Not Yet RecruitingNot Applicable

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

United States500 participantsStarted 2026-06-01

Plain-language 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).

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion Criteria: * Age ≥18 years * Scheduled outpatient visit with a participating cardiology provider in an MGB outpatient cardiology clinic * At least one prior cardiology clinic visit in the MGB system within the past 2 years * Diagnosis of heart failure by ICD code within the past 2 years * Heart failure diagnosis supported by at least one of the following: * Current or recent use of a loop diuretic * Left ventricular ejection fraction ≤40% on the most recent echocardiogram * Explicit documentation of heart failure diagnosis or heart failure signs/symptoms in a prior cardiology note Exclusion Criteria: * Systolic blood pressure \<90 mmHg on the most recent recorded measurement * Heart rate \<50 beats per minute on the most recent recorded measurement * eGFR \<20 mL/min/1.73 m² on the most recent laboratory assessment * Known cardiac amyloidosis or hypertrophic cardiomyopathy * History of heart transplant or presence of a left ventricular assist device * Severe aortic stenosis, severe aortic insufficiency, or severe mitral stenosis on the most recent echocardiogram * Encounter occurs in an adult congenital heart disease clinic

What they're measuring

Any GDMT optimization within 30 days of index visit

Timeframe: 30 days

Trial details

NCT IDNCT07337577

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-01

Contact for this trial

Jonathan W Cunningham, MD, MPH

617-732-8534 jcunningham3@bwh.harvard.edu