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医院和出院后质量改进干预对射血分数降低的心力衰竭患者临床结局和护理质量的影响:CONNECT-HF 随机临床试验。

Effect of a Hospital and Postdischarge Quality Improvement Intervention on Clinical Outcomes and Quality of Care for Patients With Heart Failure With Reduced Ejection Fraction: The CONNECT-HF Randomized Clinical Trial.

机构信息

Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.

Department of Medicine, Duke University School of Medicine, Durham, North Carolina.

出版信息

JAMA. 2021 Jul 27;326(4):314-323. doi: 10.1001/jama.2021.8844.

Abstract

IMPORTANCE

Adoption of guideline-directed medical therapy for patients with heart failure is variable. Interventions to improve guideline-directed medical therapy have failed to consistently achieve target metrics, and limited data exist to inform efforts to improve heart failure quality of care.

OBJECTIVE

To evaluate the effect of a hospital and postdischarge quality improvement intervention compared with usual care on heart failure outcomes and care.

DESIGN, SETTING, AND PARTICIPANTS: This cluster randomized clinical trial was conducted at 161 US hospitals and included 5647 patients (2675 intervention vs 2972 usual care) followed up after a hospital discharge for acute heart failure with reduced ejection fraction (HFrEF). The trial was performed from 2017 to 2020, and the date of final follow-up was August 31, 2020.

INTERVENTIONS

Hospitals (n = 82) randomized to a hospital and postdischarge quality improvement intervention received regular education of clinicians by a trained group of heart failure and quality improvement experts and audit and feedback on heart failure process measures (eg, use of guideline-directed medical therapy for HFrEF) and outcomes. Hospitals (n = 79) randomized to usual care received access to a generalized heart failure education website.

MAIN OUTCOMES AND MEASURES

The coprimary outcomes were a composite of first heart failure rehospitalization or all-cause mortality and change in an opportunity-based composite score for heart failure quality (percentage of recommendations followed).

RESULTS

Among 5647 patients (mean age, 63 years; 33% women; 38% Black; 87% chronic heart failure; 49% recent heart failure hospitalization), vital status was known for 5636 (99.8%). Heart failure rehospitalization or all-cause mortality occurred in 38.6% in the intervention group vs 39.2% in usual care (adjusted hazard ratio, 0.92 [95% CI, 0.81 to 1.05). The baseline quality-of-care score was 42.1% vs 45.5%, respectively, and the change from baseline to follow-up was 2.3% vs -1.0% (difference, 3.3% [95% CI, -0.8% to 7.3%]), with no significant difference between the 2 groups in the odds of achieving a higher composite quality score at last follow-up (adjusted odds ratio, 1.06 [95% CI, 0.93 to 1.21]).

CONCLUSIONS AND RELEVANCE

Among patients with HFrEF in hospitals randomized to a hospital and postdischarge quality improvement intervention vs usual care, there was no significant difference in time to first heart failure rehospitalization or death, or in change in a composite heart failure quality-of-care score.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03035474.

摘要

重要性

心力衰竭患者接受指南指导的医学治疗的情况存在差异。改善指南指导的医学治疗的干预措施未能始终如一地实现目标指标,而且几乎没有数据可以为改善心力衰竭护理质量的努力提供信息。

目的

评估与常规护理相比,医院和出院后质量改进干预对心力衰竭结局和护理的影响。

设计、地点和参与者:这项集群随机临床试验在 161 家美国医院进行,纳入了 5647 名患者(2675 例干预组和 2972 例常规护理组),这些患者在急性射血分数降低的心力衰竭(HFrEF)出院后接受了随访。该试验于 2017 年至 2020 年进行,最后一次随访日期为 2020 年 8 月 31 日。

干预措施

随机分配到医院和出院后质量改进干预的医院(n=82)接受了由心力衰竭和质量改进专家组成的培训小组对临床医生的定期教育,并对心力衰竭过程指标(例如,HFrEF 指南指导的医学治疗的使用)和结果进行审核和反馈。随机分配到常规护理的医院(n=79)可以访问一个通用的心力衰竭教育网站。

主要结局和测量指标

主要复合结局是首次心力衰竭再住院或全因死亡率和基于机会的心力衰竭质量综合评分(遵循建议的百分比)的变化。

结果

在 5647 名患者(平均年龄 63 岁;33%为女性;38%为黑人;87%为慢性心力衰竭;49%为近期心力衰竭住院患者)中,5636 名(99.8%)的存活状态已知。干预组心力衰竭再住院或全因死亡率为 38.6%,常规护理组为 39.2%(调整后的危险比,0.92[95%CI,0.81 至 1.05])。基线护理质量评分分别为 42.1%和 45.5%,从基线到随访的变化分别为 2.3%和-1.0%(差异为 3.3%[95%CI,-0.8%至 7.3%]),两组在最后一次随访时达到更高复合质量评分的可能性方面没有显著差异(调整后的优势比,1.06[95%CI,0.93 至 1.21])。

结论和相关性

在随机分配到医院和出院后质量改进干预的 HFrEF 患者与常规护理的患者中,首次心力衰竭再住院或死亡的时间或复合心力衰竭护理质量评分的变化均无显著差异。

试验注册

ClinicalTrials.gov 标识符:NCT03035474。

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