Comparative Effectiveness of Rehabilitation Services for Survivors of Acute Ischemic Stroke

Completed

• Conditions: Ischemic Stroke

• Registration Number: NCT02284165
• Lead Sponsor: Duke University

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?

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2014-11-03
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Results First Submitted: 2016-07-07
• Results First Submitted QC: 2016-11-10
• Results First Posted: 2017-01-09
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-01
• Last Update Posted: 2018-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164246

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

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Exclusion Criteria

• death during index hospitalization

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Home-time	12 months post-discharge	Number of days alive and living outside of inpatient care
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.

Secondary Outcome Measures

Name	Time	Method
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.
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).
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.
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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States