Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, PA; Leonard Davis Institute for Health Economics, University of Pennsylvania, Philadelphia, PA; Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA.
Penn Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA.
Am Heart J. 2024 Jul;273:83-89. doi: 10.1016/j.ahj.2024.04.013. Epub 2024 Apr 26.
In patients with or at risk for atherosclerotic vascular disease, statins reduce the incidence of major adverse cardiovascular events, but the majority of US adults with an indication for statin therapy are not prescribed statins at guideline-recommended intensity. Clinicians' limited time to address preventative care issues is cited as one factor contributing to gaps in statin prescribing. Centralized pharmacy services can fulfill a strategic role for population health management through outreach, education, and statin prescribing for patients at elevated ASCVD risk, but best practices for optimizing referrals of appropriate patients are unknown.
SUPER LIPID (NCT05537064) is a program consisting of two pragmatic clinical trials testing the effect of nudges in increasing referrals of appropriate patients to a centralized pharmacy service for lipid management, conducted within 11 primary care practices in a large community health system. In both trials, patients were eligible for inclusion if they had an assigned primary care provider (PCP) in a participating practice and were not prescribed a high- or moderate-intensity statin despite an indication, identified via an electronic health record (EHR) algorithm. Trial #1 was a stepped wedge trial, conducted at a single practice with randomization at the PCP level, of an interruptive EHR message that appeared during eligible patients' visits and facilitated referral to the pharmacy service. For the first 3 months, no PCPs received the message; for the second 3 months, half were randomly selected to receive the message; and for the last 3 months, all PCPs received the message. Trial #2 was a cluster-randomized trial conducted at 10 practices, with randomization at the practice level. Practices were randomized to usual care or to have eligible patients automatically referred to centralized pharmacy services via a referral order placed in PCPs EHR inboxes for co-signature. In both trials, when a patient was referred to centralized pharmacy services, a pharmacist reviewed the patient's chart, contacted the patient, and initiated statin therapy if the patient agreed. The primary endpoint of both trials was the proportion of patients prescribed a statin; secondary endpoints include the proportion of patients prescribed a statin at guideline-recommended intensity, the proportion of patients filling a statin prescription, and serum low-density lipoprotein level.
SUPER LIPID is a pair of pragmatic clinical trials assessing the effectiveness of two strategies to encourage referral of appropriate patients to a centralized pharmacy service for lipid management. The trial results will develop the evidence base for simple, scalable, EHR-based strategies to integrate clinical pharmacists into population health management and increase appropriate statin prescribing.
clinicaltrials.gov; NCT05537064.
在患有动脉粥样硬化性血管疾病或有此疾病风险的患者中，他汀类药物可降低主要不良心血管事件的发生率，但大多数有他汀类药物治疗指征的美国成年人并未按照指南推荐的强度开具他汀类药物。临床医生用于解决预防性护理问题的时间有限，这被认为是他汀类药物开具处方存在差距的一个因素。集中式药房服务可以通过外展、教育和为处于 ASCVD 风险升高的患者开具他汀类药物，在人群健康管理中发挥战略作用，但优化合适患者转诊的最佳实践尚不清楚。
SUPER LIPID（NCT05537064）是一个由两项实用临床试验组成的项目，旨在通过电子健康记录（EHR）算法识别出的合适患者向集中式药房服务转诊进行干预，以增加合适患者的转诊率，以提高血脂管理水平，该项目在大型社区卫生系统的 11 个初级保健实践中进行。在这两项试验中，只要患者有参与实践的指定初级保健提供者（PCP），并且尽管有指征但未开处方高强度或中强度他汀类药物，他们就有资格被纳入。试验#1是一项单中心、随机、平行、两臂、干预性试验，在参与的实践中进行，在合格患者就诊期间出现电子健康记录（EHR）消息，并促进向药房服务转诊。在前 3 个月，没有 PCP 收到消息；在接下来的 3 个月中，随机选择一半 PCP 接收消息；在最后 3 个月，所有 PCP 都收到了消息。试验#2是在 10 个实践中进行的集群随机试验，以实践为单位进行随机分组。实践随机分为常规护理或通过为 PCP 的 EHR 收件箱中的患者自动开处方，将合格患者转介到集中式药房服务。在这两项试验中，当患者被转介到集中式药房服务时，药剂师会审查患者的病历，与患者联系，并在患者同意的情况下开始他汀类药物治疗。这两项试验的主要终点均为开具他汀类药物的患者比例；次要终点包括开具指南推荐强度的他汀类药物的患者比例、开具他汀类药物处方的患者比例和血清低密度脂蛋白水平。
SUPER LIPID 是两项实用临床试验，旨在评估两种策略的有效性，以鼓励将合适的患者转介到集中式药房服务进行血脂管理。试验结果将为简单、可扩展的基于 EHR 的策略提供证据，以将临床药师整合到人群健康管理中，并增加适当的他汀类药物处方。
clinicaltrials.gov；NCT05537064。
