COULD NOT DO 
THIS ACTIVITY AT ALL? 
8=DON’T KNOW 
9=REFUSE 
(In the past two weeks, how 
difficult has it been [for 
him/her] to) Walk without 
losing your/his/her 
balance? 
 
(Would you say…) 
 
IN NOTE: THE DISTANCE IS 
NOT IMPORTANT 
 
SIS11 
1=NOT (DIFFICULT) AT ALL  
2=A LITTLE (DIFFICULT)  
3=SOMEWHAT (DIFFICULT)  
4=VERY (DIFFICULT)  
5=OR YOU COULD NOT DO 
THIS ACTIVITY AT ALL? 
(In the past two weeks, how 
difficult has it been [for 
him/her] to) Move from a 
bed to a chair? 
 
(Would you say…) 
 

March 19, 2021 
Application - IRB00035998 
130 
 
8=DON’T KNOW 
9=REFUSE 
SIS12 
1=NOT (DIFFICULT) AT ALL  
2=A LITTLE (DIFFICULT)  
3=SOMEWHAT (DIFFICULT)  
4=VERY (DIFFICULT)  
5=OR YOU COULD NOT DO 
THIS ACTIVITY AT ALL? 
8=DON’T KNOW 
9=REFUSE 
(In the past two weeks, how 
difficult has it been [for 
him/her] to) Walk fast? 
 
(Would you say…) 
 
SIS13 
1=NOT (DIFFICULT) AT ALL  
2=A LITTLE (DIFFICULT)  
3=SOMEWHAT (DIFFICULT)  
4=VERY (DIFFICULT)  
5=OR YOU COULD NOT DO 
THIS ACTIVITY AT ALL? 
8=DON’T KNOW 
9=REFUSE 
(In the past two weeks, how 
difficult has it been[for 
him/her]  to) Climb one 
flight of stairs? 
 
(Would you say…) 
 
SIS14 
1=NOT (DIFFICULT) AT ALL  
2=A LITTLE (DIFFICULT)  
3=SOMEWHAT (DIFFICULT)  
4=VERY (DIFFICULT)  
5=OR YOU COULD NOT DO 
THIS ACTIVITY AT ALL? 
8=DON’T KNOW 
9=REFUSE 
(In the past two weeks, how 
difficult has it been[for 
him/her] to ) Walk one 
block? 
 
(Would you say…) 
 
IN NOTE:  THIS COULD 
INVOLVE WALKING WITH 
SUPPORT, SUCH AS WITH A 
CANE OR A WALKER. 
 
SIS15 
1=NOT (DIFFICULT) AT ALL  
2=A LITTLE (DIFFICULT)  
3=SOMEWHAT (DIFFICULT)  
4=VERY (DIFFICULT)  
5=OR YOU COULD NOT DO 
THIS ACTIVITY AT ALL? 
8=DON’T KNOW 
9=REFUSE 
(In the past two weeks, how 
difficult has it been[for 
him/her]  to) Get in and out 
of a car? 
 
(Would you say…)  
 
IN NOTE: IF THE 
RESPONDENT WANTS 
TO KNOW WHAT KIND 
OF CAR SAY YOUR CAR 
OR THE CAR YOU RIDE 
IN THE MOST. 
 
SIS16 
1=NOT (DIFFICULT) AT ALL  
2=A LITTLE (DIFFICULT)  
3=SOMEWHAT (DIFFICULT)  
(How about) Carry heavy 
objects, for example, a bag 
of groceries, with 
 

March 19, 2021 
Application - IRB00035998 
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4=VERY (DIFFICULT)  
5=OR YOU COULD NOT DO 
THIS ACTIVITY AT ALL? 
8=DON’T KNOW 
9=REFUSE 
your/his/her affected 
hand? 
 
(Would you say…)  
IF NEEDED: By ‘affected’ we 
mean the side of your body 
that was affected by 
your/his/her stroke. 
 
IN NOTE: THIS MEANS ANY 
PART OF THEIR BODY 
AFFECTED EVEN IF NOT 
THEIR HAND.  E.G. FACE, 
LEG, ETC. 
 
HEALTH_INTRO 
 
The next two questions are 
about how you perceive or 
view your general health.  
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
RateHlt 
1=poor 
2=fair 
3=good 
4=very good 
5=excellent 
8=DON’T KNOW 
9=REFUSE 
 
Compared to others your 
age, how would you rate 
your health since your 
stroke or TIA?  
 
Would you say… 
 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
PredHlt 
1=Stay the same 
2=Improve 
3=Get worse 
8=DON’T KNOW 
9=REFUSE 
 
Over the next 3 months, do 
you think your health is 
going to: 
 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
MRS_INTRO 
 
This next set of questions is 
asking about the level of 
assistance you/he/she may 
or may not need with certain 
tasks and your/his/her 
ability to do things since 
your/his/her stroke or TIA.” 
[IF INTRO=1, 
FILL]Depending on your 
responses I may skip some 
of the questions on the 
survey you have in front of 
you.  
 

March 19, 2021 
Application - IRB00035998 
132 
 
 
IF NEEDED: TIA stands 
for transient ischemic attack 
and is sometimes referred to 
as a “mini-stroke” or 
“warning stroke.” 
 
MRS1 
0=NO (GO TO MRS4) 
1=YES (GO TO MRS2) 
 
8=DON’T KNOW (GO TO PA 
_INTRO) 
9=REFUSE (GO TO 
PA_INTRO) 
Could you/he/she live alone 
without any help from 
another person?  This 
means being able to bathe, 
use the toilet, shop, 
prepare or get meals and 
manage finances. 
 
IN:  AVOID DK OR REFUSE.  
ENCOURAGE THE R TO 
ANSWER YES OR NO. 
 
MRS2 
0=NO (GO TO PA_INTRO) 
1=YES (GO TO MRS3) 
 
8=DON’T KNOW (GO TO 
PA_INTRO) 
9=REFUSE (GO TO 
PA_INTRO) 
Can you/he/she do 
everything that you/he/she 
were/was doing right 
before your/his/her stroke, 
even if slower and not as 
much? 
 
MRS3 
0=NO (GO TO PA_INTRO) 
1=YES (GO TO PA_INTRO) 
 
8=DON’T KNOW (GO TO 
PA_INTRO) 
9=REFUSE (GO TO 
PA_INTRO) 
Are/Is you/he/she 
completely back to the way 
you/he/she were/was right 
before your/his/her stroke? 
 
MRS4 
0=NO (GO TO MRS5) 
1=YES (GO TO PA_INTRO) 
 
8=DON’T KNOW (GO TO 
PA_INTRO) 
9=REFUSE (GO 
TOPA_INTRO) 
Can you/he/she walk from 
one room to another 
without help from another 
person? 
 
IN NOTE:   WALKING FROM 
ONE ROOM TO ANOTHER 
WITHOUT THE HELP OF 
ANOTHER PERSON – 
INCLUDES WALKING WITH 
A CANE OR WALKER AS 
LONG AS THE PERSON DOES 
IT INDEPENDENTLY. 
 

March 19, 2021 
Application - IRB00035998 
133 
 
MRS5 
0=NO (GO TO PA_INTRO) 
1=YES (GO TO PA_INTRO) 
 
8=DON’T KNOW (GO TO 
PA_INTRO) 
9=REFUSE (GO TO 
PA_INTRO) 
Can you/he/she sit up in 
bed without any help? 
 
PA_INTRO 
 
The next few questions are 
about the amount of time 
you/he/she have/has spent 
walking in the last 7 days.  
 
PAday_YN 
0=NO (GO TO MOOD 
INTRO) 
1=YES (GO TO PADAY) 
 
8=DON’T KNOW (GO TO 
MOOD INTRO) 
9=REFUSE (GO TO MOOD 
INTRO) 
In the past 7 days did 
you/he/she walk 
continuously for at least 10 
minutes on any day? 
 
PAday 
ENTER A NUMBER FROM 0-
7   
IF >0, THEN GO TO PAMIN 
IF 0 GO TO MOOD_INTRO 
8=DON’T KNOW (GO TO 
MOOD_INTRO) 
9=REFUSE (GO TO MOOD 
INTRO) 
 
During the last 7 days on 
how many days did 
you/he/she walk 
continuously, for at least 10 
minutes, for recreation, 
exercise, or to get to or 
from places? 
IN: IF R RESPONDS ‘DON’T 
KNOW’, PROBE WHETHER 
DON’T KNOW # OF DAYS (IF 
THIS, ENCOURAGE BEST 
GUESS) OR DON’T KNOW IF 
10 MINUTES 
CONTINUOUSLY (IF THIS, 
GO BACK TO PADAY_YN 
AND CHOOSE DON’T 
KNOW) 
 
IF NEEDED:  Think only 
about the walking that 
you/he/she do/does for at 
least 10 minutes at a time. 
 
  
PAmin 
 
On days when you/he/she 
walked for at least 10 
minutes, how much total 
 

March 19, 2021 
Application - IRB00035998 
134 
 
Enter a numeric value 
between 10 and 840 (GO 
TO MOOD INTRO) 
 
8=DON’T KNOW (GO TO 
PAWALK) 
9=REFUSE (GO TO PAWALK)
 
 
 
 
time per day, did 
you/he/she spend walking?  
 
IN: We’re looking for an 
average time per day that 
you/he/she walked. 
PAwalk 
Enter a number of minutes 
 
8=DON’T KNOW 
9=REFUSE 
What is the total amount of 
time you/he/she spent 
walking over the last 7 
days? 
 
MOOD_INTRO 
 
The next two questions are 
about your mood. I now 
want you to think about the 
past two weeks, how often 
have you been bothered by 
any of the following 
problems?  
 
IN: STRESS 2 WEEKS SINCE 
RESPONDENT JUST 
FOCUSED ON PAST WEEK. 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
Mood1 
1=Not at all 
2=Several days 
3=More than half of the 
days 
4=Nearly every day 
8=DON’T KNOW 
9=REFUSE 
Little interest or pleasure in 
doing things? 
Would you say you’ve been 
bothered . . . 
 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
Mood2 
1=Not at all 
2=Several days 
3=More than half of the 
days 
4=Nearly every day 
8=DON’T KNOW 
9=REFUSE 
How about feeling down, 
depressed, or hopeless? 
Would you say you’ve been 
bothered . . . 
 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
 
 
 
 
 
 
EMPTY 
 
 
 
The next set of questions 
are not on the paper 
survey. This is a memory 
assessment. I am going to 
read a list of words that you 
will have to remember now 
and later on. Please listen 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
 

March 19, 2021 
Application - IRB00035998 
135 
 
carefully but do not write 
them down. When I am 
through, tell me as many 
words as you can 
remember. It doesn’t 
matter in what order you 
say them.  
Are you ready to hear the 
words? 
 
 
 
MOCA1_1 
MOCA1_2 
MOCA1_3 
MOCA1_4  
MOCA1_5 
 
1=FACE  
2=VELVET 
3=CHURCH  
4=DAISY 
5=RED   
IN: WHEN R IS READY, READ 
THE FOLLOWING OUT LOUD 
AT A RATE OF 1 WORD PER 
SECOND: 
Face, Velvet, Church, Daisy, 
Red 
 
Now, please tell me which 
words you remember. 
 
IN: IF R SAYS SIMILAR 
SOUNDING WORD, COUNT 
AS CORRECT AND SAY:  
Thank you.  I will count that 
as the correct answer, but 
to clarify, the word was 
[REPEAT WORD], spelled 
[SPELL WORD]. 
 
WHEN THE SUBJECT 
INDICATES THAT (S)HE 
HAS FINISHED (HAS 
RECALLED ALL 
WORDS), OR CAN 
RECALL NO MORE 
WORDS, MOVE ON. 
 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
 
EMPTY 
Thank you. I’m going to 
read the same list a second 
time. Try to remember and 
tell me as many words as 
you can, including words 
you said the first time.   
  
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
 
(do second trial even 
if 1st trial successful) 

March 19, 2021 
Application - IRB00035998 
136 
 
 
MOCA12_1 
 
 
 
 
 
MOCA12_2 
 
 
 
 
 
MOCA12_3 
 
 
 
 
 
MOCA12_4 
 
 
 
 
 
MOCA12_5 
1=FACE  
2=VELVET 
3=CHURCH  
4=DAISY 
5=RED 
 
1=FACE  
2=VELVET 
3=CHURCH  
4=DAISY 
5=RED 
 
1=FACE  
2=VELVET 
3=CHURCH  
4=DAISY 
5=RED 
 
1=FACE  
2=VELVET 
3=CHURCH  
4=DAISY 
5=RED 
 
1=FACE  
2=VELVET 
3=CHURCH  
4=DAISY 
5=RED   
Are you ready to hear the 
words? 
 
IN: WHEN R IS READY, READ 
THE FOLLOWING: 
Face, Velvet, Church, Daisy, 
Red 
 
IF NEEDED: Now please tell 
me which words you 
remember. 
 
IN: IF R SAYS SIMILAR 
SOUNDING WORD, COUNT 
AS CORRECT AND SAY:  
Thank you.  I will count that 
as the correct answer, but 
to clarify, the word was 
[REPEAT WORD], spelled 
[SPELL WORD]. 
 
 
CHECK EACH ONE THAT THE 
R SAYS CORRECTLY THE 2ND 
TIME. 
 
WHEN THE SUBJECT 
INDICATES THAT (S)HE 
HAS FINISHED (HAS 
RECALLED ALL 
WORDS), OR CAN 
RECALL NO MORE 
WORDS, MOVE ON. 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
MOCA_THANKS 
EMPTY 
Thank you.  I will ask you to 
recall these words again at 
the end of the test.  
 
IN: DO NOT REPEAT THE 
WORDS OR TELL THE R 
WHICH ONES S/HE FORGOT 
 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
MOCA2_01 
MOCA2_02 
MOCA2_03 
MOCA2_04 
ANIMAL1=1 
ANIMAL2=2 
ANIMAL3=3 
I’d like you to name as 
many animals as you can in 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 

March 19, 2021 
Application - IRB00035998 
137 
 
MOCA2_05 
MOCA2_06 
MOCA2_07 
MOCA2_08 
MOCA2_09 
MOCA2_10 
MOCA2_11 
MOCA2_12 
MOCA2_13 
MOCA2_14 
MOCA2_15 
MOCA2_16 
MOCA2_17 
MOCA2_18 
 
ANIMAL4=4 
ANIMAL5=5 
ANIMAL6=6 
ANIMAL7=7 
ANIMAL8=8 
ANIMAL9=9 
ANIMAL10=10 
ANIMAL11=11 
ANIMAL12=12 
ANIMAL13=13 
ANIMAL14=14 
ANIMAL15=15 
ANIMAL16=16 
ANIMAL17=17 
ANIMAL18=18 
 
Value is missing (.) when no 
animal was named 
one minute. You can start 
now. 
IF NEEDED: Animal can 
include mammals, reptiles, 
fish, birds, insects, etc.  
Anything that moves on its 
own and eats. 
 
IN: DO NOT COUNT THE 
EXACT SAME ANIMAL 
TWICE; E.G. HORSE AND 
HORSE 
DO COUNT VARIATIONS; 
E.G. BIRD AND EAGLE 
 
IN: CHECK THE BOX FOR 
EACH ANIMAL NAMED. 
STOP RESPONDENT AT ONE 
MINUTE OR WHEN 18 
ANIMALS HAVE BEEN 
NAMED, WHICHEVER 
COMES FIRST. 
MOCA3_1 
 
 
 
 
MOCA3_2 
 
 
 
 
MOCA3_3 
 
 
 
 
 
MOCA3_4 
1=MONTH  
2=DATE 
3=YEAR  
4=DAY OF THE WEEK 
 
1=MONTH  
2=DATE 
3=YEAR  
4=DAY OF THE WEEK 
 
1=MONTH  
2=DATE 
3=YEAR  
4=DAY OF THE WEEK 
 
 
1=MONTH  
2=DATE 
3=YEAR  
4=DAY OF THE WEEK 
 
Thank you.  Can you tell me 
today’s date? 
 
IF RESPONDENT GIVES AN 
INCOMPLETE ANSWER, 
PROMPT ACCORDINGLY: 
Can you tell me the year, 
month, exact date, and day 
of the week? 
 
IN: MARK EACH CORRECT 
RESPONSE, THE DATE AND 
DAY OF THE WEEK CAN BE 
OFF BY A DAY AND STILL BE 
COUNTED. E.G. TODAY’S 
DATE IS 5/10, SO 5/9, 5/10, 
OR 5/11 ARE CORRECT 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
 
 
MOCA3e 
ENTER STREET 
[50 CHAR] 
Can you tell me the name 
of the street you live on? 
 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 

March 19, 2021 
Application - IRB00035998 
138 
 
STREET ADDRESS ON 
RECORD IS: [FILL] 
 
PROGRAMMING: 
THESE ARE 
PRELOADED 
MOCA3f 
ENTER CITY 
Now, can you tell me the 
city you live in? 
 
CITY ON RECORD IS: [FILL] 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
PROGRAMMING: 
THESE ARE 
PRELOADED 
MOCA13_1 
 
 
 
 
 
MOCA13_2 
 
 
 
 
 
MOCA13_3 
 
 
 
 
 
MOCA13_4 
 
 
 
 
 
MOCA13_5 
1=FACE  
2=VELVET 
3=CHURCH  
4=DAISY 
5=RED   
 
 
1=FACE  
2=VELVET 
3=CHURCH  
4=DAISY 
5=RED 
 
1=FACE  
2=VELVET 
3=CHURCH  
4=DAISY 
5=RED 
 
1=FACE  
2=VELVET 
3=CHURCH  
4=DAISY 
5=RED 
 
1=FACE  
2=VELVET 
3=CHURCH  
4=DAISY 
5=RED 
I read some words to you 
earlier, which I asked you to 
remember. Can you tell me 
those words?  
CHECK EACH ONE THAT THE 
R SAYS CORRECTLY.  
IN: IF R SAYS SIMILAR 
SOUNDING WORD, COUNT 
AS CORRECT AND SAY:  
Thank you.  I will count that 
as the correct answer, but 
to clarify, the word was 
[REPEAT WORD], spelled 
[SPELL WORD]. 
 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
MOCA_HELP 
 
Thank you.  Let me help you 
remember the ones you 
forgot. 
 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
 
PROGRAMMING: SKIP 
TO MED INTRO IF ALL 
FIVE (MOCA1a3-
MOCA1e4) WERE 
CHECKED 
MOCA4a_MISS 
1=FACE 
IF MOCA1a3 MISSING: 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 

March 19, 2021 
Application - IRB00035998 
139 
 
8=DON’T KNOW (GO TO 
MOCA4a_MISS2) 
9=REFUSE (GO TO 
MOCA4a_MISS2) 
Do you remember the word 
that is a part of the body? 
MOCA4a_MISS2 
1=FACE 
2=OTHER RESPONSE  
8=DON’T KNOW 
9=REFUSE 
Do you think the word was 
eyes, shoulder or face? 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
 
PROGRAMMING: 
OTHER RESPONSE, 
DON’T KNOW AND 
REFUSE GO TO EITHER 
NEXT MISSED WORD 
OR MED INTRO IF NO 
MORE MISSED 
WORDS 
 
 
MOCA4b_MISS 
1=VELVET 
8=DON’T KNOW (GO TO 
MOCA4b_MISS2) 
9=REFUSE (GO TO 
MOCA4b_MISS2) 
IF MOCA1b3 MISSING: 
Do you remember the word 
that is a type of fabric? 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
MOCA4b_MISS2 
1=VELVET 
2=OTHER RESPONSE 
8=DON’T KNOW 
9=REFUSE 
Do you think the word was 
satin, velvet or cotton? 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
PROGRAMMING: 
OTHER RESPONSE, 
DON’T KNOW AND 
REFUSE GO TO EITHER 
NEXT MISSED WORD 
OR MED INTRO IF NO 
MORE MISSED 
WORDS 
 
MOCA4c_MISS 
1=CHURCH 
8=DON’T KNOW (GO TO 
MOCA4c_MISS2) 
9=REFUSE  (GO TO 
MOCA4c_MISS2) 
 
IF MOCA1c3 MISSING: 
Do you remember the word 
that is a place people go to 
worship? 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
MOCA4c_MISS2 
1=CHURCH 
2=OTHER RESPONSE 
8=DON’T KNOW 
9=REFUSE 
Do you think the word was 
library, church or store? 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
PROGRAMMING: 
OTHER RESPONSE, 
DON’T KNOW AND 
REFUSE GO TO EITHER 

March 19, 2021 
Application - IRB00035998 
140 
 
NEXT MISSED WORD 
OR MED INTRO IF NO 
MORE MISSED 
WORDS 
 
MOCA4d_MISS 
1=DAISY 
8=DON’T KNOW (GO TO 
MOCA4d_MISS2) 
9=REFUSE (GO TO 
MOCA4d_MISS2) 
IF MOCA1d4 MISSING: 
Do you remember the word 
that is a type of flower? 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
MOCA4d_MISS2 
1=DAISY 
2=OTHER RESPONSE 
8=DON’T KNOW 
9=REFUSE 
Do you think the word was 
rose, iris or daisy? 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
PROGRAMMING: 
OTHER RESPONSE, 
DON’T KNOW AND 
REFUSE GO TO EITHER 
NEXT MISSED WORD 
OR MED INTRO IF NO 
MORE MISSED 
WORDS 
 
MOCA4e_MISS 
1=RED 
8=DON’T KNOW (GO TO 
MOCA4e_MISS2) 
9=REFUSE (GO TO 
MOCA4e_MISS2) 
IF MOCA1e4 MISSING: 
Do you remember the word 
that is a color? 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
MOCA4e_MISS2 
1=RED 
2=OTHER RESPONSE 
8=DON’T KNOW 
9=REFUSE 
Do you think the word was 
red, blue or green? 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
PROGRAMMING: 
OTHER RESPONSE, 
DON’T KNOW AND 
REFUSE GO TO MED 
INTRO  
 
MED_INTRO 
 
Thank you.  The next 4 
questions are about 
medications you take. 
Think about how you have 
taken your medications 
during the past four weeks 
when answering these 
questions. 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
MMAS1 
0=NO (GO TO MMAS2 
1=YES (GO TO MMAS2 
 
Do you ever forget to take 
your medicine? 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 

March 19, 2021 
Application - IRB00035998 
141 
 
8=DON’T KNOW (GO TO 
MMAS2 
9=REFUSE (GO TO MMAS2 
MMAS2 
0=NO (GO TO MMAS3 
1=YES (GO TO MMAS3 
 
8=DON’T KNOW (GO TO 
MMAS3 
9=REFUSE (GO TO MMAS3 
Are you careless at times 
about taking your 
medicine? 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
MMAS3 
0=NO (GO TO MMAS4 
1=YES (GO TO MMAS4 
 
8=DON’T KNOW (GO TO 
MMAS4 
9=REFUSE (GO TO MMAS4 
Sometimes if you feel 
worse when you take the 
medicine, do you stop 
taking it? 
 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
MMAS4 
0=NO (GO TO BPHome 
Intro) 
1=YES (GO TO BPHome 
Intro) 
 
8=DON’T KNOW (GO TO 
BPHome Intro) 
9=REFUSE (GO TO BPHome 
Intro) 
When you feel better, do 
you sometimes stop taking 
your medicine? 
 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
BPHome_Intro 
 
Now I’d like to ask some 
questions about checking 
your/his/her blood pressure 
and your/his/her usual or 
regular health care 
provider. 
 
BPHome 
0=NO (GO TO BPVAL) 
1=YES (GO TO BPFREQ) 
 
8=DON’T KNOW(GO TO 
PCP) 
 
9=REFUSE(GO TO PCP) 
 
Do/Does you/he/she check 
your/his/her blood pressure 
at home? 
 
IN: BP COULD BE CHECKED 
BY A FAMILY MEMBER, 
FRIEND. ANY CHECKING OF 
BP SINCE INITIAL 
HOSPITALIZATION WOULD 
QUALIFY AS A YES. 
 
BPFREQ 
1=daily (GO TO BPVALsys) 
2=weekly or (GO TO 
BPVALsys) 
3=monthly? (GO TO 
BPVALsys) 
How frequently do/does 
you/he/she check 
your/his/her blood 
pressure? 
Would you say…  
 

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8=DON’T KNOW (GO TO 
BPVALsys) 
9=REFUSE (GO TO 
BPVALsys) 
 
BPVALsys 
Enter number between 50 
and 250. 
(GO TO BPVALdia) 
 
8=DON’T KNOW(GO TO 
PCP) 
9=REFUSE(GO TO PCP) 
 
What was the value of 
your/his/her last blood 
pressure?   
Please provide the systolic 
(top number) and diastolic 
(bottom number). 
 
IN: ENTER TOP NUMBER 
HERE AND BOTTOM 
NUMBER ON FOLLOWING 
SCREEN.  
 
IF NEEDED: We are 
interested in your most 
recent BP no matter who 
took the measurement. 
 
BPVALdia 
Enter number between 35 
and 135. 
(GO TO BPWHO) 
 
What was the value of 
your/his/her last blood 
pressure?   
Please provide the systolic 
(top number) and diastolic 
(bottom number). 
 
IN: ENTER BOTTOM 
NUMBER HERE  
 
BPWHO 
1=you/the patient 
himself/the patient herself 
2= a healthcare 
professional 
3= a family member, or 
4= someone else? (GO TO 
BPWHO_OTHER) 
Was this blood pressure 
measurement taken by . . .  
 
BPWHO_OTHER 
OPEN TEXT 
(50 CHARACTERS) 
Who took the blood 
pressure? 
 
PCP 
0=NO (GO TO PTVIS) 
1=YES (GO TO PCPVIS) 
 
8=DON’T KNOW (GO TO 
PTVIS) 
9=REFUSE (GO TO PTVIS) 
Is there a particular doctor's 
office, health center, or 
other place that you/he/she 
usually go/goes if 
you/he/she are/is sick and 
 

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need/needs advice about 
your/his/her health? 
 
IN: THIS COULD INCLUDE 
ANY TYPE OF DOCTOR IF 
THE RESPONDENT USES 
THEM REGULARLY. IT DOES 
NOT INCLUDE A HOSPITAL 
EMERGENCY DEPARTMENT. 
PCPvis 
0=NO (GO TO PTVIS) 
1=YES(GO TO PTVIS) 
 
8=DON’T KNOW(GO TO 
PTVIS) 
9=REFUSE(GO TO PTVIS) 
Have/Has you/he/she 
visited a doctor or nurse 
from that office, health 
center or other place since 
you/he/she were/was 
discharged from the 
hospital after your/his/her 
stroke? 
 
 
PTvis 
0=NO (GO TO OTvis) 
1=YES (GO TO PTvisL) 
 
8=DON’T KNOW (GO TO 
OTvis) 
9=REFUSED (GO TO OTvis) 
Since you/he/she were/was 
discharged home on 
[PRELOAD DISCHARGE OR 
NEW_DISCHARGE, IF 
FILLED] after your/his/her 
stroke or TIA, have/has 
you/he/she received any 
services from a physical 
therapist? 
 
IF NEEDED: Physical 
therapists help patients 
with their mobility, (for 
example, walking, moving 
from sitting to standing, 
going up stairs, getting in 
and out of bed) and 
physical activity. 
 
PTvisL 
1=your/his/her home (GO 
TO OTvis) 
2=an outpatient clinic, or 
(GO TO OTvis) 
3=both? (GO TO OTvis) 
 
8=DON’T KNOW (GO TO 
OTvis) 
9=REFUSED  (GO TO OTvis) 
Did you/he/she receive the 
services in … 
 

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OTvis 
0=NO (GO TO STvis) 
1=YES (GO TO OTvisL) 
 
8=DON’T KNOW (GO TO 
STvis) 
9=REFUSED (GO TO STvis) 
Since you/he/she were/was 
discharged home on 
<autofill date> after 
your/his/her stroke or TIA, 
have/has you/he/she 
received any services from 
an occupational therapist? 
 
IF NEEDED: Occupational 
therapists help patients 
with their activities of daily 
living (for example, 
dressing, bathing, cooking, 
eating). 
 
OTvisL 
1=your/his/her home (GO 
TO STvis) 
2=an outpatient clinic, or 
(GO TO STvis) 
3=both? (GO TO STvis) 
 
8=DON’T KNOW (GO TO 
STvis) 
9=REFUSED  (GO TO STvis) 
Did you/he/she receive the 
services in … 
 
STvis 
0=NO (GO TO FALL_INTRO) 
1=YES (GO TO STvisL) 
 
8=DON’T KNOW (GO TO 
FALL_INTRO) 
9=REFUSED (GO TO 
FALL_INTRO) 
Since you/he/she were/was 
discharged home on 
<autofill date> after 
your/his/her stroke or TIA, 
have/has you/he/she 
received any services from 
a speech therapist? 
 
IF NEEDED: Speech 
therapists help patients 
with their communication 
and swallowing. 
 
STvisL 
1=your/his/her home 
2=an outpatient clinic, or 
3=both? 
 
8=DON’T KNOW (GO TO 
FALL_INTRO) 
9=REFUSED  (GO TO 
FALL_INTRO) 
Did you/he/she receive the 
services in … 
 

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FALL_INTRO 
 
The next few questions are 
about any falls or 
hospitalizations 
you’ve/he’s/she’s had since 
your/his/her stroke/TIA. 
 
Fall1 
0=NO (GO TO ReAdmit) 
1=YES (GO TO Fall2) 
 
8=DON’T KNOW (GO TO 
ReAdmit) 
9=REFUSE (GO TO ReAdmit) 
 
Since you/he/she were/was 
discharged from the 
hospital on [PRELOAD 
DISCHARGE DATE] after 
your/his/her stroke or TIA, 
have/has you/he/she 
fallen?  
 
Fall2 
0=NO (GO TO Fall3) 
1=YES (GO TO Fall3) 
 
8=DON’T KNOW (GO TO 
Fall3) 
9=REFUSE (GO TO Fall3) 
Did you/he/she get injured 
and need to go to the 
doctor or emergency room 
due to a fall? 
 
Fall3 
0=NO (GO TO ReAdmit) 
1=YES (GO TO FALL4) 
 
8=DON’T KNOW (GO TO 
READMIT) 
9=REFUSE (GO TO 
READMIT) 
Have/Has you/he/she fallen 
more than once since 
your/his/her stroke? 
 
FALL4 
Enter a number between 2 
and 99. (GO TO ReAdmit) 
8=DON’T KNOW (GO TO 
ReAdmit) 
9=REFUSE (GO TO ReAdmit) 
 
 
 
How many times have/has 
you/he/she fallen? 
 
IF NEEDED: A best guess is 
fine. 
 
ReAdmit 
0=NO (GO TO 
PROMIS_INTRO) 
1=YES (GO TO READMITN) 
 
8=DON’T KNOW (GO TO 
PROMIS_INTRO ) 
 
9=REFUSE (GO TO 
PROMIS_INTRO ) 
 
Since you/he/she were/was 
discharged from the 
hospital on <date>, 
have/has you/he/she been 
hospitalized overnight for 
any reason? 
 
 
ReAdmitN 
Enter a number between 1 
and 99. (GO TO 
PROMIS_INTRO) 
How many times have/has 
you/he/she been in the 
 

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8=DON’T KNOW (GO TO 
PROMIS_INTRO) 
9=REFUSE (GO TO 
PROMIS_INTRO) 
hospital overnight for any 
reason?  
 
 
IN NOTE: WE ARE 
INTERESTED IN NUMBER OF 
ADMISSIONS, NOT NIGHTS 
PROMIS_INTRO 
 
The next few questions are 
about feelings of tiredness 
or fatigue 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
PROMIS1 
1=Not at all       
2=A little bit 
3=Somewhat 
4=Quite a bit 
5=Very much 
8=DON’T KNOW 
9=REFUSE 
During the past 7 days, how 
often have you felt tired or 
fatigued? 
Would you say . . . 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
PROMIS2 
1=Not at all       
2=A little bit 
3=Somewhat 
4=Quite a bit 
5=Very much 
8=DON’T KNOW 
9=REFUSE 
During the past 7 days, how 
often have you had trouble 
starting things because you 
were tired? 
Would you say . . . 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
PROMIS3 
1=NOT AT ALL       
2=A LITTLE BIT 
3=SOMEWHAT 
4=QUITE A BIT 
5=VERY MUCH 
8=DON’T KNOW 
9=REFUSE 
(In the past 7 days,) how 
run-down did you feel on 
average?         
(Would you say. . .) 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
PROMIS4 
1=NOT AT ALL       
2=A LITTLE BIT 
3=SOMEWHAT 
4=QUITE A BIT 
5=VERY MUCH 
8=DON’T KNOW 
9=REFUSE 
(In the past 7 days,) how 
fatigued were you on 
average? 
(Would you say. . .) 
PROGRAMMING: SKIP 
IF PROXY=1 OR 2 
SATIS_INTRO 
 
The next several questions 
are about the care 
you’ve/he’s/she’s received 
from your/his/her 
physicians, nurses and 
other health care providers 
since you/he/she had 
your/his/her stroke or TIA. 
 

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Satis1 
1=Never 
2=Sometimes 
3=Usually 
4=Always 
8=DON’T KNOW 
9=REFUSE 
Thinking about the care 
you/he/she have/has 
received for your/his/her 
stroke or TIA recovery since 
you/he/she were/was 
discharged from the 
hospital on [PRELOAD 
DISCHARGE DATE], how 
often did your/his/her 
physicians, nurses and 
other health care 
providers… 
Explain things in a way that 
was easy [for him/her] to 
understand? 
Would you say. . . 
 
INTERVIEWER NOTE: 
PATIENTS SHOULD 
THINK ABOUT THE 
CARE THEY’VE 
RECEIVED FROM ALL 
OF THEIR PHYSICIANS 
(E.G., SPECIALIST AND 
PRIMARY CARE 
PROVIDERS) 
 
Satis2 
1=Never 
2=Sometimes 
3=Usually 
4=Always 
8=DON’T KNOW 
9=REFUSE 
(Thinking about the health 
care providers you/he/she 
have/has seen since 
you/he/she were/was 
discharged from the 
hospital) 
How often did these 
providers listen carefully to 
you/him/her? 
Would you say. . . 
 
Satis3 
1=NEVER 
2=SOMETIMES 
3=USUALLY 
4=ALWAYS 
8=DON’T KNOW 
9=REFUSE 
(Thinking about the health 
care providers you/he/she 
have/has seen since 
you/he/she were/was 
discharged from the 
hospital) 
How often did they seem to 
know the important 
 

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information about 
your/his/her medical 
history? 
(Would you say. . .) 
Satis4 
1=NEVER 
2=SOMETIMES 
3=USUALLY 
4=ALWAYS 
8=DON’T KNOW 
9=REFUSE 
(Thinking about the health 
care providers you/he/she 
have/has seen since 
you/he/she were/was 
discharged from the 
hospital, 
How often did they) Show 
respect for what 
you/he/she had to say? 
(Would you say . . .) 
 
Satis5 
1=NEVER 
2=SOMETIMES 
3=USUALLY 
4=ALWAYS 
8=DON’T KNOW 
9=REFUSE 
(Thinking about the health 
care providers you/he/she 
have/has seen since 
you/he/she were/was 
discharged from the 
hospital, How often did 
they) Spend enough time 
with you/him/her? 
(Would you say . . .) 
 
Satis6 
1=NEVER 
2=SOMETIMES 
3=USUALLY 
4=ALWAYS 
8=DON’T KNOW 
9=REFUSE 
(Thinking about the health 
care providers you/he/she 
have/has seen since 
you/he/she were/was 
discharged from the 
hospital, How often did 
they)Talk about all the 
prescription medicines 
you/he/she were/was 
taking? 
(Would you say . . .) 
 
COMRES_INTRO 
 
Now I’d like to ask you 
about any community 
services you/he/she 
have/has used since 
your/his/her stroke or TIA 
 
ComRes1 
0=NO 
1=YES 
 
8=DON’T KNOW 
9=REFUSE 
Thinking back since 
discharge from the hospital 
after your/his/her stroke, 
have/has you/he/she used 
any adult day care 
programs or other adult 
 

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services for social support 
or recreation for stroke 
survivors? 
 
NOTE: These are programs 
that provide care and 
companionship for older adults 
who need assistance or 
supervision during the day. 
These programs offer some 
relief to family members and 
caregivers.  
 
ComRes2 
0=NO 
1=YES 
 
8=DON’T KNOW 
9=REFUSE 
Since discharge from the 
hospital after your/his/her 
stroke, have/has 
you/he/she used 
community services or 
classes to help with your 
ability to speak, read, or 
write?  
IN NOTE: An example would 
be  an aphasia support 
group.   
 
 
ComRes3 
0=NO 
1=YES 
 
8=DON’T KNOW 
9=REFUSE 
Since discharge from the 
hospital after your/his/her 
stroke, have/has 
you/he/she used counseling 
services or therapy for 
stress or depression  
 
IN NOTE: (An example is 
CareNet counseling)? 
 
 
ComRes4 
0=NO 
1=YES 
 
8=DON’T KNOW 
9=REFUSE 
(Since discharge from the 
hospital after your/his/her 
stroke) How about any 
programs that promote 
healthy living like classes on 
diet or managing diabetes?  
 
IN NOTE: Other examples 
include classes on managing 
chronic pain, problems with 
 

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breathing, high blood 
pressure. 
 
ComRes5 
0=NO 
1=YES 
 
8=DON’T KNOW 
9=REFUSE 
(Since discharge from the 
hospital after your/his/her 
stroke) How about exercise 
classes that are open to the 
general public, like ones 
offered at a church or 
fitness center?   
 
ComRes6 
0=NO 
1=YES 
2=DOES NOT SMOKE 
 
8=DON’T KNOW 
9=REFUSE 
(Since discharge from the 
hospital after your/his/her 
stroke, how about) 
programs to help you quit 
smoking? 
 
 
ComRes7 
0=NO 
1=YES 
 
8=DON’T KNOW 
9=REFUSE 
(Since discharge from the 
hospital after your/his/her 
stroke, how about) a falls 
prevention program that 
teaches you how to 
improve your balance and 
strength so you don’t fall? 
 
 
ComRes8 
0=NO 
1=YES 
 
8=DON’T KNOW 
9=REFUSE 
(Since discharge from the 
hospital after your/his/her 
stroke, how about) 
programs that provide 
meals – either delivered to 
your house or a central 
location like a church or 
community center? 
 
 
ComRes9 
0=NO 
1=YES 
 
8=DON’T KNOW 
9=REFUSE 
(Since discharge from the 
hospital after your/his/her 
stroke, how about) a 
support group for stroke 
survivors? 
IN NOTE: these are  groups 
that provide social support, 
information, and resources 
for stroke survivors   
 
ComRes10 
0=NO 
1=YES 
 
(Since discharge from the 
hospital after your/his/her 
stroke, how about) 
 

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8=DON’T KNOW 
9=REFUSE 
medication assistance or 
management services to 
help pay for the 
medications or to help 
understand and manage 
the medications? 
 
IN NOTE: management 
services are usually offered 
by pharmacists. 
 
 
 
 
ComRes11 
0=NO 
1=YES 
 
8=DON’T KNOW 
9=REFUSE 
(Since discharge from the 
hospital after your/his/her 
stroke, how about) 
transportation services to 
get you to your healthcare 
appointments or 
community activities? 
 
 
IN NOTE: THIS DOES NOT 
INCLUDE REGULAR PUBLIC 
TRANSPORTATION 
 
 
ComRes12 
0=NO 
1=YES 
 
8=DON’T KNOW 
9=REFUSE 
(Since discharge from the 
hospital after your/his/her 
stroke, how about) support 
services for your family or 
caregivers?  
 
IN NOTE: these are groups 
or services that provide 
social support, information, 
and resources for 
caregivers/family members 
of storke survivors? 
 
 
ComRes13 
0=NO (GO TO EDUC) 
1=YES (GO TO COMRES14) 
 
8=DON’T KNOW (GO TO 
EDUC) 
9=REFUSE (GO TO EDUC) 
Are there any other services 
you’ve/he’s/she’s used that 
I haven’t mentioned? 
 
ComRes14 
SPECIFY OTHER 
OPEN TEXT 
[250 CHAR] 
What are those? 
 

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Educ 
1=8TH GRADE OR LESS 
2=SOME HIGH SCHOOL, 
BUT DID NOT GRADUATE 
3=HIGH SCHOOL 
GRADUATE OR GED 
4=SOME COLLEGE OR 2-
YEAR DEGREE 
5=4-YEAR COLLEGE 
GRADUATE 
6=MORE THAN 4-YEAR 
COLLEGE DEGREE 
8=DON’T KNOW 
9=REFUSE 
What is the highest grade 
or level of school that 
you/he/she have/has 
completed? 
 
PROMIS_INTRO 
EMPTY 
These last few questions 
are about your health and 
how you have been feeling. 
 
Global01 
1=Excellent 
2=Very good 
3=Good  
4=Fair, or  
5=Poor 
In general, would you say 
your health is... 
 
Global02 
1=Excellent 
2=Very good 
3=Good  
4=Fair, or  
5=Poor 
In general, would you say 
your quality of  
life is... 
 
Global03 
1=EXCELLENT 
2=VERY GOOD 
3=GOOD  
4=FAIR, OR  
5=POOR 
In general, how would you 
rate your physical health? 
 
(Would you say...) 
 
Global04 
1=EXCELLENT 
2=VERY GOOD 
3=GOOD  
4=FAIR, OR  
5=POOR 
In general, how would you 
rate your mental  
health, including your mood 
and your ability to  
think? 
 
(Would you say...) 
 
Global05 
1=EXCELLENT 
2=VERY GOOD 
3=GOOD  
4=FAIR, OR  
5=POOR 
In general, how would you 
rate your satisfaction  
with your social activities 
and relationships? 
 
(Would you say...) 
 

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Global09 
1=EXCELLENT 
2=VERY GOOD 
3=GOOD  
4=FAIR, OR  
5=POOR 
In general, please rate how 
well you carry out  
your usual social activities 
and roles. This includes 
activities at home, at work 
and in your community, and 
responsibilities as a parent,  
child, spouse, employee, 
friend, etc. 
 
(Would you say...) 
 
 
 
Global06 
1=Completely 
2=Mostly 
3=Moderately 
4=A little, or 
5=Not at all 
To what extent are you able 
to carry out your  
everyday physical activities 
such as walking,  
climbing stairs, carrying 
groceries, or moving a  
chair?  Would you say... 
 
Global10 
1=Never 
2=Rarely 
3=Sometimes 
4=Often, or 
5=Always 
In the past 7 days, how 
often have you been 
bothered by emotional 
problems such as feeling 
anxious, depressed or 
irritable? 
Would you say ... 
 
Global08 
1=None 
2=Mild 
3=Moderate 
4=Severe, or 
5=Very severe 
In the past 7 days, how 
would you rate your fatigue 
on average? 
Would you say... 
 
Global07 
ENTER NUMBER 
(RANGE 0-10) 
Picture a scale from 0 to 10, 
with zero being no pain and 
ten being the worst 
imaginable pain.   
In the past 7 days, how 
would you rate your pain 
on average? 
 
 
 
 
 
THANK_YOU 
 
Thank you. That’s the end 
of the survey.  Goodbye. 
 
 
 
 
 

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Appendix 24 - 90d Patient Survey (Full Survey Mailed with the 80 day letter) 
 
 
 
 
 

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Appendix 25 – 90d Patient Non-Responder Survey and Letter (Mailed if unable to 
reach over phone) 
 
Dear <NAME>, 
 
 
 
 
 
 
 
 
 
<DATE> 
 
Greetings from the COMPASS Study team!  We are working with  your care team at <HOSPITAL 
NAME> to find the best ways to improve healthcare for people who had a transient ischemic 
attack (TIA), mini-stroke, stroke, or related episode.  A few weeks ago we tried calling you and 
are sorry that we haven’t been able to reach you!   
 
We’d like to know how you’ve been doing since your hospital visit 3 months ago.  Your 
participation is completely voluntary and confidential.  Your response is very valuable and will 
help improve healthcare for others in North Carolina.   
How you can participate:  
[-] Answer the questions on the next page and mail the completed survey back to 
us in the postage-paid envelope.  Please return it within 5 days.   
OR 
[-] Contact us, toll-free, at 1-844-501-7668 if you would prefer to answer the 
questions by phone. 
 
This is your last chance to let us know how you are doing.  We need your help and thank you 
for your valuable contribution!  
 
Find out more about the COMPASS Study:  
[-] To learn more about the COMPASS Study please visit our website:                  
www.nccompass-study.org 
[-] If you would like to speak with a team member about the study, call us at:                          
1-844-501-7668 
 
Thanks for filling out the included survey and returning it to us! 
 
Best regards, 
The COMPASS Study Team 
 
 

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Appendix 26 - Caregiver Letter (First Attempt) 
 

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Appendix 27 - Caregiver Survey  
 
 
 

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Appendix 28 - Proxy SIS-16  
 
Removed – COMPASS is no longer asking caregiver’s questions about the patient.  The Proxy SIS-16 has been removed. 
. 
 

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Appendix 29 - Caregiver Letter (Second Attempt) 
 
 
 

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Appendix 30 - Caregiver Thank You Note  
 Removed – COMPASS will no longer be sending a 10 dollar gift card to caregivers.  
 

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Appendix 31 - IRB Approval Letter for PCORI Stakeholder Interviews 
 

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Appendix 32 - DSMB Template Sections  
 
List of Report Sections 
 
1. Executive Summary 
2. Protocol Synopsis 
a. Project Organizational Chart 
b. Study Purpose  
c. Projected Timetable And Schedule 
d. List Of Participating Hospitals 
3. Narrative & Trial Summary 
a. Study Status 
4. Recruitment And Randomization 
5. Training 
6. Implementation Of The Compass Study And Assessment Of Fidelity 
7. Vanguard Hospital 
8. Safety And Privacy Of Participants 
9. Outcomes 
10. Publications 
11. Contract Modifications 
a. Recommendations From The DSMB 
 
b. Summary Of Protocol Changes 
12. Recruitment And Participant Status: Figures & Tables 
a. Hospital Recruitment And Randomization 
b. Participant Enrollment And Outcome Ascertainment  
13. Data Quality Tables 
a. Study Activity Completion 
b. Quality Analysis Of Implementation 
 
c. Summary Of Data Form Completion 
 
14. Appendices 
 
a. Bimonthly Survey For Implementation Site Webinars With Post-Acute Coordinators (Pac) And Advanced 
Practice Providers (App) 
 
b. Monthly Performance Report Templates  
c. Bimonthly Survey For Implementation Site Webinars With Home Health And Outpatient Rehabilitation 
Teams  
d. List Of Publications And Presentations For Compass 
 
 
 
 
 

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Appendix 33 – CTSI Supplemental Proposal (Implementation of COMPASS)  
 
Implementation of an evidence-based chronic disease care model: Identifying individual, 
organizational, and community facilitators (Gesell / Lutz) 
 
RESEARCH PLAN 
 
Specific Aims: 
 
Aim 1. Evaluate the Reach, Adoption, Implementation, and Maintenance (RE-AIM) of the COMPASS 
intervention, an evidence-based chronic disease care management model.  
 
Aim 2. Identify individual, organizational, and community factors that facilitate or are challenges to 
implementation of COMPASS.  
 
Aim 3. Identify strategies to build, maximize, and sustain community resource networks working together with 
the local hospital-based post-acute care coordination teams to support local implementation of COMPASS. 
 
Design & Methods 
Study Design: We will capture quantitative data via (1) bi-weekly questionnaires to the hospital-based post-
acute care (PAC) teams and Home Health Outpatient Therapy (HHOP) Teams to capture perceived barriers to 
uptake, and (2) real-time data on enrollment and performance measures at each site. We also will capture 
qualitative data via (1) transcription and coding of bi-weekly phone calls with PAC teams, and HOPP team and 
(2) semi-structured interviews with the Director of Implementation for the COMPASS study and members of the 
Implementation Committee. These calls will be facilitated by the Director of Implementation for the COMPASS 
study (S. Coleman) and will allow post-acute care coordinators to problem-solve together. These 4 data 
sources, collected from 20 health systems over one year, will identify which patient, staffing, and community-
level factors drive intervention uptake, challenges to uptake, and how health systems can improve 
performance on pre-defined performance measures. 
 
Sample: In the COMPASS study, 41 hospitals have been randomized (stratified by stroke volume and primary 
stroke center status) to receive COMPASS or usual care (control group). The proposed pilot will include the 20 
hospitals randomized to receive COMPASS. Roll-out of these 20 intervention sites has occurred in 3 waves 
(n=5, n=5, n=10), starting in August 2016. Within each wave, hospitals trained together and started 
implementation at the same time; they also participate in bi-monthly problem-solving calls together. We are 
adapting strategies after each wave to meet health systems’ unique environments and optimize approaches 
accordingly.  
 
Measurement Framework: The RE-AIM Framework, developed by Glasgow et al (1999), will guide the 
process evaluation of the implementation of COMPASS. RE-AIM guides the assessment of the Reach, 
Effectiveness, Adoption, Implementation, and Maintenance of public health interventions (e.g., policy or 
programmatic). Table 1 defines the RE-AIM components for COMPASS. Table 2 (Appendix) shows how the 
RE-AIM framework will guide the proposed process evaluation. Re-Aim has been used to evaluate the 
implementation of other large trials (e.g., ATTEND https://clinicaltrials.gov/ct2/show/NCT02123875).  
 
Table 1. RE-AIM Components Defined for COMPASS 
Reach 
of intended 
population 
Effectiveness 
Adoption 
by target staff, 
settings, or 
institutions 
Implementation 
consistency, and 
adaptations made 
during delivery 
Maintenance 
of intervention effects 
in individuals and 
settings over time 

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The absolute number, 
proportion, and 
representativeness of 
patients who are 
enrolled in  
COMPASS at 
hospital discharge   
The impact of 
COMPASS on 
important outcomes, 
including potential 
negative effects, 
quality of life, and 
economic outcomes 
The absolute number, 
proportion, and 
representativeness of 
hospitals and 
clinicians who are 
willing to initiate 
COMPASS 
The intervention 
agents’ fidelity to the 
various elements of 
an intervention’s 
protocol, including 
consistency of 
delivery as intended 
and the time and cost 
of the intervention 
The extent to which 
COMPASS becomes 
institutionalized or 
part of the routine 
organizational 
practices and policies 
 
Data Collection: In this mixed methods design, we will collect quantitative data via (1) bi-weekly 
questionnaires to the hospital-based post-acute care (PAC) teams and HHOP teams to capture perceived 
barriers to uptake (see Appendix for survey), and (2) how well the clinic is actually implementing the new care 
model (i.e., real-time data on enrollment and performance measures). We also will capture qualitative data via 
(1) transcription and coding of bi-weekly phone calls with PAC teams and HHOP Calls (2) semi structured 
interviews with the Director of Implementation for the COMPASS study and members of the Implementation 
Committee (see Table 3). The bi-weekly calls are facilitated by the Director of Implementation for the 
COMPASS study (Coleman) and allow PAC teams across the state to problem-solve together. These 4 data 
sources, collected from 20 health systems over one year, will allow us to triangulate which patient, staffing, and 
community-level factors drive intervention uptake, which pose challenges to uptake, and which drive health 
systems’ ability to improve performance.  
 
Table 3. Data Sources 
Quantitative Data Source 
Qualitative Data Source 
Bi-weekly questionnaires to the hospital-based post-acute 
care (PAC) and HHOP teams to capture perceived barriers 
to uptake 
Transcription of bi-weekly phone calls with PAC and 
HHOP teams to problem solve barriers to uptake 
Real-time data on patient enrollment 
Semi-structure interviews with the Director of 
Implementation for the COMPASS study (Coleman, RN) 
Real-time data on 6 performance measures  
Semi-structured interviews with members of the 
COMPASS Implementation Committee 
 
Quantitative Data Analysis: Descriptive statistics (e.g., frequencies) will be used to aggregate questionnaire 
responses. 
 
Qualitative Data Collection and Analysis: PAC team phone calls and interviews with the Director of 
Implementation and members of the Implementation Committee will be audio recorded and transcribed 
verbatim by Accukey Transcription (vendor #25466). Transcripts will be de-identified and verified by study 
investigators. Transcripts will be imported into NVivo for data management and analysis. The transcripts will be 
coded independently by members of the research team including the PI and Co-PI, and a graduate student 
research assistant (RA) trained in qualitative research methods. Initially, phone calls and interviews will be 
coded using open coding procedures as described by Charmaz (2006) and Ryan and Bernard (2003). The 
research team will meet to discuss the codes identified in the data. Codes will be sorted and categorized into 
themes that represent the factors that affect implementation (e.g. challenges, facilitators, and strategies). A 
coding schema will be developed collaboratively by the PI, Co-PI (Gesell / Lutz), and student RA. This schema 
will be used to code subsequent team meeting transcripts. The coders will meet regularly (monthly) to discuss 
the ongoing coding and resolve discrepancies. Major themes will be reported with supporting quotations. 
Credibility of analysis will be enhanced by (1) independent coding; (2) examination of negative cases and 
situations of considerable agreement or disagreement; (3) qualitative assessment of agreement between 
coders over time; and (4) discussing the major themes with the PACs in the 3 Waves to get input and feedback 
(member checking). Our analysis will also include cross-comparisons of subgroups (urban/rural sites, 
large/small volume sites) to determine differences within a heterogeneous population of health systems.  
 
 

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Table 4. Mapping the RE-AIM framework (Glasgow et al 1999) to the proposed process evaluation 
 
Reach 
Effectiveness* 
Adoption 
Implementation 
Maintenance 
Characteristics of enrolled patients (age, language, sex, race, Hispanic, insurance, 
diagnosis, aphasia, ambulatory status at discharge, NIH stroke score) 
X 
 
 
 
 
PM1. Receipt of follow-up telephone call within 2 business days of hospital discharge 
 
 
 
X 
 
PM2. Receipt of follow-up visit within 7 to 14 days of hospital discharge  
 
 
 
X 
 
PM3. Receipt of e-Care plan during follow-up clinic visit 
 
 
 
X 
 
PM4. Receipt of all home health and outpatient rehabilitation services (including physical 
therapy, occupational therapy, and speech and language therapy) prescribed at hospital 
discharge, 2-day follow-up call, or 7-14-day follow-up clinic visit by 30-days after hospital 
discharge 
 
 
 
X 
 
PM5. Receipt of all home health rehabilitation services (including physical therapy, 
occupational therapy, and speech and language therapy) prescribed at hospital 
discharge, 2-day follow-up call, or 7-14-day follow-up clinic visit by 30-days after hospital 
discharge 
 
 
 
X 
 
PM 6. Receipt of all outpatient rehabilitation services (including physical therapy, 
occupational therapy, and speech and language therapy) prescribed at hospital 
discharge, 2-day follow-up call, or 7-14-day follow-up clinic visit by 30-days after hospital 
discharge 
 
 
 
X 
 
Characteristics of enrolled health systems (size, location, Comprehensive Stroke Center 
certification) 
 
 
X 
 
 
Characteristics of PAC teams (number of FTE, license, etc) 
 
 
X 
 
 
Characteristics of Community Resource Networks  
 
 
X 
 
 
Characteristics of clinical staff participating in bi-weekly problem solving calls 
 
 
X 
 
 
Challenges with enrollment, 2 day call, 14 day visit, e care plan, receipt of therapy, 
community resource network, administrative tasks   
 
 
 
X 
 
Requests for additional training 
 
 
 
X 
 
Time it takes to integrate COMPASS components into system (ramp up) 
 
 
 
 
X 
What are sites doing to maintain COMPASS? What are they changing? Are they 
returning to their original model of care? 
 
 
 
 
X 
*90-day outcomes and claims data are part of the COMPASS trial, not this pilot 
 
*X 
 
 
 
PM = Performance Measure 
 
 
 
 
 

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Appendix 34 – 2Day Disposition Form  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 35 – Clinic Disposition Form  

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Appendix 36 – Phase 2 Patient Brochure for Sustaining COMPASS Hospitals  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 37 – Phase 2 Patient Brochure for Intervention Sites (formerly Usual Care)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 38 – Phase 2Enrollent Form  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 39 – Consent Matrix  
 
 
 
 
 
 
 
 
 
 
 

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