A Post Discharge Intervention to Improve Stroke Outcomes

January 6, 2012 updated by: Summa Health System
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

380

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Summa Health System

Investigators

  • Principal Investigator: Kyle R Allen, DO, Summa Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

May 18, 2006

First Submitted That Met QC Criteria

May 18, 2006

First Posted (Estimate)

May 22, 2006

Study Record Updates

Last Update Posted (Estimate)

January 9, 2012

Last Update Submitted That Met QC Criteria

January 6, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01NS041333-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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