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Comprehensive Post-Acute Stroke Services (COMPASS)

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ClinicalTrials.gov Identifier: NCT02588664
Recruitment Status : Completed
First Posted : October 28, 2015
Results First Posted : June 11, 2021
Last Update Posted : June 11, 2021
Sponsor:
Collaborators:
University of North Carolina, Chapel Hill
Duke University
East Carolina University
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Health Services Research
Conditions Stroke
Transient Ischemic Attack
Intervention Other: COMPASS Intervention
Enrollment 6024
Recruitment Details  
Pre-assignment Details Excluded subsequent stroke (or TIA) events within the study period (N=142)
Arm/Group Title Usual Care COMPASS Intervention
Hide 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
Reason Not Completed
Death             56             55
Lost to Follow-up             1305             990
Arm/Group Title Usual Care COMPASS Intervention Total
Hide 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 Number of Baseline Participants 3193 2689 5882
Hide Baseline Analysis Population Description
Subsequent events (i.e. secondary stroke events) were excluded within the study period.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3193 participants 2689 participants 5882 participants
66.3  (13.9) 68.0  (13.8) 67.1  (13.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3193 participants 2689 participants 5882 participants
Female
1657
  51.9%
1300
  48.3%
2957
  50.3%
Male
1536
  48.1%
1389
  51.7%
2925
  49.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3193 participants 2689 participants 5882 participants
Hispanic or Latino
71
   2.2%
43
   1.6%
114
   1.9%
Not Hispanic or Latino
3017
  94.5%
2500
  93.0%
5517
  93.8%
Unknown or Not Reported
105
   3.3%
146
   5.4%
251
   4.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3193 participants 2689 participants 5882 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
  72.0%
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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3193 participants 2689 participants 5882 participants
3193 2689 5882
Stroke Diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3193 participants 2689 participants 5882 participants
Ischemic Stroke
1829
  57.3%
1563
  58.1%
3392
  57.7%
Transient Ischemic Attack (TIA)
1149
  36.0%
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
   3.0%
188
   3.2%
NIH Stroke Scale (NIHSS)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 3193 participants 2689 participants 5882 participants
1
(0 to 3)
1
(0 to 3)
1
(0 to 3)
[1]
Measure Description: The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The median and interquartile values reflect the mild stroke population.
Health Insurance  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3193 participants 2689 participants 5882 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%
1.Primary Outcome
Title Stroke Impact Scale (SIS-16)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1832 1644
Mean (Standard Deviation)
Unit of Measure: score on a scale
79.9  (21.4) 80.6  (21.1)
2.Secondary Outcome
Title Modified Caregiver Strain Index
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 659 569
Mean (Standard Deviation)
Unit of Measure: score on a scale
21.9  (23.1) 21.9  (23.5)
3.Secondary Outcome
Title Self-reported General Health
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1684 1485
Mean (Standard Deviation)
Unit of Measure: score on a scale
65.4  (28.8) 66.2  (28.8)
4.Secondary Outcome
Title Modified Rankin Score
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1680 1529
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
1
(0 to 3)
1
(0 to 3)
5.Secondary Outcome
Title Number of Participants Physically Active and Not Physically Active
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1552 1416
Measure Type: Count of Participants
Unit of Measure: Participants
Yes Physically Active (150 min/week of physical activity or more)
488
  31.4%
431
  30.4%
Not Physically Active (Less than 150 min/week of physical activity)
1064
  68.6%
985
  69.6%
6.Secondary Outcome
Title Number of Participants With or Without Depression
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1465 1309
Measure Type: Count of Participants
Unit of Measure: Participants
Not Depressed (or a score of 2 or less on PHQ-2)
1122
  76.6%
1025
  78.3%
Yes Depressed (or a score of 3 or higher on PHQ-2)
343
  23.4%
284
  21.7%
7.Secondary Outcome
Title Cognition (MoCA 5-min Protocol)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1441 1287
Mean (Standard Deviation)
Unit of Measure: score on a scale
24.3  (4.5) 24.3  (4.7)
8.Secondary Outcome
Title Medication Adherence (Morisky Green Levine Scale-4)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1439 1291
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
0
(0 to 1)
0
(0 to 1)
9.Secondary Outcome
Title Number of Participants With or Without Falls
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1598 1457
Measure Type: Count of Participants
Unit of Measure: Participants
Yes - reported at least 1 fall
334
  20.9%
299
  20.5%
No - No falls reported
1264
  79.1%
1158
  79.5%
10.Secondary Outcome
Title Self-reported Fatigue (PROMIS Fatigue Instrument)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1432 1289
Mean (Standard Deviation)
Unit of Measure: score on a scale
51.5  (10.7) 51.0  (10.9)
11.Secondary Outcome
Title Satisfaction With Care
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1530 1399
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1586 1447
Measure Type: Count of Participants
Unit of Measure: Participants
Yes - Home BP Monitoring (at least monthly)
1013
  63.9%
1040
  71.9%
No - Home BP Monitoring (at least monthly)
573
  36.1%
407
  28.1%
13.Secondary Outcome
Title Self-reported Blood Pressure
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Number of Subjects With Claims-based All-cause Hospital Readmissions
Hide Description [Not Specified]
Time Frame post-stroke day 30
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1193 1069
Measure Type: Count of Participants
Unit of Measure: Participants
103
   8.6%
105
   9.8%
15.Secondary Outcome
Title Number of Subjects With Claims-based All-cause Hospital Readmissions
Hide Description [Not Specified]
Time Frame post-stroke day 90
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1193 1069
Measure Type: Count of Participants
Unit of Measure: Participants
222
  18.6%
210
  19.6%
16.Secondary Outcome
Title Number of Subjects With Claims-based All-cause Hospital Readmissions
Hide Description [Not Specified]
Time Frame post-discharge year 1
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1193 1069
Measure Type: Count of Participants
Unit of Measure: Participants
516
  43.3%
485
  45.4%
17.Secondary Outcome
Title Number of Subjects With All-cause Mortality Using NC State Death Index
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 3193 2689
Measure Type: Count of Participants
Unit of Measure: Participants
Yes - Did Die
56
   1.8%
55
   2.0%
No - Did Not Die
3137
  98.2%
2634
  98.0%
18.Secondary Outcome
Title Number of Subjects With All-cause Mortality Using NC State Death Index & Fee-For-Service (FFS) Medicare
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1193 1069
Measure Type: Count of Participants
Unit of Measure: Participants
Yes - Did Die
105
   8.8%
91
   8.5%
No - Did not Die
1088
  91.2%
978
  91.5%
19.Secondary Outcome
Title Number of Subjects With Claims-based Emergency Department Visits
Hide Description [Not Specified]
Time Frame post-discharge year 1
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1193 1069
Measure Type: Count of Participants
Unit of Measure: Participants
691
  57.9%
626
  58.6%
20.Secondary Outcome
Title Number of Subjects With Claims-based Admissions to Skilled Nursing Facilities (SNF) and Inpatient Rehabilitation Facilities (IRF)
Hide Description [Not Specified]
Time Frame post-discharge year 1
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1193 1069
Measure Type: Count of Participants
Unit of Measure: Participants
142
  11.9%
150
  14.0%
21.Secondary Outcome
Title Number of Subjects With Claims-based Use of Transitional Care Management Billing Codes
Hide Description [Not Specified]
Time Frame post-discharge day 14
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 1193 1069
Measure Type: Count of Participants
Unit of Measure: Participants
239
  20.0%
345
  32.3%
22.Other Pre-specified Outcome
Title Subgroup Analysis: Race
Hide Description Analyze the main endpoint of the study in white and non-white individuals
Time Frame post-stroke day 90
Hide Outcome Measure Data
Hide Analysis Population Description
This was a Subgroup Analysis: Race
Arm/Group Title Usual Care COMPASS Intervention
Hide 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
23.Other Pre-specified Outcome
Title Subgroup Analysis: Sex
Hide Description Analyze the main endpoint of the study in female and male individuals
Time Frame measured 90 days post-stroke
Hide Outcome Measure Data
Hide Analysis Population Description
Subgroup Analysis: sex
Arm/Group Title Usual Care COMPASS Intervention
Hide 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
24.Other Pre-specified Outcome
Title Subgroup Analysis: Age
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subgroup Analysis: Age
Arm/Group Title Usual Care COMPASS Intervention
Hide 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
25.Other Pre-specified Outcome
Title Subgroup Analysis: Diagnosis (Stroke Versus TIA)
Hide Description Analyze the main endpoint of the study in stroke versus TIA individuals
Time Frame measured 90 days post-stroke
Hide Outcome Measure Data
Hide Analysis Population Description
Subgroup analysis: diagnosis (stroke versus TIA)
Arm/Group Title Usual Care COMPASS Intervention
Hide 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
26.Other Pre-specified Outcome
Title Subgroup Analysis: Stroke Severity
Hide Description Analyze the main endpoint of the study in NIHSS=0, NIHSS=1-4, NIHSS>4 individuals
Time Frame measured 90 days post-stroke
Hide Outcome Measure Data
Hide Analysis Population Description
Subgroup analysis: stroke severity
Arm/Group Title Usual Care COMPASS Intervention
Hide 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
27.Other Pre-specified Outcome
Title Subgroup Analysis: Type of Health Insurance
Hide Description Analyze the main endpoint of the study in insured and uninsured individuals
Time Frame measured 90 days post-stroke
Hide Outcome Measure Data
Hide Analysis Population Description
Subgroup analysis: type of health insurance
Arm/Group Title Usual Care COMPASS Intervention
Hide 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
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
Hide 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 (%) Affected / at Risk (%)
Total   56/3193 (1.75%)   55/2689 (2.05%) 
Hide Serious Adverse Events
Usual Care COMPASS Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3137 (0.00%)   0/2689 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Care COMPASS Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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.
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
Layout table for Results Point of Contact information
Name/Title: Dr. Pamela W. Duncan
Organization: Wake Forest University Health Sciences
Phone: (336) 716-5068
EMail: pduncan@wakehealth.edu
Other Publications:
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02588664    
Other Study ID Numbers: IRB00035998
PCS-1403-14532 ( Other Identifier: Patient-Centered Outcomes Research Institute (PCORI) )
First Submitted: October 23, 2015
First Posted: October 28, 2015
Results First Submitted: April 12, 2021
Results First Posted: June 11, 2021
Last Update Posted: June 11, 2021