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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
4-6 weeks post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Pre-intervention and immediate post-intervention
Non-technical performance
Time Frame: 4-6 weeks post-intervention
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
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)
4-6 weeks post-intervention
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
Pre-intervention, immediate post-intervention, and 4-6 weeks post-intervention
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
Pre-intervention, immediate post-intervention, and 4-6 weeks post-intervention
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
Immediate post-intervention and 4-6 weeks post-intervention
Participant competitiveness
Time Frame: Pre-intervention
Difference between the two groups with respect to competitiveness as measured using the Revised Competitiveness Index
Pre-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Unity Health Toronto

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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