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

Not Applicable

Not yet recruiting

• Conditions: Heart Failure
• Interventions: Other: EHR-Emedded Alert

• Registration Number: NCT06457152
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-10
• Study First Submitted QC: 2024-06-10
• Study First Posted: 2024-06-13
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-24
• Study Start: 2025-04-30
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	EHR-Emedded Alert	Participants who are randomized to receive the intervention (i.e., displaying the automated EHR-embedded alert).

Primary Outcome Measures

Name	Time	Method
Number of Patients with a Prescription for Mineralocorticoid Antagonists (MRA)	Up to Day 30	Measured at the prescription encounter level using patient EHR data.

Secondary Outcome Measures

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

Trial Locations

Locations (4)

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, United States