- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05379699
Development and Validation of an Online Independent Training Program for TOR-BSST© Dysphagia Screeners
Study Overview
Status
Intervention / Treatment
Detailed Description
BACKGROUND: Stroke is a leading cause of death globally, and dysphagia is a common consequence of stroke, affecting approximately 55% of all acute stroke patients. Stroke best practice guidelines recommend early identification of dysphagia by screening of all patients admitted with acute stroke. Our group was the first to systematically develop and properly validate a screening tool for adult stroke patients, namely the Toronto Bedside Swallowing Screening Test (TOR-BSST©), which is supported by Canadian stroke guidelines. TOR-BSST© training consists of a live 4-hour workshop followed by a one-on-one competency evaluation, both of which are conducted by a speech-language pathologist (SLP). In its current format, screener training demands healthcare resources that are not universally available.
OBJECTIVES: The proposed study will assess whether a new shorter independent eLearning TOR-BSST© screener training is equally effective as the current standard training in achieving screener accuracy. We propose to: (AIM 1, primary) assess impact on screener accuracy when the 4-hour live training (Arm 1) is replaced with the shorter independent eLearning modules (Arm 2); (AIM 2, secondary), assess impact on screener accuracy by replacing the SLP during one-on-one competency observation in Arm 2 with a previously trained screener titled a TOR-BSST© competency mentor (Arm 3); (AIM 3, secondary), assess impact on screening accuracy by eliminating the SLP competency observation in Arm 2; (AIM 4, secondary), assess impact on screening accuracy by eliminating the TOR-BSST© competency mentor observation in Arm 3.
RESEARCH PLAN Study Design: Single-blinded 3-arm behavioural intervention randomized controlled trial. Subjects: Screener Trainees. Any healthcare professional will be considered eligible if they have no formal training in dysphagia screening and currently manage patients diagnosed with stroke. SLP Trainers. SLPs who are active TOR-BSST© trainers will conduct the 4-hour live training for all screener trainees in Arm 1, and perform the one-on-one competency evaluation with all screener trainees in Arms 1 and 2. TOR-BSST© Competency Mentors. Healthcare staff who are already independent TOR-BSST© screeners, will be considered eligible as mentors provided they remain clinically active and competent TOR-BSST© screeners. Participating Sites: Sites representing academic and community hospitals, and with English and French speaking participants.
Interventions and Comparator: Screener trainees will be randomly assigned to one of three study arms. Arm 1 (control) participants will receive the standard live training. Arm 2 (experimental) participants will independently complete the new shorter independent TOR-BSST© eLearning. Arm 3 (experimental) participants will complete the same training as those in Arm 2, except that judgements of competency during the final live one-on-one session will be made by a TOR-BSST© competency mentor (vs an SLP).
DATA ANALYSIS: Screener accuracy will be assessed using a previously validated online screener accuracy test (for primary AIM 1 and secondary AIMS 2, 3 and 4). For comparison of screener accuracy between Arms 1 vs 2 and between Arms 1 vs 3, an intention-to-treat analysis will be applied comparing the proportion of screeners who pass online screener accuracy using the Chisquare test. For comparison of screener accuracy within each Arm 2 and 3 participants, proportion of screeners who pass the eLearning module 3 will be compared to the proportion of those same screeners who pass online screener accuracy using the McNemar test. Across all comparisons, conditions will be set at α=0.05 and ß= 0.8. Sample Size: A total sample of 351 (117 in each Arm) will be sufficient to assess primary and secondary aims, setting α=0.05 and ß= 0.8.
EXPECTED RESULTS Our study is carefully designed to be the first to narrow in and identify the simplest/shortest dysphagia screener training program that is feasible yet also achieves training success.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5T 2S8
- University Health Network
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Any healthcare professional who has had no formal training in dysphagia screening and currently manages patients diagnosed with stroke.
Exclusion Criteria:
- Any healthcare professional who has had prior formal training in dysphagia screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Standard 4-hour live screener training with 1-on-1 live observation by a speech-language pathologist.
|
Standard 4-hour in-person TOR-BSST© screener training conducted by a Speech-Language Pathologist.
|
|
Experimental: 2
New eLearning training with 1-on-1 live observation by a speech-language pathologist.
|
An online self-directed training program for TOR-BSST© dysphagia screeners.
|
|
Experimental: 3
New eLearning training with 1-on-1 live observation by a competency mentor.
|
An online self-directed training program for TOR-BSST© dysphagia screeners.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Online Test of Screener Accuracy (Module 4)
Time Frame: 30 minutes
|
An online test of screening accuracy completed following the live 1-on-1 observation
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Online Assessment of Trained Screeners (Module 3)
Time Frame: 30 minutes
|
An online assessment of screening accuracy completed following either the standard live 4-hr training or the new online training, but prior to completing the live 1-on-1 observation
|
30 minutes
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Rosemary Martino, PhD, University Health Network, Toronto
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-6011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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