Section of Cardiovascular Medicine, New Haven, CT.
Clinical and Translational Research Accelerator, Yale School of Medicine, New Haven, CT.
Am Heart J. 2022 Nov;253:76-85. doi: 10.1016/j.ahj.2022.07.002. Epub 2022 Jul 14.
Despite guideline recommendations to optimize low-density lipoprotein cholesterol (LDL-C) reduction with intensification of lipid-lowering therapy (LLT) in patients with atherosclerotic cardiovascular disease (ASCVD), few of these patients achieve LDL-C < 70 mg/dL in practice.
We developed a real-time, targeted electronic health record (EHR) alert with embedded ordering capability to promote intensification of evidence based LLT in outpatients with very high risk ASCVD.
We designed a pragmatic, multicenter, single-blind, cluster randomized trial to test the effectiveness of an EHR-based LLT intensification alert. The study will enroll about 100 providers who will be randomized to either receive the alert or undergo usual care for outpatients with high risk ASCVD with LDL-C > 70 mg/dL. Total enrollment will include 2,500 patients. The primary outcome will be the proportion of patients with LLT intensification at 90 days. Secondary outcomes include achieved LDL-C at 6 months and the proportion of patients with LDL-C < 70 mg/dL or < 55 mg/dL at 6 months.
Enrollment of 1,250 patients (50% of goal) was reached within 47 days (50% women, mean age 72, median LDL-C 91). At baseline, 71%, 9%, and 3% were on statins, ezetimibe, or proprotein convertase subtilisin/kexin type 9 inhibitors, respectively.
PRagmatic Trial of Messaging to Providers about Treatment of HyperLIPIDemia has rapidly reached 50% enrollment of patients with very high risk ASCVD, demonstrating low baseline LLT utilization. This pragmatic, EHR-based trial will determine the effectiveness of a real-time, targeted EHR alert with embedded ordering capability to promote LLT intensification. Findings from this low-cost, widely scalable intervention to improve LDL-C may have important public health implications.
clinicaltrials.gov NCT04394715.
尽管指南建议通过强化降脂治疗（LLT）来优化动脉粥样硬化性心血管疾病（ASCVD）患者的低密度脂蛋白胆固醇（LDL-C）降低，但在实践中，很少有这些患者的 LDL-C 达到<70mg/dL。
我们开发了一种实时、有针对性的电子健康记录（EHR）警报，并具有嵌入式医嘱功能，以促进极高危 ASCVD 门诊患者的循证 LLT 强化。
我们设计了一项实用、多中心、单盲、集群随机试验，以测试基于 EHR 的 LLT 强化警报的有效性。该研究将招募约 100 名提供者，他们将被随机分配接受警报或接受常规护理，对象为 LDL-C>70mg/dL 的高危 ASCVD 门诊患者。总入组人数将包括 2500 名患者。主要结局为 90 天内 LLT 强化的患者比例。次要结局包括 6 个月时的 LDL-C 水平和 6 个月时 LDL-C<70mg/dL 或<55mg/dL 的患者比例。
在 47 天内（50%为女性，平均年龄 72 岁，中位数 LDL-C 为 91），达到了 1250 名患者（目标的 50%）的入组目标。基线时，分别有 71%、9%和 3%的患者正在服用他汀类药物、依折麦布或前蛋白转化酶枯草溶菌素 9 抑制剂。
治疗高脂蛋白血症的消息传递实用试验迅速达到了极高危 ASCVD 患者的 50%入组目标，表明基线 LLT 的使用率较低。这项实用的基于 EHR 的试验将确定实时、有针对性的 EHR 警报的有效性，该警报具有嵌入式医嘱功能，可促进 LLT 强化。这项低成本、广泛可扩展的改善 LDL-C 干预措施的发现可能具有重要的公共卫生意义。
clinicaltrials.gov NCT04394715。
