NCT05806970

Brief Summary

The Email Nudges to Improve GDMT (MRA) Adherence in Heart Failure (ENIGMA-HF) study is a pragmatic parallel-arm randomized control trial of a quality improvement (QI) intervention involving email nudges to cardiology clinic managers to schedule appointments specific to guideline directed medical therapy (GDMT) initiation, with the goal of optimizing mineralocorticoid-receptor antagonist (MRA) use by patients with heart failure with reduced ejection fraction (HFrEF) cared for by cardiologists within the University of California, Los Angeles (UCLA) Health System.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

March 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 10, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

March 28, 2023

Last Update Submit

April 29, 2024

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

Ambulatory CareLearning Health SystemQuality Improvement [QI]Implementation ScienceClinical Decision SupportMineralocorticoid Receptor Antagonist [MRA]Guideline Directed Medical Therapy [GDMT]

Outcome Measures

Primary Outcomes (1)

  • Percentage of eligible patients prescribed MRA

    Proportion of patients that receive an active prescription for mineralocorticoid receptor antagonist (MRA) compared between arms at the end of the study.

    60 days

Secondary Outcomes (5)

  • Percentage of eligible patients prescribed ACE/ARB/ARNI, beta blocker, or SGLT2i

    60 days

  • Percentage of eligible patients prescribed ACE/ARB/ARNI

    60 days

  • Percentage of eligible patients prescribed ARNI

    60 days

  • Percentage of eligible patients prescribed beta blocker

    60 days

  • Percentage of eligible patients prescribed SGLT2i

    60 days

Other Outcomes (4)

  • Percentage of eligible patients who have an appointment scheduled or indication changed in 60 days

    60 days

  • Percentage of eligible patients who have an appointment scheduled in 60 days

    60 days

  • Percentage of eligible patients who have an appointment indication changed in 60 days

    60 days

  • +1 more other outcomes

Study Arms (2)

Intervention - Email Nudge

EXPERIMENTAL

The intervention will include contacting UCLA Health Cardiology clinic managers with a list of all HFrEF patients eligible for an MRA who are cared for by a provider randomized to the intervention arm. Clinic managers will be asked to make an appointment in the next 60 days for these patients with the specific indication: GDMT initiation - consider MRA. If an appointment is already present in the next 60 days, the indication will be changed to: GDMT initiation - consider MRA.

Other: Email Nudge

No Intervention - Control Group

NO INTERVENTION

Providers randomized to the control arm will perform clinical duties as usual. Their patients will receive routine clinical care.

Interventions

Email NudgeOTHER

An email to UCLA Health Cardiology clinic managers with a list of MRA-eligible HFrEF patients and a request to schedule or change cardiology appointments.

Intervention - Email Nudge

Eligibility Criteria

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

You may qualify if:

  • Facility: UCLA Health System
  • Patient is 18 years of age or older
  • Patient is under the care of a UCLA cardiologist
  • Patient has a primary diagnosis of HFrEF
  • Patient is not currently prescribed an MRA

You may not qualify if:

  • Hyperkalemia
  • Chronic kidney disease stage 4 or higher
  • Pregnant or breastfeeding patients
  • Heart transplant or ventricular-assist device patients
  • Hospice patients
  • Patients without an LVEF on file
  • Patients with an EF \>35%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • Brownell NK, Ziaeian B, Fonarow GC. The Gap to Fill: Rationale for Rapid Initiation and Optimal Titration of Comprehensive Disease-modifying Medical Therapy for Heart Failure with Reduced Ejection Fraction. Card Fail Rev. 2021 Nov 26;7:e18. doi: 10.15420/cfr.2021.18. eCollection 2021 Mar.

    PMID: 34950508BACKGROUND

Study Officials

  • Nicholas K Brownell, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

  • David J Cho, MD MBA

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

  • Pooya I Bokhoor, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 10, 2023

Study Start

April 1, 2023

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

May 1, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)