Multi-Center Project: Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure

Heart Failure Clinical Trial

— BETTER CARE-HF  

Official title:

Multi-Center Project: BETTER CARE - HF (Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06457152
• Other study ID #: 24-00179
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: June 2024
• Source: NYU Langone Health
• Contact: Sarah Tsuruo
• Phone: 914-815-4079
• Email: Sarah.tsuruo[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: December 30, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• EHR-Emedded 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	OhioHealth	Columbus	Ohio
United States	NYU Langone Health	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
NYU Langone Health	Massachusetts General Hospital, OhioHealth, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Patients with a Prescription for Beta-Blocker (BB)	Measured at the prescription encounter level using patient EHR data.	Up to Day 30
Secondary	Number of Patients with a Prescription for ACE-I/ARB/ARNI	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.	Up to Month 36
Secondary	Number of Patients with a Prescription for Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i)	Measured at the prescription encounter level using patient EHR data.	Up to Month 36
Secondary	Number of Patients with Hyperkalemia	Measured using patient EHR data.	Up to Month 36
Secondary	Number of Patients who are Hospitalized	Measured using patient EHR data.	Up to Month 36
Secondary	Number of Patients who are Hospitalized for Heart Failure (HF)	Measured using patient EHR data.	Up to Month 36