Multi-Center Project: Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure
BETTER CARE-HF
Multi-Center Project: BETTER CARE - HF (Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure)
1 other identifier
interventional
1,136
1 country
4
Brief Summary
This study will test an automated, electronic health record (EHR-)embedded alert to improve prescribing of guideline-directed medical therapy for patients with heart failure and reduced ejection fraction (HFrEF). The investigators have previously tested and implemented this alert at NYU Langone Health (NYULH), and will now test and implement this alert across three other health systems.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Apr 2025
Shorter than P25 for not_applicable heart-failure
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2024
CompletedFirst Posted
Study publicly available on registry
June 13, 2024
CompletedStudy Start
First participant enrolled
April 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 4, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2026
CompletedMay 5, 2026
May 1, 2026
8 months
June 10, 2024
May 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Patients with a Prescription for Mineralocorticoid Antagonists (MRA)
Measured at the prescription encounter level using patient EHR data.
Up to Day 30
Secondary Outcomes (6)
Number of Patients with a Prescription for Beta-Blocker (BB)
Up to Day 30
Number of Patients with a Prescription for ACE-I/ARB/ARNI
Up to Month 36
Number of Patients with a Prescription for Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i)
Up to Month 36
Number of Patients with Hyperkalemia
Up to Month 36
Number of Patients who are Hospitalized
Up to Month 36
- +1 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALParticipants who are randomized to receive the intervention (i.e., displaying the automated EHR-embedded alert).
Standard of Care
NO INTERVENTIONParticipants who are randomized to the control group (i.e., not displaying the automated EHR-embedded alert).
Interventions
For patients randomized to the intervention group, an automated, EHR-embedded alert will be visible in the patient's chart that promotes appropriate medical therapy for patients with HFrEF.
Eligibility Criteria
You may qualify if:
- Patient with an encounter visit at participating cardiology practice during the study period
- Patient with EF of less than or equal to 40% on most recent echocardiogram at the time of visit
- Patient ages 18-90
You may not qualify if:
- Pregnancy
- Ventricular assist device
- Hospice
- Cardiac amyloid
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- Massachusetts General Hospitalcollaborator
- University of Pennsylvaniacollaborator
- OhioHealthcollaborator
Study Sites (4)
University of Massachusetts
Boston, Massachusetts, 01003, United States
NYU Langone Health
New York, New York, 10016, United States
OhioHealth
Columbus, Ohio, 43228, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amrita Mukhopadhyay
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2024
First Posted
June 13, 2024
Study Start
April 4, 2025
Primary Completion
December 4, 2025
Study Completion
March 29, 2026
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to amrita.mukhopadhyay@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: amrita.mukhopadhyay@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.