RightFit
RecruitingNot applicable

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Interviews, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This process will conclude with interviews with team members to assess the fidelity to the intervention, as well as gather data on adaptations to the intervention by each site."
  • "These interviews will be conducted by the central site (University of Colorado) study team and occur with those involved at each site with implementing the interventions and could include site-principal investigators and/or co-investigators, IT leadership or analysts."
  • "Clinicians' attitudes towards the new approach will be explored using clinician surveys measured before and after the trial."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a patient video and checklist, alerts for clinicians, or both help improve use of heart failure medicines. It is for adults with heart failure whose heart pumps less blood than normal, and clinicians who care for them.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Clinicians: Must be a doctor, physician assistant, or nurse practitioner in an outpatient heart clinic.
  • Clinicians: Must regularly see patients with weak heart pumping and have cared for at least 10 such heart failure patients in the past year.
  • Patients: Must be older than 18.
  • Patients: The latest heart scan must show an ejection fraction of 40% or less. This means the heart's main pumping chamber pushes out 40% or less of its blood with each beat.
  • Patients: Must have a new or follow-up visit with a study clinician within the next 7 days.
  • Patients: Must be missing at least one of four types of heart failure medicine, with no allergy to that type: beta blockers, angiotensin receptor-neprilysin inhibitors, aldosterone receptor antagonists, or sodium-glucose co-transporter medicines.

Who can't join

  • Patients: Have a left ventricular assist device, a pump that helps the heart move blood.
  • Patients: Are being checked for a transplant, are on a transplant waiting list, or have already had a transplant.
  • Patients: Have a kidney filtering rate (GFR) below 20 or receive dialysis, a treatment that filters the blood.
  • Patients: Receive hospice care.
  • Patients: Prefer a language other than English or Spanish.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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 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 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 20 or on dialysis * On hospice care * Preferred language neither English or Spanish

Study sites (5)

CA

CO

CT

  • Yale University · New Haven, CT 06510Francis P Wilson, MD, MSCE · Study contactNihar Desai, MD, MPH · Study contactMore trials in New Haven

IL

UT