PINC AI™ Applied Sciences, Premier Inc., 13034 Ballantyne Corporate Place, Charlotte, NC, 28277, USA.
Amgen Inc., Thousand Oaks, CA, USA.
Adv Ther. 2024 Jan;41(1):451-463. doi: 10.1007/s12325-023-02716-6. Epub 2023 Nov 21.
The 2018 American Heart Association (AHA)/American College of Cardiology (ACC)/Multisociety blood cholesterol guidelines recommend clinicians consider adding non-statin therapy for patients with very high-risk (VHR) atherosclerotic cardiovascular disease (ASCVD) and low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dl while receiving maximally tolerated statins. However, according to a recent study, only 17.1% of patients with established ASCVD received appropriate lipid-lowering therapy (LLT) intensification. Here, we describe the design of a prospective, 12-month study (LOGAN-CV) evaluating a multifaceted site-level intervention to enhance clinicians' adherence to guidelines to improve LDL-C levels for patients with VHR ASCVD.
Clinicians from up to ten research sites are eligible if they care for adult patients with ASCVD. Interventions include educational modules, a cloud-based performance platform providing clinicians a tailored summary of their LDL-C management performance, newsletters, periodic peer-to-peer calls, and pre- and post-intervention surveys evaluating knowledge, attitudes, and beliefs around LDL-C management, with additional interventions for clinicians demonstrating a lower readiness to make treatment decisions based on guideline recommendations. Patients with VHR ASCVD, defined as having recent myocardial infarction and LDL-C ≥ 70 mg/dl despite statin treatment, will be included in the study. Patient data will be collected from electronic medical records from baseline (clinician enrollment) through the 12-month intervention. The study started in October 2022, with anticipated completion in March 2024.
The change in proportion of patients with LDL-C < 70 mg/dl achieved at any time during the 12-month intervention (primary); LLT intensification, changes in guideline-aligned LDL-C testing and LLT titration over 12 months, and change in overall clinicians' knowledge, attitudes, and beliefs are key outcomes of interest. The LOGAN-CV study addresses a critical unmet need in LDL-C control in patients with VHR ASCVD and evaluates the effect of a multifaceted intervention targeting clinicians to improve their adherence to guidelines and consequently improve clinical outcomes for patients.
2018 年美国心脏协会（AHA）/美国心脏病学会（ACC）/多学会血胆固醇指南建议临床医生考虑为极高危（VHR）动脉粥样硬化性心血管疾病（ASCVD）和低密度脂蛋白胆固醇（LDL-C）≥70mg/dl 的患者添加非他汀类药物治疗，同时接受最大耐受剂量的他汀类药物治疗。然而，根据最近的一项研究，只有 17.1%的已确诊 ASCVD 患者接受了适当的降脂治疗（LLT）强化治疗。在这里，我们描述了一项前瞻性、12 个月研究（LOGAN-CV）的设计，该研究评估了一种多方面的现场干预措施，以增强临床医生对指南的依从性，从而改善 VHR ASCVD 患者的 LDL-C 水平。
如果他们照顾患有 ASCVD 的成年患者，来自多达十个研究地点的临床医生有资格参加。干预措施包括教育模块、一个基于云的绩效平台，为临床医生提供其 LDL-C 管理绩效的个性化摘要、通讯、定期的同行间电话以及评估 LDL-C 管理知识、态度和信念的预干预和后干预调查，对于根据指南建议更不愿意做出治疗决策的临床医生，还会提供额外的干预措施。将 VHR ASCVD 患者（定义为近期心肌梗死且 LDL-C≥70mg/dl 尽管接受了他汀类药物治疗）纳入研究。将从基线（临床医生入组）通过 12 个月的干预收集患者的数据，直至 12 个月的干预。该研究于 2022 年 10 月开始，预计 2024 年 3 月完成。
在 12 个月的干预期间任何时间达到 LDL-C<70mg/dl 的患者比例变化（主要）；12 个月内 LLT 强化、指南一致的 LDL-C 检测和 LLT 滴定的变化以及临床医生整体知识、态度和信念的变化是主要关注的结果。LOGAN-CV 研究解决了 VHR ASCVD 患者 LDL-C 控制方面的一个关键未满足需求，并评估了针对临床医生的多方面干预措施对改善他们对指南的依从性并最终改善患者临床结果的影响。
