DysphagiaNCT05379699
Development and Validation of an Online Independent Training Program for TOR-BSST© Dysphagia Screeners
A study testing TOR-BSST© eLearning Training and Standard TOR-BSST© Training in people with Dysphagia and Stroke, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- TOR-BSST© eLearning Training and Standard TOR-BSST© Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2020to 15 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any healthcare professional who has had no formal training in dysphagia screening and currently manages patients diagnosed with stroke.
Who cannot join
- Any healthcare professional who has had prior formal training in dysphagia screening
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- TOR-BSST© eLearning Training, Standard TOR-BSST© Training
- Keywords
- Stroke, Dysphagia, Screening, Randomized Controlled Trial, eLearning
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOR-BSST© eLearning TrainingOther
An online self-directed training program for TOR-BSST© dysphagia screeners.
Standard TOR-BSST© TrainingOther
Standard 4-hour in-person TOR-BSST© screener training conducted by a Speech-Language Pathologist.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Standard 4-hour live screener training with 1-on-1 live observation by a speech-language pathologist. Receives: Other: Standard TOR-BSST© Training |
| 2 | Experimental | New eLearning training with 1-on-1 live observation by a speech-language pathologist. Receives: Other: TOR-BSST© eLearning Training |
| 3 | Experimental | New eLearning training with 1-on-1 live observation by a competency mentor. Receives: Other: TOR-BSST© eLearning Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Online Test of Screener Accuracy (Module 4)
An online test of screening accuracy completed following the live 1-on-1 observation
Measured: 30 minutes
Secondary outcomes (1)
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
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Oct 2020
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Lakeridge Health Corporation, Jewish General Hospital, Red Deer Regional Hospital Centre, Red Deer, AB
- Responsible party
- Sponsor
- Investigators
- Rosemary Martino, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379699
- Sponsor's protocol ID
- 18-6011
- Status last verified
- Jun 2023
- First submitted
- 12 May 2022
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Online Independent Training Program for TOR-BSST© Dysphagia Screeners
- ClinicalTrials.gov ID
- NCT05379699
- Acronym / sponsor ID
- 18-6011
- Keywords
- Stroke, Dysphagia, Screening, Randomized Controlled Trial, eLearning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Lakeridge Health Corporation, Jewish General Hospital, Red Deer Regional Hospital Centre, Red Deer, AB
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Standard TOR-BSST© TrainingStandard 4-hour live screener training with 1-on-1 live observation by a speech-language pathologist. |
| 2 | Experimental | Other: TOR-BSST© eLearning TrainingNew eLearning training with 1-on-1 live observation by a speech-language pathologist. |
| 3 | Experimental | Other: TOR-BSST© eLearning TrainingNew eLearning training with 1-on-1 live observation by a competency mentor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any healthcare professional who has had no formal training in dysphagia screening and currently manages patients diagnosed with stroke.
Key exclusion criteria (1 listed)
- Any healthcare professional who has had prior formal training in dysphagia screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TOR-BSST© eLearning TrainingAn online self-directed training program for TOR-BSST© dysphagia screeners. | Other | 2, 3 |
| Standard TOR-BSST© TrainingStandard 4-hour in-person TOR-BSST© screener training conducted by a Speech-Language Pathologist. | Other | 1 |
Primary outcome
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
1 secondary outcome
Online Assessment of Trained Screeners (Module 3)
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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Dysphagia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosemary Martino, PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TOR-BSST© eLearning Training and Standard TOR-BSST© Training in people with Dysphagia and Stroke, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Online Test of Screener Accuracy (Module 4) (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.