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最佳情况/最差情况-ICU:一项多中心、梯次楔形、随机临床试验的方案,旨在通过情景规划改善美国创伤中心老年重症患者 ICU 中的沟通。

Best Case/Worst Case-ICU: protocol for a multisite, stepped-wedge, randomised clinical trial of scenario planning to improve communication in the ICU in US trauma centres for older adults with serious injury.

机构信息

Department of Surgery, University of Wisconsin-Madison, Madison, Wisconsin, USA.

Department of Biostatistics & Medical Informatics, University of Wisconsin-Madison, Madison, Wisconsin, USA.

出版信息

BMJ Open. 2024 Aug 28;14(8):e083603. doi: 10.1136/bmjopen-2023-083603.

Abstract

INTRODUCTION

Poor communication about serious injury in older adults can lead to treatment that is inconsistent with patient preferences, create conflict and strain healthcare resources. We developed a communication intervention called Best Case/Worst Case-intensive care unit (ICU) that uses daily scenario planning, that is, a narrative description of plausible futures, to support prognostication and facilitate dialogue among patients, their families and the trauma ICU team. This article describes a protocol for a multisite, randomised, stepped-wedge study to test the effectiveness of the intervention on the quality of communication (QOC) in the ICU.

METHODS AND ANALYSIS

We will follow all patients aged 50 and older admitted to the trauma ICU for 3 or more days after a serious injury at eight high-volume level 1 trauma centres. We aim to survey one family or 'like family' member per eligible patient 5-7 days following their loved ones' admission and clinicians providing care in the trauma ICU. Using a stepped-wedge design, we will use permuted block randomisation to assign the timing for each site to begin implementation of the intervention and routine use of the Best Case/Worst Case-ICU tool. We will use a linear mixed-effects model to test the effect of the tool on family-reported QOC (using the QOC scale) as compared with usual care. Secondary outcomes include the effect of the tool on reducing clinician moral distress (using the Measure of Moral Distress for Healthcare Professionals scale) and patients' length of stay in the ICU.

ETHICS AND DISSEMINATION

Institutional review board (IRB) approval was granted at the University of Wisconsin, and all study sites ceded review to the primary IRB. We plan to report results in peer-reviewed publications and national meetings.

TRIAL REGISTRATION NUMBER

NCT05780918.

摘要

简介

老年人严重受伤时沟通不畅可能导致治疗与患者偏好不符,引发冲突并消耗医疗资源。我们开发了一种名为“最佳情况/最差情况-重症监护病房(ICU)”的沟通干预措施,该措施使用每日情景规划,即对可能发生的未来进行叙述性描述,以支持预后判断并促进患者、家属和创伤 ICU 团队之间的对话。本文介绍了一项多中心、随机、阶梯式楔形研究的方案,以测试该干预措施对 ICU 中沟通质量(QOC)的有效性。

方法和分析

我们将在 8 个高容量 1 级创伤中心对年龄在 50 岁及以上、因严重受伤后在 ICU 中接受 3 天或以上治疗的所有患者进行随访。我们的目标是在患者入院后 5-7 天对每个符合条件的患者的 1 名家属或“类似家属”成员以及在创伤 ICU 中提供护理的临床医生进行调查。我们将使用阶梯式楔形设计,通过随机分配块对每个站点的时机进行排列,以开始实施干预措施和常规使用“最佳情况/最差情况-ICU”工具。我们将使用线性混合效应模型来测试该工具对家庭报告的 QOC(使用 QOC 量表)的影响,与常规护理相比。次要结果包括该工具对减少临床医生道德困境(使用医疗保健专业人员道德困境衡量量表)和患者 ICU 住院时间的影响。

伦理和传播

威斯康星大学的机构审查委员会(IRB)批准了该研究,所有研究站点均将审查权授予主要 IRB。我们计划在同行评议的出版物和全国会议上报告结果。

试验注册编号

NCT05780918。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/38fe/11367315/b7467f73a859/bmjopen-14-8-g001.jpg

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