RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-01
Study Completion:2028-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06526988

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Clinician (MD, PA, NP) who practices in cardiology outpatient clinics
  2. * 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)
  3. * Age \> 18 years
  4. * LVEF \</=40% on most recent cardiology imaging study
  5. * Has had a routine cardiology outpatient clinic appointment in the previous 12 months
  6. * 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
  1. * Has a left ventricular assist device
  2. * Under evaluation for or listed for transplant (or s/p transplant)
  3. * Glomerular filtration rate (GFR) less than 15
  4. * On IV inotropes
  5. * On hospice care
  6. * Non-English or Non-Spanish speaking

Contacts and Locations

Study Contact

Larry A Allen, MD, MHS
CONTACT
303-724-4713
larry.allen@cuanschutz.edu
Daniel D Matlock, MD, MPH
CONTACT
303-724-9941
daniel.matlock@cuanschutz.edu

Principal Investigator

Larry A Allen, MD, MHS
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

Sutter Health
Walnut Creek, California, 94596
United States
University of Colorado
Aurora, Colorado, 80045
United States
Yale University
New Haven, Connecticut, 06510
United States
Northwestern University
Chicago, Illinois, 60611
United States
University of Utah
Salt Lake City, Utah, 84132
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Larry A Allen, MD, MHS, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-01
Study Completion Date2028-09-01

Study Record Updates

Study Start Date2025-03-01
Study Completion Date2028-09-01

Terms related to this study

Keywords Provided by Researchers

  • Heart failure
  • Patient-centered care
  • Clinical decision support
  • Guideline-directed medical therapy

Additional Relevant MeSH Terms

  • Heart Failure With Reduced Ejection Fraction