Implementation and Interaction of Clinician And Patient-facing Tools Aiming to Intensify Neurohormonal Medicines for Heart Failure With Reduced Ejection Fraction: I-I-CAPTAIN-HF

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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 25 patients with heart failure with reduced ejection fraction (HFrEF)

⁃ Patient:

• Age \> 18 years

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

• Has had a routine cardiology outpatient clinic appointment in the previous 12 months

• Not on all 4 pillars of GDMT at optimal doses: (1) beta blockers, (2) angiotensin receptor-neprilysin inhibitor/angiotensin converting enzyme inhibitor/angio-tensin receptor blocker, (3) aldosterone receptor antagonists, (4) sodium-glucose co-transporter

Locations
United States
California
Sutter Health
RECRUITING
Walnut Creek
Colorado
University of Colorado
RECRUITING
Aurora
Connecticut
Yale University
RECRUITING
New Haven
Illinois
Northwestern University
RECRUITING
Chicago
Utah
University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Larry A Allen, MD, MHS
larry.allen@cuanschutz.edu
303-724-4713
Backup
Daniel D Matlock, MD, MPH
daniel.matlock@cuanschutz.edu
303-724-9941
Time Frame
Start Date: 2025-03-06
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 2200
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Sutter Health, Yale University, Northwestern University, University of Utah, Patient-Centered Outcomes Research Institute
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov