Initiating Preventive Care for Hyperlipidemia in the Emergency Department: The EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) Trial.

Background: Hyperlipidemia (HLD) is a major contributor to atherosclerotic cardiovascular disease (ASCVD). Nearly 30% of Emergency Department (ED) patients with chest pain have undiagnosed and/or unmanaged HLD, putting them at an increased risk of ASCVD. Although safe and effective HLD treatments exist, the ED traditionally focuses on acute care and does not offer preventive cardiovascular care services. This represents a large, missed opportunity to improve cardiovascular health for the millions of Americans evaluated in the ED each year who are not receiving appropriate preventive care in the outpatient setting. The goals of this study are to determine the efficacy of novel ED-initiated preventive care on lowering cholesterol while also informing our understanding of patient adherence and implementation determinants of ED-initiated preventive cardiovascular care.

Methods: We will use a randomized, controlled, parallel group trial of 130 ED patients being evaluated for acute coronary syndrome (ACS) at a single site. Participants will be 40-75 years old with prior ASCVD, known diabetes, or 10-year ASCVD risk ≥7.5% who are not already receiving guideline-directed outpatient preventive care. Patients will be randomized with equal probability to EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) or usual care. Patients in the EMERALD arm will be started on a statin and referred for 30-day follow-up with cardiology or primary care, depending on 10-year ASCVD risk level. Usual care arm patients will not be prescribed a statin in the ED and will be asked to follow-up with a primary care provider. The primary outcome will be percent change in low-density lipoprotein cholesterol (LDL-C) at 30-days. Secondary outcomes include percent change in LDL-C at 180-days and non-high-density lipoprotein cholesterol (non-HDL-C) at 30- and 180-days, the proportion of EMERALD patients who pick up their statin, and the proportion of patients who attend 30-day outpatient follow-up. We will also use mixed methods and semi-structured interviews to identify patient adherence facilitators and barriers as well as implementation determinants for Emergency Medicine providers.

Discussion: This is the first study to evaluate a novel, protocolized ED-initiated preventive cardiovascular care approach for HLD. If successful, the EMERALD intervention may be able to improve the cardiovascular health for at-risk patients and serve as a use case for other modifiable cardiovascular disease risk factors, such as diabetes, hypertension, tobacco use, and obesity. This single site study will inform a planned multisite trial.