EndoscopyNCT03176251
Applying Gamification to Postgraduate Endoscopic Training
A study testing Gamified-Integrated Curriculum in people with Endoscopy and Gamification, run by Unity Health Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Endoscopy, Gamification, Simulation
- What is being tested?
- Gamified-Integrated Curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2017to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants must be novice endoscopists enrolled in general surgery, adult gastroenterology and pediatric gastroenterology programs at the University of Toronto
Who cannot join
- Participants will be excluded if they have performed 25 or more real or simulated endoscopic procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Endoscopy, Gamification, Simulation
- Being tested
- Gamified-Integrated Curriculum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified-Integrated CurriculumOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Gamified-Integrated Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4-6 weeks post-intervention
Secondary outcomes (7)
Procedural Knowledge
Differences between the two groups with respect to procedural knowledge as assessed by multiple-choice questionnaires
Measured: Pre-intervention and immediate post-intervention
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)
Measured: 4-6 weeks post-intervention
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)
Measured: 4-6 weeks post-intervention
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
Measured: Pre-intervention, immediate post-intervention, and 4-6 weeks post-intervention
Cognitive load
Differences between the two groups with respect to cognitive load, as measured by the Cognitive Load Scale for Colonoscopy
Measured: Pre-intervention, immediate post-intervention, and 4-6 weeks post-intervention
Technical performance
Difference between the two groups with respect to technical performance on a VR simulated colonoscopies as assessed through the JAG/DOPS
Measured: Immediate post-intervention and 4-6 weeks post-intervention
Participant competitiveness
Difference between the two groups with respect to competitiveness as measured using the Revised Competitiveness Index
Measured: Pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 Jun 2017
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, two-arm, single-blinded
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samir Grover, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176251
- Sponsor's protocol ID
- 17-092
- Status last verified
- Jan 2021
- First submitted
- 1 Jun 2017
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30804029
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamification of a Virtual-reality Simulation Curriculum in Endoscopy: Impact on Clinical Performance
- ClinicalTrials.gov ID
- NCT03176251
- Acronym / sponsor ID
- 17-092
- Conditions
- Endoscopy, Gamification, Simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, two-arm, single-blinded
| Arm | Type | Receives |
|---|---|---|
| Control Group: Conventional Training Group | Active comparator | Other: Gamified-Integrated CurriculumThis 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. |
| Intervention Group: Gamified-Integrated Curriculum (GIC) | Experimental | Other: Gamified-Integrated CurriculumThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must be novice endoscopists enrolled in general surgery, adult gastroenterology and pediatric gastroenterology programs at the University of Toronto
Key exclusion criteria (1 listed)
- Participants will be excluded if they have performed 25 or more real or simulated endoscopic procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamified-Integrated CurriculumThe 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. | Other | Control Group: Conventional Training Group, Intervention Group: Gamified-Integrated Curriculum (GIC) |
Primary outcome
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)
7 secondary outcomes
Procedural Knowledge
Time frame: Pre-intervention and immediate post-intervention
Non-technical performance
Time frame: 4-6 weeks post-intervention
Patient comfort
Time frame: 4-6 weeks post-intervention
Participant self-efficacy
Time frame: 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
Technical performance
Time frame: Immediate post-intervention and 4-6 weeks post-intervention
Participant competitiveness
Time frame: Pre-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Derived from this study: PubMed 30804029Scaffidi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamified-Integrated Curriculum in people with Endoscopy and Gamification, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance on a clinical colonoscopy (time frame: 4-6 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03176251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.