Domain-Specific Large Language Model Assistance for Emergency Neurological Diagnosis and Treatment（DEMAND）
2026年8月6日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
1381
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Beijing、中国、100053
- Xuanwu Hospital,Capital Medical University
-
-
Henan
-
Nanyang、Henan、中国、473000
- Nanyang Nanshi Hospital
-
-
Hunan
-
Guankou、Hunan、中国、410300
- Liuyang Jili Hospital
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
介入なし：Usual-care group
Physicians in this group will provide standard emergency neurology care without large language model assistance.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diagnostic-care quality risk
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diagnostic discrepancy
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Unplanned medical care within 30 days
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月9日
一次修了 (実際)
2026年8月6日
研究の完了 (実際)
2026年8月6日
試験登録日
最初に提出
2026年5月19日
QC基準を満たした最初の提出物
2026年5月30日
最初の投稿 (実際)
2026年6月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月7日
QC基準を満たした最後の更新が送信されました
2026年8月6日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- DEMAND
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。