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Completed

NCT Number: NCT07714655

Intelligent Simulated Patient System for Gastroenterology Education

This randomized controlled trial evaluated a large language model-based Intelligent Simulated Patient System (ISPS) for gastroenterology history-taking education. The system integrates retrieval-augmented generation (RAG), electronic health record-based knowledge retrieval, virtual patient interaction, and automated scoring. Ninety medical students were randomly assigned to conventional training or ISPS-assisted training. Primary outcomes included history-taking completeness and diagnostic accuracy. Secondary outcomes included empathy performance and technology acceptance.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

About this study

History-taking is a fundamental clinical skill in gastroenterology because digestive diseases often present with complex and nonspecific symptoms that require systematic information gathering for accurate diagnosis. Traditional history-taking education relies on bedside teaching, standardized patients, and faculty supervision. However, these approaches are limited by high educational costs, restricted access to standardized patients, variability in assessment, and limited opportunities for repeated practice.

This study developed an Intelligent Simulated Patient System (ISPS) powered by a large language model (LLM) and retrieval-augmented generation (RAG) technology for gastroenterology education. The system was built using de-identified electronic health records, clinical guidelines, and textbook-based knowledge to create realistic virtual patients capable of maintaining disease-specific characteristics throughout multi-turn conversations. In addition to virtual patient simulation, the platform includes an automated scoring system that evaluates history-taking completeness using semantic similarity matching and logical completeness assessment based on predefined clinical rubrics.

This prospective randomized controlled trial aims to evaluate whether ISPS-assisted training improves clinical history-taking skills compared with conventional teaching methods. Ninety medical students who had completed courses in diagnostics and internal medicine were randomly assigned in a 1:1 ratio to either an ISPS training group or a conventional teaching group. The intervention lasted four weeks.

Participants in the control group received conventional clinical education, including bedside teaching, case-based learning, and supervised clinical discussions. Participants in the intervention group independently completed repeated history-taking practice using the ISPS platform with virtual patients representing common gastroenterology diseases.

The primary outcomes are history-taking completeness scores and diagnostic accuracy assessed during a standardized Objective Structured Clinical Examination (OSCE). Secondary outcomes include empathy performance during physician-patient communication and participants' acceptance of the ISPS assessed using the Technology Acceptance Model (TAM) questionnaire.

The study also evaluates the reliability of the automated scoring system by comparing AI-generated scores with expert ratings using Pearson correlation, intraclass correlation coefficients (ICC), and Bland-Altman analysis.

The findings are expected to provide evidence regarding the effectiveness of large language model-based virtual patient systems for improving clinical communication skills, standardized assessment, and competency-based medical education in gastroenterology.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Undergraduate medical students at Zhejiang Chinese Medical University who had completed their clinical clerkship and the required coursework in Diagnostics and Internal Medicine (Gastroenterology).
  • Postgraduate students in Clinical Medicine at the First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine).
  • Able and willing to provide written informed consent.
  • Willing to complete the entire 4-week study protocol and all outcome assessments.

Exclusion criteria

  • Individuals with extensive prior clinical experience in gastroenterology that could substantially influence baseline performance.
  • Individuals with severe visual, hearing, or other impairments that would prevent effective participation in the Intelligent Simulated Patient System training.
  • Individuals unable to complete the required training sessions or the final Objective Structured Clinical Examination (OSCE).
  • Individuals who withdrew informed consent or had incomplete outcome assessment.

Treatment and study plan

Intelligent Simulated Patient System (ISPS)

Other

Participants received four weeks of self-directed training using the Intelligent Simulated Patient System (ISPS), a large language model-based educational platform developed for gastroenterology history-taking training. The system integrates retrieval-augmented generation (RAG), de-identified electronic health records, disease-specific knowledge retrieval, virtual patient simulation, automated history-taking assessment, and individualized feedback. Participants independently selected clinical cases, conducted repeated history-taking interviews with virtual patients, received automated evaluations of history-taking completeness, and reviewed personalized feedback throughout the intervention period.

Conventional Clinical Teaching

Other

Participants received conventional clinical education for four weeks, including bedside teaching, case-based learning, paper-based medical record review, and faculty-guided clinical discussions according to the standard curriculum.

Primary outcomes

  1. Diagnostic accuracy

    Time frame: Immediately after the 4-week intervention

    Diagnostic accuracy was defined as the proportion of participants who correctly identified the primary diagnosis during the standardized OSCE.

  2. History-taking completeness score

    Time frame: Immediately after the 4-week intervention

    History-taking completeness was evaluated during a standardized Objective Structured Clinical Examination (OSCE) using a validated rubric with a total score ranging from 0 to 100. Higher scores indicate more complete history-taking performance.

Secondary outcomes

  1. Empathy performance

    Time frame: Immediately after the 4-week intervention

    Empathy performance was assessed during the standardized OSCE using a quantitative empathy assessment scale developed from the "Understand the Patient's Perspective" dimension of the SEGUE framework.

  2. Technology acceptance

    Time frame: Immediately after completion of the intervention

    Participants' acceptance of the Intelligent Simulated Patient System was assessed using a Technology Acceptance Model (TAM)-based questionnaire evaluating perceived usefulness, perceived ease of use, perceived enjoyment, behavioral intention, and perceived risks.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Zhejiang Chinese Medical University

Other

Registry information

Official study title

Development and Evaluation of an Intelligent Simulated Patient System Based on Large Language Models for Gastroenterology History-Taking Education: A Prospective Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

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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