Development and Evaluation of an Intelligent Simulated Patient System Based on Large Language Models for Gastroenterology History-Taking Education: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
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.
详细描述
Background and Objective
The Intelligent Simulated Patient System (ISPS) was developed to provide repeatable history-taking practice, automated formative assessment, and structured feedback for medical students learning gastroenterology. The study evaluated the reliability of the automated history-taking scoring system and the educational effectiveness of ISPS-assisted training.
ISPS Intervention
Teachers configured structured disease templates, patient-specific case information, examination tasks, scoring items, and reference diagnoses within the system. Students conducted multiround history-taking interviews with large language model-driven simulated patients. The simulated patients were instructed to respond only according to the teacher-defined patient information.
After each training encounter, the ISPS evaluated history-taking completeness item by item against a predefined 100-point Medical History-Taking Assessment (MHTA) rubric and generated formative feedback. Patient-centered communication was assessed separately in four domains: exploring the patient's ideas, exploring the patient's concerns, exploring the impact of illness, and expressing understanding and support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Intelligent Simulated Patient System (ISPS) (Other)
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.
干预措施: Conventional Clinical Teaching (Other)
结局指标
主要结局
Diagnostic accuracy
时间窗: 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.
History-taking completeness score
时间窗: 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.
次要结局
- Empathy performance(Immediately after the 4-week intervention)
- Technology acceptance(Immediately after completion of the intervention)
- Communication Competence(Immediately after the 4-week intervention)
- Acceptance of the Intelligent Simulated Patient System(Immediately after completion of the intervention)