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养老院中的减药方案:嵌套随机对照混合试验研究减药干预措施的方案。

Deprescribing in nursing homes: Protocol for nested, randomised controlled hybrid trials of deprescribing interventions.

机构信息

Community Pharmacy, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland; School of Pharmaceutical Sciences, University of Geneva, Switzerland; Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, University of Lausanne, Switzerland.

Community Pharmacy, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland.

出版信息

Res Social Adm Pharm. 2021 Apr;17(4):786-794. doi: 10.1016/j.sapharm.2020.05.026. Epub 2020 May 27.

DOI:10.1016/j.sapharm.2020.05.026
PMID:32622774
Abstract

INTRODUCTION

Polypharmacy and the use of potentially inappropriate medication (PIMs) are frequent among nursing home (NH) residents, and are associated with adverse health outcomes like falls, hospitalisation and death. Deprescribing has been proposed as a way to curtail both problems; however, the best way to implement deprescribing and its real impact are still unclear. This article describes nested trials of two consecutive deprescribing interventions, the first at the NH level, and the second at the resident level.

METHODS AND ANALYSIS

The first intervention (QC-DeMo) will be a deprescribing module to be carried out in existing interprofessional quality circles in NHs, with the goal to develop a NH-wide deprescribing consensus. Its effects will be evaluated on the use of PIMs and on patient safety outcomes such as death, hospitalisation and falls. All NHs in the cantons of Vaud and Fribourg with an integrated pharmacy service will be eligible. The second intervention (IDeI), at the resident level, will be a deprescribing-focused medication review, resulting in the implementation of a deprescribing plan. Its effects will be evaluated on the use of PIMs and chronic medications, and on quality of life. This second trial will take place in the NHs allocated to the intervention group of the first trial. All residents of these NHs over 65 years old, living in the NH for at least 4 months, and taking 5 or more medications will be eligible to participate. Both trials will be hybrid effectiveness and implementation trials, aiming to understand the implementation process for the interventions, and to identify barriers and facilitators.

ETHICS, REGISTRATION AND FUNDING: Both trials were approved by the relevant ethics committee, registered on ClinicalTrials.gov (QC-DeMo: NCT03688542; IDeI: NCT03655405), and funded by the Swiss National Fund for Scientific Research.

摘要

简介

疗养院(NH)居民经常同时服用多种药物和潜在不适当的药物(PIMs),这与跌倒、住院和死亡等不良健康结果有关。减少用药已被提议作为解决这两个问题的一种方法;然而,实施减少用药的最佳方法及其实际影响仍不清楚。本文描述了两项连续的减少用药干预措施的嵌套试验,第一项是在 NH 层面进行的,第二项是在居民层面进行的。

方法和分析

第一项干预措施(QC-DeMo)将是在 NH 中现有的跨专业质量圈中开展的减少用药模块,目的是制定一个 NH 范围内的减少用药共识。它的效果将通过评估 PIM 的使用情况以及患者安全结果(如死亡、住院和跌倒)来评估。沃州和弗里堡州所有拥有综合药房服务的 NH 都有资格参加。第二项干预措施(IDeI),在居民层面,将是一项以减少用药为重点的药物审查,从而制定减少用药计划。它的效果将通过评估 PIM 和慢性药物的使用情况以及生活质量来评估。第二项试验将在第一项试验的干预组分配的 NH 中进行。所有这些 NH 中年龄在 65 岁以上、在 NH 中居住至少 4 个月、服用 5 种或更多药物的居民都有资格参加。这两项试验都是混合有效性和实施试验,旨在了解干预措施的实施过程,并确定障碍和促进因素。

伦理、注册和资金:两项试验均获得了相关伦理委员会的批准,在 ClinicalTrials.gov 上注册(QC-DeMo:NCT03688542;IDeI:NCT03655405),并由瑞士国家科学基金会资助。

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