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Generative AI-Assisted Clinical Decision Support for Medical Intensive Care Unit Physicians: A Pilot Cluster-Randomized Crossover Study

12 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

15

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Corea del Sud
    • Seoul
      • Seoul, Seoul, Corea del Sud, 03080
        • Seoul National University Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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:

Declined or did not provide written informed consent. Withdrew consent from study participation.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: Generative AI-Assisted Clinical Decision Support
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.
Altro: Usual Clinical Information Resources
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.
Sperimentale: 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.
Altro: Generative AI-Assisted Clinical Decision Support
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.
Altro: Usual Clinical Information Resources
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Daily Physician Satisfaction Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Confidence
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Seoul National University Hospital

Investigatori

  • Investigatore principale: Minju Han, M.D., Seoul National University Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 dicembre 2025

Completamento primario (Effettivo)

31 maggio 2026

Completamento dello studio (Effettivo)

31 maggio 2026

Date di iscrizione allo studio

Primo inviato

12 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

12 luglio 2026

Primo Inserito (Effettivo)

16 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 2510-145-1689

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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