Implementation and Interaction of Clinician And Patient-facing Tools Aiming to Intensify Neurohormonal Medicines for Heart Failure (NCT06526988)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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 can join: Review the eligibility criteria below.
Location: Sutter Health โ Walnut Creek, California
Age range: 18 Years
๐งช Interventions in This Study
- EPIC-HF Patient-facing Tool (BEHAVIORAL)
- PROMPT-HF Clinician-facing Alert (BEHAVIORAL)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (5 Sites)
- Sutter Health โ Walnut Creek, California
- University of Colorado โ Aurora, Colorado
- Yale University โ New Haven, Connecticut
- Northwestern University โ Chicago, Illinois
- University of Utah โ Salt Lake City, Utah
๐ Contact the Study Coordinator
Phone: (303) 724-4713
Email: larry.allen@cuanschutz.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Heart Failure With Reduced Ejection Fraction
- Study of JK07 in Patients With Chronic Heart Failure โ Alexander City, Alabama
- A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction โ Bradenton, Florida
- Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure โ Baltimore, Maryland
- PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction โ Charlottesville, Virginia
- Conduction System Vs Surgical Left Ventricular Epicardial Pacing For Coronary Sinus Lead Failure โ Overland Park, Kansas
- Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure โ Tulsa, Oklahoma
Explore by condition: All Heart Failure With Reduced Ejection Fraction clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.