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

5. juni 2026 opdateret af: Ji Xunming,MD,PhD, Capital Medical University

Domain-Specific Large Language Model Assistance for Emergency Neurological Diagnosis and Treatment: A Randomized Controlled Clinical 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1360

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
      • Beijing, Kina, 100053
        • Ikke rekrutterer endnu
        • Xuanwu Hospital，Capital Medical University
        • Kontakt:
    • Henan
      • Nanyang, Henan, Kina, 473000
        • Rekruttering
        • Nanyang Nanshi Hospital
        • Kontakt:
          • Shuai Zhu
    • Hunan
      • Guankou, Hunan, Kina, 410300
        • Rekruttering
        • Liuyang Jili Hospital
        • Kontakt:
          • Yong He

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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:

  • Presention 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: AI-assisted group
Physicians in this group will use Xuanwu-NeuroAid 2.0 during emergency evaluation and management.
Enhed: Xuanwu-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.
Ingen indgriben: Usual-care group
Physicians in this group will provide standard emergency neurology care without large language model assistance.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diagnostic-care quality risk
Tidsramme: 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.
Day 30

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diagnostic discrepancy
Tidsramme: Day 30
Diagnostic discrepancy is defined as disagreement between the emergency department final diagnosis and the 30-day expert-adjudicated reference diagnosis.
Day 30
Quality of diagnostic testing and management recommendations
Tidsramme: 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.
Day 30
Patient satisfaction with emergency care
Tidsramme: 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.
Immediately after the index emergency department encounter, within 48 hours
Time spent per patient encounter
Tidsramme: 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.
Time from start of physician evaluation to completion of final diagnosis and disposition decision, within 48 hours.
Clinician-reported workload
Tidsramme: 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.
Immediately after each index emergency department encounter, within 48 hours.
EQ-5D-5L at 30 days
Tidsramme: 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.
Day 30

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Unplanned medical care within 30 days
Tidsramme: From completion of the index emergency department encounter to Day 30
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.
From completion of the index emergency department encounter to Day 30
Harms related to this emergency care within 30 days
Tidsramme: From completion of the index emergency department encounter to Day 30
Harms are defined as adverse clinical events within 30 days after the index emergency department encounter.
From completion of the index emergency department encounter to Day 30
All-cause death within 30 days
Tidsramme: From completion of the index emergency department encounter to Day 30
All-cause death is defined as death from any cause within 30 days after the index emergency department encounter.
From completion of the index emergency department encounter to Day 30

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Capital Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

8. juni 2026

Primær færdiggørelse (Anslået)

30. august 2026

Studieafslutning (Anslået)

30. september 2026

Datoer for studieregistrering

Først indsendt

19. maj 2026

Først indsendt, der opfyldte QC-kriterier

30. maj 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DEMAND

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Sygdomme i nervesystemet

Kliniske forsøg med Xuanwu-NeuroAid 2.0

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