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

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Self-directed learning group; Behavioral: Curriculum Group

• Registration Number: NCT01991522
• Lead Sponsor: Unity Health Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-25
• Results First Submitted: 2017-04-28
• Status Verified: 2018-02
• Results First Submitted QC: 2018-02-19
• Last Update Submitted: 2018-02-19
• Results First Posted: 2018-11-05
• Last Update Posted: 2018-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Trainee endoscopists from the gastroenterology and general surgery programs at the University of Toronto

Exclusion Criteria

• Greater than 20 colonoscopies performed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-directed learning group	Self-directed learning group	The self-directed group will receive 8 hours of colonoscopic virtual reality (VR) simulation practice with an experienced endoscopist present, but without structured training.
Curriculum Group	Curriculum Group	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.

Primary Outcome Measures

Name	Time	Method
Transfer of Skills to Clinical Colonoscopy	less than 2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Retention of Clinical Skills	4-6 weeks after intervention	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.

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada