Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06526988

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

Led by University of Colorado, Denver · Updated on 2025-06-12

2200

Participants Needed

5

Research Sites

182 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

P

Patient-Centered Outcomes Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinician (MD, PA, NP) practicing in cardiology outpatient clinics
  • Clinician regularly sees patients with left ventricular ejection fraction (EF) ≤40%, with at least 25 HFrEF patients in the past year
  • Patient age greater than 18 years
  • Patient has left ventricular ejection fraction (LVEF) ≤40% on the most recent cardiology imaging
  • Patient had a routine cardiology outpatient clinic appointment in the previous 12 months
  • Patient is not currently on all four pillars of guideline-directed medical therapy at optimal doses: beta blockers, angiotensin receptor-neprilysin inhibitor/angiotensin converting enzyme inhibitor/angiotensin receptor blocker, aldosterone receptor antagonists, sodium-glucose co-transporter inhibitors
Not Eligible

You will not qualify if you...

  • Patient has a left ventricular assist device
  • Patient is under evaluation for or listed for heart transplant, or has had a transplant
  • Patient has a glomerular filtration rate (GFR) less than 15
  • Patient is receiving intravenous inotropes
  • Patient is receiving hospice care
  • Patient does not speak English or Spanish

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Sutter Health

Walnut Creek, California, United States, 94596

Actively Recruiting

2

University of Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

3

Yale University

New Haven, Connecticut, United States, 06510

Actively Recruiting

4

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

5

University of Utah

Salt Lake City, Utah, United States, 84132

Actively Recruiting

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Research Team

L

Larry A Allen, MD, MHS

CONTACT

D

Daniel D Matlock, MD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

4

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