Clinical trial NCT02284165: Comparative Effectiveness of Rehabilitation Services for Survivors of Acute Ischemic Stroke
Official title: Comparative Effectiveness of Rehabilitation Services for Survivors of Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-11-05
Enrollment: 164246
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized for acute ischemic stroke in 2006-2008, and successfully linked to Medicare claims available through 2009

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?

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Receiving Inpatient, Home, or Community Based Rehabilitation Services
timeFrame: discharge through 90 days
measure: Home-time
timeFrame: 12 months post-discharge
Secondary outcomes:
measure: Number of Participants Who Were Functionally Dependent or Dead 12 Months After Hospital Discharge
timeFrame: 12 months post-discharge
measure: Quality of Life (QOL)
timeFrame: 12 months post-discharge
measure: Number of Participants Who Were Institutionalized in a Nursing Home for Long-term Care Within 12 Months of Hospital Discharge.
timeFrame: 12 months post-discharge
measure: Number of Participants Who Were Rehospitalized or Died Within 12 Months of Stroke Hospitalization.
timeFrame: 12 months post-discharge
measure: Number of Participants Who Died Within 12 Months of Stroke Hospitalization
timeFrame: 12 months post-discharge
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Janet Bettger, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.