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Comparing AI Role-Play and Peer Role-Play for Informed Consent Training in Endoscopy: A Randomized Control Trial

NCT07069504 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-16

No results posted yet for this study

Summary

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.

Conditions

  • Informed Consent Process

Interventions

OTHER

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

Peer role play

Participants will role play informed consent discussions with a peer (i.e., another participant randomized to this group)

Sponsors & Collaborators

  • University of Toronto

    collaborator OTHER

  • Scarborough General Hospital

    collaborator OTHER

  • The Hospital for Sick Children

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-02
Primary Completion
2025-09-01
Completion
2026-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07069504 on ClinicalTrials.gov