Ischemic StrokeNCT02284165

Comparative Effectiveness of Rehabilitation Services for Survivors of Acute Ischemic Stroke

An observational study of Ischemic Stroke, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Ischemic Stroke
What is being tested?: retrospective analysis
How many people: 164,246 participants
Where: 1 siteUnited States
Study dates: May 2013to May 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients hospitalized for acute ischemic stroke in 2006-2008, and successfully linked to Medicare claims available through 2009

Who may be able to join

acute ischemic stroke within the Get With the Guidelines-Stroke data set for 2006-2008, and successfully linked to Medicare claims through 2009

Who cannot join

death during index hospitalization

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Center
Durham, North Carolina, 27705

Other trials in United States

About this study

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.

Read the detailed description

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?

Conditions: Ischemic Stroke
Being tested: retrospective analysis
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: discharge through 90 days
Home-time
Number of days alive and living outside of inpatient care
Measured: 12 months post-discharge

Secondary outcomes (5)

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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12 months post-discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013May 2016

First posted5 Nov 2014 (estimated)
Study startMay 2013
Primary completionMay 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ischemic StrokeStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 164,246 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02284165
Sponsor's protocol ID: Pro00044034
Status last verified: Feb 2018
First submitted: 3 Nov 2014
Last updated: 1 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 28830975

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Effectiveness of Rehabilitation Services for Survivors of Acute Ischemic Stroke
ClinicalTrials.gov ID: NCT02284165
Acronym / sponsor ID: Pro00044034
Conditions: Ischemic Stroke
Study type: Observational
Recruitment status: Completed
Enrolment: 164,246 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute
Study start: May 2013 (actual)
Primary completion: May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 5 Nov 2014 (estimated)
Results: Posted 9 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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?

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients hospitalized for acute ischemic stroke in 2006-2008, and successfully linked to Medicare claims available through 2009

Key inclusion criteria (1 listed)

acute ischemic stroke within the Get With the Guidelines-Stroke data set for 2006-2008, and successfully linked to Medicare claims through 2009

Key exclusion criteria (1 listed)

death during index hospitalization

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
retrospective analysisAnalysis of data for patients hospitalized in 2006-2008 with acute ischemic stroke, and successfully linked with Medicare claims through 2009	Other	–

Primary outcome

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

5 secondary outcomes

Number of Participants Who Were Functionally Dependent or Dead 12 Months After Hospital Discharge
Time frame: 12 months post-discharge
Quality of Life (QOL)
Time frame: 12 months post-discharge
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
Number of Participants Who Were Rehospitalized or Died Within 12 Months of Stroke Hospitalization.
Time frame: 12 months post-discharge
Number of Participants Who Died Within 12 Months of Stroke Hospitalization
Time frame: 12 months post-discharge

Results and safety

Results posted to the registry on 9 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Inpatient Rehab Facility (IRF)	36,448	36,448
Skilled Nursing Facility (SNF)	40,272	40,272
Discharged Home	70,996	70,996

Primary outcome: Number of Participants Receiving Inpatient, Home, or Community Based Rehabilitation Services

Time frame: discharge through 90 days. Number. Unit: participants

Measure	All Patients n = 162432
Short-term inpatient rehab (inpt, skilled nurs.)	76720
Home or community-based rehab	32350

Population analysed: 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.

Primary outcome: Home-time

Time frame: 12 months post-discharge. Mean (Standard Deviation). Unit: days

Measure	Inpatient Rehab Facility (IRF) n = 34815	Skilled Nursing Facility (SNF) n = 34397
Value	271.2 (112.5)	195.5 (138.5)

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Patients	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28830975Xian 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.
Individual participant dataSharing planned: No

Related trials for Ischemic Stroke

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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janet Bettger, ScD principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Receiving Inpatient, Home, or Community Based Rehabilitation Services (time frame: discharge through 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02284165, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.