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.
研究概览
地位
完全的
详细说明
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.
研究类型
介入性
注册 (实际的)
15
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Seoul
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Seoul、Seoul、韩国、03080
- Seoul National University Hospital
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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实验性的：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Daily Physician Satisfaction Score
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Confidence
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Minju Han, M.D.、Seoul National University Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年12月1日
初级完成 (实际的)
2026年5月31日
研究完成 (实际的)
2026年5月31日
研究注册日期
首次提交
2026年7月12日
首先提交符合 QC 标准的
2026年7月12日
首次发布 (实际的)
2026年7月16日
研究记录更新
最后更新发布 (实际的)
2026年7月21日
上次提交的符合 QC 标准的更新
2026年7月19日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 2510-145-1689
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.