Heart Failure With Reduced Ejection Fraction
Conditions
Keywords
Ambulatory Care, Learning Health System, Quality Improvement [QI], Implementation Science, Clinical Decision Support, Mineralocorticoid Receptor Antagonist [MRA], Guideline Directed Medical Therapy [GDMT]
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.
Interventions
OTHEREmail 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.
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of eligible patients prescribed MRA | 60 days | Proportion of patients that receive an active prescription for mineralocorticoid receptor antagonist (MRA) compared between arms at the end of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of eligible patients prescribed ACE/ARB/ARNI | 60 days | 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 ACE/ARB/ARNI, beta blocker, or SGLT2i | 60 days | 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 ARNI | 60 days | 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 | 60 days | 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 | 60 days | Proportion of patients that receive an active prescription for sodium-glucose cotransporter-2 inhibitor (SGLT2i) compared between arms at the end of the study. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of eligible patients who have an appointment indication changed in 60 days | 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. |
| Percentage of eligible patients who have a BMP ordered after MRA initiation | 60 days | Safety endpoint: Proportion of patients that receive an active order for a basic metabolic panel (BMP) after being prescribed a mineralocorticoid receptor antagonist (MRA) |
| Percentage of eligible patients who have an appointment scheduled in 60 days | 60 days | Proportion of patients that have an appointment actively scheduled within 60 days of study initiation. |
| Percentage of eligible patients who have an appointment scheduled or indication changed in 60 days | 60 days | Proportion of patients that have an appointment actively scheduled or an appointment indication actively changed within 60 days of study initiation. |
Countries
United States
Outcome results
None listed