NCT06526988Recruiting
Implementation and Interaction of Clinician And Patient-facing Tools Aiming to Intensify Neurohormonal Medicines for Heart Failure
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
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2200 (estimated)
- First submitted
- 18 Jul 2024
- Start date
- 6 Mar 2025
- Primary completion date
- 1 Sept 2028
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Heart failure
- NCT number
- NCT06526988
What you commit to
- Study type: Interventional
- Planned participants: 2200
- From 6 Mar 2025 to the primary completion date, 1 Sept 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Under evaluation for or listed for transplant (or s/p transplant)
Lab values
- Glomerular filtration rate (GFR) less than 20 or on dialysis
Other
- Patient:
- Has a left ventricular assist device
- On hospice care
- Preferred language neither English or Spanish
Who the study is looking for
- 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 10 patients with heart failure with reduced ejection fraction (HFrEF)
- Patient:
- Age \> 18 years
- LVEF \</=40% on most recent cardiology imaging study
- Has a new or return clinic visit with an enrolled clinician within the next 7 days
- Is missing at least one of the four classes of medications and does not have an allergy to that class: (1) beta blockers, (2) angiotensin receptor-neprilysin inhibitor, (3) aldosterone receptor antagonists, (4) sodium-glucose co-transporter
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| Sutter Health Coordinator of this site? Confirm its status | Walnut Creek | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.