- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03176251
Applying Gamification to Postgraduate Endoscopic Training
January 12, 2021 updated by: Samir Grover, Unity Health Toronto
Gamification of a Virtual-reality Simulation Curriculum in Endoscopy: Impact on Clinical Performance
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Control Group: Conventional Training Group
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.
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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.
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EXPERIMENTAL: Intervention Group: Gamified-Integrated Curriculum (GIC)
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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance on a clinical colonoscopy
Time Frame: 4-6 weeks post-intervention
|
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)
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4-6 weeks post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Procedural Knowledge
Time Frame: Pre-intervention and immediate post-intervention
|
Differences between the two groups with respect to procedural knowledge as assessed by multiple-choice questionnaires
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Pre-intervention and immediate post-intervention
|
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Non-technical performance
Time Frame: 4-6 weeks post-intervention
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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)
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4-6 weeks post-intervention
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Patient comfort
Time Frame: 4-6 weeks post-intervention
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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
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|
Participant self-efficacy
Time Frame: Pre-intervention, immediate post-intervention, and 4-6 weeks post-intervention
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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
|
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Cognitive load
Time Frame: Pre-intervention, immediate post-intervention, and 4-6 weeks post-intervention
|
Differences between the two groups with respect to cognitive load, as measured by the Cognitive Load Scale for Colonoscopy
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Pre-intervention, immediate post-intervention, and 4-6 weeks post-intervention
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Technical performance
Time Frame: Immediate post-intervention and 4-6 weeks post-intervention
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Difference between the two groups with respect to technical performance on a VR simulated colonoscopies as assessed through the JAG/DOPS
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Immediate post-intervention and 4-6 weeks post-intervention
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Participant competitiveness
Time Frame: Pre-intervention
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Difference between the two groups with respect to competitiveness as measured using the Revised Competitiveness Index
|
Pre-intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2017
Primary Completion (ACTUAL)
August 30, 2019
Study Completion (ACTUAL)
August 30, 2019
Study Registration Dates
First Submitted
June 1, 2017
First Submitted That Met QC Criteria
June 1, 2017
First Posted (ACTUAL)
June 5, 2017
Study Record Updates
Last Update Posted (ACTUAL)
January 14, 2021
Last Update Submitted That Met QC Criteria
January 12, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 17-092
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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