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. 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

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)

• Communication Competence

  Immediately after the 4-week intervention

• Acceptance of the Intelligent Simulated Patient System

  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 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

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: August 6, 2026

Record last verified: 2026-08

Locations

CN (1)