Trial Outcomes & Findings for Comprehensive Post-Acute Stroke Services (NCT NCT02588664)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6024 participants

Primary outcome timeframe

post-stroke day 90

Results posted on

2021-06-11

Participant Flow

Excluded subsequent stroke (or TIA) events within the study period (N=142)

Participant milestones

Participant milestones
Measure	Usual Care Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.	COMPASS Intervention 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 Study STARTED	3193	2689
Overall Study COMPLETED	1832	1644
Overall Study NOT COMPLETED	1361	1045

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Care Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.	COMPASS Intervention 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 Study Death	56	55
Overall Study Lost to Follow-up	1305	990

Baseline Characteristics

Comprehensive Post-Acute Stroke Services

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=3193 Participants Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.	COMPASS Intervention n=2689 Participants 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 n=5882 Participants Total of all reporting groups
Age, Continuous	66.3 years STANDARD_DEVIATION 13.9 • n=99 Participants	68.0 years STANDARD_DEVIATION 13.8 • n=107 Participants	67.1 years STANDARD_DEVIATION 13.9 • n=206 Participants
Sex: Female, Male Female	1657 Participants n=99 Participants	1300 Participants n=107 Participants	2957 Participants n=206 Participants
Sex: Female, Male Male	1536 Participants n=99 Participants	1389 Participants n=107 Participants	2925 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	71 Participants n=99 Participants	43 Participants n=107 Participants	114 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3017 Participants n=99 Participants	2500 Participants n=107 Participants	5517 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	105 Participants n=99 Participants	146 Participants n=107 Participants	251 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	18 Participants n=99 Participants	20 Participants n=107 Participants	38 Participants n=206 Participants
Race (NIH/OMB) Asian	18 Participants n=99 Participants	7 Participants n=107 Participants	25 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) Black or African American	942 Participants n=99 Participants	489 Participants n=107 Participants	1431 Participants n=206 Participants
Race (NIH/OMB) White	2122 Participants n=99 Participants	2112 Participants n=107 Participants	4234 Participants n=206 Participants
Race (NIH/OMB) More than one race	5 Participants n=99 Participants	13 Participants n=107 Participants	18 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	86 Participants n=99 Participants	46 Participants n=107 Participants	132 Participants n=206 Participants
Region of Enrollment United States	3193 participants n=99 Participants	2689 participants n=107 Participants	5882 participants n=206 Participants
Stroke Diagnosis Ischemic Stroke	1829 Participants n=99 Participants	1563 Participants n=107 Participants	3392 Participants n=206 Participants
Stroke Diagnosis Transient Ischemic Attack (TIA)	1149 Participants n=99 Participants	986 Participants n=107 Participants	2135 Participants n=206 Participants
Stroke Diagnosis Intracerebral Hemorrhage	107 Participants n=99 Participants	60 Participants n=107 Participants	167 Participants n=206 Participants
Stroke Diagnosis Stroke, not otherwise specified	108 Participants n=99 Participants	80 Participants n=107 Participants	188 Participants n=206 Participants
NIH Stroke Scale (NIHSS)	1 units on a scale n=99 Participants	1 units on a scale n=107 Participants	1 units on a scale n=206 Participants
Health Insurance Insured	2823 Participants n=99 Participants	2440 Participants n=107 Participants	5263 Participants n=206 Participants
Health Insurance Uninsured	293 Participants n=99 Participants	230 Participants n=107 Participants	523 Participants n=206 Participants
Health Insurance Missing Insurance Status	77 Participants n=99 Participants	19 Participants n=107 Participants	96 Participants n=206 Participants

PRIMARY outcome

Timeframe: post-stroke day 90

Population: 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

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

Outcome measures

Outcome measures
Measure	Usual Care n=1832 Participants Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.	COMPASS Intervention n=1644 Participants 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.
Stroke Impact Scale (SIS-16)	79.9 score on a scale Standard Deviation 21.4	80.6 score on a scale Standard Deviation 21.1

SECONDARY outcome

Timeframe: post-stroke day 90

Population: 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.

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

Outcome measures

Outcome measures
Measure	Usual Care n=659 Participants Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.	COMPASS Intervention n=569 Participants 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.
Modified Caregiver Strain Index	21.9 score on a scale Standard Deviation 23.1	21.9 score on a scale Standard Deviation 23.5

SECONDARY outcome

Timeframe: post-stroke day 90

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Usual Care n=1684 Participants Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.	COMPASS Intervention n=1485 Participants 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.
Self-reported General Health	65.4 score on a scale Standard Deviation 28.8	66.2 score on a scale Standard Deviation 28.8

SECONDARY outcome

Timeframe: post-stroke day 90

Population: 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.

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

Outcome measures

Outcome measures
Measure	Usual Care n=1680 Participants Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.	COMPASS Intervention n=1529 Participants 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.
Modified Rankin Score	1 score on a scale Interval 0.0 to 3.0	1 score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: post-stroke day 90

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Usual Care n=1552 Participants Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.	COMPASS Intervention n=1416 Participants 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.
Number of Participants Physically Active and Not Physically Active Yes Physically Active (150 min/week of physical activity or more)	488 Participants	431 Participants
Number of Participants Physically Active and Not Physically Active Not Physically Active (Less than 150 min/week of physical activity)	1064 Participants	985 Participants

SECONDARY outcome

Timeframe: post-stroke day 90

Population: 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.

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

Outcome measures

Outcome measures
Measure	Usual Care n=1465 Participants Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.	COMPASS Intervention n=1309 Participants 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.
Number of Participants With or Without Depression Not Depressed (or a score of 2 or less on PHQ-2)	1122 Participants	1025 Participants
Number of Participants With or Without Depression Yes Depressed (or a score of 3 or higher on PHQ-2)	343 Participants	284 Participants

SECONDARY outcome

Timeframe: post-stroke day 90

Population: 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.

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

Outcome measures

Outcome measures
Measure	Usual Care n=1441 Participants Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.	COMPASS Intervention n=1287 Participants 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.
Cognition (MoCA 5-min Protocol)	24.3 score on a scale Standard Deviation 4.5	24.3 score on a scale Standard Deviation 4.7

SECONDARY outcome

Timeframe: post-stroke day 90

Population: 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.

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

Outcome measures

Outcome measures
Measure	Usual Care n=1439 Participants Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.	COMPASS Intervention n=1291 Participants 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.
Medication Adherence (Morisky Green Levine Scale-4)	0 score on a scale Interval 0.0 to 1.0	0 score on a scale Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: post-stroke day 90

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Usual Care n=1598 Participants Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.	COMPASS Intervention n=1457 Participants 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.
Number of Participants With or Without Falls Yes - reported at least 1 fall	334 Participants	299 Participants
Number of Participants With or Without Falls No - No falls reported	1264 Participants	1158 Participants

SECONDARY outcome

Timeframe: post-stroke day 90

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Usual Care n=1432 Participants Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.	COMPASS Intervention n=1289 Participants 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.
Self-reported Fatigue (PROMIS Fatigue Instrument)	51.5 score on a scale Standard Deviation 10.7	51.0 score on a scale Standard Deviation 10.9

SECONDARY outcome

Timeframe: post-stroke day 90

Population: 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.

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

Outcome measures

Outcome measures
Measure	Usual Care n=1530 Participants Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.	COMPASS Intervention n=1399 Participants 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.
Satisfaction With Care	6.9 score on a scale Standard Deviation 1.5	7.0 score on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: post-stroke day 90

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Usual Care n=1586 Participants Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.	COMPASS Intervention n=1447 Participants 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.
Number of Participants Who Do or Do Not Monitor Blood Pressure at Home Yes - Home BP Monitoring (at least monthly)	1013 Participants	1040 Participants
Number of Participants Who Do or Do Not Monitor Blood Pressure at Home No - Home BP Monitoring (at least monthly)	573 Participants	407 Participants

SECONDARY outcome

Timeframe: post-stroke day 90

Timeframe: post-stroke day 90

Population: Mortality by 90-days post-stroke according to the NC State Death Index was collected on all 5,882 enrolled patients.

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.

Outcome measures

Outcome measures
Measure	Usual Care n=3193 Participants Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.	COMPASS Intervention n=2689 Participants 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.
Number of Subjects With All-cause Mortality Using NC State Death Index Yes - Did Die	56 Participants	55 Participants
Number of Subjects With All-cause Mortality Using NC State Death Index No - Did Not Die	3137 Participants	2634 Participants

SECONDARY outcome

Timeframe: post-discharge year 1

Population: Of the enrolled patients, 2262 were linked to Fee-For-Service (FFS) Medicare claims and included in the analyses.

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.

Outcome measures

Outcome measures
Measure	Usual Care n=1193 Participants Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.	COMPASS Intervention n=1069 Participants 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.
Number of Subjects With All-cause Mortality Using NC State Death Index & Fee-For-Service (FFS) Medicare Yes - Did Die	105 Participants	91 Participants
Number of Subjects With All-cause Mortality Using NC State Death Index & Fee-For-Service (FFS) Medicare No - Did not Die	1088 Participants	978 Participants

SECONDARY outcome

Timeframe: post-discharge year 1

Population: Of the enrolled patients, 2262 were linked to Fee-For-Service (FFS) Medicare claims and included in the analyses.

Outcome measures

Outcome measures
Measure	Usual Care n=1193 Participants Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.	COMPASS Intervention n=1069 Participants 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.
Number of Subjects With Claims-based Emergency Department Visits	691 Participants	626 Participants

SECONDARY outcome

Timeframe: post-discharge year 1

Population: Of the enrolled patients, 2262 were linked to Fee-For-Service (FFS) Medicare claims and included in the analyses.

Outcome measures

Outcome measures
Measure	Usual Care n=1193 Participants Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.	COMPASS Intervention n=1069 Participants 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.
Number of Subjects With Claims-based Admissions to Skilled Nursing Facilities (SNF) and Inpatient Rehabilitation Facilities (IRF)	142 Participants	150 Participants

SECONDARY outcome

Timeframe: post-discharge day 14

Population: Of the enrolled patients, 2262 were linked to Fee-For-Service (FFS) Medicare claims and included in the analyses.

Outcome measures

Outcome measures
Measure	Usual Care n=1193 Participants Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.	COMPASS Intervention n=1069 Participants 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.
Number of Subjects With Claims-based Use of Transitional Care Management Billing Codes	239 Participants	345 Participants

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 56 deaths

COMPASS Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 55 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Pamela W. Duncan

Wake Forest University Health Sciences

Phone: (336) 716-5068

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place