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Development and Validation of an Online Independent Training Program for TOR-BSST© Dysphagia Screeners

Primary Purpose

Dysphagia, Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
TOR-BSST© eLearning Training
Standard TOR-BSST© Training
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dysphagia focused on measuring Stroke, Dysphagia, Screening, Randomized Controlled Trial, eLearning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Health Network

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Standard 4-hour live screener training with 1-on-1 live observation by a speech-language pathologist.

New eLearning training with 1-on-1 live observation by a speech-language pathologist.

New eLearning training with 1-on-1 live observation by a competency mentor.

Outcomes

Primary Outcome Measures

Online Test of Screener Accuracy (Module 4)
An online test of screening accuracy completed following the live 1-on-1 observation

Secondary Outcome Measures

Online Assessment of Trained Screeners (Module 3)
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

Full Information

First Posted
May 12, 2022
Last Updated
June 22, 2023
Sponsor
University Health Network, Toronto
Collaborators
Lakeridge Health Corporation, Jewish General Hospital, Red Deer Regional Hospital Centre, Red Deer, AB
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1. Study Identification

Unique Protocol Identification Number
NCT05379699
Brief Title
Development and Validation of an Online Independent Training Program for TOR-BSST© Dysphagia Screeners
Official Title
Development and Validation of an Online Independent Training Program for TOR-BSST© Dysphagia Screeners
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
February 15, 2023 (Actual)
Study Completion Date
February 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
Collaborators
Lakeridge Health Corporation, Jewish General Hospital, Red Deer Regional Hospital Centre, Red Deer, AB

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
Stroke is a leading cause of death and disability globally. Dysphagia, swallowing difficulty, is common following stroke, affecting about 55% of all stroke patients. People with stroke and dysphagia are three times more likely to develop pneumonia compared to patients with no dysphagia. Stroke best practice guidelines recommend early identification of dysphagia by bedside testing (called screening) of all patients admitted to hospital with stroke. Our group was the first to develop a screening tool for stroke patients, the Toronto Bedside Swallowing Screening Test (TOR-BSST©). It uses a step-by-step process to identify patients with dysphagia risk. TOR-BSST© screeners are health professionals who have successfully completed a live 4-hr training provided by a Speech Language Pathologist (SLP). There is good evidence that this training increases the accuracy of screening. However, a 4-hr live session is not acceptable with limited healthcare resources. Our aim is to evaluate the accuracy of an innovative eLearning program to train TOR-BSST© screeners. If successful, this project will shorten training time, reduce hospital resource burden, and ensure a sustainable dysphagia screening program for people with stroke in all hospitals.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Stroke
Keywords
Stroke, Dysphagia, Screening, Randomized Controlled Trial, eLearning

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Standard 4-hour live screener training with 1-on-1 live observation by a speech-language pathologist.
Arm Title
2
Arm Type
Experimental
Arm Description
New eLearning training with 1-on-1 live observation by a speech-language pathologist.
Arm Title
3
Arm Type
Experimental
Arm Description
New eLearning training with 1-on-1 live observation by a competency mentor.
Intervention Type
Other
Intervention Name(s)
TOR-BSST© eLearning Training
Intervention Description
An online self-directed training program for TOR-BSST© dysphagia screeners.
Intervention Type
Other
Intervention Name(s)
Standard TOR-BSST© Training
Intervention Description
Standard 4-hour in-person TOR-BSST© screener training conducted by a Speech-Language Pathologist.
Primary Outcome Measure Information:
Title
Online Test of Screener Accuracy (Module 4)
Description
An online test of screening accuracy completed following the live 1-on-1 observation
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Online Assessment of Trained Screeners (Module 3)
Description
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
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosemary Martino, PhD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Development and Validation of an Online Independent Training Program for TOR-BSST© Dysphagia Screeners

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