Effect of a Self-care Intervention on 90-Day Outcomes in Patients With Acute Heart Failure Discharged From the Emergency Department A Randomized Clinical Trial
Effect of a Self-care Intervention on 90-Day Outcomes in Patients With Acute Heart Failure Discharged From the Emergency Department A Randomized Clinical Trial
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DOI：
10.1001/jamacardio.2020.5763
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发表时间：
2020-11-18
期刊：
影响因子：
24
通讯作者：
Butler, Javed
中科院分区：
文献类型：
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作者：
Collins, Sean P.;Liu, Dandan;Butler, Javed
重要性 高达 20% 因急性心力衰竭 (AHF) 到急诊科 (ED) 就诊的患者无需住院即可出院。与住院患者相比，急诊科患者的再入院率和死亡率更高。 目的 评估自我护理干预对出院的 AHF 患者 90 天结局的影响。设计、环境和参与者遵守急诊科心力衰竭患者指南是一项非盲、平行组、多中心随机试验。患者按 1:1 的比例随机分配至常规护理组和量身定制的自我护理干预组。纳入的 AHF 患者在 15 个不同地区的 ED 进行基于 ED 的管理后出院。该试验于 2015 年 10 月 28 日至 2019 年 9 月 5 日进行。 干预措施 出院 7 天内进行家访，每月两次进行电话自我护理辅导，为期 3 个月。 主要结果和测量 主要结果是心血管死亡、心力衰竭相关事件（因心力衰竭、急诊室复诊或住院导致的计划外就诊）以及堪萨斯城的变化的全球排名心肌病问卷 12 (KCCQ-12) 90 天总结评分 (SS)。关键的次要结果包括 30 天的全球排名结果以及 30 天和 90 天的 KCCQ-12 SS 评分变化。对主要、次要和安全性结果进行了意向治疗分析。进行了符合方案的分析，包括在干预组完成家访并安排门诊随访的患者。 结果 由于入组缓慢，计划的 700 名患者中有 479 名被随机分配：235 名进入干预组，244 名进入常规护理组。中位年龄为 63.0 岁（四分位距，54.7-70.2），302 名患者（63%）为非裔美国人，305 名患者（64%）为男性，178 名患者（37%）既往射血分数大于 50%。干预组患者与常规治疗组患者之间的主要结局没有显着差异（风险比 [HR]，0.89；95% CI，0.73-1.10；P = .28）。第 30 天时，干预组患者的总体排名显着提高（HR，0.80；95% CI，0.64-0.99；P = .04），KCCQ-12 SS 高出 5.5 分（95% CI，1.3-9.7；P = .01），而在第 90 天，KCCQ-12 SS 高出 2.7 分（95% CI，-1.9 至 7.2；P = .25）。 结论和相关性 在本试验中，自我保健干预并未改善 90 天的主要总体排名结果。然而，在 30 天时观察到全球排名和 KCCQ-12 SS 的益处，这表明在 AHF 急诊就诊时启动的定制自我护理计划的早期益处无法持续到 90 天。
IMPORTANCE Up to 20% of patients who present to the emergency department (ED) with acute heart failure (AHF) are discharged without hospitalization. Compared with rates in hospitalized patients, readmission and mortality are worse for ED patients.OBJECTIVE To assess the impact of a self-care intervention on 90-day outcomes in patients with AHF who are discharged from the ED.DESIGN, SETTING, AND PARTICIPANTS Get With the Guidelines in Emergency Department Patients With Heart Failure was an unblinded, parallel-group, multicenter randomized trial. Patients were randomized 1:1 to usual care vs a tailored self-care intervention. Patients with AHF discharged after ED-based management at 15 geographically diverse EDs were included. The trial was conducted from October 28, 2015, to September 5, 2019.INTERVENTIONS Home visit within 7 days of discharge and twice-monthly telephone-based self-care coaching for 3 months.MAIN OUTCOMES AND MEASURES The primary outcome was a global rank of cardiovascular death, HF-related events (unscheduled clinic visit due to HF, ED revisit, or hospitalization), and changes in the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) summary score (SS) at 90 days. Key secondary outcomes included the global rank outcome at 30 days and changes in the KCCQ-12 SS score at 30 and 90 days. Intention-to-treat analysis was performed for the primary, secondary, and safety outcomes. Per-protocol analysis was conducted including patients who completed a home visit and had scheduled outpatient follow-up in the intervention arm.RESULTS Owing to slow enrollment, 479 of a planned 700 patients were randomized: 235 to the intervention arm and 244 to the usual care arm. The median age was 63.0 years (interquartile range, 54.7-70.2), 302 patients (63%) were African American, 305 patients (64%) were men, and 178 patients (37%) had a previous ejection fraction greater than 50%. There was no significant difference in the primary outcome between patients in the intervention vs usual care arm (hazard ratio [HR], 0.89; 95% CI, 0.73-1.10; P = .28). At day 30, patients in the intervention arm had significantly better global rank (HR, 0.80; 95% CI, 0.64-0.99; P = .04) and a 5.5-point higher KCCQ-12 SS (95% CI, 1.3-9.7; P = .01), while at day 90, the KCCQ-12 SS was 2.7 points higher (95% CI, -1.9 to 7.2; P = .25).CONCLUSIONS AND RELEVANCE The self-care intervention did not improve the primary global rank outcome at 90 days in this trial. However, benefit was observed in the global rank and KCCQ-12 SS at 30 days, suggesting that an early benefit of a tailored self-care program initiated at an ED visit for AHF was not sustained through 90 days.