Intelligent Simulated Patient System for Gastroenterology Education

NCT07714655 | Completed

• 1 other identifier: ISPS-2026-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Medical Education; Clinical Competence; History Taking

Keywords

Large Language Model; Artificial Intelligence; Virtual Patient; Gastroenterology; Medical Education; History Taking; Simulation Training; Clinical Skills; Automated Assessment

Outcome Measures

Primary Outcomes (2)

• Diagnostic accuracy

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

  Immediately after the 4-week intervention

• History-taking completeness score

  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.

  Immediately after the 4-week intervention

Secondary Outcomes (2)

• Empathy performance

  Immediately after the 4-week intervention

• Technology acceptance

  Immediately after completion of the intervention

Study Arms (2)

ISPS Group

EXPERIMENTAL

Participants received four weeks of training using the Intelligent Simulated Patient System (ISPS), a large language model-based virtual patient platform for gastroenterology education. The system provides repeated history-taking practice, automated assessment, and individualized feedback.

Other: Intelligent Simulated Patient System (ISPS)

Control Group

ACTIVE COMPARATOR

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

Other: Conventional Clinical Teaching

Interventions

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.

Control Group

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.

ISPS Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and instructors were aware of group assignment because of the nature of the educational intervention. Outcome assessors who evaluated the OSCE performance were blinded to group allocation. Statistical analyses were also performed by an independent statistician blinded to treatment assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomly assigned in a 1:1 ratio to either the Intelligent Simulated Patient System (ISPS) group or the conventional teaching group for four weeks.

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: March 1, 2026
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

CN (1)