Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia.
JAMA Intern Med. 2022 Jun 1;182(6):643-649. doi: 10.1001/jamainternmed.2022.1383.
Close remote monitoring of patients following discharge for heart failure (HF) may reduce readmissions or death.
To determine whether remote monitoring of diuretic adherence and weight changes with financial incentives reduces hospital readmissions or death following discharge with HF.
DESIGN, SETTING, AND PARTICIPANTS: The Electronic Monitoring of Patients Offers Ways to Enhance Recovery (EMPOWER) study, a 3-hospital pragmatic trial, randomized 552 adults recently discharged with HF to usual care (n = 280) or a compound intervention (n = 272) designed to inform clinicians of diuretic adherence and changes in patient weight. Patients were recruited from May 25, 2016, to April 8, 2019, and followed up for 12 months. Investigators were blinded to assignment but patients were not. Analysis was by intent to treat.
Participants randomized to the intervention arm received digital scales, electronic pill bottles for diuretic medication, and regret lottery incentives conditional on the previous day's adherence to both medication and weight measurement, with $1.40 expected daily value. Participants' physicians were alerted if participants' weights increased 1.4 kg in 24 hours or 2.3 kg in 72 hours or if diuretic medications were missed for 5 days. Alerts and weights were integrated into the electronic health record. Participants randomized to the control arm received usual care and no further study contact.
Time to death or readmission for any cause within 12 months.
Of the 552 participants, 290 were men (52.5%); 291 patients (52.7%) were Black, 231 were White (41.8%), and 16 were Hispanic (2.9%); mean (SD) age was 64.5 (11.8) years. The mean (SD) ejection fraction was 43% (18.1%). Each month, approximately 75% of participants were 80% adherent to both medication and weight measurement. There were 423 readmissions and 26 deaths in the control group and 377 readmissions and 23 deaths in the intervention group. There was no significant difference between the 2 groups for the combined outcome of all-cause inpatient readmission or death (unadjusted hazard ratio, 0.91; 95% CI, 0.74-1.13; P = .40) and no significant differences in all-cause inpatient readmission or observation stay or death, all-cause cardiovascular readmission or death, time to first event, and total all-cause deaths. Participants in the intervention group were slightly more likely to spend fewer days in the hospital.
In this randomized clinical trial, there was no reduction in the combined outcome of readmission or mortality in a year-long intensive remote monitoring program with incentives for patients previously hospitalized for HF.
ClinicalTrials.gov Identifier: NCT02708654.
对心力衰竭（HF）出院后的患者进行远程密切监测可能会减少再入院或死亡。
确定远程监测利尿剂依从性和体重变化并辅以经济激励措施是否可以降低 HF 出院后患者的住院再入院率或死亡率。
设计、设置和参与者：电子监测患者提供康复方法（EMPOWER）研究是一项 3 家医院的实用试验，将 552 名近期因 HF 出院的成年人随机分为常规护理组（n = 280）或复合干预组（n = 272），旨在告知临床医生利尿剂的依从性和患者体重的变化。研究对象于 2016 年 5 月 25 日至 2019 年 4 月 8 日期间招募，并随访 12 个月。研究者对分组情况不知情，但患者知情。分析采用意向治疗。
随机分配到干预组的患者接受了电子秤、利尿剂药物的电子药瓶，以及基于前一天对药物和体重测量的依从性的遗憾彩票奖励，如果连续 5 天漏服利尿剂药物或 24 小时内体重增加 1.4 公斤或 72 小时内体重增加 2.3 公斤，医生会收到警报。警报和体重数据被整合到电子健康记录中。随机分配到对照组的患者接受常规护理，不再进行进一步的研究接触。
在 12 个月内任何原因导致的死亡或再入院时间。
在 552 名参与者中，290 人为男性（52.5%）；291 人为黑人（52.7%），231 人为白人（41.8%），16 人为西班牙裔（2.9%）；平均（SD）年龄为 64.5（11.8）岁。平均（SD）射血分数为 43%（18.1%）。每月约有 75%的参与者对药物和体重测量的依从率达到 80%。对照组有 423 次再入院和 26 例死亡，干预组有 377 次再入院和 23 例死亡。两组在全因住院再入院或死亡的综合结局（未调整的危险比，0.91；95%置信区间，0.74-1.13；P = .40）、全因住院再入院或观察住院或死亡、全因心血管再入院或死亡、首次事件时间以及全因死亡总数方面均无显著差异。干预组的参与者住院天数略有减少。
在这项随机临床试验中，对 HF 住院患者进行为期 1 年的强化远程监测计划，辅以对患者的经济激励措施，并没有降低再入院或死亡的综合结局。
ClinicalTrials.gov 标识符：NCT02708654。
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