Domain-Specific Large Language Model Assistance for Emergency Neurological Diagnosis and Treatment（DEMAND）
6 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
1381
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Beijing, Porcelana, 100053
- Xuanwu Hospital,Capital Medical University
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Henan
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Nanyang, Henan, Porcelana, 473000
- Nanyang Nanshi Hospital
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Hunan
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Guankou, Hunan, Porcelana, 410300
- Liuyang Jili Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Sin intervención: Usual-care group
Physicians in this group will provide standard emergency neurology care without large language model assistance.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Diagnostic-care quality risk
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Diagnostic discrepancy
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Unplanned medical care within 30 days
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
9 de junio de 2026
Finalización primaria (Actual)
6 de agosto de 2026
Finalización del estudio (Actual)
6 de agosto de 2026
Fechas de registro del estudio
Enviado por primera vez
19 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
30 de mayo de 2026
Publicado por primera vez (Actual)
4 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
6 de agosto de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- DEMAND
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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