Recruiting

HFrEF Tools

Sponsor:

University of Colorado, Denver

Code:

NCT06526988

Conditions

Heart Failure With Reduced Ejection Fraction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EPIC-HF Patient-facing Tool

PROMPT-HF Clinician-facing Alert

Study Details

Brief summary:

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Study ID

NCT06526988

Start date

Mar 6, 2025

Status verified date

Jul, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

2200 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Usual Care

Patients will receive care as usual.

experimental: EPIC-HF Patient-facing Tool

Patients will receive the patient engagement video and HeartMeds Guide checklist electronically about 2-7 days and 0-1 days prior to their next clinic appointment after enrollment.

experimental: PROMPT-HF Clinician-facing Alert

Clinicians will receive tailored electronic health record (EHR) alerts recommending guideline-directed medical therapy (GDMT) in eligible patients with HFrEF during outpatient visits.

experimental: Both (EPIC-HF and PROMPT-HF Interventions)

Patients will receive the patient engagement video and HeartMeds Guide checklist electronically about 2-7 days and 0-1 days prior to their next clinic appointment after enrollment, and clinicians will receive tailored electronic health record (EHR) alerts recommending guideline-directed medical therapy (GDMT) in eligible patients with HFrEF during outpatient visits.

Interventions

EPIC-HF Patient-facing Tool

A brief, animated video designed to engage and activate patients around their HFrEF medication prescribing sent prior to routine cardiology clinic visit, accompanied by a one-page HeartMeds Guide checklist.

PROMPT-HF Clinician-facing Alert

A best practice alert will appear for each eligible patient upon opening of the order entry screen in the patient's medical record. This alerts the provider of the presence of HFrEF, notes the patient's current LVEF and current evidence-based medications, and gives access to an order set with recommended evidence-based, guideline-recommended, and FDA- approved therapies for patients with HFrEF. Providers will also have access to a link to best available guideline recommended information regarding treatment of heart failure to allow further education if desired by the provider. The alerts will also clearly state the expected monitoring and follow-up required for prescriptions of these medications.

Primary outcome measure

  • Intensification of GDMT in patients with Heart Failure with Reduced Ejection Fraction [ Time Frame: From pre-clinic visit to 1 day after ]

Central Contacts and Locations

Central contacts

Locations

Sutter Health

Recruiting

Walnut Creek, California, United States, 94596

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Heart failure
  • Patient-centered care
  • Clinical decision support
  • Guideline-directed medical therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-07-13.