Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial SCORE-IT)

March 19, 2008 updated by: Toronto Rehabilitation Institute

Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial (SCORE IT)

The aim of this project is to evaluate whether using an implementation intervention promotes use of best practices by rehabilitation professionals and leads to improvements in patient outcomes for individuals with stroke.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Stroke is a leading cause of disability in Canada and frequently causes hemiparesis (upper limb and lower limb weakness on one side of the body). Approximately one third of stroke survivors require physical rehabilitation to improve their motor and functional recovery (1). Although many strategies have been shown to be effective in promoting recovery after stroke, the uptake of evidence-based practice by rehabilitation professionals across Canada is variable. The aim of this project is to evaluate whether using an implementation intervention promotes use of best practices by rehabilitation professionals and leads to improvements in patient outcomes for individuals with stroke.

This project is a cluster randomized implementation trial for upper and lower limb interventions. Rehabilitation centres across Canada will be randomized to receive either an outcome-oriented implementation strategy (OOI) to facilitate implementation of the EIPRs or a process-oriented implementation strategy (POI). At the onset, rehabilitation professionals practicing in all centres will receive education in using best practice outcome measures related to stroke rehabilitation. All centres will be assessed for baseline adherence to the EIPRs. Centres in the OOI will receive "usual care" (i.e. passive dissemination of the written protocols and information about outcome measures). Centres in the POI arm will receive a combination of strategies to facilitate EIPR uptake (i.e., use of a local facilitator, practice audits with feedback, reminder systems and educational sessions). Following exposure to the EIPRs, all centres will document adherence to the EIPRs, and patient outcomes as assessed by the measures. An analysis of the costs associated with rehabilitation interventions and the incremental expense of a POI strategy will be undertaken. These data will be used to compare the OOI and POI centres with respect to the level of uptake and implementation of EIPRs and related expenses.

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2A2
        • Recruiting
        • Toronto Rehabilitation Institute
        • Contact:
        • Principal Investigator:
          • Mark T Bayley, MD
    • Quebec
      • Montreal, Quebec, Canada, H3G 1Y5
        • Not yet recruiting
        • McGill University
        • Contact:
        • Principal Investigator:
          • Sharon Wood-Dauphinee, PhD

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

Rehabilitation Hospitals/Research Sites:

Inclusion Criteria:

  • hospital with designated rehabilitation beds;
  • regularly treats stroke patients;
  • has access to at least one physical (PT) and one occupational (OT) therapist on the health professional team

Exclusion Criteria:

  • Inadequate staffing to administer the outcome measures consistently

Patients:

Inclusion Criteria:

  • medically stable;
  • stroke with residual disability;
  • requires complex rehabilitation interventions from at least 3 health care professionals, one of them being an OT or a PT;
  • admitted to rehabilitation centre within 90 days of stroke onset;
  • and age >18 years

Exclusion Criteria:

  • having a medical condition that is expected to result in death within 6 months;
  • presence of a serious chronic disabling condition that impacts on either the rehabilitation process or rehabilitation outcomes such as severe arthritis, dementia, Parkinson's disease;
  • active suicidal ideation or symptoms of psychosis

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Arm function as measured by the Box and Block test
Walking speed as measured by the 6 minutes walk test

Secondary Outcome Measures

Outcome Measure
Arm function as measured by the Chedoke Arm and Hand Activity Inventory (CAHAI- 9)
Impairment as measured by the Chedoke-McMaster Stroke Assessment Scale (CMSA)
Independence of daily living as measured by the 3. Functional Independence Measure (FIM)
Economic outcomes measured by the Quality Adjusted Life Years (QALY)

Collaborators and Investigators

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

Sponsor

Toronto Rehabilitation Institute

Collaborators

McGill University

Investigators

  • Principal Investigator: Mark T Bayley, MD, Toronto Rehabilitation Institute
  • Principal Investigator: Sharon Wood-Dauphinee, PhD, McGill University

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

Helpful Links

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

September 1, 2006

Study Completion (Anticipated)

April 1, 2008

Study Registration Dates

First Submitted

July 31, 2006

First Submitted That Met QC Criteria

July 31, 2006

First Posted (Estimate)

August 2, 2006

Study Record Updates

Last Update Posted (Estimate)

March 20, 2008

Last Update Submitted That Met QC Criteria

March 19, 2008

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSNscore

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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