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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03176251
Other study ID # 17-092
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date August 30, 2019

Study information

Verified date January 2021
Source St. Michael's Hospital, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Simulation-based training curricula for gastrointestinal endoscopy have been developed and have been shown to be effective. It is possible that these curricula may be further improved. Gamification, the application of game-design principles to non-game contexts, has been shown to improve learning and skill performance in medical education. In gastrointestinal endoscopy, however, no dedicated curricula have been developed using gamification principles. We aim to evaluate the impact of applying gamification to a curriculum using SBT in endoscopy on clinical performance, compared to an identical curriculum without gamification. 36 novice endoscopists from the general surgery and gastroenterology programs at the University of Toronto will be recruited. Participants will be randomized into two groups: the Conventional Training Curriculum (CTC) Group, in which participants will receive 6 hours of training on a simulator augmented with expert feedback and interlaced with 4 hours of didactic training on the theory of colonoscopy; and the Gamified Integrated Curriculum (GIC) Group, in which participants will receive the same curriculum, using the following applications of gamified learning: a leaderboard of participant performances; badges for achievement of training landmarks; and rewards for top performance. Participants will be trained to perform colonoscopies progressively moving from a low to high complexity simulators, starting with the bench-top model (1 hour) and then moving to the EndoVR® virtual reality (VR) gastroenterology simulator (5 hours). Performance will be assessed at three points: prior to training (pre-test), immediately after training (acquisition post-test) and 4-6 weeks after training (retention test). Assessment will take place on the simulator at all three time points and during two live colonoscopies at the retention test. The primary outcome measure will be the difference in clinical colonoscopy performance between the two training groups, as assessed by the Joint Advisory Group for GI Endoscopy Direct Observation of Procedural Skills (JAG/DOPS). We aim to have data collection finished by 2018. Our results have the potential to improve existing curricula for training in colonoscopy. Moreover, the development of a gamified curriculum in procedural skills may have applicability to other specialities, such as general surgery and anesthesiology.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 30, 2019
Est. primary completion date August 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Participants must be novice endoscopists enrolled in general surgery, adult gastroenterology and pediatric gastroenterology programs at the University of Toronto Exclusion Criteria: - Participants will be excluded if they have performed 25 or more real or simulated endoscopic procedures

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Gamified-Integrated Curriculum
The experimental group will receive identical training compared to the control group, with the additional incorporation of several elements of gamification, as outlined in the Arm/Group descriptions.

Locations

Country Name City State
Canada St. Michael's Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Performance on a clinical colonoscopy Difference between the control and intervention groups during two clinical colonoscopies as assessed by two independent, blinded, expert endoscopists using the Joint Advisory Group for GI Endoscopy Direct Observation of Procedural Skills (JAG/DOPS) 4-6 weeks post-intervention
Secondary Procedural Knowledge Differences between the two groups with respect to procedural knowledge as assessed by multiple-choice questionnaires Pre-intervention and immediate post-intervention
Secondary Non-technical performance Differences between the two groups with respect to non-technical performance during clinical colonoscopies and an integrated scenario format test 4-6 weeks after training, as assessed by the modified objective structured assessment of nontechnical skills (M-OSANTS) 4-6 weeks post-intervention
Secondary Patient comfort Differences between the two groups with respect to patient comfort during the clinical colonoscopies, as assessed by the Nurse-Assessed Patient Comfort Score (NAPCOMS) 4-6 weeks post-intervention
Secondary Participant self-efficacy Differences between the two groups with respect to participant self-efficacy, as measured by an adapted scale based on the General Self-Efficacy Scale Pre-intervention, immediate post-intervention, and 4-6 weeks post-intervention
Secondary Cognitive load Differences between the two groups with respect to cognitive load, as measured by the Cognitive Load Scale for Colonoscopy Pre-intervention, immediate post-intervention, and 4-6 weeks post-intervention
Secondary Technical performance Difference between the two groups with respect to technical performance on a VR simulated colonoscopies as assessed through the JAG/DOPS Immediate post-intervention and 4-6 weeks post-intervention
Secondary Participant competitiveness Difference between the two groups with respect to competitiveness as measured using the Revised Competitiveness Index Pre-intervention
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