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目标导向的药物审查电子决策支持系统(G-MEDSS)©在家庭药物审查中的实施:一项针对老年人的集群随机临床试验方案。

Implementation of the Goal-directed Medication review Electronic Decision Support System (G-MEDSS)© into home medicines review: a protocol for a cluster-randomised clinical trial in older adults.

机构信息

NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.

Departments of Clinical Pharmacology and Aged Care, Kolling Institute of Medical Research, Royal North Shore Hospital, St Leonards, New South Wales, 2065, Australia.

出版信息

BMC Geriatr. 2020 Feb 12;20(1):51. doi: 10.1186/s12877-020-1442-2.

Abstract

BACKGROUND

Older people living in the community have a high prevalence of polypharmacy and are vulnerable to adverse drug events. Home Medicines Review (HMR) is a collaborative medication review service involving general practitioners (GPs), accredited clinical pharmacists (ACPs) and patients, which aims to prevent medication-related problems. This study aims to evaluate the implementation of a Computerised Clinical Decision Support System (CCDSS) called G-MEDSS© (Goal-directed Medication Review Electronic Decision Support System) in HMRs to deprescribe anticholinergic and sedative medications, and to assess the effect of deprescribing on clinical outcomes.

METHODS

This study consists of 2 stages: Stage I - a two-arm parallel-group cluster-randomised clinical trial, and Stage II - process evaluation of the CCDSS intervention in HMR. Community-dwelling older adults living with and without dementia who are referred for HMR by their GP and recruited by ACPs will be included in this study. G-MEDSS is a CCDSS designed to provide clinical decision support for healthcare practitioners when completing a medication review, to tailor care to meet the patients' goals and preferences. The G-MEDSS contains three tools: The Goals of Care Management Tool, The Drug Burden Index (DBI) Calculator©, and The revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire. The G-MEDSS produces patient-specific deprescribing reports, to be included as part of the ACPs communication with the patient's GP, and patient-specific reports for the patient (or carer). ACPs randomised to the intervention arm of the study will use G-MEDSS to create deprescribing reports for the referring GP and for their patient (or carer) when submitting the HMR report. ACPs in the comparison arm will provide the usual care HMR service (without the G-MEDSS).

OUTCOMES

The primary outcome is reduction in DBI exposure 3 months after HMR ± G-MEDSS intervention between comparison and intervention groups. The secondary outcomes include changes in clinical outcomes (physical and cognitive function, falls, institutionalisation, GP visits, medication adherence and mortality) 3-months after HMR.

DISCUSSION

This study is expected to add to the evidence that the combination of CCDSS supporting medication review can improve prescribing and clinical outcomes in older adults.

TRIAL REGISTRATION

The trial was registered on the Australian New Zealand Clinical Trials Registry ACTRN12617000895381 on 19th June 2017.

摘要

背景

社区中老年人普遍存在多种药物并用的情况,易发生药物不良反应。家庭用药审查(HMR)是一项协作药物审查服务,涉及全科医生(GP)、认证临床药师(ACP)和患者,旨在预防与药物相关的问题。本研究旨在评估一种名为 G-MEDSS©(目标导向药物审查电子决策支持系统)的计算机临床决策支持系统(CCDSS)在 HMR 中减少抗胆碱能和镇静药物的使用情况,并评估减药对临床结果的影响。

方法

本研究分为两个阶段:第一阶段 - 一项两臂平行组随机对照临床试验,第二阶段 - HMR 中 CCDSS 干预的过程评估。该研究将纳入由全科医生转介并由 ACP 招募的患有和不患有痴呆症的社区居住的老年成年人。G-MEDSS 是一种 CCDSS,旨在为医疗保健从业者在进行药物审查时提供临床决策支持,以根据患者的目标和偏好定制护理。G-MEDSS 包含三个工具:《关怀目标管理工具》、《药物负担指数(DBI)计算器©》和《修订后的患者对减药的态度(rPATD)问卷》。G-MEDSS 生成针对患者的减药报告,作为 ACP 与患者的 GP 沟通的一部分,并为患者(或护理人员)生成针对患者的报告。随机分配到研究干预组的 ACP 将使用 G-MEDSS 为转介的 GP 以及提交 HMR 报告时的患者(或护理人员)创建减药报告。比较组的 ACP 将提供常规 HMR 服务(不使用 G-MEDSS)。

结果

主要结局是 HMR 后 3 个月比较组和干预组之间 DBI 暴露的减少。次要结局包括 HMR 后 3 个月临床结局(身体和认知功能、跌倒、住院、GP 就诊、药物依从性和死亡率)的变化。

讨论

这项研究有望为证据增添内容,证明支持药物审查的 CCDSS 组合可以改善老年人的用药和临床结局。

试验注册

该试验于 2017 年 6 月 19 日在澳大利亚新西兰临床试验注册中心 ACTRN12617000895381 注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ca7a/7017507/19803752fa6f/12877_2020_1442_Fig1_HTML.jpg

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