ABSTRACT Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death in the United States (U.S.)(1). Statins reduce the risk of cardiovascular events by 30% in those with prior history of ASCVD (2). Despite being inexpensive and well-tolerated, however, statins are underused in clinical practice, particularly in patients who identify as Black. A large-scale intervention to improve evidence-based statin initiation among individuals with ASCVD is needed, particularly for the Black population. To meet this need, we aim to conduct a multi-center, pragmatic, cluster randomized, controlled trial to assess the impact of a provider- and patient-directed intervention to increase the prescription of, and adherence to, appropriate statin therapy among those with ASCVD (ACHIEVE: A Controlled trial to improve use of High IntEnsity statins for Vascular protEction). The intervention will be pharmacist-led, embedded in commercial payer systems, partnering with the National Committee for Quality Assurance (NCQA), and with a particular emphasis on improving statin use in the Black population. Eligible patients and their clinicians will be identified through commercial payer records. The pharmacist will then work with the patient and the clinician to overcome barriers and to achieve evidence- based statin therapy and patient adherence to the medication. As with all pragmatic trials that operate outside of the traditional clinic-based recruitment model, the optimal method to reach and engage both clinicians and patients in this trial is uncertain. Our objective for this planning grant is to determine whether our strategies for clinician and patient recruitment yield a high enough degree of engagement, including among Blacks, to justify moving forward with the larger trial. Our specific aims are: (1) To evaluate our strategy for recruitment and engagement of providers to participate in this multifaceted intervention to improve statin prescription and adherence, with the goal of recruiting at least 25% of identified providers. (2) To evaluate our strategy for recruitment and engagement of patients to participate in this multifaceted intervention to improve statin prescription and adherence, with the goal of recruiting at least 30% of identified patients overall and within the Black patient population. To our knowledge, this approach of engaging providers and their patients through commercial payer networks has not been tried on the scale envisioned for the ACHIEVE trial. Understanding whether we can recruit clinicians and patients in this setting will benefit not only the ACHIEVE program, but also future pragmatic trials across therapeutic areas.

PROJECT NARRATIVE We aim to conduct a multi-center, pragmatic, cluster randomized, controlled trial to assess the impact of a provider- and patient-directed intervention to increase the prescription of, and adherence to, appropriate statin therapy among those with ASCVD, and particularly among Blacks. As with all pragmatic trials that operate outside of the traditional clinic-based recruitment model, the optimal method to reach and engage both clinicians and patients in this trial is uncertain. Our objective for this planning grant is to determine whether our strategies for clinician and patient recruitment yield a high enough degree of engagement, including among Blacks, to justify moving forward with the larger trial.