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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00359593
• Other study ID #: CSNscore
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 31, 2006
• Last updated: March 19, 2008
• Start date: September 2006
• Est. completion date: April 2008

Study information

• Verified date: July 2006
• Source: Toronto Rehabilitation Institute
• Contact: Amanda G Hurdowar, MSc
• Phone: 416-597-3422
• Email: Hurdowar.Amanda[@]TorontoRehab.on.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Knowledge translation intervention package

Locations

Country	Name	City	State
Canada	McGill University	Montreal	Quebec
Canada	Toronto Rehabilitation Institute	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Toronto Rehabilitation Institute	McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arm function as measured by the Box and Block test
Primary	Walking speed as measured by the 6 minutes walk test
Secondary	Arm function as measured by the Chedoke Arm and Hand Activity Inventory (CAHAI- 9)
Secondary	Impairment as measured by the Chedoke-McMaster Stroke Assessment Scale (CMSA)
Secondary	Independence of daily living as measured by the 3. Functional Independence Measure (FIM)
Secondary	Economic outcomes measured by the Quality Adjusted Life Years (QALY)