Clinical trial NCT05806970: Email Nudges to Improve GDMT (MRA) Adherence in Heart Failure
Official title: Email Nudges to Improve GDMT (MRA) Adherence in Heart Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: Ambulatory Care
Learning Health System
Quality Improvement [QI]
Implementation Science
Clinical Decision Support
Mineralocorticoid Receptor Antagonist [MRA]
Guideline Directed Medical Therapy [GDMT]
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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%

Primary outcomes:
measure: Percentage of eligible patients prescribed MRA
timeFrame: 60 days
Secondary outcomes:
measure: Percentage of eligible patients prescribed ACE/ARB/ARNI, beta blocker, or SGLT2i
timeFrame: 60 days
measure: Percentage of eligible patients prescribed ACE/ARB/ARNI
timeFrame: 60 days
measure: Percentage of eligible patients prescribed ARNI
timeFrame: 60 days
measure: Percentage of eligible patients prescribed beta blocker
timeFrame: 60 days
measure: Percentage of eligible patients prescribed SGLT2i
timeFrame: 60 days
Other outcomes:
measure: Percentage of eligible patients who have an appointment scheduled or indication changed in 60 days
timeFrame: 60 days
measure: Percentage of eligible patients who have an appointment scheduled in 60 days
timeFrame: 60 days
measure: Percentage of eligible patients who have an appointment indication changed in 60 days
timeFrame: 60 days
measure: Percentage of eligible patients who have a BMP ordered after MRA initiation
timeFrame: 60 days
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Nicholas K Brownell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: David J Cho, MD MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Pooya I Bokhoor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.