Nervous System Diseases
Conditions
Keywords
Large Language Model, Emergency Neurology, Diagnostic, Acute Neurological Symptoms
Brief summary
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.
Detailed description
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.
Interventions
DEVICEXuanwu-NeuroAid 2.0
Xuanwu-NeuroAid 2.0 is a large language model used to support emergency neurology evaluation and management. It generates diagnostic and management suggestions based on available clinical information, including history, physical examination, laboratory results, and imaging data. Physicians may interact with the model multiple times, but remain responsible for all final clinical decisions. Its recommendations may be overridden when considered inappropriate.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic-care quality risk | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic discrepancy | Day 30 | Diagnostic discrepancy is defined as disagreement between the emergency department final diagnosis and the 30-day expert-adjudicated reference diagnosis. |
| Quality of diagnostic testing and management recommendations | Day 30 | The quality of diagnostic testing and management recommendations made during the index emergency department encounter will be assessed by blinded expert adjudicators after completion of 30-day follow-up, using a 5-point Likert scale. Higher scores indicate higher quality of diagnostic testing and management recommendations. |
| Patient satisfaction with emergency care | Immediately after the index emergency department encounter, within 48 hours | Patient satisfaction with emergency care will be assessed after the index emergency department encounter using a 5-point Likert scale, ranging from 1 to 5, with higher scores indicating greater satisfaction. |
| Time spent per patient encounter | Time from start of physician evaluation to completion of final diagnosis and disposition decision, within 48 hours. | Time spent per patient encounter is defined as the duration from the start of physician evaluation to completion of the emergency department final diagnosis and disposition decision during the index emergency department encounter. |
| Clinician-reported workload | Immediately after each index emergency department encounter, within 48 hours. | Clinician-reported workload will be assessed by the treating physician using a single-item 5-point Likert scale, ranging from 1 to 5. Higher scores indicate greater perceived workload. |
| EQ-5D-5L at 30 days | Day 30 | Health-related quality of life will be assessed using the EuroQol five-dimension five-level questionnaire. The EQ-5D-5L utility index score will be derived according to the applicable value set. The maximum score is 1, indicating full health; higher scores indicate better health status. |
Countries
China
Outcome results
None listed