荷兰终末期关怀中适当药物使用的研究方案：一项多中心阶梯式楔形集群随机对照试验（AMUSE 研究）。

Appropriate medication use in Dutch terminal care: study protocol of a multicentre stepped-wedge cluster randomized controlled trial (the AMUSE study).

机构信息

Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.

Department of Internal Medicine, Noordwest Ziekenhuis, Alkmaar, The Netherlands.

出版信息

BMC Palliat Care. 2024 Jan 3;23(1):6. doi: 10.1186/s12904-023-01334-x.

DOI:10.1186/s12904-023-01334-x

PMID:38172930

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10762916/

Abstract

BACKGROUND

Polypharmacy is common among patients with a limited life expectancy, even shortly before death. This is partly inevitable, because these patients often have multiple symptoms which need to be alleviated. However, the use of potentially inappropriate medications (PIMs) in these patients is also common. Although patients and relatives are often willing to deprescribe medication, physicians are sometimes reluctant due to the lack of evidence on appropriate medication management for patients in the last phase of life. The aim of the AMUSE study is to investigate whether the use of CDSS-OPTIMED, a software program that gives weekly personalized medication recommendations to attending physicians of patients with a limited life expectancy, improves patients' quality of life.

METHODS

A multicentre stepped-wedge cluster randomized controlled trial will be conducted among patients with a life expectancy of three months or less. The stepped-wedge cluster design, where the clusters are the different study sites, involves sequential crossover of clusters from control to intervention until all clusters are exposed. In total, seven sites (4 hospitals, 2 general practices and 1 hospice from the Netherlands) will participate in this study. During the control period, patients will receive 'care as usual'. During the intervention period, CDSS-OPTIMED will be activated. CDSS-OPTIMED is a validated software program that analyses the use of medication based on a specific set of clinical rules for patients with a limited life expectancy. The software program will provide the attending physicians with weekly personalized medication recommendations. The primary outcome of this study is patients' quality of life two weeks after baseline assessment as measured by the EORTC QLQ-C15-PAL questionnaire, quality of life question.

DISCUSSION

This will be the first study investigating the effect of weekly personalized medication recommendations to attending physicians on the quality of life of patients with a limited life expectancy. We hypothesize that the CDSS-OPTIMED intervention could lead to improved quality of life in patients with a life expectancy of three months or less.

TRIAL REGISTRATION

This trial is registered at ClinicalTrials.gov (NCT05351281, Registration Date: April 11, 2022).

摘要

背景

即使在生命预期很短的情况下，患者也常常需要服用多种药物，这在生命预期有限的患者中很常见。这在一定程度上是不可避免的，因为这些患者通常有多种需要缓解的症状。然而，这些患者也经常使用潜在不适当的药物（PIMs）。尽管患者及其家属通常愿意减少药物的使用，但由于缺乏关于生命末期患者适当药物管理的证据，医生有时会不愿意这样做。AMUSE 研究的目的是调查使用 CDSS-OPTIMED（一种每周为生命预期有限的患者的主治医生提供个性化药物建议的软件程序）是否可以提高患者的生活质量。

方法

一项针对预期寿命为三个月或更短的患者的多中心、逐步楔形集群随机对照试验将进行。逐步楔形集群设计，其中集群是不同的研究地点，涉及从控制到干预的顺序交叉集群，直到所有集群都暴露。共有 7 个地点（荷兰的 4 家医院、2 家普通诊所和 1 家临终关怀医院）将参与这项研究。在对照期间，患者将接受“常规护理”。在干预期间，将激活 CDSS-OPTIMED。CDSS-OPTIMED 是一个经过验证的软件程序，它根据针对生命预期有限的患者的特定临床规则分析药物的使用情况。该软件程序将每周为主治医生提供个性化的药物建议。本研究的主要结果是在基线评估后两周患者的生活质量，使用 EORTC QLQ-C15-PAL 问卷（生活质量问题）进行测量。