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

Heart Failure With Reduced Ejection Fraction Clinical Trial

— ENIGMA-HF  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05806970
• Other study ID #: UCLA IRB#23-000305
• Status: Withdrawn
• Phase: N/A
• Start date: April 2023
• Est. completion date: July 2023

Study information

• Verified date: April 2024
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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