- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06457152
Multi-Center Project: Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure (BETTER CARE-HF)
May 4, 2026 updated by: NYU Langone Health
Multi-Center Project: BETTER CARE - HF (Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure)
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
1136
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 01003
- University of Massachusetts
-
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New York
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New York, New York, United States, 10016
- NYU Langone Health
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Ohio
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Columbus, Ohio, United States, 43228
- OhioHealth
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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-
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.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnancy
- Ventricular assist device
- Hospice
- Cardiac amyloid
- Medication-specific exclusion for MRA: most recent systolic blood pressure less than 105 mm Hg, most recent potassium < 5.1, any potassium > 5.5, most recent glomerular filtration rate < 30 (using MDRD equation), or a documented MRA allergy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Participants who are randomized to receive the intervention (i.e., displaying the automated EHR-embedded alert).
|
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.
|
|
No Intervention: Standard of Care
Participants who are randomized to the control group (i.e., not displaying the automated EHR-embedded alert).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Patients with a Prescription for Mineralocorticoid Antagonists (MRA)
Time Frame: Up to Day 30
|
Measured at the prescription encounter level using patient EHR data.
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Up to Day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Patients with a Prescription for Beta-Blocker (BB)
Time Frame: Up to Day 30
|
Measured at the prescription encounter level using patient EHR data.
|
Up to Day 30
|
|
Number of Patients with a Prescription for ACE-I/ARB/ARNI
Time Frame: Up to Month 36
|
Prescription for angiotensin converting enzyme-inhibitors/angiotensin receptor blockers/angiotensin receptor neprilysin inhibitors (ACE-I/ARB/ARNI) measured at the prescription encounter level using patient EHR data.
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Up to Month 36
|
|
Number of Patients with a Prescription for Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i)
Time Frame: Up to Month 36
|
Measured at the prescription encounter level using patient EHR data.
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Up to Month 36
|
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Number of Patients with Hyperkalemia
Time Frame: Up to Month 36
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Measured using patient EHR data.
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Up to Month 36
|
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Number of Patients who are Hospitalized
Time Frame: Up to Month 36
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Measured using patient EHR data.
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Up to Month 36
|
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Number of Patients who are Hospitalized for Heart Failure (HF)
Time Frame: Up to Month 36
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Measured using patient EHR data.
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Up to Month 36
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amrita Mukhopadhyay, NYU Langone Health
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 Major Dates
Study Start (Actual)
April 4, 2025
Primary Completion (Actual)
December 4, 2025
Study Completion (Actual)
March 29, 2026
Study Registration Dates
First Submitted
June 10, 2024
First Submitted That Met QC Criteria
June 10, 2024
First Posted (Actual)
June 13, 2024
Study Record Updates
Last Update Posted (Actual)
May 5, 2026
Last Update Submitted That Met QC Criteria
May 4, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-00179
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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