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

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ClinicalTrials.gov Identifier: NCT00359593
Recruitment Status : Unknown
Verified July 2006 by Toronto Rehabilitation Institute.
Recruitment status was:  Recruiting
First Posted : August 2, 2006
Last Update Posted : March 20, 2008
Sponsor:
Collaborator:
McGill University
Information provided by:
Toronto Rehabilitation Institute

Tracking Information
First Submitted Date  ICMJE July 31, 2006
First Posted Date  ICMJE August 2, 2006
Last Update Posted Date March 20, 2008
Study Start Date  ICMJE September 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2006)
  • Arm function as measured by the Box and Block test
  • Walking speed as measured by the 6 minutes walk test
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2006)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial SCORE-IT)
Official Title  ICMJE Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial (SCORE IT)
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Condition  ICMJE Stroke
Intervention  ICMJE Behavioral: Knowledge translation intervention package
Study Arms  ICMJE Not Provided
Publications * Salbach NM, Wood-Dauphinee S, Desrosiers J, Eng JJ, Graham ID, Jaglal SB, Korner-Bitensky N, MacKay-Lyons M, Mayo NE, Richards CL, Teasell RW, Zwarenstein M, Bayley MT; Stroke Canada Optimization of Rehabilitation By Evidence - Implementation Trial (SCORE-IT) Team. Facilitated interprofessional implementation of a physical rehabilitation guideline for stroke in inpatient settings: process evaluation of a cluster randomized trial. Implement Sci. 2017 Aug 1;12(1):100. doi: 10.1186/s13012-017-0631-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 31, 2006)
2000
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00359593
Other Study ID Numbers  ICMJE CSNscore
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Toronto Rehabilitation Institute
Collaborators  ICMJE McGill University
Investigators  ICMJE
Principal Investigator: Mark T Bayley, MD Toronto Rehabilitation Institute
Principal Investigator: Sharon Wood-Dauphinee, PhD McGill University
PRS Account Toronto Rehabilitation Institute
Verification Date July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP