Intelligent Simulated Patient System for Gastroenterology Education

NCT07714655 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-08-06

No results posted yet for this study

Summary

This randomized controlled trial evaluated a large language model-based Intelligent Simulated Patient System (ISPS) for gastroenterology history-taking education. Ninety medical students were randomly assigned in a 1:1 ratio to 4 weeks of conventional clinical learning or ISPS-assisted training.

The ISPS used teacher-defined structured case information to support simulated patient interactions and generated item-level formative feedback using predefined scoring rubrics. The implemented system did not use external electronic health record retrieval, retrieval-augmented generation, a vector database, or semantic-similarity threshold scoring.

The primary outcomes were post-intervention medical history-taking performance and clinical diagnostic accuracy. History-taking performance was assessed in a standardized Objective Structured Clinical Examination by two senior physicians who were blinded to group allocation. Secondary outcomes included patient-centered communication competence and participants' acceptance of the ISPS.

Conditions

  • Medical Education
  • Clinical Competence
  • History Taking

Interventions

OTHER

Intelligent Simulated Patient System (ISPS)

Participants received 4 weeks of self-directed gastroenterology history-taking training using the Intelligent Simulated Patient System (ISPS). Participants selected teacher-configured clinical cases and conducted multiround history-taking interviews with large language model-driven simulated patients. Simulated-patient responses were constrained by teacher-defined structured patient information. After each training encounter, the ISPS evaluated history-taking completeness item by item using a predefined 100-point Medical History-Taking Assessment rubric and provided individualized formative feedback. Patient-centered communication competence was assessed separately from the complete interview transcript using a four-domain scale. These automated scores and feedback were used solely for formative training and were not used as the primary post-intervention outcome of the randomized trial. In the system version evaluated in this study, case information and scoring criteria were configure

OTHER

Conventional Clinical Teaching

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhejiang Chinese Medical University

    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
2026-03-01
Primary Completion
2026-06-01
Completion
2026-06-01

Countries

  • China

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 NCT07714655 on ClinicalTrials.gov