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Completed

NCT Number: NCT02284165

Comparative Effectiveness of Rehabilitation Services for Survivors of Acute Ischemic Stroke

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

The investigators will seek to answer three questions:

  • What are the person- and system-level factors associated with use of rehabilitation services following acute ischemic stroke?
  • 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?
  • 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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

retrospective analysis

Other

Analysis of data for patients hospitalized in 2006-2008 with acute ischemic stroke, and successfully linked with Medicare claims through 2009

Primary outcomes

  1. Number of Participants Receiving Inpatient, Home, or Community Based Rehabilitation Services

    Time frame: discharge through 90 days

    Received either inpatient care in an inpatient rehabilitation or skilled nursing facility, or home or community-based rehabilitation.

  2. Home-time

    Time frame: 12 months post-discharge

    Number of days alive and living outside of inpatient care

Secondary outcomes

  1. Number of Participants Who Were Functionally Dependent or Dead 12 Months After Hospital Discharge

    Time frame: 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.

  2. Quality of Life (QOL)

    Time frame: 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).

  3. Number of Participants Who Were Institutionalized in a Nursing Home for Long-term Care Within 12 Months of Hospital Discharge.

    Time frame: 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.

  4. Number of Participants Who Were Rehospitalized or Died Within 12 Months of Stroke Hospitalization.

    Time frame: 12 months post-discharge

    All-cause rehospitalization or death within 12 months of index stroke hospitalization as indicated in Medicare claims files.

  5. Number of Participants Who Died Within 12 Months of Stroke Hospitalization

    Time frame: 12 months post-discharge

    Death within 12 months of discharge from index stroke hospitalization as indicated in Medicare claims files

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 5, 2014
Registry last updated
Mar 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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