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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06847438
Acronym
TAILORD-HF
Enrollment
3966
Registered
2025-02-26
Start date
2025-03-24
Completion date
2026-06-15
Last updated
2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Detailed 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.

Interventions

BEHAVIORALOptimized version of the EPIC-HF Checklist

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.

BEHAVIORALClinician-facing Decision Support

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.

BEHAVIORALStandard of Care

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

Sponsors

Emory University
Lead SponsorOTHER
Merck Sharp & Dohme LLC
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with GDMT Initiation or Intensification30 Days after Clinic VisitChanges 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORNeal W Dickert, MD, PhD

Emory University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026