ACHIEVE

摘要 动脉粥样硬化性心血管疾病(ASCVD)是美国的主要死亡原因(1)。 在有ASCVD病史的患者中，他汀类药物可将心血管事件的风险降低30%(2)。尽管 然而，他汀类药物价格低廉且耐受性良好，在临床实践中未得到充分利用，尤其是在 识别为黑人。一项大规模干预措施，以改善患者中基于证据的他汀类药物的启动 ASCVD是必要的，特别是对黑人人口来说。为了满足这一需求，我们的目标是进行多中心， 用于评估提供者和患者导向的影响的务实、整群随机对照试验 干预措施以增加患者中适当的他汀类药物的处方和依从性 ASCVD(ACEIVE：一项改善高强度他汀类药物用于血管保护的对照试验)。这个 干预将由药剂师领导，嵌入商业支付系统，与国家 质量保证委员会(NCQA)，并特别强调改善他汀类药物在黑色中的使用 人口。符合条件的患者和他们的临床医生将通过商业付款人记录进行识别。这个 然后，药剂师将与患者和临床医生合作，克服障碍，获得证据- 基于他汀类药物的治疗和患者对药物的依从性。就像所有在外部运作的务实试验一样 在传统的以诊所为基础的招聘模式中，接触和吸引临床医生和 这项试验中的患者还不确定。我们这笔规划拨款的目标是确定我们的战略是否 临床医生和患者的招募产生了足够高的参与度，包括在黑人中，以证明 继续进行更大规模的试验。我们的具体目标是：(1)评估我们的招聘战略和 让提供者参与这一多方面的干预，以改善他汀类药物的处方和 坚持，目标是招募至少25%的已确定供应商。(2)评估我们的战略 招募和吸引患者参与这一改善他汀类药物的多方面干预 处方和依从性，目标是在整个范围内招募至少30%的已确定患者 黑人患者群体。据我们所知，这种让提供者和他们的患者通过 商业支付者网络还没有在实现试验所设想的规模上进行试验。理解 我们能否在这种情况下招聘临床医生和患者，不仅对ACELE计划有利，而且 此外，还将在治疗领域进行未来的务实试验。

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.