Domain-Specific Large Language Model Assistance for Emergency Neurological Diagnosis and Treatment（DEMAND）
6. august 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
1381
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
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Beijing, Kina, 100053
- Xuanwu Hospital,Capital Medical University
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Henan
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Nanyang, Henan, Kina, 473000
- Nanyang Nanshi Hospital
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Hunan
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Guankou, Hunan, Kina, 410300
- Liuyang Jili Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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:
- 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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Ingen inngripen: Usual-care group
Physicians in this group will provide standard emergency neurology care without large language model assistance.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Diagnostic-care quality risk
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Diagnostic discrepancy
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Unplanned medical care within 30 days
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
9. juni 2026
Primær fullføring (Faktiske)
6. august 2026
Studiet fullført (Faktiske)
6. august 2026
Datoer for studieregistrering
Først innsendt
19. mai 2026
Først innsendt som oppfylte QC-kriteriene
30. mai 2026
Først lagt ut (Faktiske)
4. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
7. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. august 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DEMAND
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