Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07293078
PHASE1/PHASE2

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

Sponsor: MetroWest Artificial Intelligence Research Workgroup

View on ClinicalTrials.gov

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.

Official title: Prospective Evaluation of a Point-of-Care Artificial Intelligence Model in Critical Care Outcomes

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2026-01-01

Completion Date

2029-06-30

Last Updated

2025-12-18

Healthy Volunteers

No

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.

Locations (1)

Framingham Union Hospital/MetroWest Medical Center

Framingham, Massachusetts, United States