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Completed

NCT Number: NCT06847438

Tailored Electronic Intervention to Improve Therapy in a Diverse Cohort of Patients With Heart Failure

Recent medical guidelines for the management of heart failure (HF) have established a combination of specific classes of medications as the best treatment for patients with heart failure with reduced ejection fraction (HFrEF). However, studies have shown that these medications, known together as guideline-directed medical therapy (GDMT), are not being used in clinical practice less often than they could be. Several tools to promote broader use of these treatments (including patient checklists) have shown promise for increasing use of GDMT. However, these tools have not been broadly implemented within large health systems. The goal of this study is to see if using these tools broadly within cardiology clinics will increase the use of GDMT. This study is important because it could help improve the use of GDMT, which may lead to improved patient care and outcomes.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory Saint Joseph's Hospital, Atlanta, Georgia, United States

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About this study

The 2022 American College of Cardiology Foundation (ACCF)/American Heart Association (AHA)/Heart Failure Society of America (HFSA) and 2021 European Society of Cardiology (ESC) guidelines for the management of heart failure (HF) firmly establish that quadruple therapy with angiotensin receptor neprilysin inhibitors (ARNI), sodium glucose cotransporter-2 inhibitors (SGLT2i), evidence-based β-blockers, and mineralocorticoid receptor antagonists now form the foundational standard for guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF). Despite multiple randomized controlled trials establishing the clinical benefit of novel therapies like ARNI and SGLT2i, adoption of these novel therapeutic agents in clinical practice has been slower than expected. For example, a recent population-level cohort study using IQVIA Inc. National Prescription Audit data in the US showed that only 13.8% of patients with HFrEF were using sacubitril-valsartan from 2016-2019. Similarly, a recent retrospective cohort analysis of commercially insured patients with type 2 diabetes in the US demonstrated that only 8.7% were treated with an SGLT2i from 2015 to 2019. There is a need for interventions that increase utilization of these important medications.

The investigators have previously demonstrated a high burden of HF and suboptimal use of GDMT among a broad cohort of patients. There is a need to improve prescription of GDMT and to improve clinical outcomes for patients with HF with the use of evidence-based methods to improve care quality.

The EPIC-HF checklist is a patient activation tool that allows patients to see recommended doses and categories of GDMT, which they can use to compare to their current medications and dosing. In this implementation study, eight cardiology and heart failure clinics will be randomized to implement the EPIC-HF checklist or to perform standard of care for two 6-month periods. During the first 6-month period, patients will be provided with the EPIC-HF checklist prior to their clinic appointment via EMR message. During the second 6-month period, clinician-facing decision support for GDMT intensification will be added.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ejection fraction (EF) less than or equal to 40% by echocardiogram performed in the prior 18 months
  • Diagnosis of heart failure

Exclusion criteria

  • Heart failure (HF) etiology for which GDMT is not indicated: including hypertrophic or restrictive cardiomyopathy (e.g. amyloid cardiomyopathy), constrictive pericarditis, or complex congenital heart disease
  • End-stage HF requiring continuous inotrope infusion, heart transplant, or left ventricular assist device
  • Estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73m^2
  • Any conditions other than HF that are likely to alter the patient's status over 6 months, indicated by active hospice status

Treatment and study plan

Optimized version of the EPIC-HF Checklist

Behavioral

The EPIC-HF checklist is a 1-page patient activation tool that contains approved and guideline-recommended medications and target doses for HFrEF. The EPIC-HF checklist allows patients to see recommended doses and categories of GDMT, which they can compare to their current medications and dosing. The EPIC-HF checklist has been refined and updated to include GDMT prescription and has been optimized for delivery through electronic medical record (EMR) systems. The checklist is being used as a patient activation/ discussion tool only and data entered on the checklist will not be collected for purposes of this study.

Clinician-facing Decision Support

Behavioral

Information regarding GDMT (including target doses and medications) analogous to what is contained in the checklist will be provided to clinicians in intervention clinics. This information will be visible at the time of the encounter.

Standard of Care

Behavioral

Patients of clinics that are not implementing EPIC-HF checklist will not have the checklist available to them through the electronic medical record (EMR).

Primary outcomes

  1. Number of Participants with GDMT Initiation or Intensification

    Time frame: 30 Days after Clinic Visit

    Changes in medication are assessed as the initiation or intensification of recommended heart failure medications including foundational GDMTs (angiotensin-converting enzyme inhibitors (ACEI)/angiotensin receptor blockers (ARB)/angiotensin receptor neprilysin inhibitors (ARNI), beta-blockers (BB), mineralocorticoid receptor antagonists (MRA), and sodium glucose cotransporter-2 inhibitors (SGLT2i)) as well as other guideline recommended therapies for HFrEF including ivabradine, digoxin, and soluble guanylate cyclase stimulators.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Acronym: TAILORD-HF

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 26, 2025
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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