A Randomized Control Trial of a Simulation-based Curriculum to Enhance Skills in Colonoscopy

Study Overview
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Brief Summary
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Colonoscopy is a commonly used medical procedure. Medical and surgical residents learning colonoscopy typically learn the procedure experientially but simulation based teaching is increasingly being integrated into training programs. The optimal manner to teach colonoscopy on virtual-reality simulators is uncertain. We aim to test a curriculum in simulation-based colonoscopy with self-directed learning on simulators.

Official Title
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A Comprehensive Simulation-based Curriculum as a Means to Enhance Technical and Non-technical Skills in Colonoscopy: a Randomized Control Trial

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: Curriculum Group
* Behavioral: Self-directed learning group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Trainee endoscopists from the gastroenterology and general surgery programs at the University of Toronto Exclusion Criteria: Greater than 20 colonoscopies performed

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curriculum Group<br>The curriculum group will undergo a comprehensive curriculum in colonoscopy utilizing a virtual reality (VR) colonoscopic simulator. This curriculum involves 6 hours of interactive, small-group didactic teaching on colonoscopy interlaced with 8 hours of supervised one-on-one endoscopy VR simulation training with experienced endoscopists. | Behavioral: Curriculum Group<br> <br> |
| Active Comparator: Self-directed learning group<br>The self-directed group will receive 8 hours of colonoscopic virtual reality (VR) simulation practice with an experienced endoscopist present, but without structured training. | Behavioral: Self-directed learning group<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfer of Skills to Clinical Colonoscopy | The Joint Advisory Group (JAG) Direct Observation of Procedural Skills (DOPS) tool is a tool to assess colonoscopic competency and includes ratings of the following domains: (i) assessment, consent and communication; (ii) safety and sedation; (iii) endoscopic skills during insertion and withdrawal; and, (iv) diagnostic and therapeutic ability. Scores range from 0-100, with higher scores representing higher colonoscopic competency. These were measured across two endoscopic procedures, performed consecutively within two weeks of completion of the course. Data from two procedures were used to limit the influence of spurious findings from single procedures. | less than 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention of Clinical Skills | The Joint Advisory Group (JAG) Direct Observation of Procedural Skills (DOPS) tool is a tool to assess colonoscopic competency and includes ratings of the following domains: (i) assessment, consent and communication; (ii) safety and sedation; (iii) endoscopic skills during insertion and withdrawal; and, (iv) diagnostic and therapeutic ability. Scores range from 0-100, with higher scores representing higher colonoscopic competency. The tool will be used to assess participants during an integrated scenario. A change in these ratings before and after intervention is the secondary outcome. | 4-6 weeks after intervention |