Recruiting

AI-Based Role Play vs. Peer Role Play

Sponsor:

The Hospital for Sick Children

Code:

NCT07069504

Conditions

Informed Consent Process

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

AI-based role play

Peer role play

Study Details

Brief 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

Study ID

NCT07069504

Start date

Jul 2, 2025

Status verified date

Jul, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1\) physician trainee enrolled at the University of Toronto.

Exclusion Criteria:

1\) have previously obtained informed consent for an endoscopic procedure 25 or more times in either real clinical or simulated settings.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: AI Role Play

Participants will interact with a generative AI-driven patient simulation designed to mimic a realistic consent discussion for an endoscopic procedure. The AI will respond dynamically to trainee input, prompting key elements of the consent process. After each case, the generative AI platform will provide the trainee with individualized feedback. Training will last 30 minutes. The same patient cases will be used in both groups.

active comparator: Peer Role Play

Participants will be paired with another trainee (i.e., peer) in this group to conduct role play exercises, alternating between the roles of physician and patient, using standardized prompts and guidelines. After each case, the trainee portraying the patient will be asked to provide feedback to the individual portraying the participant. Training will last 30 minutes. The same patient cases will be used in both groups.

Interventions

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.

Peer role play

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

Primary outcome measure

  • Informed consent checklist [ Time Frame: Day 1 (immediately post-training) ]
  • Communication Skills [ Time Frame: Day 1 (immediately post-training) ]

Central Contacts and Locations

Locations

Scarborough Health Network, University of Toronto

Recruiting

Toronto, Ontario, Canada, M5G 0A4

Contacts

Samir Grover, MD, MEd, FRCPC

416284-8131sgrover@shn.ca

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Jul 16, 2025

Last verified

Jul, 2025

Keywords

  • artificial intelligence
  • virtual patient
  • simulation-based training
  • simulation training
  • education
  • informed consent
  • role play

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2025-07-16.