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Point-of-Care AI Assistance and Critical Care Outcomes: A Randomized Trial

NCT07293078 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2025-12-18

No results posted yet for this study

Summary

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.

Conditions

  • Critical Illness
  • Sepsis
  • Acute Respiratory Failure (ARF)
  • Multi-organ Failure
  • Acute Kidney Injury
  • Delirium Confusional State
  • Shock

Interventions

OTHER

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

Use of a large language model (ChatGPT-5) to analyze de-identified ICU admission data (history, physical examination, laboratory results, imaging reports, and other documentation) at the time of admission. The model generates diagnostic and therapeutic recommendations that are shared with clinicians in the AI-assisted arm only.

Sponsors & Collaborators

  • MetroWest Artificial Intelligence Research Workgroup

    lead OTHER

Principal Investigators

  • Eric Silverman, M.D. · MetroWest Medical Center and St. Vincent Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-12-31
Completion
2029-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07293078 on ClinicalTrials.gov