AI Assistance for Critical Illness

(POC-AI-ICU Trial)

Overseen By Eric Silverman, M.D. principal Investigator, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: MetroWest Artificial Intelligence Research Workgroup

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a prospective, unmasked, randomized, multicenter clinical trial evaluating the impact of point-of-care large language model (LLM)-based decision support on diagnostic accuracy and clinical outcomes in adult medical intensive care unit (MICU) patients.

Consecutive adult ICU admissions at participating community hospitals (initially MetroWest Medical Center and St. Vincent Hospital) will be screened for eligibility. Eligible patients will be randomized 1:1 to standard care or an AI-assisted group. In both arms, initial evaluation and management will follow usual practice. For patients randomized to AI assistance, de-identified admission data (history and physical, labs, imaging reports, and other relevant documentation) will be formatted and submitted to a state-of-the-art LLM (ChatGPT-5) at the time of admission. The AI-generated differential diagnosis and therapeutic recommendations will be provided to the admitting team for consideration. For the standard care arm, LLM output will be generated but not shared with clinicians.

After discharge, a masked chart review will determine the "ground truth" primary diagnosis and extract outcomes including: Primary Outcome - a composite of medical errors (from time of ICU admission through day 7 of ICU stay, or ICU discharge, whichever comes first); Secondary Outcomes - 90-day mortality, ICU and hospital length of stay, and ventilator-free days.

Who Is on the Research Team?

Eric Silverman, M.D.

Principal Investigator

MetroWest Medical Center and St. Vincent Hospital

Are You a Good Fit for This Trial?

This trial is for adult ICU patients at certain hospitals. It's not clear who can't join because the exclusion criteria aren't provided, but typically those with conditions that could skew results or put them at risk are excluded.

Inclusion Criteria

Direct admissions from the emergency department or transfers from medical wards to the MICU

I am 18 or older and admitted to the ICU at a participating hospital.

I meet the criteria for being admitted to the ICU.

Exclusion Criteria

Prisoners

I had surgery for a primary condition or a serious heart attack.

I am currently pregnant or have recently given birth.

What Are the Treatments Tested in This Trial?

Interventions

• Point-of-care large language model decision support (ChatGPT-5)

Trial Overview

The trial tests if AI (ChatGPT-5) can help doctors by giving a diagnosis and treatment advice when patients are admitted to the ICU. Half of the patients will get this AI assistance; the other half won't.

How Is the Trial Designed?

Group I: AI-Assisted Care Experimental Treatment 1 Intervention

Patients receive standard ICU care plus point-of-care LLM-based decision support at admission. De-identified admission data are formatted and submitted to an LLM (ChatGPT-5). The model returns a primary diagnosis, ranked differential diagnosis list, suggested additional information, and prioritized therapeutic recommendations. This output is provided to the admitting team for consideration in ongoing management.

Group II: Standard Care Active Control 1 Intervention

Patients receive usual ICU care per local practice. De-identified admission data may be processed and submitted to the LLM for research purposes, but AI output is not shared with treating clinicians and does not influence real-time management.

Who Is Running the Clinical Trial?

MetroWest Artificial Intelligence Research Workgroup

Lead Sponsor