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Completed

NCT Number: NCT07708155

Generative AI-Assisted Clinical Decision Support for Medical Intensive Care Unit Physicians

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.

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Key information

Conditions

Clinical Decision Support Clinical Decision-making

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Generative AI-Assisted Clinical Decision Support

Other

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.

Usual Clinical Information Resources

Other

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.

Primary outcomes

  1. Daily Physician Satisfaction Score

    Time frame: 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.

  2. Daily Clinical Decision-Making Score

    Time frame: 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.

  3. Perceived Quality Score for ChatGPT

    Time frame: 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.

  4. Generative AI Usability Score

    Time frame: 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.

  5. Satisfaction Score for Generative AI Use

    Time frame: 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.

Other outcomes

  1. Confidence

    Time frame: 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.

  2. Perceived Acquisition of New Knowledge or Clinical Insight

    Time frame: 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.

  3. Application of Generative AI-Derived Knowledge to Other Clinical Situations

    Time frame: 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.

  4. Intention to Continue Using Generative AI (ChatGPT) in Future Clinical Practice

    Time frame: 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.

  5. Perceived Reliance on Generative AI (ChatGPT)

    Time frame: 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.

  6. Perceived Reduction in Clinical Workload

    Time frame: 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.

  7. Clinical Specialty Area in Which Generative AI (ChatGPT) Was Most Helpful

    Time frame: 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.

  8. Percentage of Generative AI (ChatGPT) Suggestions Reflected in Clinical Plans

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Evaluation of the Feasibility and Effectiveness of Generative AI-Assisted Multidisciplinary Decision Support in Medical Intensive Care: A Pilot Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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