NCT03176251

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

2.2 years

First QC Date

June 1, 2017

Last Update Submit

January 12, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Procedural Knowledge

    Pre-intervention and immediate post-intervention

  • Non-technical performance

    4-6 weeks post-intervention

  • Patient comfort

    4-6 weeks post-intervention

  • Participant self-efficacy

    Pre-intervention, immediate post-intervention, and 4-6 weeks post-intervention

  • Cognitive load

    Pre-intervention, immediate post-intervention, and 4-6 weeks post-intervention

  • +2 more secondary outcomes

Study Arms (2)

Control Group: Conventional Training Group

ACTIVE COMPARATOR

This group will receive 4 hours of didactic and hands-on sessions on colonoscopy theory and non-technical skills. Participants will also watch a video that demonstrates an ideal endoscopic procedure. After each didactic session, a short multiple-choice questionnaire based on the topics covered in that session will be administered. In addition to didactic training, the control group will be given six hours of expert-assisted instruction on low-fidelity (1 hour) and high-fidelity (5 hours) colonoscopy simulators. Six modules of increasing difficulty in colonoscopy will be taught using one-on-one feedback from an expert academic endoscopist. The endoscopy instructor will demonstrate techniques and provide feedback. During training on the high-fidelity simulator, the last two hours will take the form of the integrated scenario, which will feature a standardized patient (SP) and standardized nurse (SN). Feedback will be given after each integrated scenario by the instructor.

Other: Gamified-Integrated Curriculum

Intervention Group: Gamified-Integrated Curriculum (GIC)

EXPERIMENTAL

The intervention group will receive the same core training as the control group with additional elements of gamification: leaderboards and badges. First, leaderboards will be used to track and rank participants' performances. This will be done through an anonymized ID tag that allows a participant to identify only their position on the leaderboard. This leaderboard will include 4 components: non-technical skills, technical skills, cognitive skills, and overall ranking. Scores will be aggregated only from participants training on the same days. The leaderboard will be displayed on a central laptop and/or TV screen and will be accessible at any time throughout the day. Second, participants in the GIC group will have the opportunity to be rewarded for their performances using achievement badges which are visual cues to the player that he or she has achieved something. Awards will be given to participants at the top of the leaderboard and with the most badges.

Other: Gamified-Integrated Curriculum

Interventions

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.

Control Group: Conventional Training GroupIntervention Group: Gamified-Integrated Curriculum (GIC)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be novice endoscopists enrolled in general surgery, adult gastroenterology and pediatric gastroenterology programs at the University of Toronto

You may not qualify if:

  • Participants will be excluded if they have performed 25 or more real or simulated endoscopic procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (1)

  • Scaffidi MA, Khan R, Walsh CM, Pearl M, Winger K, Kalaichandran R, Lin P, Grover SC. Protocol for a randomised trial evaluating the effect of applying gamification to simulation-based endoscopy training. BMJ Open. 2019 Feb 24;9(2):e024134. doi: 10.1136/bmjopen-2018-024134.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized, two-arm, single-blinded
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Samir C. Grover, MD, MEd, FRCPC

Study Record Dates

First Submitted

June 1, 2017

First Posted

June 5, 2017

Study Start

June 1, 2017

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations