NCT06457152

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,136

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

April 4, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2026

Completed
Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

June 10, 2024

Last Update Submit

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

EXPERIMENTAL

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

Other: EHR-Emedded Alert

Standard of Care

NO INTERVENTION

Participants 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.

Intervention

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (4)

University of Massachusetts

Boston, Massachusetts, 01003, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

OhioHealth

Columbus, Ohio, 43228, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Amrita Mukhopadhyay

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

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

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.

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.

Locations