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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
The investigators will seek to answer three questions:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| retrospective analysis | Other | Analysis of data for patients hospitalized in 2006-2008 with acute ischemic stroke, and successfully linked with Medicare claims through 2009 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | discharge through 90 days |
| Home-time | Number of days alive and living outside of inpatient care | 12 months post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients hospitalized for acute ischemic stroke in 2006-2008, and successfully linked to Medicare claims available through 2009
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| Name | Affiliation | Role |
|---|---|---|
| Janet Bettger, ScD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28830975 | Derived | Xian Y, Thomas L, Liang L, Federspiel JJ, Webb LE, Bushnell CD, Duncan PW, Schwamm LH, Stein J, Fonarow GC, Hoenig H, Montalvo C, George MG, Lutz BJ, Peterson ED, Bettger JP. Unexplained Variation for Hospitals' Use of Inpatient Rehabilitation and Skilled Nursing Facilities After an Acute Ischemic Stroke. Stroke. 2017 Oct;48(10):2836-2842. doi: 10.1161/STROKEAHA.117.016904. Epub 2017 Aug 22. |
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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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Inpatient Rehab Facility (IRF) | Discharged from hospital to inpatient rehabilitation facility |
| FG001 | Skilled Nursing Facility (SNF) | Discharged from hospital to skilled nursing facility |
| FG002 | Discharged Home | Discharged from hospital to home with or without services |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Acute ischemic stroke patients in the Get With the Guidelines registry with Medicare fee-for-service health insurance. Differentiation into study arms by discharge location meets the first primary aim of the study, to describe rehab service use through 90 days.
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| ID | Title | Description |
|---|---|---|
| BG000 | Inpatient Rehab Facility (IRF) | Discharged from hospital to Inpatient Rehabilitation Facility |
| BG001 | Skilled Nursing Facility (SNF) | Discharged from hospital to Skilled Nursing Facility |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All analyses calculated by comparing only non-missing values. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | participants | discharge through 90 days |
|
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This was a retrospective analysis of pre-existing data for acute ischemic stroke patients in the Get With the Guidelines registry with Medicare fee-for-service health insurance, or with 12-month follow-up as part of the Adherence Evaluation After Ischemic Stroke Longitudinal (AVAIL) registry. Adverse events were not assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | Not applicable. This was a retrospective analysis of pre-existing data for acute ischemic stroke patients in the Get With the Guidelines registry with 12-month follow-up as part of the Adherence Evaluation After Ischemic Stroke Longitudinal (AVAIL) registry. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janet Prvu Bettger, ScD | Duke Clinical Resarch Institute | 617-901-0277 | janet.bettger@duke.edu |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 12 months post-discharge |
| 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). | 12 months post-discharge |
| 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. | 12 months post-discharge |
| 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. | 12 months post-discharge |
| 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 | 12 months post-discharge |
| BG002 | Discharged Home | Discharged from hospital to home with or without services |
| BG003 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex/Gender, Customized | All analyses calculated by comparing only non-missing values. Gender missing among 5 patients discharged to IRF, and 2 patients discharged to SNF. | Number | participants |
|
| Ethnicity (NIH/OMB) | All analyses calculated by comparing only non-missing values. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | All analyses calculated by comparing only non-missing values. Hispanic ethnicity collected as a category under Race, prior to revision of collection standards to match NIH/OMB. | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Home-time | Number of days alive and living outside of inpatient care | 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. | Posted | Mean | Standard Deviation | days | 12 months post-discharge |
|
|
|
| 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. | 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. | Posted | Number | participants | 12 months post-discharge |
|
|
|
| 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). | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 12 months post-discharge |
|
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| 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. | 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. | Posted | Number | participants | 12 months post-discharge |
|
|
|
| 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. | 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. | Posted | Number | participants | 12 months post-discharge |
|
|
|
| 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 | 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. | Posted | Number | participants | 12 months post-discharge |
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| 0 |
| 0 |
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| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |