- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07714655
Intelligent Simulated Patient System for Gastroenterology Education
Development and Evaluation of an Intelligent Simulated Patient System Based on Large Language Models for Gastroenterology History-Taking Education: A Prospective Randomized Controlled Trial
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Zhejiang
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Hangzhou, Zhejiang, Čína
- The First Affiliated Hospital of Zhejiang Chinese Medical University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: ISPS Group
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.
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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.
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Aktivní komparátor: Control Group
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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Diagnostic accuracy
Časové okno: Immediately after the 4-week intervention
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Diagnostic accuracy was defined as the proportion of participants who correctly identified the primary diagnosis during the standardized OSCE.
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Immediately after the 4-week intervention
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History-taking completeness score
Časové okno: Immediately after the 4-week intervention
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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.
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Immediately after the 4-week intervention
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Empathy performance
Časové okno: Immediately after the 4-week intervention
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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.
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Immediately after the 4-week intervention
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Technology acceptance
Časové okno: Immediately after completion of the intervention
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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.
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Immediately after completion of the intervention
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- ISPS-2026-001
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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