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将以需求为导向的老年重症加强护理病房姑息治疗付诸实践:PCplanner 随机临床试验的设计和原理。

Operationalizing needs-focused palliative care for older adults in intensive care units: Design of and rationale for the PCplanner randomized clinical trial.

机构信息

Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America.

Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, United States of America; Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, Durham, NC, United States of America.

出版信息

Contemp Clin Trials. 2020 Nov;98:106163. doi: 10.1016/j.cct.2020.106163. Epub 2020 Sep 29.

Abstract

INTRODUCTION

The number of older adults who receive life support in an intensive care unit (ICU), now 2 million per year, is increasing while survival remains unchanged. Because the quality of ICU-based palliative care is highly variable, we developed a mobile app intervention that integrates into the electronic health records (EHR) system called PCplanner (Palliative Care planner) with the goal of improving collaborative primary and specialist palliative care delivery in ICU settings.

OBJECTIVE

To describe the methods of a randomized clinical trial (RCT) being conducted to compare PCplanner vs. usual care.

METHODS AND ANALYSIS

The goal of this two-arm, parallel group mixed methods RCT is to determine the clinical impact of the PCplanner intervention on outcomes of interest to patients, family members, clinicians, and policymakers over a 3-month follow up period. The primary outcome is change in unmet palliative care needs measured by the NEST instrument between baseline and 1 week post-randomization. Secondary outcomes include goal concordance of care, patient-centeredness of care, and quality of communication at 1 week post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder at 3 months post-randomization. We will use general linear models for repeated measures to compare outcomes across the main effects and interactions of the factors. We hypothesize that compared to usual care, PCplanner will have a greater impact on the quality of ICU-based palliative care delivery across domains of core palliative care needs, psychological distress, patient-centeredness, and healthcare resource utilization.

摘要

简介

目前每年有 200 万重症监护病房(ICU)中的老年人接受生命支持,这一数字在不断增加,而存活率却保持不变。由于 ICU 姑息治疗的质量差异很大,我们开发了一种名为 PCplanner(姑息治疗计划者)的移动应用程序干预措施,该措施与电子健康记录(EHR)系统集成,旨在改善 ICU 环境中初级和专科姑息治疗的协作。

目的

描述正在进行的一项随机临床试验(RCT)的方法,比较 PCplanner 与常规护理。

方法和分析

这项两臂、平行组混合方法 RCT 的目标是确定 PCplanner 干预对患者、家属、临床医生和政策制定者关注的结果的临床影响,随访期为 3 个月。主要结局是通过 NEST 工具测量的基线和随机分组后 1 周之间未满足的姑息治疗需求的变化。次要结局包括随机分组后 1 周时护理的目标一致性、护理的以患者为中心程度以及沟通质量;住院时间;以及随机分组后 3 个月时的抑郁、焦虑和创伤后应激障碍症状。我们将使用重复测量的一般线性模型来比较主要效应和因素相互作用下的结果。我们假设与常规护理相比,PCplanner 将对 ICU 姑息治疗提供的质量产生更大的影响,涵盖核心姑息治疗需求、心理困扰、以患者为中心和医疗资源利用等各个领域。

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