Effects of an Educational Intervention on Rehabilitation Clinicians' Practices for Health-related Outcomes After Stroke
Primary Purpose
Stroke, Knowledge, Attitudes, Practice, Physical Disability
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Implementation of stroke mobility guidelines
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Rehabilitation, Knowledge translation intervention, Walking capacity
Eligibility Criteria
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.
Sites / Locations
- Nanaimo General Hospital
- Riverview Health Centre
- Nova Scotia Health Authority
- St. John's Rehab - Sunnybrook Hospital
- Bridgepoint Rehabilitation Hospital
- Wascana Rehabilitation Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Intervention
Control
Arm Description
Arm: Intervention: Implementation of stroke mobility guidelines
Arm: Control: Usual care
Outcomes
Primary Outcome Measures
Six minute walk test (walking ability)
Measurement of the total distance walked over six minutes on a hard, flat surface
Functional Independence Measure
7-level measurement of functional independence (1=total assist; 7=complete independence)
Functional Ambulation Category
6-point measurement of functional ambulation (0=nonfunctional ambulation; 5=ambulator independent)
Secondary Outcome Measures
Information Assessment Method
Clinician-reported feedback on weekly delivery and retrieval of health information provided in educational capsules
Clinician-reported feedback on caseload (Calculation of Indicators)
Number of patients with stroke treated per week
Clinician-reported feedback on delivery of interventions (Calculation of Indicators)
Duration of interventions delivered per stroke patient per week (in 5 minute increments)
Clinician-reported feedback on confidence level in ability to deliver interventions (Calculation of Indicators)
Confidence level in ability to deliver interventions on 10-point scale (0=not at all confident; 10=extremely confident)
My Guidelines Implementation Barometer
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.
Full Information
NCT ID
NCT03807115
First Posted
December 21, 2018
Last Updated
February 22, 2021
Sponsor
McGill University
Collaborators
Heart and Stroke Foundation of Canada - Canadian Partnership for Stroke Recovery, Réseau Provincial De Recherche En Adaptation-Réadaptation (REPAR)
1. Study Identification
Unique Protocol Identification Number
NCT03807115
Brief Title
Effects of an Educational Intervention on Rehabilitation Clinicians' Practices for Health-related Outcomes After Stroke
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
October 15, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University
Collaborators
Heart and Stroke Foundation of Canada - Canadian Partnership for Stroke Recovery, Réseau Provincial De Recherche En Adaptation-Réadaptation (REPAR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Knowledge, Attitudes, Practice, Physical Disability, Motor Skills Disorders
Keywords
Stroke, Rehabilitation, Knowledge translation intervention, Walking capacity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Other
Arm Description
Arm: Intervention: Implementation of stroke mobility guidelines
Arm Title
Control
Arm Type
No Intervention
Arm Description
Arm: Control: Usual care
Intervention Type
Other
Intervention Name(s)
Implementation of stroke mobility guidelines
Intervention Description
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.
Primary Outcome Measure Information:
Title
Six minute walk test (walking ability)
Description
Measurement of the total distance walked over six minutes on a hard, flat surface
Time Frame
1-3 months
Title
Functional Independence Measure
Description
7-level measurement of functional independence (1=total assist; 7=complete independence)
Time Frame
1-3 months
Title
Functional Ambulation Category
Description
6-point measurement of functional ambulation (0=nonfunctional ambulation; 5=ambulator independent)
Time Frame
1-3 months
Secondary Outcome Measure Information:
Title
Information Assessment Method
Description
Clinician-reported feedback on weekly delivery and retrieval of health information provided in educational capsules
Time Frame
1-3 months
Title
Clinician-reported feedback on caseload (Calculation of Indicators)
Description
Number of patients with stroke treated per week
Time Frame
1-3 months
Title
Clinician-reported feedback on delivery of interventions (Calculation of Indicators)
Description
Duration of interventions delivered per stroke patient per week (in 5 minute increments)
Time Frame
1-3 months
Title
Clinician-reported feedback on confidence level in ability to deliver interventions (Calculation of Indicators)
Description
Confidence level in ability to deliver interventions on 10-point scale (0=not at all confident; 10=extremely confident)
Time Frame
1-3 months
Title
My Guidelines Implementation Barometer
Description
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.
Time Frame
1-3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aliki Thomas, PhD
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanaimo General Hospital
City
Nanaimo
State/Province
British Columbia
ZIP/Postal Code
V9S 2B7
Country
Canada
Facility Name
Riverview Health Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3L 2P4
Country
Canada
Facility Name
Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
St. John's Rehab - Sunnybrook Hospital
City
North York
State/Province
Ontario
ZIP/Postal Code
M2M 2G1
Country
Canada
Facility Name
Bridgepoint Rehabilitation Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4M 2B5
Country
Canada
Facility Name
Wascana Rehabilitation Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4S 0A5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12161823
Citation
Mayo NE, Wood-Dauphinee S, Cote R, Durcan L, Carlton J. Activity, participation, and quality of life 6 months poststroke. Arch Phys Med Rehabil. 2002 Aug;83(8):1035-42. doi: 10.1053/apmr.2002.33984.
Results Reference
background
PubMed Identifier
18382825
Citation
Korner-Bitensky N, Desrosiers J, Rochette A. A national survey of occupational therapists' practices related to participation post-stroke. J Rehabil Med. 2008 Apr;40(4):291-7. doi: 10.2340/16501977-0167.
Results Reference
background
PubMed Identifier
19372171
Citation
Salbach NM, Veinot P, Rappolt S, Bayley M, Burnett D, Judd M, Jaglal SB. Physical therapists' experiences updating the clinical management of walking rehabilitation after stroke: a qualitative study. Phys Ther. 2009 Jun;89(6):556-68. doi: 10.2522/ptj.20080249. Epub 2009 Apr 16.
Results Reference
background
PubMed Identifier
21040248
Citation
Salbach NM, Veinot P, Jaglal SB, Bayley M, Rolfe D. From continuing education to personal digital assistants: what do physical therapists need to support evidence-based practice in stroke management? J Eval Clin Pract. 2011 Aug;17(4):786-93. doi: 10.1111/j.1365-2753.2010.01456.x. Epub 2010 Oct 12.
Results Reference
background
PubMed Identifier
17724549
Citation
Rochette A, Korner-Bitensky N, Desrosiers J. Actual vs best practice for families post-stroke according to three rehabilitation disciplines. J Rehabil Med. 2007 Sep;39(7):513-9. doi: 10.2340/16501977-0082.
Results Reference
background
PubMed Identifier
33058172
Citation
Cahill LS, Carey LM, Lannin NA, Turville M, Neilson CL, Lynch EA, McKinstry CE, Han JX, O'Connor D. Implementation interventions to promote the uptake of evidence-based practices in stroke rehabilitation. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD012575. doi: 10.1002/14651858.CD012575.pub2.
Results Reference
derived
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Effects of an Educational Intervention on Rehabilitation Clinicians' Practices for Health-related Outcomes After Stroke
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