Domain-Specific Large Language Model Assistance for Emergency Neurological Diagnosis and Treatment（DEMAND）
6 augusti 2026 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
1381
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Beijing, Kina, 100053
- Xuanwu Hospital,Capital Medical University
-
-
Henan
-
Nanyang, Henan, Kina, 473000
- Nanyang Nanshi Hospital
-
-
Hunan
-
Guankou, Hunan, Kina, 410300
- Liuyang Jili Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: AI-assisted group
Physicians in this group will use Xuanwu-NeuroAid 2.0 during emergency evaluation and management.
|
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.
|
|
Inget ingripande: Usual-care group
Physicians in this group will provide standard emergency neurology care without large language model assistance.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Diagnostic-care quality risk
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Diagnostic discrepancy
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Unplanned medical care within 30 days
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
9 juni 2026
Primärt slutförande (Faktisk)
6 augusti 2026
Avslutad studie (Faktisk)
6 augusti 2026
Studieregistreringsdatum
Först inskickad
19 maj 2026
Först inskickad som uppfyllde QC-kriterierna
30 maj 2026
Första postat (Faktisk)
4 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
7 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 augusti 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- DEMAND
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .