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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

Qualifiers

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)

Age > 18 years

LVEF </=40% on most recent cardiology imaging study

Disqualifiers

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

Trial design

Treatments tested in this trial

  • EPIC-HF Patient-facing Tool
  • PROMPT-HF Clinician-facing Alert

Treatment groups

2,200 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University of Colorado, Denver

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Yale University

Collaborator

Northwestern University

Collaborator

University of Utah

Collaborator

Sutter Health

Collaborator