Comparative Effectiveness of Rehabilitation Services for Survivors of Acute Ischemic Stroke

Ischemic Stroke Clinical Trial

Official title:

Comparative Effectiveness of Rehabilitation Services for Survivors of Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284165
• Other study ID #: Pro00044034
• Status: Completed
• Phase: N/A
• First received: November 3, 2014
• Last updated: February 1, 2018
• Start date: May 2013
• Est. completion date: May 2016

Study information

• Verified date: February 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164246
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	discharge through 90 days
Primary	Home-time	Number of days alive and living outside of inpatient care	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.	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).	12 months post-discharge
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.	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.	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	12 months post-discharge