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

NCT06847438 | Recruiting

• 2 other identifiers: STUDY000067162025P013491
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Number of Participants with GDMT Initiation or Intensification

  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.

  30 Days after Clinic Visit

Study Arms (3)

Optimized version of the EPIC-HF Checklist

OTHER

Patients of clinics that are randomized to implement the checklist will be sent the checklist in advance of their visit via their electronic medical record (EMR) portal.

Behavioral: Optimized version of the EPIC-HF Checklist

EPIC-HF Checklist for Patients and Clinician-facing Decision Support

OTHER

Patients of clinics that are randomized to implement the checklist will be sent the checklist in advance of their visit via their electronic medical record (EMR) portal. During this period of the study, clinicians in intervention clinics will also have access to analogous decision-support via EMR.

Behavioral: Optimized version of the EPIC-HF Checklist; Behavioral: Clinician-facing Decision Support

Standard of Care

ACTIVE COMPARATOR

Patients of clinics that are randomized to the standard of care will not have the EPIC-HF checklist available for viewing in their electronic medical record (EMR).

Behavioral: Standard of Care

Interventions

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.

EPIC-HF Checklist for Patients and Clinician-facing Decision Support; Optimized version of the EPIC-HF Checklist

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.

EPIC-HF Checklist for Patients and Clinician-facing Decision Support

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).

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (4)

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30308, United States

RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

Emory Johns Creek Hospital

Johns Creek, Georgia, 30097, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Neal W Dickert, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neal W Dickert, MD, PhD

CONTACT

404-712-6834; njr@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Clinics will be randomly assigned to implement the checklist or to not implement the checklist.

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: March 24, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Individual participant data will be available for sharing beginning 9 months after publication and 36 months following article publication.
• Access Criteria: Data will be available for sharing with researchers who provide a methodologically sound proposal, in order to achieve the aims of the proposal. Proposals should be directed to njr@emory.edu. To gain access, requestors will need to sign a data access agreement.

Locations

US (4)