Comparing AI-based role play with Peer role play for informed consent process
Official title: Comparing AI Role-Play and Peer Role-Play for Informed Consent Training in Endoscopy: A Randomized Control Trial
COMPARING AI ROLE-PLAY AND PEER ROLE-PLAY FOR INFORMED CONSENT TRAINING IN ENDOSCOPY: A RANDOMIZED CONTROL TRIAL
- 2 groups
- One site, in Toronto
- Recruiting
Interventions
- Other intervention
AI-based role play
Participants will role play informed consent scenarios with a generative AI-driven patient simulation designed to mimic a realistic consent discussion for an endoscopic procedure.
- Other intervention
Peer role play
Participants will role play informed consent discussions with a peer (i.e., another participant randomized to this group)
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Scarborough Health Network, University of Toronto
Toronto, Ontario
Eligibility Criteria
See who this study is looking for2 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +\) physician trainee enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → at the University of Toronto.
Exclusion
- −\) have previously obtained informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → for an endoscopic procedure 25 or more times in either real clinical or simulated settings.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study does not fall into the standard research categories.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives AI-based role play.
Registry label: A: AI Role Play
Group B, the comparison group, receives Peer role play.
Registry label: B: Peer Role Play
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 40 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: Day 1 (immediately post-training).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → checklist — measured over Day 1 (immediately post-training).
Communication Skills — measured over Day 1 (immediately post-training).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07069504 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About AI-based role playOther
Participants will role play informed consent scenarios with a generative AI-driven patient simulation designed to mimic a realistic consent discussion for an endoscopic procedure.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Peer role playOther
Participants will role play informed consent discussions with a peer (i.e., another participant randomized to this group)
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Day 1 (immediately post-training).
The study as a whole is currently expected to finish around 2026-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 40 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The goal of this randomized controlled trial is to find out whether AI-based role play is effective in teaching healthcare trainees how to obtain informed consent from patients for endoscopic procedures. The main question is: • How does generative AI-based role play compare to traditional peer role play in training healthcare trainees to deliver informed consent for endoscopic procedures? Researchers will compare AI-based role play with peer role play to see which method is more effective for teaching this skill. What participants will do: * Attend a lecture on how to obtain informed consent. * Take part in simulation-based training using either peer role play or AI-based role play. * Participate in a simulated clinical encounter to assess their ability to obtain informed consent.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.