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A Post Discharge Intervention to Improve Stroke Outcomes

Primary Purpose

Cerebrovascular Accident

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
care management
Sponsored by
Summa Health System
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebrovascular Accident focused on measuring patient care management, cerebrovascular accident

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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). -

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 18, 2006
    Last Updated
    January 6, 2012
    Sponsor
    Summa Health System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00328471
    Brief Title
    A Post Discharge Intervention to Improve Stroke Outcomes
    Official Title
    A Post Discharge Intervention to Improve Stroke Outcomes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2002 (undefined)
    Primary Completion Date
    January 2008 (Actual)
    Study Completion Date
    June 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Summa Health System

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebrovascular Accident
    Keywords
    patient care management, cerebrovascular accident

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    380 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    care management

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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). -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kyle R Allen, DO
    Organizational Affiliation
    Summa Health System
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    14687400
    Citation
    Allen KR, Hazelett SE, Palmer RR, Jarjoura DG, Wickstrom GC, Weinhardt JA, Lada R, Holder CM, Counsell SR. Developing a stroke unit using the acute care for elders intervention and model of care. J Am Geriatr Soc. 2003 Nov;51(11):1660-7. doi: 10.1046/j.1532-5415.2003.51521.x.
    Results Reference
    result
    PubMed Identifier
    17903862
    Citation
    Allen KR, Hazelett S, Jarjoura D, Wickstrom GC, Hua K, Weinhardt J, Wright K. Effectiveness of a postdischarge care management model for stroke and transient ischemic attack: a randomized trial. J Stroke Cerebrovasc Dis. 2002 Mar-Apr;11(2):88-98. doi: 10.1053/jscd.2002.127106.
    Results Reference
    result
    Citation
    Allen KR, Hazelett SE, Jarjoura DG, Wright K, Clough L, Weinhardt J. Improving stroke outcomes: implementation of a postdischarge care management model. Journal of clinical outocmes management 11(11):707-714,2004.
    Results Reference
    result

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    A Post Discharge Intervention to Improve Stroke Outcomes

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