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Completed

NCT Number: NCT06766383

Simulated Patient and AI-based Roleplay for History-taking

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Medical education enrollment:

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.

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Exclusion criteria

Non-medical background:

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.

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Treatment and study plan

GPT-simulated patients

Behavioral

GPT-simulated patients

traditional role-playing

Behavioral

traditional role-playing

Primary outcomes

  1. structured clinical examination to measure students' abilities in history taking

    Time frame: From enrollment to the end of treatment at 4 weeks

    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

Secondary outcomes

  1. Training Feedback Assessment

    Time frame: From enrollment to the end of treatment at 4 weeks

    Training Feedback Assessment Measurement Tool: Structured Questionnaire on a 5-point Likert scale.

    Components Assessed:

    • Post-class self-directed learning.
    • Enthusiasm for learning.
    • Communication and feedback skills.
    • Expressiveness.
    • Interview logical reasoning ability.
    • Anxiety levels during the interview process. Description: This secondary endpoint collects feedback on the training methods' effectiveness through a structured questionnaire. Each aspect is rated on a 5-point Likert scale, where 1 indicates 'strongly disagree' and 5 indicates 'strongly agree'.
  2. Student Satisfaction Survey

    Time frame: From enrollment to the end of treatment at 4 weeks

    Measurement Tool: Satisfaction Questionnaire on a 5-point Likert scale.

    Components Assessed:

    • Diversity of diseases encountered during training.
    • Naturalness of patient interaction.
    • Usability of the training methods.
    • Likelihood of recommending the training to peers. Description: This secondary endpoint evaluates student satisfaction concerning various aspects of the training experience. The questionnaire assesses each factor on a 5-point Likert scale, where 1 is 'very dissatisfied' and 5 is 'very satisfied'.

Sponsors and collaborators

Lead sponsor

Zhen Wang

Other

Registry information

Official study title

Feasibility Study of Using GPT for History-taking Training in Medical Education

Acronym: SPAR-H

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2025
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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