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

Conditions

• Heart Failure With Reduced Ejection Fraction

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• EPIC-HF Patient-facing Tool — BEHAVIORAL
  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 — BEHAVIORAL
  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.

Study Details

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 Dates

Start date

Mar 6, 2025

Status verified

Jun 2025

Primary completion

Sep 1, 2028

Completion

Sep 1, 2028

Study Design

Enrollment

2,200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

HEALTH_SERVICES_RESEARCH

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.

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

• Larry A Allen, MD, MHS
  303-724-4713
  [email protected]
• Daniel D Matlock, MD, MPH
  303-724-9941
  [email protected]

Locations (5)

Find similar trials in Walnut Creek, CA

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