Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05379699 |
| Other study ID # |
HSF - G-20-0028667; AFP - n/a |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2020 |
| Est. completion date |
February 15, 2023 |
Study information
| Verified date |
June 2023 |
| Source |
University Health Network, Toronto |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
