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Targeted Artificial Intelligence Language mOdel Recommendations for Heart Failure (TAILOR-HF)

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether an artificial intelligence (AI) tool helps heart care providers improve recommended medicines for heart failure. It is for adults with heart failure who have clinic visits at Mass General Brigham (MGB). The tool reviews health records and sends suggestions to providers, but patients and providers make all treatment decisions.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You have a scheduled visit with a participating heart care provider at an MGB outpatient heart clinic.
  • You had at least one MGB heart clinic visit in the past 2 years.
  • Your record has a diagnosis code for heart failure from the past 2 years.
  • Your heart failure is also supported by at least one of these: current or recent use of a loop diuretic (a water pill); a heart ultrasound showing that the main pumping chamber pumps out 40% or less of its blood with each beat; or a past heart clinic note clearly describing heart failure or its signs or symptoms.

Who can't join

  • Your latest top blood pressure number is below 90 mmHg.
  • Your latest heart rate is below 50 beats per minute.
  • Your latest eGFR, a test of how well your kidneys filter blood, is below 20 mL/min/1.73 m².
  • You have cardiac amyloidosis (abnormal protein buildup in the heart) or hypertrophic cardiomyopathy (thickened heart muscle).
  • You have had a heart transplant or have a left ventricular assist device, a pump that helps your heart move blood.
  • Your latest heart ultrasound shows severe narrowing or leaking of the aortic valve, or severe narrowing of the mitral valve.
  • Your visit is at an adult clinic for heart problems present at birth.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

MA