A Post Discharge Intervention to Improve Stroke Outcomes

This study has been completed.
Sponsor:
Information provided by:
Summa Health System
ClinicalTrials.gov Identifier:
NCT00328471
First received: May 18, 2006
Last updated: January 6, 2012
Last verified: January 2012

May 18, 2006
January 6, 2012
June 2002
January 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00328471 on ClinicalTrials.gov Archive Site
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A Post Discharge Intervention to Improve Stroke Outcomes
A Post Discharge Intervention to Improve Stroke Outcomes

The purpose of this randomized controlled trial (RCT) is to test the effectiveness of a comprehensive interdisciplinary post-discharge stroke care management intervention in improving the overall well-being of 190 stroke survivors as compared to 190 patients who receive usual post-discharge stroke care.

The major components of the model of post-stroke care being tested include equal emphasis on physical and psychosocial issues known to impact stroke outcomes, an Advanced Practice Nurse care manager (APN-CM), an interdisciplinary healthcare team, evidenced-based care plans, collaboration with the patient's primary care physician (PCP), and ongoing patient monitoring. The APN-CM will work as part of an interdisciplinary post-stroke consultation team (PSC-Team) that will review problems identified at an in-home patient assessment. The core PSC-Team will include a geriatrician, a community-based general internist, a Clinical Nurse Specialist from the acute stroke unit, the APN-CM, and a physical therapist. Extended team members will be available as-needed and will include a neurologist, pharmacist, physiatrist, social worker, speech therapist, occupational therapist, and dietitian. The PSC-Team will develop patient care plans specific to each problem identified by the APN-CM. A copy of the care plans, evidence-based guidelines, pertinent references, and a short paragraph providing "academic detailing" specific to the patient's problems will be given to the patient's PCP by phone and in writing. The APN-CM will work collaboratively with the PCP to implement the recommendations and provide ongoing monitoring.The primary outcome of overall well-being of stroke survivors will be obtained at 6 months.

Interventional
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Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Cerebrovascular Accident
Behavioral: care management
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
380
June 2009
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

Diagnosis of ischemic stroke. NIH Stroke Scale score >1. Discharged to home from the acute care hospital, or discharged to home within 4 weeks from a short term skilled nursing facility (SNF) or acute rehabilitation facility.

Live within 25 miles of the study site. English speaking. Do not have an endarterectomy planned at the time of discharge to home.

Exclusion Criteria:

Has other illness that would dominate post-stroke care (e.g., terminal diagnosis, dialysis patient, severe dementia/Alzheimer's disease).

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Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00328471
1 R01 NS41333-01A1, 1 R01 NS41333-01A1
Yes
Dr. Kyle Allen, Summa Health system
Summa Health System
Not Provided
Principal Investigator: Kyle R Allen, DO Summa Health System
Summa Health System
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP