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Behavioral Intervention

Tools to Improve Medication Management for Heart Failure (IICAPTAIN-HF Trial)

N/A

Waitlist Available

Led By Larry A Allen, MD, MHS

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must be over 18 years of age

Patient's left ventricular ejection fraction (LVEF) must be ≤40% on the most recent cardiology imaging study

Must not have

Patient is non-English or non-Spanish speaking

Patient is under evaluation for or listed for transplant (or s/p transplant)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at study completion (about 2.5 years)

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test two different tools to help improve the prescription of guideline-directed medical therapies for patients with chronic heart failure. The tools include a brief video and checklist for patients to use before clinic visits

Who is the study for?

This trial is for patients with chronic heart failure who have a reduced ability of the heart to pump blood (HFrEF). It's designed to help these individuals improve their cardiac function and quality of life by optimizing their medication regimen. Participants should be willing to use new tools aimed at enhancing treatment.

What is being tested?

The study tests two digital tools: EPIC-HF, which is a video and checklist for patients before clinic visits, and PROMPT-HF, an alert system for clinicians during visits. The goal is to see if these tools can help increase the use of recommended heart failure medications across five health systems.

What are the potential side effects?

Since this trial focuses on implementing decision-support tools rather than new medications, there are no direct side effects from drugs being tested. However, changes in medication regimens as a result could lead to typical heart failure medication side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

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My heart's pumping ability is 40% or less.

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I am not taking all four recommended heart failure medications at their full doses.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not speak English or Spanish.

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I am being considered for or have had a transplant.

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My kidney function is severely reduced.

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I am currently receiving IV inotropes.

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I am currently receiving hospice care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at study completion (about 2.5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at study completion (about 2.5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at study completion (about 2.5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intensification of GDMT in patients with Heart Failure with Reduced Ejection Fraction

Secondary study objectives

Adoption of PROMPT-HF intervention

Clinician acceptability and feasibility of interventions

Clinician attitudes toward patient activation tools and clinical decision support

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: PROMPT-HF Clinician-facing AlertExperimental Treatment1 Intervention

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

Group II: EPIC-HF Patient-facing ToolExperimental Treatment1 Intervention

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.

Group III: Both (EPIC-HF and PROMPT-HF Interventions)Experimental Treatment2 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.

Group IV: Usual CareActive Control1 Intervention

Patients will receive care as usual.

0 / 8Eligibility criteria met