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改善对患有严重疾病的住院患者的关怀目标沟通:两项互补随机试验的研究方案。

Improving communication about goals of care for hospitalized patients with serious illness: Study protocol for two complementary randomized trials.

机构信息

Cambia Palliative Care Center of Excellence at UW Medicine, University of Washington, Seattle, WA, United States of America; Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA, United States of America.

Cambia Palliative Care Center of Excellence at UW Medicine, University of Washington, Seattle, WA, United States of America; Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA, United States of America.

出版信息

Contemp Clin Trials. 2022 Sep;120:106879. doi: 10.1016/j.cct.2022.106879. Epub 2022 Aug 10.

DOI:10.1016/j.cct.2022.106879
PMID:35963531
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10042145/
Abstract

BACKGROUND

Although goals-of-care discussions are important for high-quality palliative care, this communication is often lacking for hospitalized older patients with serious illness. Electronic health records (EHR) provide an opportunity to identify patients who might benefit from these discussions and promote their occurrence, yet prior interventions using the EHR for this purpose are limited. We designed two complementary yet independent randomized trials to examine effectiveness of a communication-priming intervention (Jumpstart) for hospitalized older adults with serious illness.

METHODS

We report the protocol for these 2 randomized trials. Trial 1 has two arms, usual care and a clinician-facing Jumpstart, and is a pragmatic trial assessing outcomes with the EHR only (n = 2000). Trial 2 has three arms: usual care, clinician-facing Jumpstart, and clinician- and patient-facing (bi-directional) Jumpstart (n = 600). We hypothesize the clinician-facing Jumpstart will improve outcomes over usual care and the bi-directional Jumpstart will improve outcomes over the clinician-facing Jumpstart and usual care. We use a hybrid effectiveness-implementation design to examine implementation barriers and facilitators.

OUTCOMES

For both trials, the primary outcome is EHR documentation of a goals-of-care discussion within 30 days of randomization; additional outcomes include intensity of end-of-life care. Trial 2 also examines patient- or family-reported outcomes assessed by surveys targeting 3-5 days and 4-8 weeks after randomization including quality of goals-of-care communication, receipt of goal-concordant care, and psychological symptoms.

CONCLUSIONS

This novel study incorporates two complementary randomized trials and a hybrid effectiveness-implementation approach to improve the quality and value of care for hospitalized older adults with serious illness.

CLINICAL TRIALS REGISTRATION

STUDY00007031-A and STUDY00007031-B.

摘要

背景

尽管目标关怀讨论对于高质量的姑息治疗很重要,但对于患有严重疾病的住院老年患者来说,这种沟通往往是缺乏的。电子健康记录(EHR)提供了一个识别可能受益于这些讨论并促进其发生的患者的机会,但之前出于此目的使用 EHR 的干预措施是有限的。我们设计了两项互补但独立的随机试验,以检验针对患有严重疾病的住院老年患者的沟通启动干预(Jumpstart)的有效性。

方法

我们报告了这两项随机试验的方案。试验 1 有两个组,常规护理和面向临床医生的 Jumpstart,是一项仅使用 EHR 评估结果的实用试验(n=2000)。试验 2 有三组:常规护理、面向临床医生的 Jumpstart 和面向临床医生和患者的(双向)Jumpstart(n=600)。我们假设面向临床医生的 Jumpstart 将改善常规护理的结果,而双向 Jumpstart 将改善常规护理和面向临床医生的 Jumpstart 的结果。我们使用混合有效性实施设计来检查实施障碍和促进因素。

结果

对于这两项试验,主要结果是在随机分组后 30 天内 EHR 记录的目标关怀讨论;其他结果包括生命末期护理的强度。试验 2还检查了通过针对随机分组后 3-5 天和 4-8 周的调查评估的患者或家属报告的结果,包括目标关怀沟通的质量、接受与目标一致的护理以及心理症状。

结论

这项新颖的研究结合了两项互补的随机试验和混合有效性实施方法,旨在提高患有严重疾病的住院老年患者的护理质量和价值。

临床试验注册

STUDY00007031-A 和 STUDY00007031-B。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b936/10042145/aa69e667d777/nihms-1879631-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b936/10042145/aa69e667d777/nihms-1879631-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b936/10042145/aa69e667d777/nihms-1879631-f0001.jpg

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