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一种优化养老机构中抗菌药物使用的多模式干预措施(ENGAGEMENT):一项阶梯式楔形群随机试验方案。

A multimodal intervention to optimise antimicrobial use in residential aged care facilities (ENGAGEMENT): protocol for a stepped-wedge cluster randomised trial.

机构信息

UQ Centre for Health Services Research, Faculty of Medicine, The University of Queensland, The University of Queensland, Brisbane, QLD, 4102, Australia.

Department of Pharmacy, Princess Alexandra Hospital, Metro South Health, Brisbane, QLD, 4102, Australia.

出版信息

Trials. 2022 May 21;23(1):427. doi: 10.1186/s13063-022-06323-8.

Abstract

BACKGROUND

Inappropriate antibiotic use can cause harm and promote antimicrobial resistance, which has been declared a major health challenge by the World Health Organization. In Australian residential aged care facilities (RACFs), the most common indications for antibiotic prescribing are for infections of the urinary tract, respiratory tract and skin and soft tissue. Studies indicate that a high proportion of these prescriptions are non-compliant with best prescribing guidelines. To date, a variety of interventions have been reported to address inappropriate prescribing and overuse of antibiotics but with mixed outcomes. This study aims to identify the impact of a set of sustainable, multimodal interventions in residential aged care targeting three common infection types.

METHODS

This protocol details a 20-month stepped-wedge cluster-randomised trial conducted across 18 RACFs (as 18 clusters). A multimodal multi-disciplinary set of interventions, the 'AMS ENGAGEMENT bundle', will be tailored to meet the identified needs of participating RACFs. The key elements of the intervention bundle include education for nurses and general practitioners, telehealth support and formation of an antimicrobial stewardship team in each facility. Prior to the randomised sequential introduction of the intervention, each site will act as its own control in relation to usual care processes for antibiotic use and stewardship. The primary outcome for this study will be antibiotic consumption measured using defined daily doses (DDDs). Cluster-level rates will be calculated using total occupied bed numbers within each RACF during the observation period as the denominator. Results will be expressed as rates per 1000 occupied bed days. An economic analysis will be conducted to compare the costs associated with the intervention to that of usual care. A comprehensive process evaluation will be conducted using the REAIM Framework, to enable learnings from the trial to inform sustainable improvements in this field.

DISCUSSION

A structured AMS model of care, incorporating targeted interventions to optimise antimicrobial use in the RACF setting, is urgently needed and will be delivered by our trial. The trial will aim to empower clinicians, residents and families by providing a robust AMS programme to improve antibiotic-related health outcomes.

TRIAL REGISTRATION

US National Library of Medicine Clinical Trials.gov ( NCT04705259 ). Prospectively registered in 12th of January 2021.

摘要

背景

不适当的抗生素使用会造成危害并促进抗菌药物耐药性的产生,世界卫生组织已宣布这是一项重大的健康挑战。在澳大利亚的养老院(RACF)中,抗生素处方最常见的指征是尿路感染、呼吸道感染和皮肤及软组织感染。研究表明,很大一部分处方不符合最佳处方指南。迄今为止,已经报道了多种干预措施来解决抗生素的不适当使用和过度使用问题,但结果喜忧参半。本研究旨在确定一套针对三种常见感染类型的可持续、多模式干预措施对养老院的影响。

方法

本方案详细介绍了一项在 18 家养老院(18 个集群)中进行的为期 20 个月的逐步楔形集群随机试验。一套多模式多学科的干预措施,即“AMS ENGAGEMENT 包”,将根据参与养老院的需求进行定制。干预包的关键要素包括护士和全科医生的教育、远程医疗支持以及在每个设施中组建一个抗菌药物管理团队。在随机顺序引入干预措施之前,每个地点将根据抗生素使用和管理的常规护理流程作为自身对照。本研究的主要结果将是使用定义的每日剂量(DDD)衡量的抗生素消耗。使用每个 RACF 观察期内的总占用床位数作为分母计算集群水平率。结果将表示为每 1000 个占用床日的比率。将进行经济分析比较干预相关成本与常规护理成本。将使用 REAIM 框架进行全面的过程评估,以便从试验中吸取经验教训,为该领域的可持续改进提供信息。

讨论

我们的试验将提供一种结构化的 AMS 护理模式,结合有针对性的干预措施,优化养老院环境中的抗菌药物使用,这是迫切需要的。该试验旨在通过提供一个强大的 AMS 计划来增强临床医生、居民和家属的能力,以改善与抗生素相关的健康结果。

试验注册

美国国立卫生研究院临床试验.gov(NCT04705259)。于 2021 年 1 月 12 日前瞻性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aaee/9124417/c2948caaceca/13063_2022_6323_Fig1_HTML.jpg

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