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MIRROR-TCM:一项随机对照试验的多中心复制——过渡护理模式。

MIRROR-TCM: Multisite Replication of a Randomized Controlled Trial - Transitional Care Model.

机构信息

NewCourtland Center for Transitions and Health, University of Pennsylvania School of Nursing, 418 Curie Blvd., Philadelphia, PA 19103, United States of America.

NewCourtland Center for Transitions and Health, University of Pennsylvania School of Nursing, 418 Curie Blvd., Philadelphia, PA 19103, United States of America.

出版信息

Contemp Clin Trials. 2022 Jan;112:106620. doi: 10.1016/j.cct.2021.106620. Epub 2021 Nov 14.

DOI:10.1016/j.cct.2021.106620
PMID:34785306
Abstract

In the U.S., older adults hospitalized with acute episodes of chronic conditions often are rehospitalized within 30 days of discharge. Numerous studies reveal that poor management of the complex needs of this population remains the norm. METHODS: This prospective, intent-to-treat, randomized controlled trial (RCT) will assess the effects of replicating the rigorously studied Transitional Care Model (TCM) in four U.S. healthcare systems. The TCM is an advanced practice registered nurse led, team-based, care management intervention that supports older adults throughout vulnerable care episodes that span hospital to home. This RCT will compare health and economic outcomes demonstrated by at-risk older adults hospitalized with heart failure, chronic obstructive pulmonary disease or pneumonia randomized to receive usual discharge planning (control group, N = 800) to those observed by a similar group of older adults randomized to receive the TCM protocol (N = 800). The primary outcome is number of rehospitalizations at 12 months post-discharge, with secondary resource use outcomes measured at multiple intervals. Patient experience with care, health and quality of life outcomes will be assessed at 90 days post-discharge. DISCUSSION: Based on health and economic benefits demonstrated in multiple NIH funded RCTs, the study team hypothesizes that the intervention group, both within and across participating health systems, will have decreased acute care resource use and costs at 12 months and better ratings of the care experience and health and quality of life through 90 days post-discharge compared to the control group. The impact of COVID-19 on implementation of this study also is discussed.

摘要

在美国,患有慢性疾病急性发作的老年患者在出院后 30 天内再次住院的情况较为常见。许多研究表明,对这一人群复杂需求的管理不善仍然是常态。方法:这项前瞻性、意向治疗、随机对照试验(RCT)将评估在美国四个医疗保健系统中复制经过严格研究的过渡护理模式(TCM)的效果。TCM 是一种由高级实践注册护士领导的、以团队为基础的护理管理干预措施,旨在为在从医院到家庭的脆弱护理期间的老年患者提供支持。这项 RCT 将比较因心力衰竭、慢性阻塞性肺疾病或肺炎住院且有风险的老年患者在接受常规出院计划(对照组,N=800)和接受 TCM 方案(N=800)随机分组的健康和经济结果。主要结果是出院后 12 个月内的再住院次数,次要资源使用结果在多个时间点进行测量。出院后 90 天评估患者对护理的体验、健康和生活质量结果。讨论:基于在多个 NIH 资助的 RCT 中证明的健康和经济效益,研究团队假设干预组(包括参与的各个医疗系统内)在 12 个月时将减少急性护理资源的使用和成本,并且在出院后 90 天对护理体验以及健康和生活质量的评价会更好,与对照组相比。还讨论了 COVID-19 对这项研究实施的影响。

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