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Applying Gamification to Postgraduate Endoscopic Training

This study is currently recruiting participants.
Verified October 2017 by Samir Grover, St. Michael's Hospital, Toronto
Sponsor:
ClinicalTrials.gov Identifier:
NCT03176251
First Posted: June 5, 2017
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Samir Grover, St. Michael's Hospital, Toronto
  Purpose
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.

Condition Intervention
Endoscopy Gamification Simulation Other: Gamified-Integrated Curriculum

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, two-arm, single-blinded
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Gamification of a Virtual-reality Simulation Curriculum in Endoscopy: Impact on Clinical Performance

Resource links provided by NLM:


Further study details as provided by Samir Grover, St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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

  • Non-technical performance [ Time Frame: 4-6 weeks post-intervention ]
    Differences between the two groups with respect to non-technical performance during an integrated scenario format test 4-6 weeks after training, as assessed by the modified objective structured assessment of nontechnical skills (M-OSANTS)

  • Patient comfort [ Time Frame: 4-6 weeks post-intervention ]
    Differences between the two groups with respect to patient comfort during the clinical colonoscopies, as assessed by the Nurse-Assessed Patient Comfort Score (NAPCOMS)

  • Participant self-efficacy [ Time Frame: Pre-intervention, immediate post-intervention, and 4-6 weeks post-intervention ]
    Differences between the two groups with respect to participant self-efficacy, as measured by an adapted scale based on the General Self-Efficacy Scale

  • Case Length [ Time Frame: Pre-intervention, immediate post-intervention, and 4-6 weeks post-intervention ]
    Differences between the two groups with respect to practice case length on the simulator, which will be measured by the length of time spent on each case

  • Technical performance [ Time Frame: Immediate post-intervention and 4-6 weeks post-intervention ]
    Difference between the two groups with respect to technical performance on a VR simulated colonoscopies as assessed through the JAG/DOPS


Estimated Enrollment: 36
Actual Study Start Date: August 1, 2017
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176251


Locations
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Michael Scaffidi    416-864-6060 ext 5628    scaffidim@smh.ca   
Sponsors and Collaborators
St. Michael's Hospital, Toronto
  More Information

Responsible Party: Samir Grover, Dr. Samir C. Grover, MD, MEd, FRCPC, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03176251     History of Changes
Other Study ID Numbers: 17-092
First Submitted: June 1, 2017
First Posted: June 5, 2017
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No