Effects of an Educational Intervention on Rehabilitation Clinicians' Practices for Health-related Outcomes After Stroke

Sponsor
McGill University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03807115
Collaborator
Heart and Stroke Foundation of Canada - Canadian Partnership for Stroke Recovery (Other), Réseau Provincial De Recherche En Adaptation-Réadaptation (REPAR) (Other)
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Study Details

Study Description

Brief Summary

The overall aim of this pilot study is to evaluate the feasibility of a study protocol for a future stepped wedge cluster randomized clinical trial (c-RCT) that will investigate the effects of an innovative KT intervention on 1) walking capacity and independence in ADL in patients undergoing rehabilitation after stroke (patient outcomes); and 2) clinicians' practice (i.e. use of 4 evidence-based stroke rehabilitation interventions: motor imagery/mental practice, rhythmic auditory stimulation gait therapy, task oriented training including fitness and mobility exercises and aerobic training) (provider outcome) aimed at improving walking capacity. The specific objectives are: 1) To evaluate the feasibility (effectiveness of clinician recruitment strategies, extent of losses to follow-up across sites, and data analysis plans) of the study protocol in terms of methodology (stepped wedge design is an innovative methodology); 2) To estimate intervention effect sizes on study outcomes (patient and clinician); 3) To evaluate the secondary outcome (clinicians' use of the 4 interventions) with regard to reliability and validity.

Condition or Disease Intervention/Treatment Phase
  • Other: Implementation of stroke mobility guidelines
N/A

Detailed Description

Walking capacity is the major priority for patients after stroke. Strong research evidence shows that walking capacity can be improved by rehabilitation interventions such as motor imagery, rhythmic auditory cueing, task-oriented training and aerobic exercise. Despite strong evidence for the effectiveness of these interventions on walking capacity, many clinicians (occupational therapists (OTs) and physical therapists (PTs)) do not use these in their practice. This knowledge translation (KT) pilot study aims to support evidence-based practice amongst rehabilitation clinicians working in stroke rehabilitation and collect data to inform a future larger clinical trial that will investigate if having repeated exposure to an innovative KT intervention will: increase clinicians' use of four targeted rehabilitation interventions (listed above) and positively affect walking capacity and independence in daily activities in patients after stroke. The investigators will recruit 2-3 OTs and 2-3 PTs per site from 6 major inpatient stroke rehabilitation centres across Canada to participate in a KT intervention consisting of an interactive and readily accessible web-based platform to deliver evidence-based knowledge on 4 rehabilitation interventions targeting walking capacity. This will be done via email in short online educational capsules including strategies for implementing the interventions and tools to promote reflection on current and future practice. They will then ask clinicians for feedback on: 1) the value of the knowledge delivered via email; 2) their perceptions about the success of using the guidelines with specific stroke patients; 3) the barriers they experienced when using the platform; and 4) the actual benefits for their patients. Through this innovative KT intervention, clinicians will have an opportunity to reflect upon and subsequently modify their practice to include evidence-based interventions known to improve walking capacity and functional independence.

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
This is a pilot stepped-wedge c-RCT. Data collection will take place over 16 weeks at 6 sites. Patient chart data (Functional Independence Measure (FIM), Functional Ambulation Category (FAC), 6-Minute-Walk-Test) will be collected weekly at all sites. Weeks 1-12: Participants at sites 1-6 will submit a weekly Calculation of Indicators (COI). Weeks 1-12: Sites 1 and 2 will receive 4 weekly online intervention packages and submit Information Assessment Method (IAM) and COI questionnaires for 12 weeks. Weeks 5-12: Sites 3 and 4 will receive 4 weekly online intervention packages and submit IAM and COI questionnaires for 8 weeks. Weeks 9-12: Sites 5 and 6 will receive 4 weekly online intervention packages and submit IAM and COI questionnaires for a total of 4 weeks. The longest exposure to the intervention will be 3 months and the minimum will be 1 month as per stepped-wedge c-RCT design. All participants will complete a My Guideline Implementation Barometer (MGIB) questionnaire at month 4.This is a pilot stepped-wedge c-RCT. Data collection will take place over 16 weeks at 6 sites. Patient chart data (Functional Independence Measure (FIM), Functional Ambulation Category (FAC), 6-Minute-Walk-Test) will be collected weekly at all sites. Weeks 1-12: Participants at sites 1-6 will submit a weekly Calculation of Indicators (COI). Weeks 1-12: Sites 1 and 2 will receive 4 weekly online intervention packages and submit Information Assessment Method (IAM) and COI questionnaires for 12 weeks. Weeks 5-12: Sites 3 and 4 will receive 4 weekly online intervention packages and submit IAM and COI questionnaires for 8 weeks. Weeks 9-12: Sites 5 and 6 will receive 4 weekly online intervention packages and submit IAM and COI questionnaires for a total of 4 weeks. The longest exposure to the intervention will be 3 months and the minimum will be 1 month as per stepped-wedge c-RCT design. All participants will complete a My Guideline Implementation Barometer (MGIB) questionnaire at month 4.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of an Innovative Continuing Professional Development Intervention on Rehabilitation Clinicians' Practices to Improve Walking and Independence in Activities of Daily Living After Stroke: a Pilot Study
Actual Study Start Date :
Feb 24, 2020
Anticipated Primary Completion Date :
Oct 15, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Intervention

Arm: Intervention: Implementation of stroke mobility guidelines

Other: Implementation of stroke mobility guidelines
Delivery of weekly online educational capsules on 4 evidence-based stroke recommendations (motor imagery/mental practice, rhythmic auditory stimulation gait therapy, task-oriented training including fitness and mobility exercises, and aerobic training) plus feedback on participant's awareness, agreement, satisfaction with, and perceived value of the content, perceived implementation success and facilitators and barriers encountered.

No Intervention: Control

Arm: Control: Usual care

Outcome Measures

Primary Outcome Measures

  1. Six minute walk test (walking ability) [1-3 months]

    Measurement of the total distance walked over six minutes on a hard, flat surface

  2. Functional Independence Measure [1-3 months]

    7-level measurement of functional independence (1=total assist; 7=complete independence)

  3. Functional Ambulation Category [1-3 months]

    6-point measurement of functional ambulation (0=nonfunctional ambulation; 5=ambulator independent)

Secondary Outcome Measures

  1. Information Assessment Method [1-3 months]

    Clinician-reported feedback on weekly delivery and retrieval of health information provided in educational capsules

  2. Clinician-reported feedback on caseload (Calculation of Indicators) [1-3 months]

    Number of patients with stroke treated per week

  3. Clinician-reported feedback on delivery of interventions (Calculation of Indicators) [1-3 months]

    Duration of interventions delivered per stroke patient per week (in 5 minute increments)

  4. Clinician-reported feedback on confidence level in ability to deliver interventions (Calculation of Indicators) [1-3 months]

    Confidence level in ability to deliver interventions on 10-point scale (0=not at all confident; 10=extremely confident)

  5. My Guidelines Implementation Barometer [1-3 months]

    Clinician-reported feedback on application of guideline recommendations in clinical practice, barriers to implementation and expected health benefits. Clinicians will be asked to list the factors that influenced the use of those recommendations in their practice.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Occupational therapists and physical therapists with a minimum of 1 year clinical experience, working in an in-patient stroke rehabilitation centre in Canada.

  • Sites will be eligible if they do not have an existing format knowledge translation initiative directed at enhancing practice in mobility training, have at least 10 people with stroke on their unit on a regular basis, and have an interdisciplinary team consisting of 2-3 occupational therapists and 2-3 physical therapists.

  • Patients with a documented walking deficit (documented in patient's chart) and which are on the caseload of a minimum of one participating clinician.

Exclusion Criteria:
  • Occupational or physical therapists who are currently participating in another knowledge translation study directed at enhancing practice in mobility training.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nanaimo General Hospital Nanaimo British Columbia Canada V9S 2B7
2 Riverview Health Centre Winnipeg Manitoba Canada R3L 2P4
3 Nova Scotia Health Authority Halifax Nova Scotia Canada
4 St. John's Rehab - Sunnybrook Hospital North York Ontario Canada M2M 2G1
5 Bridgepoint Rehabilitation Hospital Toronto Ontario Canada M4M 2B5
6 Wascana Rehabilitation Centre Regina Saskatchewan Canada S4S 0A5

Sponsors and Collaborators

  • McGill University
  • Heart and Stroke Foundation of Canada - Canadian Partnership for Stroke Recovery
  • Réseau Provincial De Recherche En Adaptation-Réadaptation (REPAR)

Investigators

  • Principal Investigator: Aliki Thomas, PhD, McGill University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Aliki Thomas, Associate Professor, McGill University
ClinicalTrials.gov Identifier:
NCT03807115
Other Study ID Numbers:
  • CPSR-REPAR Research Award
First Posted:
Jan 16, 2019
Last Update Posted:
Feb 23, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aliki Thomas, Associate Professor, McGill University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2021