A Post Discharge Intervention to Improve Stroke Outcomes

Cerebrovascular Accident Clinical Trial

Official title:

A Post Discharge Intervention to Improve Stroke Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328471
• Other study ID #: 1R01NS041333-01A1
• Secondary ID: 1R01NS041333-01A
• Status: Completed
• Phase: N/A
• First received: May 18, 2006
• Last updated: January 6, 2012
• Start date: June 2002
• Est. completion date: June 2009

Study information

• Verified date: January 2012
• Source: Summa Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: June 2009
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Behavioral:
• care management

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Summa Health System

References & Publications (3)

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. — View 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. Review. — View Citation

Jones ML, Day S, Creely J, Woodland MB, Gerdes JB. Implementation of a clinical pathway system in maternal newborn care: a comprehensive documentation system for outcomes management. J Perinat Neonatal Nurs. 1999 Dec;13(3):1-20. — View Citation