Ignite Creation Date:
2024-05-06 @ 5:38 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05379699
Status:
COMPLETED
Last Update Posted:
2023-06-23
First Post:
2022-05-12
Brief Title:
Development and Validation of an Online Independent Training Program for TOR-BSST Dysphagia Screeners
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Development and Validation of an Online Independent Training Program for TOR-BSST Dysphagia Screeners
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 α005 and ß 08 Sample Size A total sample of 351 117 in each Arm will be sufficient to assess primary and secondary aims setting α005 and ß 08
EXPECTED RESULTS Our study is carefully designed to be the first to narrow in and identify the simplestshortest dysphagia screener training program that is feasible yet also achieves training success
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 α005 and ß 08 Sample Size A total sample of 351 117 in each Arm will be sufficient to assess primary and secondary aims setting α005 and ß 08
EXPECTED RESULTS Our study is carefully designed to be the first to narrow in and identify the simplestshortest dysphagia screener training program that is feasible yet also achieves training success
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None