Recruiting

GDMT Optimization

Sponsor:

Brigham and Women's Hospital

Code:

NCT07337577

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

LLM-GDMT Clinical Decision Support Tool

Study Details

Brief 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).

Conditions

Heart Failure

Study ID

NCT07337577

Start date

Aug 27, 2026

Status verified date

Aug, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Early Implementation

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.

no intervention: Usual Care (Delayed Implementation)

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.

Interventions

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.

Primary outcome measure

  • Any GDMT optimization within 30 days of index visit [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Jonathan W Cunningham, MD, MPH

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

Locations

Mass General Brigham

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Jonathan W Cunningham, MD, MPH

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

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • Guideline-directed medical therapy
  • Artificial Intelligence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-08-31.