RecruitingRecruiting
Tailored Electronic Intervention to Improve Therapy in a Diverse Cohort of Patients With Heart Failure
NCT06847438 · Emory University
In plain English
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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.
Eligibility criteria
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
Study design
Enrollment target: 4000 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-03-24
Estimated completion: 2026-06
Last updated: 2026-04-14
Interventions
Behavioral: Optimized version of the EPIC-HF ChecklistBehavioral: Clinician-facing Decision SupportBehavioral: Standard of Care
Primary outcomes
- • Number of Participants with GDMT Initiation or Intensification (30 Days after Clinic Visit)
Sponsor
Emory University · other
With: Merck Sharp & Dohme LLC
Contacts & investigators
ContactNeal W Dickert, MD, PhD · contact · njr@emory.edu · 404-712-6834
InvestigatorNeal W Dickert, MD, PhD · principal_investigator, Emory University
All locations (4)
Emory Saint Joseph's HospitalRecruiting
Atlanta, Georgia, United States
Emory University Hospital MidtownRecruiting
Atlanta, Georgia, United States
Emory University HospitalRecruiting
Atlanta, Georgia, United States
Emory Johns Creek HospitalRecruiting
Johns Creek, Georgia, United States