Clincosm LogoSign in Get a demo

COMPASS: Comprehensive Post-Acute Stroke Services

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT02588664
Collaborator
University of North Carolina, Chapel Hill (Other), Duke University (Other), East Carolina University (Other)
6,024
Enrollment
40
Locations
2
Arms
43.7
Actual Duration (Months)
150.6
Patients Per Site
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this pragmatic study is to investigate whether implementation of a comprehensive post-acute stroke service model that integrates Early Supported Discharge (ESD) and Transitional Care Management (TCM) for stroke survivors discharged home improves functional outcomes post-stroke, reduces caregiver stress, and reduces readmission rates.

Condition or Disease Intervention/Treatment Phase
  • Other: COMPASS Intervention
 N/A

Detailed Description

Stroke mortality is 20-40% higher in North Carolina (NC) than in the overall United States. After discharge, stroke patients are at high risk for complications. Although a model of stroke post-care (early supported discharge) exists in Europe and Canada, it has not been adapted for and tested in the US, although patients and stakeholders attest that post-acute care does not meet their needs. Transitional care services from hospital to home are now reimbursed by Centers for Medicaid and Medicare Services (CMS), but only for 30 days after discharge. The study team proposed a pragmatic, cluster randomized trial of 41 NC hospitals to determine the effectiveness of COMprehensive Post-Acute Stroke Services (COMPASS), a patient-centered intervention uniting transitional care management services and elements of early supported discharge in stroke patients discharged directly home.

The study team will build on the successful North Carolina Stroke Care Collaborative (NCSCC) registry, a prospective stroke database in which 51 (of 113) hospitals in NC enroll patients. In preparation for COMPASS, the study team engaged these hospitals via webinars. Over 80% of NCSCC hospitals demonstrated an interest in participation and provided letters of support.

The main question of this pragmatic trial is: Does implementation of COMPASS for all stroke patients discharged directly home improve functional outcomes as measured by the Stroke Impact Scale-16 (SIS-16) at 90 days post-stroke? The primary aim is to: compare the COMPASS model versus usual care on stroke survivors' self-reported functional status at 90 days post-stroke. The secondary aims are to determine if the COMPASS model affects: (1) caregiver strain (Modified Caregiver Strain Index); (2) self-reported general health; (3) disability (Modified Rankin Score); (4) self-reported physical activity; (5) depression (PHQ-2); (6) cognition (MoCA 5-min protocol); (7) medication adherence (Morisky Green Levine Scale-4); (8) self-reported falls; (9) self-reported fatigue (PROMIS Fatigue Instrument); (10) satisfaction with care; (11) secondary prevention - home blood pressure monitoring; (12) self-reported blood pressure; (13-15) all-cause hospital readmissions at 30-days, at 90-days and at 1 year after index discharge; (16-17) mortality at 90-days and at 1 year after index discharge; (18-20) healthcare utilization (emergency department visits, admissions to skilled nursing facilities/inpatient rehabilitation facilities); and (21) use of transitional care management billing codes. This study will also evaluate the effectiveness of the COMPASS Intervention in key patient subgroups based on race, sex, age, diagnosis (stroke versus TIA), stroke severity, and type of health insurance.

English and Spanish-speaking patients ages 18 and older who are admitted to a participating hospital with a diagnosis of ischemic or hemorrhagic stroke or transient ischemic attack and discharged from acute care hospitalization to home will be included (about 6,000 patients/year).

Participating hospitals will be randomized (stratified by stroke volume and primary stroke center status) to receive COMPASS or usual care (control group) in Phase 1. In Phase 2, usual care hospitals will cross over to COMPASS, while the early intervention hospitals sustain the intervention using hospital-based resources.

The trial has three integrated intervention components: (1) COMPASS, which combines transitional care services provided by advanced practice providers (APPs) and early supported discharge services coordinated by the Post-Acute Coordinators (PAC); (2) COMPASS-funded post-acute care coordinators who will engage patient and stakeholder communities to improve post-acute stroke comprehensive stroke services; and (3) development of a stroke metrics scorecard for participating sites. Well-trained APPs and coordinators will have access to online learning and ongoing support/consultation from WFBH personnel and board-certified vascular neurologists.

The study team will assess 90-day and 1-year outcomes. Outcomes at 90-days will be assessed by telephone surveyors blinded to patient's group assignment. Patients will be informed about COMPASS in the hospital and can opt out of 90-day phone follow-up at any time. Those who agree to be surveyed will be asked to provide informed consent at the 90-day phone call to collect outcomes data.

This proposal is led by three highly experienced researchers as co-principal investigators. The team includes expertise in stroke care, large clinical trials, biostatistics, managing clinical registries, survey and acquisition of patient or proxy-reported outcomes, community-based practice improvement, building community coalitions to reduce readmissions, claims analyses, registry management, translating evidence into practice with large multi-site collaboratives, and engaging patients and stakeholders in research. The planning phase of this project has been guided by patients and stakeholders. Each community will form a community resource network to advise and support the implementation of COMPASS, provide feedback to the team, and help create sustainability. If the COMPASS model shows effectiveness, engaged patients and stakeholders will be key partners to disseminate and implement COMPASS throughout the state and beyond.

Study Design

Study Type:
Interventional
Actual Enrollment :
6024 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Early Supported Discharge for Improving Functional Outcomes After Stroke
Actual Study Start Date :
Jul 25, 2016
Actual Primary Completion Date :
Jul 25, 2018
Actual Study Completion Date :
Mar 15, 2020

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Usual Care

Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.
Active Comparator: COMPASS Intervention

Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care.

Other: COMPASS Intervention
A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.

Outcome Measures

Primary Outcome Measures

  1. Stroke Impact Scale (SIS-16) [post-stroke day 90]

    16-item survey to assess the difficulty level of performing basic physical activities; scores range from 0-100; higher scores correspond to more favorable outcomes

Secondary Outcome Measures

  1. Modified Caregiver Strain Index [post-stroke day 90]

    13-item survey to measure strain that caregivers may experience; scores range from 0-100; higher scores indicate more caregiver burden

  2. Self-reported General Health [post-stroke day 90]

    Self-reported general health is a single question to rate their general health. Responses on a 5-point Likert Scale (Excellent, Very Good, Good, Fair, or Poor) will be analyzed as a continuous variable. Scores range from 95-15 with a higher score indicating better health.

  3. Modified Rankin Score [post-stroke day 90]

    to measure the degree of disability or dependence; scores range from 0-6; higher scores correspond to less favorable outcomes

  4. Number of Participants Physically Active and Not Physically Active [post-stroke day 90]

    Participants are asked whether they walked continuously for at least 10 minutes on any of the last seven days, how many of those days they walked continuously for at least 10 minutes and how many minutes they walked, on average, each day. The physical activity endpoint will be self-reported total number of minutes walked during the past seven days.

  5. Number of Participants With or Without Depression [post-stroke day 90]

    Based on answers to Patient Health Questionnaire 2-Item (PHQ-2) which is a 2-item questionnaire to determine the frequency of depressed mood; scores range from 0-6; higher scores correspond to less favorable outcomes

  6. Cognition (MoCA 5-min Protocol) [post-stroke day 90]

    4-item questionnaire to determine vascular cognitive impairment; scores range from 0-30; higher scores are more favorable

  7. Medication Adherence (Morisky Green Levine Scale-4) [post-stroke day 90]

    4 items with yes/no response options; scores range from 0-4; higher scores correspond to less medication adherence

  8. Number of Participants With or Without Falls [post-stroke day 90]

    Participants are asked 4 questions to determine whether they have fallen (yes versus no) since hospital discharge, whether or not the fall resulted in a doctor/emergency room visit, whether they have fallen multiple times since discharge, and how many times they have fallen since discharge. Analysis of falls will be based on incidence of any fall since hospital discharge (no falls versus at least one fall).

  9. Self-reported Fatigue (PROMIS Fatigue Instrument) [post-stroke day 90]

    4-question instrument to determine level of fatigue; higher scores correspond to less favorable outcomes; The total raw score is obtained by summing individual question scores and has a range of 4-20. For analysis, raw scores are translated into T-scores which range from 33.7 - 75.8. The T-score rescales the raw score into a standardized score with a mean of 50 and a SD of 10.

  10. Satisfaction With Care [post-stroke day 90]

    6 questions to determine satisfaction with care; scores range from 0-100; higher scores correspond to higher satisfaction of care

  11. Number of Participants Who Do or Do Not Monitor Blood Pressure at Home [post-stroke day 90]

    Participants are asked 2 questions to determine whether they monitor their blood pressure at home (yes or no) and, if they answer in the affirmative, how frequently (daily, weekly, and monthly). Home blood pressure monitoring was analyzed as a dichotomous endpoint (monitoring with any frequency versus no monitoring).

  12. Self-reported Blood Pressure [post-stroke day 90]

    1 question to determine self-reported blood pressure. Self-reported systolic and diastolic BP will each be analyzed as a continuous endpoint. In addition, self-reported systolic and diastolic BP will be used to create a dichotomous hypertension endpoint (systolic BP >= 140 versus systolic BP < 140).

  13. Number of Subjects With Claims-based All-cause Hospital Readmissions [post-stroke day 30]

  14. Number of Subjects With Claims-based All-cause Hospital Readmissions [post-stroke day 90]

  15. Number of Subjects With Claims-based All-cause Hospital Readmissions [post-discharge year 1]

  16. Number of Subjects With All-cause Mortality Using NC State Death Index [post-stroke day 90]

    Deaths within 90 days of index discharge were ascertained from the North Carolina State Death Index as well as insurance claims beneficiary summary files (i.e. FFS Medicare). A death identified in either database is considered a death.

  17. Number of Subjects With All-cause Mortality Using NC State Death Index & Fee-For-Service (FFS) Medicare [post-discharge year 1]

    Deaths within 1 year of index discharge were ascertained from the North Carolina State Death Index as well as insurance claims beneficiary summary files (i.e. FFS Medicare). A death identified in either database is considered a death.

  18. Number of Subjects With Claims-based Emergency Department Visits [post-discharge year 1]

  19. Number of Subjects With Claims-based Admissions to Skilled Nursing Facilities (SNF) and Inpatient Rehabilitation Facilities (IRF) [post-discharge year 1]

  20. Number of Subjects With Claims-based Use of Transitional Care Management Billing Codes [post-discharge day 14]

Other Outcome Measures

  1. Subgroup Analysis: Race [post-stroke day 90]

    Analyze the main endpoint of the study in white and non-white individuals

  2. Subgroup Analysis: Sex [measured 90 days post-stroke]

    Analyze the main endpoint of the study in female and male individuals

  3. Subgroup Analysis: Age [measured 90 days post-stroke]

    Analyze the main endpoint of the study in <45; 45-<55; 55-<65; 65-<75; >=75 individuals

  4. Subgroup Analysis: Diagnosis (Stroke Versus TIA) [measured 90 days post-stroke]

    Analyze the main endpoint of the study in stroke versus TIA individuals

  5. Subgroup Analysis: Stroke Severity [measured 90 days post-stroke]

    Analyze the main endpoint of the study in NIHSS=0, NIHSS=1-4, NIHSS>4 individuals

  6. Subgroup Analysis: Type of Health Insurance [measured 90 days post-stroke]

    Analyze the main endpoint of the study in insured and uninsured individuals

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • English and Spanish speaking stroke patients with diagnosis of ischemic stroke, hemorrhagic stroke or TIA who are discharged home from participating hospitals

  • Must be 18 years of age and older at the time of the stroke

Exclusion Criteria:
  • Excludes subdural or aneurysmal subarachnoid hemorrhage

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHS Stanly Albemarle North Carolina United States 28001
2 Mission Hospital Asheville North Carolina United States 28801
3 UNC Hospital Chapel Hill North Carolina United States 27514
4 CHS Carolinas Medical Center Charlotte North Carolina United States 28203
5 Novant Health Presbyterian Medical Center Charlotte North Carolina United States 28204
6 CHS Carolinas Medical Center-Mercy Charlotte North Carolina United States 28207
7 CHS University Charlotte North Carolina United States 28265
8 CHS Northeast Concord North Carolina United States 28025
9 Betsy Johnson Hospital Dunn North Carolina United States 28334
10 Morehead Memorial Hospital Eden North Carolina United States 27288
11 Hugh Chatham Memorial Hospital Elkin North Carolina United States 28621
12 Cape Fear Valley Medical Center Fayetteville North Carolina United States 28304
13 Angel Medical Center Franklin North Carolina United States 28734
14 Pardee Health Hendersonville North Carolina United States 28791
15 Frye Regional Medical Center Hickory North Carolina United States 28601
16 Novant Health Huntersville Huntersville North Carolina United States 28078
17 Onslow Memorial Hospital Jacksonville North Carolina United States 28546
18 Ashe Memorial Hospital Jefferson North Carolina United States 28640
19 Vidant Duplin Hospital Kenansville North Carolina United States 28349
20 CHS Kings Mountain Kings Mountain North Carolina United States 28086
21 Lenoir Memorial Hospital Kinston North Carolina United States 28503
22 Caldwell Memorial Hospital Lenoir North Carolina United States 28645
23 WFBH Lexington Medical Center Lexington North Carolina United States 27292
24 CHS Lincoln Lincolnton North Carolina United States 28092
25 Novant Health Matthews Medical Center Matthews North Carolina United States 28105
26 CHS Union Monroe North Carolina United States 28112
27 Carteret County General Hospital Morehead City North Carolina United States 28557
28 CHS Blue Ridge Morganton North Carolina United States 28655
29 Northern Hospital of Surry County Mount Airy North Carolina United States 27030
30 Wilkes Regional Medical Center North Wilkesboro North Carolina United States 28659
31 FirstHealth Moore Regional Pinehurst North Carolina United States 28374
32 Washington County Hospital Plymouth North Carolina United States 27962
33 UNC Rex Healthcare Raleigh North Carolina United States 27607
34 Duke Raleigh Hospital Raleigh North Carolina United States 27609
35 WakeMed Health and Hospital Raleigh North Carolina United States 27610
36 CHS Cleveland Shelby North Carolina United States 28150
37 Alleghany County Memorial Hospital Sparta North Carolina United States 28675
38 Blue Ridge Regional Hospital Spruce Pine North Carolina United States 28777
39 Vidant Edgecombe Hospital Tarboro North Carolina United States 27886
40 New Hanover Regional Medical Center Wilmington North Carolina United States 28401

Sponsors and Collaborators

  • Wake Forest University Health Sciences
  • University of North Carolina, Chapel Hill
  • Duke University
  • East Carolina University

Investigators

  • Principal Investigator: Pamela Duncan, PhD, Wake Forest University Health Sciences

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT02588664
Other Study ID Numbers:
  • IRB00035998
  • PCS-1403-14532
First Posted:
Oct 28, 2015
Last Update Posted:
Jun 11, 2021
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wake Forest University Health Sciences
Early Supported Discharge
Transitional Care
Post-acute Stroke Care
Pragmatic Trial
Recovery and Rehabilitation
Secondary Prevention
Additional relevant MeSH terms:
Stroke
Ischemic Attack, Transient

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail Excluded subsequent stroke (or TIA) events within the study period (N=142)
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Period Title: Overall Study
STARTED 3193 2689
COMPLETED 1832 1644
NOT COMPLETED 1361 1045

Baseline Characteristics

Arm/Group Title Usual Care COMPASS Intervention Total
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services. Total of all reporting groups
Overall Participants 3193 2689 5882
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
66.3
(13.9)
68.0
(13.8)
67.1
(13.9)
Sex: Female, Male (Count of Participants)
Female
1657
51.9%
1300
48.3%
2957
50.3%
Male
1536
48.1%
1389
51.7%
2925
49.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
71
2.2%
43
1.6%
114
1.9%
Not Hispanic or Latino
3017
94.5%
2500
93%
5517
93.8%
Unknown or Not Reported
105
3.3%
146
5.4%
251
4.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
18
0.6%
20
0.7%
38
0.6%
Asian
18
0.6%
7
0.3%
25
0.4%
Native Hawaiian or Other Pacific Islander
2
0.1%
2
0.1%
4
0.1%
Black or African American
942
29.5%
489
18.2%
1431
24.3%
White
2122
66.5%
2112
78.5%
4234
72%
More than one race
5
0.2%
13
0.5%
18
0.3%
Unknown or Not Reported
86
2.7%
46
1.7%
132
2.2%
Region of Enrollment (participants) [Number]
United States
3193
100%
2689
100%
5882
100%
Stroke Diagnosis (Count of Participants)
Ischemic Stroke
1829
57.3%
1563
58.1%
3392
57.7%
Transient Ischemic Attack (TIA)
1149
36%
986
36.7%
2135
36.3%
Intracerebral Hemorrhage
107
3.4%
60
2.2%
167
2.8%
Stroke, not otherwise specified
108
3.4%
80
3%
188
3.2%
NIH Stroke Scale (NIHSS) (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]
1
1
1
Health Insurance (Count of Participants)
Insured
2823
88.4%
2440
90.7%
5263
89.5%
Uninsured
293
9.2%
230
8.6%
523
8.9%
Missing Insurance Status
77
2.4%
19
0.7%
96
1.6%

Outcome Measures

1. Primary Outcome
Title Stroke Impact Scale (SIS-16)
Description 16-item survey to assess the difficulty level of performing basic physical activities; scores range from 0-100; higher scores correspond to more favorable outcomes
Time Frame post-stroke day 90

Outcome Measure Data

Analysis Population Description
Of the 5,882 that were enrolled in the study, 3476 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 1832 1644
Mean (Standard Deviation) [score on a scale]
79.9
(21.4)
80.6
(21.1)
2. Secondary Outcome
Title Modified Caregiver Strain Index
Description 13-item survey to measure strain that caregivers may experience; scores range from 0-100; higher scores indicate more caregiver burden
Time Frame post-stroke day 90

Outcome Measure Data

Analysis Population Description
Each enrolled patient was asked to identify a caregiver. A total of 4208 caregivers were identified and asked to complete the Caregiver Questionnaire. A total of 1228 caregivers completed the Caregiver Survey. However, to account for missing data, we utilized inverse probability weight to perform the analysis so the final analysis included was 4208 for this outcome.
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 659 569
Mean (Standard Deviation) [score on a scale]
21.9
(23.1)
21.9
(23.5)
3. Secondary Outcome
Title Self-reported General Health
Description Self-reported general health is a single question to rate their general health. Responses on a 5-point Likert Scale (Excellent, Very Good, Good, Fair, or Poor) will be analyzed as a continuous variable. Scores range from 95-15 with a higher score indicating better health.
Time Frame post-stroke day 90

Outcome Measure Data

Analysis Population Description
Of the 5,882 that were enrolled in the study, 3169 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure.
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 1684 1485
Mean (Standard Deviation) [score on a scale]
65.4
(28.8)
66.2
(28.8)
4. Secondary Outcome
Title Modified Rankin Score
Description to measure the degree of disability or dependence; scores range from 0-6; higher scores correspond to less favorable outcomes
Time Frame post-stroke day 90

Outcome Measure Data

Analysis Population Description
Of the 5,882 that were enrolled in the study, 3209 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure.
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 1680 1529
Median (Inter-Quartile Range) [score on a scale]
1
1
5. Secondary Outcome
Title Number of Participants Physically Active and Not Physically Active
Description Participants are asked whether they walked continuously for at least 10 minutes on any of the last seven days, how many of those days they walked continuously for at least 10 minutes and how many minutes they walked, on average, each day. The physical activity endpoint will be self-reported total number of minutes walked during the past seven days.
Time Frame post-stroke day 90

Outcome Measure Data

Analysis Population Description
Of the 5,882 that were enrolled in the study, 2968 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure.
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 1552 1416
Yes Physically Active (150 min/week of physical activity or more)
488
15.3%
431
16%
Not Physically Active (Less than 150 min/week of physical activity)
1064
33.3%
985
36.6%
6. Secondary Outcome
Title Number of Participants With or Without Depression
Description Based on answers to Patient Health Questionnaire 2-Item (PHQ-2) which is a 2-item questionnaire to determine the frequency of depressed mood; scores range from 0-6; higher scores correspond to less favorable outcomes
Time Frame post-stroke day 90

Outcome Measure Data

Analysis Population Description
Of the 5,882 that were enrolled in the study, 2,774 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure.
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 1465 1309
Not Depressed (or a score of 2 or less on PHQ-2)
1122
35.1%
1025
38.1%
Yes Depressed (or a score of 3 or higher on PHQ-2)
343
10.7%
284
10.6%
7. Secondary Outcome
Title Cognition (MoCA 5-min Protocol)
Description 4-item questionnaire to determine vascular cognitive impairment; scores range from 0-30; higher scores are more favorable
Time Frame post-stroke day 90

Outcome Measure Data

Analysis Population Description
Of the 5,882 that were enrolled in the study, 2,728 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure.
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 1441 1287
Mean (Standard Deviation) [score on a scale]
24.3
(4.5)
24.3
(4.7)
8. Secondary Outcome
Title Medication Adherence (Morisky Green Levine Scale-4)
Description 4 items with yes/no response options; scores range from 0-4; higher scores correspond to less medication adherence
Time Frame post-stroke day 90

Outcome Measure Data

Analysis Population Description
Of the 5,882 that were enrolled in the study, 2,730 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure.
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 1439 1291
Median (Inter-Quartile Range) [score on a scale]
0
0
9. Secondary Outcome
Title Number of Participants With or Without Falls
Description Participants are asked 4 questions to determine whether they have fallen (yes versus no) since hospital discharge, whether or not the fall resulted in a doctor/emergency room visit, whether they have fallen multiple times since discharge, and how many times they have fallen since discharge. Analysis of falls will be based on incidence of any fall since hospital discharge (no falls versus at least one fall).
Time Frame post-stroke day 90

Outcome Measure Data

Analysis Population Description
Of the 5,882 that were enrolled in the study, 3,055 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure.
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 1598 1457
Yes - reported at least 1 fall
334
10.5%
299
11.1%
No - No falls reported
1264
39.6%
1158
43.1%
10. Secondary Outcome
Title Self-reported Fatigue (PROMIS Fatigue Instrument)
Description 4-question instrument to determine level of fatigue; higher scores correspond to less favorable outcomes; The total raw score is obtained by summing individual question scores and has a range of 4-20. For analysis, raw scores are translated into T-scores which range from 33.7 - 75.8. The T-score rescales the raw score into a standardized score with a mean of 50 and a SD of 10.
Time Frame post-stroke day 90

Outcome Measure Data

Analysis Population Description
Of the 5,882 that were enrolled in the study, 2,721 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure.
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 1432 1289
Mean (Standard Deviation) [score on a scale]
51.5
(10.7)
51.0
(10.9)
11. Secondary Outcome
Title Satisfaction With Care
Description 6 questions to determine satisfaction with care; scores range from 0-100; higher scores correspond to higher satisfaction of care
Time Frame post-stroke day 90

Outcome Measure Data

Analysis Population Description
Of the 5,882 that were enrolled in the study, 2,929 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure.
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 1530 1399
Mean (Standard Deviation) [score on a scale]
6.9
(1.5)
7.0
(1.4)
12. Secondary Outcome
Title Number of Participants Who Do or Do Not Monitor Blood Pressure at Home
Description Participants are asked 2 questions to determine whether they monitor their blood pressure at home (yes or no) and, if they answer in the affirmative, how frequently (daily, weekly, and monthly). Home blood pressure monitoring was analyzed as a dichotomous endpoint (monitoring with any frequency versus no monitoring).
Time Frame post-stroke day 90

Outcome Measure Data

Analysis Population Description
Of the 5,882 that were enrolled in the study, 3,033 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure.
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 1586 1447
Yes - Home BP Monitoring (at least monthly)
1013
31.7%
1040
38.7%
No - Home BP Monitoring (at least monthly)
573
17.9%
407
15.1%
13. Secondary Outcome
Title Self-reported Blood Pressure
Description 1 question to determine self-reported blood pressure. Self-reported systolic and diastolic BP will each be analyzed as a continuous endpoint. In addition, self-reported systolic and diastolic BP will be used to create a dichotomous hypertension endpoint (systolic BP >= 140 versus systolic BP < 140).
Time Frame post-stroke day 90

Outcome Measure Data

Analysis Population Description
Data was not considered reliable and was therefore not used for analysis. Responses to blood pressure was frequently "120 over 80". This response was so frequent that investigative team did not think the data was a valid measured blood pressure.
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 0 0
14. Secondary Outcome
Title Number of Subjects With Claims-based All-cause Hospital Readmissions
Description
Time Frame post-stroke day 30

Outcome Measure Data

Analysis Population Description
Of the enrolled patients, 2,262 were linked to Fee-For-Service (FFS) Medicare claims and included in the analyses.
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 1193 1069
Count of Participants [Participants]
103
3.2%
105
3.9%
15. Secondary Outcome
Title Number of Subjects With Claims-based All-cause Hospital Readmissions
Description
Time Frame post-stroke day 90

Outcome Measure Data

Analysis Population Description
Of the enrolled patients, 2,262 were linked to Fee-For-Service (FFS) Medicare claims and included in the analyses.
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 1193 1069
Count of Participants [Participants]
222
7%
210
7.8%
16. Secondary Outcome
Title Number of Subjects With Claims-based All-cause Hospital Readmissions
Description
Time Frame post-discharge year 1

Outcome Measure Data

Analysis Population Description
Of the enrolled patients, 2,262 were linked to Fee-For-Service (FFS) Medicare claims and included in the analyses.
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 1193 1069
Count of Participants [Participants]
516
16.2%
485
18%
17. Secondary Outcome
Title Number of Subjects With All-cause Mortality Using NC State Death Index
Description Deaths within 90 days of index discharge were ascertained from the North Carolina State Death Index as well as insurance claims beneficiary summary files (i.e. FFS Medicare). A death identified in either database is considered a death.
Time Frame post-stroke day 90

Outcome Measure Data

Analysis Population Description
Mortality by 90-days post-stroke according to the NC State Death Index was collected on all 5,882 enrolled patients.
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 3193 2689
Yes - Did Die
56
1.8%
55
2%
No - Did Not Die
3137
98.2%
2634
98%
18. Secondary Outcome
Title Number of Subjects With All-cause Mortality Using NC State Death Index & Fee-For-Service (FFS) Medicare
Description Deaths within 1 year of index discharge were ascertained from the North Carolina State Death Index as well as insurance claims beneficiary summary files (i.e. FFS Medicare). A death identified in either database is considered a death.
Time Frame post-discharge year 1

Outcome Measure Data

Analysis Population Description
Of the enrolled patients, 2262 were linked to Fee-For-Service (FFS) Medicare claims and included in the analyses.
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 1193 1069
Yes - Did Die
105
3.3%
91
3.4%
No - Did not Die
1088
34.1%
978
36.4%
19. Secondary Outcome
Title Number of Subjects With Claims-based Emergency Department Visits
Description
Time Frame post-discharge year 1

Outcome Measure Data

Analysis Population Description
Of the enrolled patients, 2262 were linked to Fee-For-Service (FFS) Medicare claims and included in the analyses.
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 1193 1069
Count of Participants [Participants]
691
21.6%
626
23.3%
20. Secondary Outcome
Title Number of Subjects With Claims-based Admissions to Skilled Nursing Facilities (SNF) and Inpatient Rehabilitation Facilities (IRF)
Description
Time Frame post-discharge year 1

Outcome Measure Data

Analysis Population Description
Of the enrolled patients, 2262 were linked to Fee-For-Service (FFS) Medicare claims and included in the analyses.
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 1193 1069
Count of Participants [Participants]
142
4.4%
150
5.6%
21. Secondary Outcome
Title Number of Subjects With Claims-based Use of Transitional Care Management Billing Codes
Description
Time Frame post-discharge day 14

Outcome Measure Data

Analysis Population Description
Of the enrolled patients, 2262 were linked to Fee-For-Service (FFS) Medicare claims and included in the analyses.
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 1193 1069
Count of Participants [Participants]
239
7.5%
345
12.8%
22. Other Pre-specified Outcome
Title Subgroup Analysis: Race
Description Analyze the main endpoint of the study in white and non-white individuals
Time Frame post-stroke day 90

Outcome Measure Data

Analysis Population Description
This was a Subgroup Analysis: Race
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 0 0
23. Other Pre-specified Outcome
Title Subgroup Analysis: Sex
Description Analyze the main endpoint of the study in female and male individuals
Time Frame measured 90 days post-stroke

Outcome Measure Data

Analysis Population Description
Subgroup Analysis: sex
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 0 0
24. Other Pre-specified Outcome
Title Subgroup Analysis: Age
Description Analyze the main endpoint of the study in <45; 45-<55; 55-<65; 65-<75; >=75 individuals
Time Frame measured 90 days post-stroke

Outcome Measure Data

Analysis Population Description
Subgroup Analysis: Age
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 0 0
25. Other Pre-specified Outcome
Title Subgroup Analysis: Diagnosis (Stroke Versus TIA)
Description Analyze the main endpoint of the study in stroke versus TIA individuals
Time Frame measured 90 days post-stroke

Outcome Measure Data

Analysis Population Description
Subgroup analysis: diagnosis (stroke versus TIA)
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 0 0
26. Other Pre-specified Outcome
Title Subgroup Analysis: Stroke Severity
Description Analyze the main endpoint of the study in NIHSS=0, NIHSS=1-4, NIHSS>4 individuals
Time Frame measured 90 days post-stroke

Outcome Measure Data

Analysis Population Description
Subgroup analysis: stroke severity
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 0 0
27. Other Pre-specified Outcome
Title Subgroup Analysis: Type of Health Insurance
Description Analyze the main endpoint of the study in insured and uninsured individuals
Time Frame measured 90 days post-stroke

Outcome Measure Data

Analysis Population Description
Subgroup analysis: type of health insurance
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Measure Participants 0 0

Adverse Events

Time Frame All-Cause Mortality was collected up through day 90 for all subjects and up through year 1 for subjects with Fee-for-Service (FFS) Medicare
Adverse Event Reporting Description Only All-Cause Mortality was collected for the study retrospectively using North Carolina State Death Index. Other adverse Events were not collected as COMPASS was a minimal to no risk study.
Arm/Group Title Usual Care COMPASS Intervention
Arm/Group Description Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. COMPASS Intervention: *A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
All Cause Mortality
Usual Care COMPASS Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 56/3193 (1.8%) 55/2689 (2%)
Serious Adverse Events
Usual Care COMPASS Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/3137 (0%) 0/2689 (0%)
Other (Not Including Serious) Adverse Events
Usual Care COMPASS Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)

Limitations/Caveats

Only 58% of intervention hospitals staffed TC clinics continuously. Patient-level barriers were also present and included preference to see primary care providers, affordability, and transportation. Only 35% of patients enrolled through Intervention hospitals received the COMPASS TC Intervention.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Pamela W. Duncan
Organization Wake Forest University Health Sciences
Phone (336) 716-5068
Email pduncan@wakehealth.edu
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT02588664
Other Study ID Numbers:
  • IRB00035998
  • PCS-1403-14532
First Posted:
Oct 28, 2015
Last Update Posted:
Jun 11, 2021
Last Verified:
Dec 1, 2020