Domain-Specific Large Language Model Assistance for Emergency Neurological Diagnosis and Treatment（DEMAND）
6 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
1381
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Beijing, China, 100053
- Xuanwu Hospital,Capital Medical University
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Henan
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Nanyang, Henan, China, 473000
- Nanyang Nanshi Hospital
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Hunan
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Guankou, Hunan, China, 410300
- Liuyang Jili Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: AI-assisted group
Physicians in this group will use Xuanwu-NeuroAid 2.0 during emergency evaluation and management.
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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.
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Geen tussenkomst: Usual-care group
Physicians in this group will provide standard emergency neurology care without large language model assistance.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Diagnostic-care quality risk
Tijdsspanne: Day 30
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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.
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Day 30
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Diagnostic discrepancy
Tijdsspanne: Day 30
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Diagnostic discrepancy is defined as disagreement between the emergency department final diagnosis and the 30-day expert-adjudicated reference diagnosis.
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Day 30
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Quality of diagnostic testing and management recommendations
Tijdsspanne: Day 30
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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.
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Day 30
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Patient satisfaction with emergency care
Tijdsspanne: Immediately after the index emergency department encounter, within 48 hours
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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.
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Immediately after the index emergency department encounter, within 48 hours
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Time spent per patient encounter
Tijdsspanne: Time from start of physician evaluation to completion of final diagnosis and disposition decision, within 48 hours.
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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.
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Time from start of physician evaluation to completion of final diagnosis and disposition decision, within 48 hours.
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Clinician-reported workload
Tijdsspanne: Immediately after each index emergency department encounter, within 48 hours.
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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.
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Immediately after each index emergency department encounter, within 48 hours.
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EQ-5D-5L at 30 days
Tijdsspanne: Day 30
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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.
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Day 30
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Unplanned medical care within 30 days
Tijdsspanne: From completion of the index emergency department encounter to Day 30
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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.
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From completion of the index emergency department encounter to Day 30
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Harms related to this emergency care within 30 days
Tijdsspanne: From completion of the index emergency department encounter to Day 30
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Harms are defined as adverse clinical events within 30 days after the index emergency department encounter.
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From completion of the index emergency department encounter to Day 30
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All-cause death within 30 days
Tijdsspanne: From completion of the index emergency department encounter to Day 30
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All-cause death is defined as death from any cause within 30 days after the index emergency department encounter.
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From completion of the index emergency department encounter to Day 30
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
9 juni 2026
Primaire voltooiing (Werkelijk)
6 augustus 2026
Studie voltooiing (Werkelijk)
6 augustus 2026
Studieregistratiedata
Eerst ingediend
19 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
30 mei 2026
Eerst geplaatst (Werkelijk)
4 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
7 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
6 augustus 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- DEMAND
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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