Domain-Specific Large Language Model Assistance for Emergency Neurological Diagnosis and Treatment: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,381
- 试验地点
- 3
- 主要终点
- Diagnostic-care quality risk
研究概览
简要总结
This study will evaluate whether Xuanwu-NeuroAid 2.0, a large language model for emergency neurology, can improve 30-day diagnostic quality in adults with acute neurological symptoms. Physicians will be randomly assigned to AI-assisted care or usual care. In the AI-assisted group, the model will provide diagnostic and management suggestions, while physicians will make all final clinical decisions. The usual-care group will receive standard emergency neurology care without large language model assistance.
详细描述
This multicenter, prospective, cluster randomized trial will evaluate whether Xuanwu-NeuroAid 2.0, a domain-specific large language model for emergency neurology, can improve diagnostic quality in adults presenting with acute neurological symptoms. Physicians will be randomized to AI-assisted care or usual care. In the AI-assisted group, the model will provide diagnostic and management suggestions based on available clinical information, while physicians will remain responsible for all final clinical decisions. the model's recommendations could be disregarded when they were considered inappropriate. The usual-care group will receive standard emergency neurology care without large language model assistance.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Presentation to the emergency neurology service with acute neurological symptoms;
- •Written informed consent provided by the patient or a legally authorized representative.
排除标准
- •Presentation primarily for trauma;
- •Pregnancy;
- •Requiring immediate life-saving interventions;
- •Estimated life expectancy of less than 30 days;
- •Participation in another clinical trial within the previous 30 days or in a trial that could interfere with the study or outcome assessment;
- •Any condition that, in the opinion of the investigators, would interfere with the conduct of the trial or the interpretation of the results.
研究组 & 干预措施
AI-assisted group
Physicians in this group will use Xuanwu-NeuroAid 2.0 during emergency evaluation and management.
干预措施: Xuanwu-NeuroAid 2.0 (Device)
Usual-care group
Physicians in this group will provide standard emergency neurology care without large language model assistance.
结局指标
主要结局
Diagnostic-care quality risk
时间窗: Day 30
A composite outcome defined as the occurrence of any of the following: a diagnostic discrepancy within 30 days; unplanned medical care within 30 days; harms related to the index emergency care within 30 days; or all-cause death within 30 days.
次要结局
- Diagnostic discrepancy(Day 30)
- Quality of diagnostic testing and management recommendations(Day 30)
- Patient satisfaction with emergency care(Immediately after the index emergency department encounter, within 48 hours)
- Time spent per patient encounter(Time from start of physician evaluation to completion of final diagnosis and disposition decision, within 48 hours.)
- Clinician-reported workload(Immediately after each index emergency department encounter, within 48 hours.)
- EQ-5D-5L at 30 days(Day 30)
研究者
Ji Xunming,MD,PhD
Professor of Neurology, Xuanwu Hospital, Capital Medical University
Capital Medical University