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NOT YET RECRUITING
NCT07337577
NA

Large Language Model-Generated Messages to Improve Guideline-Directed Medical Therapy in Heart Failure

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

Summary

This study is an investigator-initiated, cluster-randomized implementation trial evaluating a large language model (LLM)-based clinical decision support (CDS) tool designed to improve guideline-directed medical therapy (GDMT) for adult patients with heart failure seen in outpatient cardiology clinics at Mass General Brigham. For eligible heart failure encounters, the CDS tool reviews existing electronic health record (EHR) data, including diagnoses, medications, vital signs, laboratory results, and recent notes, and generates brief, clinician-facing messages suggesting opportunities to initiate or optimize GDMT and highlighting relevant safety considerations. Messages are delivered to cardiology providers via Epic InBasket and/or institutional email prior to scheduled visits. The tool is advisory only and cannot place orders or change medications automatically; all treatment decisions remain at the discretion of the treating clinician and patient. Cardiology providers are assigned at the provider/clinic level to early implementation of the CDS tool versus usual care (no messages) during the initial phase. The primary outcome is GDMT optimization within 30 days of an index visit. Secondary outcomes include feasibility of CDS generation and delivery and a 30-day safety composite (e.g., heart failure hospitalization, acute kidney injury, hyperkalemia, hypotension or bradyarrhythmia plausibly related to GDMT).

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2026-03-01

Completion Date

2027-09-01

Last Updated

2026-01-13

Healthy Volunteers

No

Conditions

Interventions

DEVICE

LLM-GDMT Clinical Decision Support Tool

Software-only, large language model-based clinical decision support tool that reviews structured and unstructured EHR data for adult heart failure patients and generates brief, clinician-facing messages suggesting opportunities to initiate or optimize guideline-directed medical therapy (GDMT) and highlighting relevant safety considerations. Messages are delivered to cardiology providers via Epic InBasket and/or institutional email prior to eligible outpatient visits. The tool is advisory only and cannot place orders or directly change medications; all treatment decisions remain at the discretion of the treating clinician and patient.

Locations (1)

Mass General Brigham

Boston, Massachusetts, United States