Implementation and Interaction of Clinician And Patient-facing Tools Aiming to Intensify Neurohormonal Medicines for Heart Failure

Recruiting now · Not applicable

Conditions studied: Heart Failure With Reduced Ejection Fraction

In brief

An increasing number of guideline-directed medical therapies (GDMT) have been developed for patients with chronic heart failure with reduced ejection fraction (HFrEF). When used in combination at recommended doses, patients often experience significant improvements in cardiac function, quality of life, and survival.1,2 However, GDMT underuse occurs for the vast majority of patients with HFrEF. Two recent trials demonstrated improved GDMT prescribing during a clinic visit, each using automated delivery of a patient-centered decision support tool to promote a proactive and holistic approach to prescribing: EPIC-HF (NCT03334188) tested a brief video and checklist document sent to patients just prior to a clinic visit encouraging them to work with their clinicians to make at least 1 positive change to their GDMT; PROMPT-HF (NCT05433220) tested tailored electronic health record (EHR) alerts for GDMT intensification delivered to clinicians during clinic visits. The current I-I-CAPTAIN-HF study aims to broadly implement and test the EPIC-HF patient-facing and PROMPT-HF clinician-facing tools for HFrEF medication intensification at 5 health systems around the country through a pragmatic cluster-randomized implementation-effectiveness trial. This will occur through an initial phase of adaptation of the 2 tools at each health system. Once ready, the 2 tools will be tested using a 2x2 randomization at the clinician-level. In parallel, formal assessment of the implementation of EPIC-HF and PROMPT-HF will work to understand the most effective means of intervention design and delivery, as well as adaptations due to contextual factors to optimize use.

Key facts

Study ID: NCT06526988
Run by: University of Colorado, Denver
People needed: 2200
Starts: 2025-03-06
Expected to finish: 2028-09-01
Last updated by the study team: 2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Clinician:
Clinician (MD, PA, NP) who practices in cardiology outpatient clinics
Regularly sees patients with left ventricular ejection fraction (EF) </=40%, where their panel of patients over the last year included at least 10 patients with heart failure with reduced ejection fraction (HFrEF)
Patient:
Age > 18 years
LVEF </=40% on most recent cardiology imaging study
Has a new or return clinic visit with an enrolled clinician within the next 7 days
Is missing at least one of the four classes of medications and does not have an allergy to that class: (1) beta blockers, (2) angiotensin receptor-neprilysin inhibitor, (3) aldosterone receptor antagonists, (4) sodium-glucose co-transporter

You may not qualify if…

Patient:
Has a left ventricular assist device
Under evaluation for or listed for transplant (or s/p transplant)
Glomerular filtration rate (GFR) less than 20 or on dialysis
On hospice care
Preferred language neither English or Spanish

Where it is running

Sutter Health — Walnut Creek, California, United States (enrolling)
University of Colorado — Aurora, Colorado, United States (enrolling)
Yale University — New Haven, Connecticut, United States (enrolling)
Northwestern University — Chicago, Illinois, United States (enrolling)
University of Utah — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.