Impact of a Simulation-based Training Curriculum of Non-technical Skills on Colonoscopy Performance

NCT02877420 | Completed

• 1 other identifier: 15-164c
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to test a curriculum of non-technical skills (NTS) training for simulation-based training of colonoscopy. There is no known literature to date on the optimal approach on how to teach NTS in endoscopy. The objectives are to evaluate a simulation-based curriculum to teach NTS, to explore the relationship between NTS and other domains of competency, and understand how NTS are acquired in endoscopic training.

Conditions

Endoscopy Simulation

Keywords

Endoscopy; Simulation Training; Non-technical Skills

Outcome Measures

Primary Outcomes (1)

• Difference in performance between two groups in clinical colonoscopy

  Each videotaped clinical colonoscopy will be independently assessed by two experienced endoscopists using the Joint Advisory Group for GI Endoscopy Direct Observation of Procedural Skills (JAG/DOPS). The raters will be blinded to the group assignment. Training on how to use the tool will be provided for raters by the investigators of the study.

  During clinical colonoscopy 4-6 weeks after NTS training curriculum

Secondary Outcomes (8)

• Differences in procedural knowledge

  One day

• Technical performance on a VR simulated colonoscopy - JAG/DOPS

  4-6 weeks

• Technical performance on a VR simulated colonoscopy - GiECAT

  4-6 weeks

• Patient comfort during clinical colonoscopies

  4-6 weeks

• Non-technical performance on clinical colonoscopies

  4-6 weeks

Study Arms (2)

Non-Technical Skills Training Curriculum

EXPERIMENTAL

This group will receive 4 hours of small-group and hands-on sessions and 1 hour of didactic NTS sessions. Participants will watch a video that demonstrates ideal endoscopic performance. They will use the E-NTS Checklist during the integrated scenario training. This checklist targets NTS. The group will be given 7 hours of expert-assisted instruction on the low-fidelity simulator (1 hour) and the high-fidelity VR simulator (6 hours). Six modules of increasing difficulty in colonoscopy and polypectomy will be taught with feedback from an expert endoscopist who will demonstrate techniques, answer questions and provide individualized performance feedback with a focus on NTS. The last three hours on the high fidelity simulator will be an integrated scenario (IG) featuring standardized patient (SP) and standardized nurse (SN). Feedback will be given after each IG by the instructor, SP and SN. Participants can view the E-NTS Checklist before and after each case.

Other: Non-Technical Skills Training Curriculum

Conventional Simulation Training Group

ACTIVE COMPARATOR

This group will receive 4 hours of small-group and hands-on sessions on colonoscopy theory from an expert endoscopist. The core curriculum is designed on the basis of the American Society for Gastrointestinal Endoscopy colonoscopy curriculum and an endoscopic training textbook. This curriculum has been shown to be effective when compared to self-regulated learning on the simulator. The sessions will be interlaced with eight hours of expert-assisted instruction on both the low-fidelity simulator (1 hour) and on the high-fidelity VR simulator (7 hours). Six modules of increasing difficulty in colonoscopy and polypectomy will be taught with feedback from an expert endoscopist. The expert will demonstrate techniques, answer questions and provide feedback on global performance. Feedback, in the form of performance metrics, will be provided by the simulator upon completion/failure of each module.

Other: Conventional Simulation Training Group

Interventions

Non-Technical Skills Training Curriculum OTHER

Non-Technical Skills Training Curriculum

Conventional Simulation Training Group OTHER

Conventional Simulation Training Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Novice endoscopists from general surgery, gastroenterology, or pediatrics gastroenterology residency programs at the University of Toronto

You may not qualify if:

• If participants have performed more than 25 endoscopies

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St.Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

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  PMID: 28778849 DERIVED

Study Officials

• Samir C Grover, MD, MEd

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MEd, FRCPC

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 24, 2016
• Study Start: June 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 2, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)