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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Email Nudges to Improve GDMT (MRA) Adherence in Heart Failure

Conditions
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Heart Failure With Reduced Ejection Fraction

Intervention / Treatment
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* Other: Email Nudge


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ambulatory Care, Learning Health System, Quality Improvement [QI], Implementation Science, Clinical Decision Support, Mineralocorticoid Receptor Antagonist [MRA], Guideline Directed Medical Therapy [GDMT]