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Behavioral Intervention

PROMPT-HF Clinician-facing Alert 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
* 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at study completion (about 2.5 years)
Awards & highlights

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.

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

Timeline

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

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.

Find a Location

Who is running the clinical trial?

Yale UniversityOTHER
1,890 Previous Clinical Trials
3,014,490 Total Patients Enrolled
34 Trials studying Heart Failure
56,009 Patients Enrolled for Heart Failure
University of Colorado, DenverLead Sponsor
1,776 Previous Clinical Trials
2,772,889 Total Patients Enrolled
26 Trials studying Heart Failure
7,258 Patients Enrolled for Heart Failure
Patient-Centered Outcomes Research InstituteOTHER
568 Previous Clinical Trials
30,054,414 Total Patients Enrolled
17 Trials studying Heart Failure
238,219 Patients Enrolled for Heart Failure
~1467 spots leftby Sep 2028