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

Primary Purpose

Heart Failure With Reduced Ejection Fraction

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Email Nudge
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure With Reduced Ejection Fraction focused on measuring Ambulatory Care, Learning Health System, Quality Improvement [QI], Implementation Science, Clinical Decision Support, Mineralocorticoid Receptor Antagonist [MRA], Guideline Directed Medical Therapy [GDMT]

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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%

Sites / Locations

  • University of California, Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention - Email Nudge

No Intervention - Control Group

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
March 28, 2023
Last Updated
April 7, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT05806970
Brief Title
Email Nudges to Improve GDMT (MRA) Adherence in Heart Failure
Acronym
ENIGMA-HF
Official Title
Email Nudges to Improve GDMT (MRA) Adherence in Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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]

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention - Email Nudge
Arm Type
Experimental
Arm 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.
Arm Title
No Intervention - Control Group
Arm Type
No Intervention
Arm Description
Providers randomized to the control arm will perform clinical duties as usual. Their patients will receive routine clinical care.
Intervention Type
Other
Intervention Name(s)
Email Nudge
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of eligible patients prescribed MRA
Description
Proportion of patients that receive an active prescription for mineralocorticoid receptor antagonist (MRA) compared between arms at the end of the study.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Percentage of eligible patients prescribed ACE/ARB/ARNI, beta blocker, or SGLT2i
Description
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.
Time Frame
60 days
Title
Percentage of eligible patients prescribed ACE/ARB/ARNI
Description
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.
Time Frame
60 days
Title
Percentage of eligible patients prescribed ARNI
Description
Proportion of patients that receive an active prescription for angiotensin receptor neprilysin inhibitor (ARNI) compared between arms at the end of the study.
Time Frame
60 days
Title
Percentage of eligible patients prescribed beta blocker
Description
Proportion of patients that receive an active prescription for beta-blocker compared between arms at the end of the study.
Time Frame
60 days
Title
Percentage of eligible patients prescribed SGLT2i
Description
Proportion of patients that receive an active prescription for sodium-glucose cotransporter-2 inhibitor (SGLT2i) compared between arms at the end of the study.
Time Frame
60 days
Other Pre-specified Outcome Measures:
Title
Percentage of eligible patients who have an appointment scheduled or indication changed in 60 days
Description
Proportion of patients that have an appointment actively scheduled or an appointment indication actively changed within 60 days of study initiation.
Time Frame
60 days
Title
Percentage of eligible patients who have an appointment scheduled in 60 days
Description
Proportion of patients that have an appointment actively scheduled within 60 days of study initiation.
Time Frame
60 days
Title
Percentage of eligible patients who have an appointment indication changed in 60 days
Description
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."
Time Frame
60 days
Title
Percentage of eligible patients who have a BMP ordered after MRA initiation
Description
Safety endpoint: Proportion of patients that receive an active order for a basic metabolic panel (BMP) after being prescribed a mineralocorticoid receptor antagonist (MRA)
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicholas K Brownell, MD
Phone
310-825-9011
Email
NBrownell@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas K Brownell, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David J Cho, MD MBA
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pooya I Bokhoor, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas K Brownell, MD
Phone
310-825-9011
Email
NBrownell@mednet.ucla.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34950508
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.
Results Reference
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Email Nudges to Improve GDMT (MRA) Adherence in Heart Failure

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