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
  Purpose

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.


Condition Intervention
Cerebrovascular Accident
Behavioral: care management

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Post Discharge Intervention to Improve Stroke Outcomes

Further study details as provided by Summa Health System:

Enrollment: 380
Study Start Date: June 2002
Study Completion Date: June 2009
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00328471

Sponsors and Collaborators
Summa Health System
Investigators
Principal Investigator: Kyle R Allen, DO Summa Health System
  More Information

Publications:
Responsible Party: Dr. Kyle Allen, Summa Health system
ClinicalTrials.gov Identifier: NCT00328471     History of Changes
Other Study ID Numbers: 1 R01 NS41333-01A1, 1 R01 NS41333-01A1
Study First Received: May 18, 2006
Last Updated: January 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Summa Health System:
patient care management
cerebrovascular accident

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 02, 2014