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

Last updated: April 2, 2025
Sponsor: Emory University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Heart Failure

Hyponatremia

Treatment

Standard of Care

Clinician-facing Decision Support

Optimized version of the EPIC-HF Checklist

Clinical Study ID

NCT06847438
STUDY00006716
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ejection fraction (EF) less than or equal to 40% by echocardiogram performed in theprior 18 months

  • Diagnosis of heart failure

Exclusion

Exclusion Criteria:

  • Heart failure (HF) etiology for which GDMT is not indicated: including hypertrophicor restrictive cardiomyopathy (e.g. amyloid cardiomyopathy), constrictivepericarditis, or complex congenital heart disease

  • End-stage HF requiring continuous inotrope infusion, heart transplant, or leftventricular 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 6months, indicated by active hospice status

Study Design

Total Participants: 4000
Treatment Group(s): 3
Primary Treatment: Standard of Care
Phase:
Study Start date:
March 24, 2025
Estimated Completion Date:
June 30, 2026

Study Description

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.

Connect with a study center

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia 30308
    United States

    Active - Recruiting

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia 30308
    United States

    Active - Recruiting

  • Emory Johns Creek Hospital

    Johns Creek, Georgia 30097
    United States

    Active - Recruiting

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