Email Nudges to Improve GDMT (MRA) Adherence in Heart Failure (ENIGMA-HF)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Other: Email Nudge

Detailed Description

Importance: Guideline directed medical therapy (GDMT) is a specific set of 4 medications proven to improve morbidity and mortality for patients with heart failure (HF) with reduced ejection fraction (HFrEF), yet they are underutilized nationally and internationally. Various quality improvement (QI) interventions have had varying degrees of success at increasing GDMT prescription and titration.

Objective: The purpose of the study is to assess whether email nudges to UCLA Health cardiology clinic managers to schedule GDMT-specific appointments can lead to increased utilization of a specific medication within GDMT called a mineralocorticoid-receptor antagonist (MRA). Pertinent secondary objectives will include evaluating whether email nudges specific to MRA would increase utilization of the other medications in GDMT and whether they would increase appointments specific to GDMT.

Design, Setting, and Participants: The basic design is a pragmatic parallel-arm randomized control trial of a QI intervention. The setting is cardiology outpatient clinics at a large university-based single integrated healthcare system (UCLA Health). Participants are outpatients with HFrEF under the care of a UCLA cardiologist, with an ejection fraction on file, and currently not prescribed an MRA.

Hypothesis: The investigators hypothesize that the intervention will lead to an increased utilization of MRA, compared to the control arm.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicholas K Brownell, MD; Phone Number: 310-825-9011; Email: NBrownell@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles
      • Contact: Nicholas K Brownell, MD; Phone Number: 310-825-9011; Email: NBrownell@mednet.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention - Email Nudge; 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; 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.
No Intervention: No Intervention - Control Group; Providers randomized to the control arm will perform clinical duties as usual. Their patients will receive routine clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of eligible patients prescribed ACE/ARB/ARNI, beta blocker, or SGLT2i	Proportion of patients that receive an active prescription for angiotensin-converting enzyme inhibitor (ACE), angiotensin II receptor blocker (ARB), angiotensin receptor neprilysin inhibitor (ARNI), beta blocker, or sodium-glucose cotransporter-2 inhibitor (SGLT2i) compared between arms at the end of the study.	60 days
Percentage of eligible patients prescribed ACE/ARB/ARNI	Proportion of patients that receive an active prescription for angiotensin-converting enzyme inhibitor (ACE), angiotensin II receptor blocker (ARB), or angiotensin receptor neprilysin inhibitor (ARNI) compared between arms at the end of the study.	60 days
Percentage of eligible patients prescribed ARNI	Proportion of patients that receive an active prescription for angiotensin receptor neprilysin inhibitor (ARNI) compared between arms at the end of the study.	60 days
Percentage of eligible patients prescribed beta blocker	Proportion of patients that receive an active prescription for beta-blocker compared between arms at the end of the study.	60 days
Percentage of eligible patients prescribed SGLT2i	Proportion of patients that receive an active prescription for sodium-glucose cotransporter-2 inhibitor (SGLT2i) compared between arms at the end of the study.	60 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of eligible patients who have an appointment scheduled or indication changed in 60 days	Proportion of patients that have an appointment actively scheduled or an appointment indication actively changed within 60 days of study initiation.	60 days
Percentage of eligible patients who have an appointment scheduled in 60 days	Proportion of patients that have an appointment actively scheduled within 60 days of study initiation.	60 days
Percentage of eligible patients who have an appointment indication changed in 60 days	Proportion of patients that have an appointment already scheduled within 60 days of study initiation, but have the indication changed to "GDMT initiation - consider MRA."	60 days
Percentage of eligible patients who have a BMP ordered after MRA initiation	Safety endpoint: Proportion of patients that receive an active order for a basic metabolic panel (BMP) after being prescribed a mineralocorticoid receptor antagonist (MRA)	60 days

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Clinical Decision Support; Implementation Science; Ambulatory Care; Learning Health System; Quality Improvement [QI]; Mineralocorticoid Receptor Antagonist [MRA]; Guideline Directed Medical Therapy [GDMT]
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: UCLA IRB#23-000305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No