Improving heart failure treatment through clinician and patient tools
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
This study is testing new tools for doctors and patients to see if they can help improve heart failure treatment for people with reduced heart function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 5 sites (Walnut Creek, California and 4 other locations) |
| Trial ID | NCT06526988 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to enhance the use of guideline-directed medical therapies (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF) by implementing two innovative interventions: the EPIC-HF patient-facing tool and the PROMPT-HF clinician-facing alert. Conducted across five health systems, the trial will utilize a participatory approach to optimize the delivery and effectiveness of these tools, ensuring they are tailored to the unique needs of each clinic and patient population. The study will explore various implementation strategies to maximize equitable access and long-term adoption of these interventions.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a left ventricular ejection fraction of 40% or less who have not been prescribed all four pillars of GDMT at optimal doses.
Not a fit: Patients with advanced heart failure requiring devices like left ventricular assist devices or those on hospice care may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could significantly improve the management and outcomes for patients with heart failure by ensuring they receive optimal medical therapy.
How similar studies have performed: Previous studies have shown success with similar patient-centered and clinician-focused interventions, indicating a promising approach for improving GDMT prescribing.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 25 patients with heart failure with reduced ejection fraction (HFrEF) Patient: * Age \> 18 years * LVEF \</=40% on most recent cardiology imaging study * Has had a routine cardiology outpatient clinic appointment in the previous 12 months * Not on all 4 pillars of GDMT at optimal doses: (1) beta blockers, (2) angiotensin receptor-neprilysin inhibitor/angiotensin converting enzyme inhibitor/angio-tensin receptor blocker, (3) aldosterone receptor antagonists, (4) sodium-glucose co-transporter Exclusion Criteria: Patient: * Has a left ventricular assist device * Under evaluation for or listed for transplant (or s/p transplant) * Glomerular filtration rate (GFR) less than 15 * On IV inotropes * On hospice care * Non-English or Non-Spanish speaking
Where this trial is running
Walnut Creek, California and 4 other locations
- Sutter Health — Walnut Creek, California, United States (Recruiting)
- University of Colorado — Aurora, Colorado, United States (Recruiting)
- Yale University — New Haven, Connecticut, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Larry A Allen, MD, MHS — University of Colorado, Denver
- Study coordinator: Larry A Allen, MD, MHS
- Email: larry.allen@cuanschutz.edu
- Phone: 303-724-4713
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.