Generative AI-Assisted Clinical Decision Support for Medical Intensive Care Unit Physicians
2026年7月19日 更新者：Seoul National University Hospital
Evaluation of the Feasibility and Effectiveness of Generative AI-Assisted Multidisciplinary Decision Support in Medical Intensive Care: A Pilot Randomized Controlled Trial
This pilot study evaluated the feasibility and usefulness of generative artificial intelligence (AI) as a clinical decision-support tool for physicians working in a medical intensive care unit.
Participating physicians were assigned by work period to either use a generative AI system in addition to usual clinical information resources or to use usual resources without generative AI.
The assigned condition was then switched so that participants experienced both approaches.
During the AI-assisted periods, physicians used de-identified clinical information and considered the AI-generated responses as reference information.
All final clinical decisions remained the responsibility of the treating physicians.
The study assessed acceptability, usability, satisfaction, perceived decision support, workload, confidence, and learning experience through repeated questionnaires.
調査の概要
状態
完了
詳細な説明
This was a single-center, open-label, pilot cluster-randomized crossover study involving physicians working in a medical intensive care unit. Each participating physician was observed during a scheduled one-month rotation in the medical intensive care unit. At the beginning of each monthly rotation, participating physicians were divided into two clusters. The clusters were randomized to begin with either the ChatGPT-assisted condition or the control condition. After approximately two weeks, each cluster crossed over to the alternate condition for the remainder of the one-month rotation. This design allowed participating physicians to experience both study conditions within the same rotation.
During the AI-assisted condition, physicians were encouraged to use ChatGPT (OpenAI) as a reference tool to support clinical information review and decision-making. Only non-identifiable clinical information was permitted to be entered into ChatGPT. Patient names, medical record numbers, contact information, and other information that could directly identify an individual patient were not entered. Physicians summarized clinically relevant information in their own words and considered the responses generated by ChatGPT when planning patient management. The Situation-Background-Assessment-Recommendation framework was recommended as an optional structure for organizing clinical information, but its use was not mandatory. Physicians were otherwise free to formulate their queries and interact with ChatGPT according to their clinical needs. A suggested prompt encouraged ChatGPT to present multiple management options, together with their rationale, potential benefits and risks, relevant supporting evidence, and areas of uncertainty. ChatGPT did not make or implement clinical decisions.
During the control condition, physicians used usual information resources, including discussions with other clinicians, multidisciplinary rounds, consultations, textbooks, clinical practice guidelines, PubMed, and other established clinical reference services, without using ChatGPT or other generative AI tools for study-related clinical decision support.
All diagnostic and treatment decisions were made independently by the treating physicians. Repeated questionnaires assessed satisfaction, decision-making experience, confidence, perceived efficiency, workload, educational value, and other aspects of clinical decision support. At study completion, participants also evaluated usability, satisfaction, perceived learning, reliance on ChatGPT, intention for future use, and the extent to which ChatGPT-generated suggestions were reflected in their clinical plans.
研究の種類
介入
入学 (実際)
15
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
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Seoul
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Seoul、Seoul、韓国、03080
- Seoul National University Hospital
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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
はい
説明
Inclusion Criteria:
- Age 19 years or older.
- Physicians, including residents, fellows, and attending physicians, working in the medical intensive care unit at Seoul National University Hospital.
- Scheduled to work as a primary treating physician for at least 5 days during a planned observation period.
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Did not provide written informed consent.
- Withdrew consent from study participation.
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：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：ChatGPT-Assisted Condition First, Then Control Condition
Physician clusters used ChatGPT-assisted clinical decision support during the first approximately two weeks of their one-month medical intensive care unit rotation.
They then crossed over to the control condition and used usual clinical information resources without generative AI for the remainder of the rotation.
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During the assigned period, physicians were encouraged to use ChatGPT (OpenAI) as a generative AI-based reference tool to support clinical information review and decision-making.
During the control period, physicians used usual clinical information resources, including discussions with other clinicians, multidisciplinary rounds, specialty consultations, textbooks, clinical practice guidelines, PubMed, and established clinical reference services.
No generative AI tool was used for clinical decision support during this period.
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実験的：Control Condition First, Then ChatGPT-Assisted Condition
Physician clusters used usual clinical information resources without generative AI during the first approximately two weeks of their one-month medical intensive care unit rotation.
They then crossed over to the ChatGPT-assisted clinical decision-support condition for the remainder of the rotation.
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During the assigned period, physicians were encouraged to use ChatGPT (OpenAI) as a generative AI-based reference tool to support clinical information review and decision-making.
During the control period, physicians used usual clinical information resources, including discussions with other clinicians, multidisciplinary rounds, specialty consultations, textbooks, clinical practice guidelines, PubMed, and established clinical reference services.
No generative AI tool was used for clinical decision support during this period.
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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 |
|---|---|---|
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Daily Physician Satisfaction Score
時間枠：At the end of each working day during the one-month medical intensive care unit rotation
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The score of 10 questionnaire items assessing physicians' satisfaction with their daily clinical work, modified from Shore and Franks (1986) and Suchman et al. (1993).
Each item was rated on a 5-point Likert scale from -2 (strongly disagree) to +2 (strongly agree).
Negatively worded items were reverse-scored.
The mean score ranges from -2 to +2, with higher scores indicating greater satisfaction.
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At the end of each working day during the one-month medical intensive care unit rotation
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Daily Clinical Decision-Making Score
時間枠：At the end of each working day during the one-month medical intensive care unit rotation
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The score of 6 questionnaire items assessing satisfaction with the clinical decision-making process, perceived decision difficulty, clarity of the preferred treatment, availability of relevant information, and identification of factors affecting the decision.
Items were modified from Gedney (1994) and Dolan (1999) and rated on a 5-point Likert scale from -2 (strongly disagree) to +2 (strongly agree).
Negatively worded items were reverse-scored.
The mean score ranges from -2 to +2, with higher scores indicating a more favorable decision-making experience.
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At the end of each working day during the one-month medical intensive care unit rotation
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Perceived Quality Score for ChatGPT
時間枠：At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
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The score of 8 questionnaire items assessing the perceived information quality, system quality, and service quality of ChatGPT, modified from Pillong et al. (2025).
Each item was rated on a 5-point Likert scale from -2 (strongly disagree) to +2 (strongly agree).
The negatively worded response-time item was reverse-scored.
The mean score ranges from -2 to +2, with higher scores indicating better perceived quality.
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At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
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Generative AI Usability Score
時間枠：At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
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The score of 3 questionnaire items assessing ease of use, ease of learning, and clarity of interaction with Generative AI (ChatGPT), modified from Pillong et al. (2025).
Each item was rated on a 5-point Likert scale from -2 (strongly disagree) to +2 (strongly agree).
The mean score ranges from -2 to +2, with higher scores indicating greater usability.
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At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
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Satisfaction Score for Generative AI Use
時間枠：At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
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The score of 6 questionnaire items assessing the perceived usefulness, productivity, effectiveness, overall satisfaction, appropriateness, and intention to reuse Generative AI (ChatGPT), modified from Pillong et al. (2025).
Each item was rated on a 5-point Likert scale from -2 (strongly disagree) to +2 (strongly agree).
The mean score ranges from -2 to +2, with higher scores indicating greater satisfaction.
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At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Confidence
時間枠：At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
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A single questionnaire item assessing whether use of Generative AI (ChatGPT) increased the physician's confidence in clinical decision-making.
The item was rated on a 5-point Likert scale from -2 (strongly disagree) to +2 (strongly agree), with higher scores indicating a greater perceived increase in confidence.
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At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
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Perceived Acquisition of New Knowledge or Clinical Insight
時間枠：At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
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A single questionnaire item assessing whether the physician acquired new knowledge or clinical insight while using Generative AI (ChatGPT).
The item was rated on a 5-point Likert scale from -2 to +2, with higher scores indicating greater perceived learning.
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At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
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Application of Generative AI-Derived Knowledge to Other Clinical Situations
時間枠：At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
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A single questionnaire item assessing whether knowledge obtained through Generative AI (ChatGPT) was applied to the care of other patients.
The item was rated on a 5-point Likert scale from -2 to +2, with higher scores indicating greater transfer of learning.
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At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
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Intention to Continue Using Generative AI (ChatGPT) in Future Clinical Practice
時間枠：At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
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A single questionnaire item assessing the physician's intention to continue using Generative AI (ChatGPT) in future clinical practice.
The item was rated on a 5-point Likert scale from -2 to +2, with higher scores indicating stronger intention for continued use.
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At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
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Perceived Reliance on Generative AI (ChatGPT)
時間枠：At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
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A single questionnaire item assessing whether the physician perceived increased reliance on Generative AI (ChatGPT) during clinical care.
The item was rated on a 5-point Likert scale from -2 to +2, with higher scores indicating greater perceived reliance.
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At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
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Perceived Reduction in Clinical Workload
時間枠：At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
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A single questionnaire item assessing whether use of Generative AI (ChatGPT) reduced the physician's perceived clinical workload.
The item was rated on a 5-point Likert scale from -2 to +2, with higher scores indicating greater perceived workload reduction.
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At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
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Clinical Specialty Area in Which Generative AI (ChatGPT) Was Most Helpful
時間枠：At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
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The clinical specialty area in which the physician perceived the greatest practical benefit from Generative AI (ChatGPT), selected from predefined categories or reported as free text, including cardiology, infectious diseases, pulmonology, and nephrology.
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At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
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Percentage of Generative AI (ChatGPT) Suggestions Reflected in Clinical Plans
時間枠：At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
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The physician-reported percentage of Generative AI (ChatGPT)-generated suggestions that were reflected in actual clinical management plans.
Scores range from 0% to 100%, with higher percentages indicating greater incorporation of ChatGPT suggestions.
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At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
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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。
捜査官
- 主任研究者：Minju Han, M.D.、Seoul National University Hospital
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)
2025年12月1日
一次修了 (実際)
2026年5月31日
研究の完了 (実際)
2026年5月31日
試験登録日
最初に提出
2026年7月12日
QC基準を満たした最初の提出物
2026年7月12日
最初の投稿 (実際)
2026年7月16日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月21日
QC基準を満たした最後の更新が送信されました
2026年7月19日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2510-145-1689
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?
いいえ
IPD プランの説明
Individual participant data will not be shared because of the small sample size, the limited number of physicians working in the study setting, and the potential risk of re-identification even after removal of direct identifiers.
External sharing of individual-level data was not included in the participant consent or institutional review board-approved data management plan.
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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
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