NCT07760051招募中不适用
Effects of Agent-assisted, LLM-assisted and Traditional Workflows on Diagnosis and Management Planning at Admission: A Randomized Controlled Study
Second Affiliated Hospital, Zhejiang University, School of Medicine1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2026年9月6日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Mean Normalized Structured Score
研究概览
简要总结
The goal of this clinical trial is to evaluate whether AI-assisted workflows improve physicians' admission diagnosis and management planning performance on standardized simulated inpatient cases, among practicing internal medicine and surgery physicians across all seniority levels and across three tiers of the Chinese healthcare system.
The main questions it aims to answer are:
- Does the Agent-assisted workflow yield better structured admission diagnosis and management planning scores than standalone LLM assistance?
- Does the Agent-assisted workflow outperform the traditional workflow without AI tools? Researchers will compare three parallel groups (traditional workflow group, LLM-assisted group, Agent-assisted group) to determine whether the Agent tool can improve diagnostic accuracy and efficiency.
Participants will:
- Be recruited from 15 hospitals in China and participate remotely under video proctoring
- Be randomly assigned to one of the three fixed workflows, with randomization stratified by hospital tier, specialty and seniority
- Complete 6 anonymized simulated HIS admission cases within one hour
- Submit structured answers for each case covering principal diagnosis, secondary diagnoses, differential diagnoses, diagnostic justification, next diagnostic or therapeutic steps, consultation and referral decisions, and diagnostic confidence
- Have their operation logs and time consumption recorded automatically by the study platform
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and investigators cannot be masked, as the intervention is the workflow itself. Outcome assessors scoring the structured answers are blinded to group allocation; submitted answers are anonymized and stripped of workflow-identifying information before scoring.
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
- •Hold a Medical Practitioner Qualification Certificate and/or Medical License, or be a recognized standardized resident physician; able to independently read electronic medical records, laboratory and imaging reports on an HIS.
- •Currently engaged in clinical work in internal medicine or surgery at one of the 15 participating hospitals.
- •Able to complete the case assessment in one continuous hour without breaks.
- •Able to participate remotely under video proctoring, with a stable internet connection and a working camera.
- •Voluntarily agree to participate and sign the informed consent form, including the declaration not to use unauthorized AI tools during the assessment.
- •Have not participated in case drafting, review, rubric development, or any activity that may leak the reference standard.
排除标准
- •Have previously accessed the official test cases or reference standard of this study.
- •Unable to complete the training module, qualification test, or all experimental tasks.
- •Have conflicts of interest, e.g. participation in developing core algorithms of the tested system.
- •Unwilling to comply with remote proctoring, including keeping the camera on throughout.
- •Judged unsuitable by the investigators.
研究组 & 干预措施
Agent-assisted group
Experimental
干预措施: Agent-assisted workflow (Other)
LLM-assisted group
Experimental
干预措施: LLM-assisted workflow (Other)
Traditional group
Active Comparator
干预措施: Traditional Workflow (Other)
结局指标
主要结局
Mean Normalized Structured Score
时间窗: Within one-hour study
Mean of the rescaled case scores (each case rescaled to 100), divided by the number of cases completed; range 0 to 100.
次要结局
- Degree of Adherence to AI-Generated Recommendations(Within one-hour study)
- Active Response Time per Case(Within one-hour study)
研究者
研究点 (1)
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