Trial Outcomes & Findings for Comparative Effectiveness of Rehabilitation Services for Survivors of Acute Ischemic Stroke (NCT NCT02284165)
NCT ID: NCT02284165
Last Updated: 2018-03-01
Results Overview
Received either inpatient care in an inpatient rehabilitation or skilled nursing facility, or home or community-based rehabilitation.
COMPLETED
164246 participants
discharge through 90 days
2018-03-01
Participant Flow
Starting population = 164,246 acute ischemic stroke patients with data in Get With the Guidelines linked to Medicare fee-for-service (FFS) claims. This was a retrospective analysis of existing data, so there were no patient milestones.
The following exclusions were applied prior to group assignment: death during index admission (n=10,466); loss of FFS eligibility not due to death during follow-up (n=1683); discharged to Federal hospital (n=102); transferred to another acute care hospital or discharged directly to nursing home for long-term care (n=4279).
Participant milestones
| Measure |
Inpatient Rehab Facility (IRF)
Discharged from hospital to inpatient rehabilitation facility
|
Skilled Nursing Facility (SNF)
Discharged from hospital to skilled nursing facility
|
Discharged Home
Discharged from hospital to home with or without services
|
|---|---|---|---|
|
Overall Study
STARTED
|
36448
|
40272
|
70996
|
|
Overall Study
COMPLETED
|
36448
|
40272
|
70996
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Effectiveness of Rehabilitation Services for Survivors of Acute Ischemic Stroke
Baseline characteristics by cohort
| Measure |
Inpatient Rehab Facility (IRF)
n=36448 Participants
Discharged from hospital to Inpatient Rehabilitation Facility
|
Skilled Nursing Facility (SNF)
n=40272 Participants
Discharged from hospital to Skilled Nursing Facility
|
Discharged Home
n=70996 Participants
Discharged from hospital to home with or without services
|
Total
n=147716 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
79 years
n=99 Participants
|
83 years
n=107 Participants
|
78 years
n=206 Participants
|
80 years
n=7 Participants
|
|
Sex/Gender, Customized
Female
|
20570 participants
n=99 Participants
|
26801 participants
n=107 Participants
|
38726 participants
n=206 Participants
|
86097 participants
n=7 Participants
|
|
Sex/Gender, Customized
Male
|
15873 participants
n=99 Participants
|
13469 participants
n=107 Participants
|
32270 participants
n=206 Participants
|
61612 participants
n=7 Participants
|
|
Sex/Gender, Customized
Missing
|
5 participants
n=99 Participants
|
2 participants
n=107 Participants
|
0 participants
n=206 Participants
|
7 participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1358 Participants
n=99 Participants
|
1231 Participants
n=107 Participants
|
2576 Participants
n=206 Participants
|
5165 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35090 Participants
n=99 Participants
|
39041 Participants
n=107 Participants
|
68420 Participants
n=206 Participants
|
142551 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
74 participants
n=99 Participants
|
43 participants
n=107 Participants
|
110 participants
n=206 Participants
|
227 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
508 participants
n=99 Participants
|
580 participants
n=107 Participants
|
1091 participants
n=206 Participants
|
2179 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
67 participants
n=99 Participants
|
56 participants
n=107 Participants
|
135 participants
n=206 Participants
|
258 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1358 participants
n=99 Participants
|
1231 participants
n=107 Participants
|
2576 participants
n=206 Participants
|
5165 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
29720 participants
n=99 Participants
|
33087 participants
n=107 Participants
|
58290 participants
n=206 Participants
|
121097 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
4721 participants
n=99 Participants
|
5275 participants
n=107 Participants
|
8794 participants
n=206 Participants
|
18790 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
36448 participants
n=99 Participants
|
40272 participants
n=107 Participants
|
70996 participants
n=206 Participants
|
147716 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: discharge through 90 daysPopulation: Acute ischemic stroke patients in the Get With the Guidelines registry with Medicare fee-for-service health insurance, analyzed as one cohort rather than by arm to differentiate the different types of rehabilitation services within the full patient population.
Received either inpatient care in an inpatient rehabilitation or skilled nursing facility, or home or community-based rehabilitation.
Outcome measures
| Measure |
All Patients
n=162432 Participants
Examined descriptively for all patients in the study in order to differentiate the different types of rehabilitation services for the full stroke patient population.
|
Skilled Nursing Facility (SNF)
Discharged from hospital to Skilled Nursing Facility
|
|---|---|---|
|
Number of Participants Receiving Inpatient, Home, or Community Based Rehabilitation Services
Short-term inpatient rehab (inpt, skilled nurs.)
|
76720 participants
|
—
|
|
Number of Participants Receiving Inpatient, Home, or Community Based Rehabilitation Services
Home or community-based rehab
|
32350 participants
|
—
|
PRIMARY outcome
Timeframe: 12 months post-dischargePopulation: Acute ischemic stroke patients in the Get With the Guidelines registry with Medicare fee-for-service health insurance, discharged to inpatient rehab or skilled nursing care and without survival limitations identified in-hospital. 69,212 patients met these criteria.
Number of days alive and living outside of inpatient care
Outcome measures
| Measure |
All Patients
n=34815 Participants
Examined descriptively for all patients in the study in order to differentiate the different types of rehabilitation services for the full stroke patient population.
|
Skilled Nursing Facility (SNF)
n=34397 Participants
Discharged from hospital to Skilled Nursing Facility
|
|---|---|---|
|
Home-time
|
271.2 days
Standard Deviation 112.5
|
195.5 days
Standard Deviation 138.5
|
SECONDARY outcome
Timeframe: 12 months post-dischargePopulation: Acute ischemic stroke patients in the Get With the Guidelines registry discharged to inpatient rehabilitation or skilled nursing facility, without survival limitations identified in-hospital and with 12-month follow-up as part of the Adherence Evaluation After Ischemic Stroke Longitudinal (AVAIL) registry. 473 participants met these criteria.
12-month functional status as measured by modified Rankin scale scores ranging between 0 (no symptoms) and 6 (death), among patients discharged to inpatient rehabilitation or skilled nursing facility. Outcome measure reports number of participants with Rankin score of 3-6. The outcome was not assessed among patients discharged home.
Outcome measures
| Measure |
All Patients
n=345 Participants
Examined descriptively for all patients in the study in order to differentiate the different types of rehabilitation services for the full stroke patient population.
|
Skilled Nursing Facility (SNF)
n=128 Participants
Discharged from hospital to Skilled Nursing Facility
|
|---|---|---|
|
Number of Participants Who Were Functionally Dependent or Dead 12 Months After Hospital Discharge
|
203 participants
|
77 participants
|
SECONDARY outcome
Timeframe: 12 months post-dischargePopulation: Acute ischemic stroke patients in the Get With the Guidelines registry discharged to inpatient rehabilitation or skilled nursing facility, without survival limitations identified in-hospital and with 12-month follow-up as part of the Adherence Evaluation After Ischemic Stroke Longitudinal (AVAIL) registry. 323 patients met these criteria.
EuroQOL-5 Dimensions (EQ-5D) to assess health-related quality of life by asking and scoring the level of severity (1 = no problems, 2 = some problems, 3 = extreme problems) in 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Score for each question is added together to provide total score, which is converted to provide a range from 1 (maximum and highest health state for quality of life) down to 0 (lowest health state and quality of life).
Outcome measures
| Measure |
All Patients
n=239 Participants
Examined descriptively for all patients in the study in order to differentiate the different types of rehabilitation services for the full stroke patient population.
|
Skilled Nursing Facility (SNF)
n=84 Participants
Discharged from hospital to Skilled Nursing Facility
|
|---|---|---|
|
Quality of Life (QOL)
|
0.76 units on a scale
Interval 0.46 to 0.84
|
0.68 units on a scale
Interval 0.0 to 0.83
|
SECONDARY outcome
Timeframe: 12 months post-dischargePopulation: Acute ischemic stroke patients in the Get With the Guidelines registry discharged to inpatient rehabilitation or skilled nursing facility, without survival limitations identified in-hospital and with 12-month follow-up as part of the Adherence Evaluation After Ischemic Stroke Longitudinal (AVAIL) registry. 473 patients met these criteria.
Institutionalization (primary living location in a nursing home for long-term care and not for rehabilitation or short-term skilled stay) as measured by patient or proxy family member report on 12-month follow-up phone call.
Outcome measures
| Measure |
All Patients
n=345 Participants
Examined descriptively for all patients in the study in order to differentiate the different types of rehabilitation services for the full stroke patient population.
|
Skilled Nursing Facility (SNF)
n=128 Participants
Discharged from hospital to Skilled Nursing Facility
|
|---|---|---|
|
Number of Participants Who Were Institutionalized in a Nursing Home for Long-term Care Within 12 Months of Hospital Discharge.
|
64 participants
|
60 participants
|
SECONDARY outcome
Timeframe: 12 months post-dischargePopulation: Acute ischemic stroke patients in the Get With the Guidelines registry with Medicare fee-for-service health insurance, discharged to inpatient rehabilitation or skilled nursing facility and without survival limitations identified in-hospital. 69,212 patients met these criteria.
All-cause rehospitalization or death within 12 months of index stroke hospitalization as indicated in Medicare claims files.
Outcome measures
| Measure |
All Patients
n=34815 Participants
Examined descriptively for all patients in the study in order to differentiate the different types of rehabilitation services for the full stroke patient population.
|
Skilled Nursing Facility (SNF)
n=34397 Participants
Discharged from hospital to Skilled Nursing Facility
|
|---|---|---|
|
Number of Participants Who Were Rehospitalized or Died Within 12 Months of Stroke Hospitalization.
|
18884 participants
|
23411 participants
|
SECONDARY outcome
Timeframe: 12 months post-dischargePopulation: Acute ischemic stroke patients in the Get With the Guidelines registry with Medicare fee-for-service health insurance, discharged to inpatient rehabilitation or skilled nursing facility and without survival limitations identified in-hospital. 69,212 patients met these criteria.
Death within 12 months of discharge from index stroke hospitalization as indicated in Medicare claims files
Outcome measures
| Measure |
All Patients
n=34815 Participants
Examined descriptively for all patients in the study in order to differentiate the different types of rehabilitation services for the full stroke patient population.
|
Skilled Nursing Facility (SNF)
n=34397 Participants
Discharged from hospital to Skilled Nursing Facility
|
|---|---|---|
|
Number of Participants Who Died Within 12 Months of Stroke Hospitalization
|
6221 participants
|
13274 participants
|
Adverse Events
All Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Janet Prvu Bettger, ScD
Duke Clinical Resarch Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place