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电子传递患者激活工具,用于强化射血分数降低的慢性心力衰竭药物治疗:EPIC-HF 试验。

An Electronically Delivered Patient-Activation Tool for Intensification of Medications for Chronic Heart Failure With Reduced Ejection Fraction: The EPIC-HF Trial.

机构信息

University of Colorado School of Medicine, Aurora (L.A.A., G.V., C.K.M., C.E.K., L.J.H., P.K., P.N.P., K.P., G.H., J.S.T., K.E.T., D.P.K., D.J.M., P.M.B., D.D.M.).

University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora (R.L.P., K.E.T.).

出版信息

Circulation. 2021 Feb 2;143(5):427-437. doi: 10.1161/CIRCULATIONAHA.120.051863. Epub 2020 Nov 17.

Abstract

BACKGROUND

Major gaps exist in the routine initiation and dose up-titration of guideline-directed medical therapies (GDMT) for patients with heart failure with reduced ejection fraction. Without novel approaches to improve prescribing, the cumulative benefits of heart failure with reduced ejection fraction treatment will be largely unrealized. Direct-to-consumer marketing and shared decision making reflect a culture where patients are increasingly involved in treatment choices, creating opportunities for prescribing interventions that engage patients.

METHODS

The EPIC-HF (Electronically Delivered, Patient-Activation Tool for Intensification of Medications for Chronic Heart Failure with Reduced Ejection Fraction) trial randomized patients with heart failure with reduced ejection fraction from a diverse health system to usual care versus patient activation tools-a 3-minute video and 1-page checklist-delivered electronically 1 week before, 3 days before, and 24 hours before a cardiology clinic visit. The tools encouraged patients to work collaboratively with their clinicians to "make one positive change" in heart failure with reduced ejection fraction prescribing. The primary endpoint was the percentage of patients with GDMT medication initiations and dose intensifications from immediately preceding the cardiology clinic visit to 30 days after, compared with usual care during the same period.

RESULTS

EPIC-HF enrolled 306 patients, 290 of whom attended a clinic visit during the study period: 145 were sent the patient activation tools and 145 were controls. The median age of patients was 65 years; 29% were female, 11% were Black, 7% were Hispanic, and the median ejection fraction was 32%. Preclinic data revealed significant GDMT opportunities, with no patients on target doses of β-blocker, sacubitril/valsartan, and mineralocorticoid receptor antagonists. From immediately preceding the cardiology clinic visit to 30 days after, 49.0% in the intervention and 29.7% in the control experienced an initiation or intensification of their GDMT (=0.001). The majority of these changes were made at the clinician encounter itself and involved dose uptitrations. There were no deaths and no significant differences in hospitalization or emergency department visits at 30 days between groups.

CONCLUSIONS

A patient activation tool delivered electronically before a cardiology clinic visit improved clinician intensification of GDMT. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03334188.

摘要

背景

在患有射血分数降低的心力衰竭患者中,指南指导的医学治疗(GDMT)的常规起始和剂量滴定存在重大差距。如果没有新的方法来改善处方,那么心力衰竭治疗的累积益处将在很大程度上无法实现。直接面向消费者的营销和共同决策反映了一种文化,即患者越来越多地参与治疗选择,为参与患者的处方干预创造了机会。

方法

EPIC-HF(通过电子方式传递的用于强化射血分数降低的慢性心力衰竭药物治疗的患者激活工具)试验将来自不同医疗系统的射血分数降低的心力衰竭患者随机分为常规护理组与患者激活工具组-在心脏病学诊所就诊前一周、前三天和前 24 小时通过电子方式发送 3 分钟的视频和 1 页的检查表。这些工具鼓励患者与他们的临床医生合作,在心力衰竭的处方治疗中“做出一项积极的改变”。主要终点是与同期相比,从心脏病学诊所就诊前到就诊后 30 天内接受 GDMT 药物起始和剂量强化治疗的患者比例。

结果

EPIC-HF 纳入了 306 名患者,其中 290 名在研究期间就诊:145 名患者接受了患者激活工具,145 名患者为对照组。患者的中位年龄为 65 岁;29%为女性,11%为黑人,7%为西班牙裔,中位射血分数为 32%。就诊前的数据显示存在显著的 GDMT 机会,没有患者接受目标剂量的β受体阻滞剂、沙库巴曲缬沙坦和盐皮质激素受体拮抗剂。从心脏病学诊所就诊前到就诊后 30 天,干预组有 49.0%的患者和对照组有 29.7%的患者开始或强化了他们的 GDMT(=0.001)。这些变化中的大多数是在临床医生就诊时做出的,涉及剂量调整。两组在 30 天内的死亡率、住院率或急诊就诊率均无显著差异。

结论

在心脏病学诊所就诊前通过电子方式提供的患者激活工具可提高临床医生对 GDMT 的强化治疗。注册:网址:https://www.clinicaltrials.gov;唯一标识符:NCT03334188。

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