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RECRUITING NA

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

NCT06526988 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

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

Study Locations (5)

California

  • Sutter Health — Walnut Creek

Colorado

  • University of Colorado — Aurora

Connecticut

  • Yale University — New Haven

Illinois

  • Northwestern University — Chicago

Utah

  • University of Utah — Salt Lake City

Trial Details

FieldValue
Enrollment Target 2,200 participants
Start Date 2025-03-06
Est. Completion 2028-09-01
Phase NA

Sponsor

University of Colorado, Denver

1,447 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06526988

The ClinicalTrials.gov registry entry for NCT06526988 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,447 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Heart Failure With Reduced Ejection Fraction appearing as the primary indexed condition, and to 2 interventions — of which EPIC-HF Patient-facing Tool is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06526988 reports 5 study locations spanning 5 distinct geographic areas — top geographies include California, Colorado, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06526988 about?

NCT06526988 is a clinical study titled "Implementation and Interaction of Clinician And Patient-facing Tools Aiming to Intensify Neurohormonal Medicines for Heart Failure". 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 li...

What is the current status of trial NCT06526988?

This trial is currently recruiting. It is a NA study. The enrollment target is 2,200 participants. The study started on 2025-03-06. Estimated completion is 2028-09-01.

What conditions does trial NCT06526988 study?

This clinical trial studies the following conditions: Heart Failure With Reduced Ejection Fraction. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06526988?

The interventions under investigation include: EPIC-HF Patient-facing Tool (BEHAVIORAL), PROMPT-HF Clinician-facing Alert (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06526988?

This trial is sponsored by University of Colorado, Denver, which has 1,447 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06526988 being conducted?

This trial has 5 study locations across California, Colorado, Connecticut, Illinois, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial