Pragmatic Trial of Messaging to Providers About Treatment of Hyperlipidemia (PROMPT-LIPID): A Randomized Clinical Trial

Nimish N. Shah, Lama Ghazi, Yu Yamamoto, Sanchit Kumar, Melissa Martin, Michael Simonov, Ralph J. Riello III, Kamil F. Faridi, Tariq Ahmad, F. Perry Wilson, Nihar R. Desai
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Abstract

BACKGROUND:Lipid-lowering therapy (LLT) is underutilized for very high-risk atherosclerotic cardiovascular disease. PROMPT-LIPID (PRagmatic Trial of Messaging to Providers about Treatment of HyperLIPIDemia) sought to determine whether electronic health record (EHR) alerts improve 90-day LLT intensification in patients with very high-risk atherosclerotic cardiovascular disease.METHODS:PROMPT-LIPID was a pragmatic trial in which cardiovascular and internal medicine clinicians within Yale New Haven Health (New Haven, CT) were cluster-randomized to receive an EHR alert with individualized LLT recommendations or no alert for outpatients with very high-risk atherosclerotic cardiovascular disease and LDL-C (low-density lipoprotein cholesterol), ≥70 mg/dL. The primary outcome was 90-day LLT intensification (change to high-intensity statin and addition of ezetimibe or PCSK9i [proprotein subtilisin/kexin type 9 inhibitors]). Secondary outcomes included LDL-C level, proportion of patients with LDL-C of <70 or < 55 mg/dL, rate of major adverse cardiovascular events, ED visit incidence, and 6-month mortality. Results were analyzed using logistic and linear regression clustered at the provider level.RESULTS:The no-alert group included 47 clinicians and 1370 patients (median age, 71 years; 50.1% female, median LDL-C, 93 mg/dL); the alert group included 49 clinicians and 1130 patients (median age, 72 years; 47% female, median LDL-C 91, mg/dL). The primary outcome was observed in 14.1% of patients in the alert group as compared with 10.4% in the no-alert group. There were no differences in any secondary outcomes at 6 months. Among 542 patients whose clinicians (n=46) did not dismiss the EHR alert recommendations, LLT intensification was significantly greater (21.2% versus 10.4%, odds ratio, 2.33 [95% CI, 1.48–3.66]).CONCLUSIONS:With a real-time, targeted, individualized EHR alert as compared with usual care, the proportion of patients with atherosclerotic cardiovascular disease with LLT intensification was numerically higher but not statistically significant. Among clinicians who did not dismiss the alert, there was a > 2-fold increase in LLT intensification. EHR alerts, coupled with strategies to reduce clinician dismissal, may help address persistent gaps in LDL-C management.REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT04394715, https://www.clinicaltrials.gov/ct2/show/study/NCT04394715
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向医疗服务提供者发送高脂血症治疗信息的务实试验(PROMPT-LIPID):随机临床试验
背景:对于极高危的动脉粥样硬化性心血管疾病,降脂疗法(LLT)的使用率很低。PROMPT-LIPID(向医疗服务提供者发送有关高脂血症治疗信息的实用试验)旨在确定电子健康记录(EHR)警报是否能改善极高危动脉粥样硬化性心血管疾病患者的 90 天 LLT 强化治疗。方法:PROMPT-LIPID 是一项实用性试验,耶鲁大学纽黑文健康中心(康涅狄格州纽黑文)的心血管和内科临床医生被分组随机分配到接受带有个性化 LLT 建议的电子病历提示或不接受提示的高危动脉粥样硬化性心血管疾病门诊患者中,LDL-C(低密度脂蛋白胆固醇)≥70 mg/dL。主要结果是90天的LLT强化(改用高强度他汀类药物,并添加依折麦布或PCSK9i[蛋白枯草酶/kexin 9型抑制剂])。次要结果包括 LDL-C 水平、LDL-C 为 70 或 55 mg/dL 的患者比例、主要不良心血管事件发生率、急诊室就诊率和 6 个月死亡率。结果:无预警组包括 47 名临床医生和 1370 名患者(中位年龄 71 岁;50.1% 为女性;中位 LDL-C 93 mg/dL);预警组包括 49 名临床医生和 1130 名患者(中位年龄 72 岁;47% 为女性;中位 LDL-C 91 mg/dL)。预警组中有 14.1% 的患者观察到了主要结果,而无预警组中只有 10.4% 的患者观察到了主要结果。6 个月后的任何次要结果均无差异。结论:与常规护理相比,通过实时、有针对性、个性化的电子病历提醒,动脉粥样硬化性心血管疾病患者接受 LLT 加强治疗的比例在数量上有所增加,但无统计学意义。而在未解除警报的临床医生中,LLT强化治疗的比例增加了2倍。电子病历警报加上减少临床医生忽视的策略,可能有助于解决低密度脂蛋白胆固醇管理中持续存在的差距。注册:URL:https://www.clinicaltrials.gov;唯一标识符:NCT04394715, https://www.clinicaltrials.gov/ct2/show/study/NCT04394715
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