Ischemic Stroke
Conditions
Brief summary
Retrospective analysis of Get With the Guidelines-Stroke data linked with Medicare claims and the AVAIL longitudinal data sets to assess patterns, predictors, and outcomes associated with the use of rehabilitation services following hospitalization for ischemic stroke. Primary completion defined as the end of primary analyses, consistent with the end of the PCORI Cycle I grant period. Study completion defined as acceptance of final research report and lay abstract by PCORI.
Detailed description
The investigators will seek to answer three questions: 1. What are the person- and system-level factors associated with use of rehabilitation services following acute ischemic stroke? 2. Among stroke survivors discharged to short-term inpatient rehabilitation, are high-intensity services performed at an Inpatient Rehabilitation Facility (IRF) more effective than lower intensity services performed at a Skilled Nursing Facility (SNF), at improving patient outcomes at 3 and 12 months? 3. Among stroke survivors discharged home, is early follow-up with a physician more effective than follow-up after 7 days at 3 and 12 months?
Interventions
Analysis of data for patients hospitalized in 2006-2008 with acute ischemic stroke, and successfully linked with Medicare claims through 2009
Sponsors
Patient-Centered Outcomes Research Institute
Duke University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* acute ischemic stroke within the Get With the Guidelines-Stroke data set for 2006-2008, and successfully linked to Medicare claims through 2009
Exclusion criteria
* death during index hospitalization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Receiving Inpatient, Home, or Community Based Rehabilitation Services | discharge through 90 days | Received either inpatient care in an inpatient rehabilitation or skilled nursing facility, or home or community-based rehabilitation. |
| Home-time | 12 months post-discharge | Number of days alive and living outside of inpatient care |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Were Institutionalized in a Nursing Home for Long-term Care Within 12 Months of Hospital Discharge. | 12 months post-discharge | 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. |
| Number of Participants Who Were Functionally Dependent or Dead 12 Months After Hospital Discharge | 12 months post-discharge | 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. |
| Number of Participants Who Died Within 12 Months of Stroke Hospitalization | 12 months post-discharge | Death within 12 months of discharge from index stroke hospitalization as indicated in Medicare claims files |
| Number of Participants Who Were Rehospitalized or Died Within 12 Months of Stroke Hospitalization. | 12 months post-discharge | All-cause rehospitalization or death within 12 months of index stroke hospitalization as indicated in Medicare claims files. |
| Quality of Life (QOL) | 12 months post-discharge | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Inpatient Rehab Facility (IRF) Discharged from hospital to Inpatient Rehabilitation Facility | 36,448 |
| Skilled Nursing Facility (SNF) Discharged from hospital to Skilled Nursing Facility | 40,272 |
| Discharged Home Discharged from hospital to home with or without services | 70,996 |
| Total | 147,716 |
Baseline characteristics
| Characteristic | Inpatient Rehab Facility (IRF) | Total | Discharged Home | Skilled Nursing Facility (SNF) |
|---|---|---|---|---|
| Age, Continuous | 79 years | 80 years | 78 years | 83 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1358 Participants | 5165 Participants | 2576 Participants | 1231 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35090 Participants | 142551 Participants | 68420 Participants | 39041 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 74 participants | 227 participants | 110 participants | 43 participants |
| Race/Ethnicity, Customized Asian | 508 participants | 2179 participants | 1091 participants | 580 participants |
| Race/Ethnicity, Customized Black or African American | 1358 participants | 5165 participants | 2576 participants | 1231 participants |
| Race/Ethnicity, Customized More than one race | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 67 participants | 258 participants | 135 participants | 56 participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 4721 participants | 18790 participants | 8794 participants | 5275 participants |
| Race/Ethnicity, Customized White | 29720 participants | 121097 participants | 58290 participants | 33087 participants |
| Region of Enrollment United States | 36448 participants | 147716 participants | 70996 participants | 40272 participants |
| Sex/Gender, Customized Female | 20570 participants | 86097 participants | 38726 participants | 26801 participants |
| Sex/Gender, Customized Male | 15873 participants | 61612 participants | 32270 participants | 13469 participants |
| Sex/Gender, Customized Missing | 5 participants | 7 participants | 0 participants | 2 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Home-time
Number of days alive and living outside of inpatient care
Time frame: 12 months post-discharge
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Home-time | 271.2 days | Standard Deviation 112.5 |
| Skilled Nursing Facility (SNF) | Home-time | 195.5 days | Standard Deviation 138.5 |
Primary
Number of Participants Receiving Inpatient, Home, or Community Based Rehabilitation Services
Received either inpatient care in an inpatient rehabilitation or skilled nursing facility, or home or community-based rehabilitation.
Time frame: discharge through 90 days
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | Number of Participants Receiving Inpatient, Home, or Community Based Rehabilitation Services | Short-term inpatient rehab (inpt, skilled nurs.) | 76720 participants |
| All Patients | Number of Participants Receiving Inpatient, Home, or Community Based Rehabilitation Services | Home or community-based rehab | 32350 participants |
Secondary
Number of Participants Who Died Within 12 Months of Stroke Hospitalization
Death within 12 months of discharge from index stroke hospitalization as indicated in Medicare claims files
Time frame: 12 months post-discharge
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Number of Participants Who Died Within 12 Months of Stroke Hospitalization | 6221 participants |
| Skilled Nursing Facility (SNF) | Number of Participants Who Died Within 12 Months of Stroke Hospitalization | 13274 participants |
Secondary
Number of Participants Who Were Functionally Dependent or Dead 12 Months After Hospital Discharge
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.
Time frame: 12 months post-discharge
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Number of Participants Who Were Functionally Dependent or Dead 12 Months After Hospital Discharge | 203 participants |
| Skilled Nursing Facility (SNF) | Number of Participants Who Were Functionally Dependent or Dead 12 Months After Hospital Discharge | 77 participants |
Secondary
Number of Participants Who Were Institutionalized in a Nursing Home for Long-term Care Within 12 Months of Hospital Discharge.
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.
Time frame: 12 months post-discharge
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Number of Participants Who Were Institutionalized in a Nursing Home for Long-term Care Within 12 Months of Hospital Discharge. | 64 participants |
| Skilled Nursing Facility (SNF) | Number of Participants Who Were Institutionalized in a Nursing Home for Long-term Care Within 12 Months of Hospital Discharge. | 60 participants |
Secondary
Number of Participants Who Were Rehospitalized or Died Within 12 Months of Stroke Hospitalization.
All-cause rehospitalization or death within 12 months of index stroke hospitalization as indicated in Medicare claims files.
Time frame: 12 months post-discharge
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Number of Participants Who Were Rehospitalized or Died Within 12 Months of Stroke Hospitalization. | 18884 participants |
| Skilled Nursing Facility (SNF) | Number of Participants Who Were Rehospitalized or Died Within 12 Months of Stroke Hospitalization. | 23411 participants |
Secondary
Quality of Life (QOL)
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).
Time frame: 12 months post-discharge
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Patients | Quality of Life (QOL) | 0.76 units on a scale |
| Skilled Nursing Facility (SNF) | Quality of Life (QOL) | 0.68 units on a scale |