NCT06766383

Brief Summary

The goal of this clinical trial is to evaluate whether AI-based simulated patient training can improve clinical reasoning and history-taking skills in medical students. The main questions it aims to answer is: Does GPT-based simulated patient training improve medical students' history-taking skills compared to traditional role-playing methods? Participants will: Participants in the intervention group perform medical history-taking conversations with an AI-simulated patient. Receive AI-generated structured feedback on their performance. The control group participated in role-playing exercises with instructors who acted as patients, receiving feedback after each session. Complete standardized assessments to evaluate clinical reasoning and decision-making skills.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
Last Updated

January 14, 2025

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

December 27, 2024

Last Update Submit

January 11, 2025

Conditions

Keywords

History-taking TrainingArtificial IntelligenceMedical EducationGPT Simulation

Outcome Measures

Primary Outcomes (1)

  • structured clinical examination to measure students' abilities in history taking

    Pre and Post Training: This primary endpoint measures improvements in students' clinical skills using a structured clinical examination conducted both before and after the training. The total score is out of 100 points, aggregated from four components: History Collection (30 points): Assesses the level of detail in the chief complaint and symptoms (10 points), the ability to understand and identify patient information (10 points), and the appropriateness and logic of follow-up questions (10 points). Clinical Reasoning (30 points): Evaluates the thoroughness of diagnostic thinking (15 points) and efficiency in processing information and forming clinical judgments (15 points). Communication Skills (20 points): Includes interaction with patients (10 points) and clarity of information delivery (10 points). Professional Behavior (20 points): Measures adherence to clinical procedural norms (10 points) and professional attitude towards patients (1

    From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (2)

  • Training Feedback Assessment

    From enrollment to the end of treatment at 4 weeks

  • Student Satisfaction Survey

    From enrollment to the end of treatment at 4 weeks

Study Arms (2)

intervention group

EXPERIMENTAL

using GPT-simulated patients

Behavioral: GPT-simulated patients

control group

ACTIVE COMPARATOR

using traditional role-playing

Behavioral: traditional role-playing

Interventions

GPT-simulated patients

intervention group

traditional role-playing

control group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Students enrolled in a medical or health-related professional program.
  • Clinical coursework completion:
  • Students who have completed basic clinical coursework, including foundational topics in patient communication and clinical reasoning.
  • Age group:
  • Participants aged 18-30 years to reflect typical medical student demographics.
  • Language proficiency:
  • Adequate proficiency in the language used for the study (e.g., English) to effectively interact with the AI-simulated patient and understand feedback.
  • Willingness and availability:
  • Students who provide informed consent and are willing to participate in all required study activities, including training sessions and assessments.
  • Access to technology:
  • Ability to access and use the necessary technology, such as a computer and internet connection, to complete the simulated patient interactions.

You may not qualify if:

  • Students not enrolled in medical or related health professions programs. Students in early years of study who have not completed basic clinical coursework.
  • Technical limitations:
  • Inability to access or use the required technology (e.g., computer or online platforms).
  • Time constraints:
  • Inability to complete all required training and assessments within the study timeline.
  • Language barriers:
  • Insufficient proficiency in the language used for the study (e.g., English) to effectively communicate or understand the simulated patient interactions.
  • Health-related factors:
  • Conditions that may impair participation, such as significant hearing or vision impairment, or severe psychological conditions.
  • Prior participation in similar studies:
  • Students who have already participated in studies involving similar AI-based simulated patient training or feedback.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Related Publications (1)

  • Wang Z, Fan TT, Li ML, Zhu NJ, Wang XC. Feasibility study of using GPT for history-taking training in medical education: a randomized clinical trial. BMC Med Educ. 2025 Jul 10;25(1):1030. doi: 10.1186/s12909-025-07614-9.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
physician

Study Record Dates

First Submitted

December 27, 2024

First Posted

January 9, 2025

Study Start

October 7, 2024

Primary Completion

December 15, 2024

Study Completion

December 15, 2024

Last Updated

January 14, 2025

Record last verified: 2024-10

Locations