Clinical Decision Support Tool for Heart Failure

(LLM-GDMT Trial)

Overseen By Jonathan W Cunningham, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must be taking: Loop diuretics

Disqualifiers: Low blood pressure, Low heart rate, Low eGFR, Cardiac amyloidosis, others

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 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).

Are You a Good Fit for This Trial?

This trial is for adult patients with heart failure who are seen in outpatient cardiology clinics at Mass General Brigham. It's designed to test if a new tool can help doctors follow heart failure treatment guidelines better.

Inclusion Criteria

At least one prior cardiology clinic visit in the MGB system within the past 2 years

I am currently using or have recently used water pills for heart failure.

Scheduled outpatient visit with a participating cardiology provider in an MGB outpatient cardiology clinic

Exclusion Criteria

History of heart transplant or presence of a left ventricular assist device

Systolic blood pressure <90 mmHg on the most recent recorded measurement

Heart rate <50 beats per minute on the most recent recorded measurement

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Evaluation

Providers are assigned to early implementation of the CDS tool or usual care. The CDS tool reviews EHR data and generates advisory messages for eligible encounters.

4 weeks

Messages delivered prior to scheduled visits

Follow-up

Participants are monitored for GDMT optimization and safety outcomes within 30 days of the index visit.

30 days

Extension

The CDS tool may be expanded to providers in the usual care arm as part of routine care after the initial evaluation phase.

What Are the Treatments Tested in This Trial?

Interventions

• LLM-GDMT Clinical Decision Support Tool

Trial Overview

The study tests a clinical decision support tool that uses a large language model to analyze patient data and suggest improvements in heart failure treatments. Doctors receive these suggestions via their electronic health record system or email.

How Is the Trial Designed?

Group I: Early Implementation Experimental Treatment 1 Intervention

Providers in this arm receive a large language model-based clinical decision support (LLM-GDMT CDS) intervention. For eligible outpatient heart failure encounters, the CDS tool reviews existing EHR data (diagnoses, medications, vitals, labs, recent notes) and generates a brief, clinician-facing message summarizing HF status, suggesting opportunities to initiate or optimize guideline-directed medical therapy (GDMT), and highlighting safety considerations. Messages are delivered via Epic InBasket and/or institutional email in advance of the visit. 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.

Group II: Usual Care (Delayed Implementation) Active Control 1 Intervention

Providers in this arm continue usual care and do not receive LLM-GDMT CDS messages during the initial evaluation phase. Eligible outpatient heart failure encounters are managed according to routine clinical practice without additional CDS messages. EHR data from these encounters are used to compute GDMT utilization and safety outcomes for comparison with the early-implementation arm. After the initial evaluation phase is complete, the LLM-GDMT CDS tool may be expanded to providers in this arm as part of routine care.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+