Tailored Electronic Intervention to Improve Therapy in a Diverse Cohort of Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,966
- 试验地点
- 4
- 主要终点
- Number of Participants with GDMT Initiation or Intensification
研究概览
简要总结
Recent medical guidelines for the management of heart failure (HF) have established a combination of specific classes of medications as the best treatment for patients with heart failure with reduced ejection fraction (HFrEF). However, studies have shown that these medications, known together as guideline-directed medical therapy (GDMT), are not being used in clinical practice less often than they could be. Several tools to promote broader use of these treatments (including patient checklists) have shown promise for increasing use of GDMT. However, these tools have not been broadly implemented within large health systems. The goal of this study is to see if using these tools broadly within cardiology clinics will increase the use of GDMT. This study is important because it could help improve the use of GDMT, which may lead to improved patient care and outcomes.
详细描述
The 2022 American College of Cardiology Foundation (ACCF)/American Heart Association (AHA)/Heart Failure Society of America (HFSA) and 2021 European Society of Cardiology (ESC) guidelines for the management of heart failure (HF) firmly establish that quadruple therapy with angiotensin receptor neprilysin inhibitors (ARNI), sodium glucose cotransporter-2 inhibitors (SGLT2i), evidence-based β-blockers, and mineralocorticoid receptor antagonists now form the foundational standard for guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF). Despite multiple randomized controlled trials establishing the clinical benefit of novel therapies like ARNI and SGLT2i, adoption of these novel therapeutic agents in clinical practice has been slower than expected. For example, a recent population-level cohort study using IQVIA Inc. National Prescription Audit data in the US showed that only 13.8% of patients with HFrEF were using sacubitril-valsartan from 2016-2019. Similarly, a recent retrospective cohort analysis of commercially insured patients with type 2 diabetes in the US demonstrated that only 8.7% were treated with an SGLT2i from 2015 to 2019. There is a need for interventions that increase utilization of these important medications.
The investigators have previously demonstrated a high burden of HF and suboptimal use of GDMT among a broad cohort of patients. There is a need to improve prescription of GDMT and to improve clinical outcomes for patients with HF with the use of evidence-based methods to improve care quality.
The EPIC-HF checklist is a patient activation tool that allows patients to see recommended doses and categories of GDMT, which they can use to compare to their current medications and dosing. In this implementation study, eight cardiology and heart failure clinics will be randomized to implement the EPIC-HF checklist or to perform standard of care for two 6-month periods. During the first 6-month period, patients will be provided with the EPIC-HF checklist prior to their clinic appointment via EMR message. During the second 6-month period, clinician-facing decision support for GDMT intensification will be added.
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
- None
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
- •Ejection fraction (EF) less than or equal to 40% by echocardiogram performed in the prior 18 months
- •Diagnosis of heart failure
排除标准
- •Heart failure (HF) etiology for which GDMT is not indicated: including hypertrophic or restrictive cardiomyopathy (e.g. amyloid cardiomyopathy), constrictive pericarditis, or complex congenital heart disease
- •End-stage HF requiring continuous inotrope infusion, heart transplant, or left ventricular assist device
- •Estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73m^2
- •Any conditions other than HF that are likely to alter the patient's status over 6 months, indicated by active hospice status
研究组 & 干预措施
Standard of Care
Patients of clinics that are randomized to the standard of care will not have the EPIC-HF checklist available for viewing in their electronic medical record (EMR).
干预措施: Standard of Care (Behavioral)
EPIC-HF Checklist for Patients and Clinician-facing Decision Support
Patients of clinics that are randomized to implement the checklist will be sent the checklist in advance of their visit via their electronic medical record (EMR) portal. During this period of the study, clinicians in intervention clinics will also have access to analogous decision-support via EMR.
干预措施: Clinician-facing Decision Support (Behavioral)
Optimized version of the EPIC-HF Checklist
Patients of clinics that are randomized to implement the checklist will be sent the checklist in advance of their visit via their electronic medical record (EMR) portal.
干预措施: Optimized version of the EPIC-HF Checklist (Behavioral)
EPIC-HF Checklist for Patients and Clinician-facing Decision Support
Patients of clinics that are randomized to implement the checklist will be sent the checklist in advance of their visit via their electronic medical record (EMR) portal. During this period of the study, clinicians in intervention clinics will also have access to analogous decision-support via EMR.
干预措施: Optimized version of the EPIC-HF Checklist (Behavioral)
结局指标
主要结局
Number of Participants with GDMT Initiation or Intensification
时间窗: 30 Days after Clinic Visit
Changes in medication are assessed as the initiation or intensification of recommended heart failure medications including foundational GDMTs (angiotensin-converting enzyme inhibitors (ACEI)/angiotensin receptor blockers (ARB)/angiotensin receptor neprilysin inhibitors (ARNI), beta-blockers (BB), mineralocorticoid receptor antagonists (MRA), and sodium glucose cotransporter-2 inhibitors (SGLT2i)) as well as other guideline recommended therapies for HFrEF including ivabradine, digoxin, and soluble guanylate cyclase stimulators.
次要结局
未报告次要终点
研究者
Neal Dickert
Associate Professor
Emory University
