Generative AI-Assisted Clinical Decision Support for Medical Intensive Care Unit Physicians
19 de julho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
15
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Seoul
-
Seoul, Seoul, Coréia do Sul, 03080
- Seoul National University Hospital
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
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.
|
|
Experimental: 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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Daily Physician Satisfaction Score
Prazo: At the end of each working day during the one-month medical intensive care unit rotation
|
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.
|
At the end of each working day during the one-month medical intensive care unit rotation
|
|
Daily Clinical Decision-Making Score
Prazo: At the end of each working day during the one-month medical intensive care unit rotation
|
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.
|
At the end of each working day during the one-month medical intensive care unit rotation
|
|
Perceived Quality Score for ChatGPT
Prazo: At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
|
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.
|
At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
|
|
Generative AI Usability Score
Prazo: At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
|
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.
|
At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
|
|
Satisfaction Score for Generative AI Use
Prazo: At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
|
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.
|
At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Confidence
Prazo: At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
|
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.
|
At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
|
|
Perceived Acquisition of New Knowledge or Clinical Insight
Prazo: At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
|
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.
|
At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
|
|
Application of Generative AI-Derived Knowledge to Other Clinical Situations
Prazo: At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
|
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.
|
At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
|
|
Intention to Continue Using Generative AI (ChatGPT) in Future Clinical Practice
Prazo: At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
|
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.
|
At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
|
|
Perceived Reliance on Generative AI (ChatGPT)
Prazo: At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
|
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.
|
At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
|
|
Perceived Reduction in Clinical Workload
Prazo: At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
|
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.
|
At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
|
|
Clinical Specialty Area in Which Generative AI (ChatGPT) Was Most Helpful
Prazo: At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
|
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.
|
At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
|
|
Percentage of Generative AI (ChatGPT) Suggestions Reflected in Clinical Plans
Prazo: At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
|
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.
|
At the end of the one-month medical intensive care unit rotation, after completion of both crossover periods
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Minju Han, M.D., Seoul National University Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de dezembro de 2025
Conclusão Primária (Real)
31 de maio de 2026
Conclusão do estudo (Real)
31 de maio de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
12 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de julho de 2026
Primeira postagem (Real)
16 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
21 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 2510-145-1689
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .