Email Nudges to Improve GDMT (MRA) Adherence in Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Percentage of eligible patients prescribed MRA
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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%
结局指标
主要结局
Percentage of eligible patients prescribed MRA
时间窗: 60 days
Proportion of patients that receive an active prescription for mineralocorticoid receptor antagonist (MRA) compared between arms at the end of the study.
次要结局
- Percentage of eligible patients prescribed ACE/ARB/ARNI, beta blocker, or SGLT2i(60 days)
- Percentage of eligible patients prescribed ACE/ARB/ARNI(60 days)
- Percentage of eligible patients prescribed SGLT2i(60 days)
- Percentage of eligible patients prescribed ARNI(60 days)
- Percentage of eligible patients prescribed beta blocker(60 days)
研究者
Nicholas K. Brownell, MD
Principal Investigator
University of California, Los Angeles