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

University of California, Los Angeles (UCLA)

Status: Withdrawn

Conditions: Heart Failure With Reduced Ejection Fraction

Treatments: Other: Email Nudge

Study type: Interventional

Funder types: Other

Identifiers

NCT05806970

UCLA IRB#23-000305

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Intervention - Email Nudge

Experimental group

Description:

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.

Treatment:

Other: Email Nudge

No Intervention - Control Group

No Intervention group

Description:

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