Domain-Specific Large Language Model Assistance for Emergency Neurological Diagnosis and Treatment(DEMAND)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCapital Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Presentation primarily for trauma;

Pregnancy;

Requiring immediate life-saving interventions;

Estimated life expectancy of less than 30 days;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Xuanwu-NeuroAid 2.0

    Device

    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.

Treatment groups

1,360 Participants
are divided into 2 treatment groups
Group A: AI-assisted groupExperimental treatment 1 intervention
Group B: Usual-care groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Diagnostic-care quality risk

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.

Time frame
Day 30

Secondary outcomes

1

Diagnostic discrepancy

Diagnostic discrepancy is defined as disagreement between the emergency department final diagnosis and the 30-day expert-adjudicated reference diagnosis.

Time frame
Day 30
2

Quality of diagnostic testing and management recommendations

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.

Time frame
Day 30
3

Patient satisfaction with emergency care

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 frame
Immediately after the index emergency department encounter, within 48 hours
4

Time spent per patient encounter

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.

Time frame
Time from start of physician evaluation to completion of final diagnosis and disposition decision, within 48 hours.

Other outcomes

1

Unplanned medical care within 30 days

Unplanned medical care is defined as any unscheduled emergency department visit, outpatient visit, or hospital admission within 30 days after the index emergency department encounter.

Time frame
From completion of the index emergency department encounter to Day 30
2

Harms related to this emergency care within 30 days

Harms are defined as adverse clinical events within 30 days after the index emergency department encounter.

Time frame
From completion of the index emergency department encounter to Day 30
3

All-cause death within 30 days

All-cause death is defined as death from any cause within 30 days after the index emergency department encounter.

Time frame
From completion of the index emergency department encounter to Day 30

Sponsors and contacts

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