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综合老年医学主导的药物审查(CHARMER):一项医院药物减量行为改变干预措施可行性研究的方案。

CompreHensive geriAtRician-led MEdication Review (CHARMER): protocol for a feasibility study of a hospital deprescribing behaviour change intervention.

机构信息

School of Healthcare, College of Life Sciences, University of Leicester, Leicester, UK.

Norwich Clinical Trials Unit, Norwich Medical School, University of East Anglia, Norwich, UK.

出版信息

BMJ Open. 2023 Aug 4;13(8):e075795. doi: 10.1136/bmjopen-2023-075795.

DOI:10.1136/bmjopen-2023-075795
PMID:37541754
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10407388/
Abstract

INTRODUCTION

Over 50% of older adults are prescribed a medicine where the risk of harm outweighs the chances of benefit. During a hospital admission, older adults and carers expect medicines to be reviewed for appropriateness and any inappropriate medicines proactively deprescribed. While the principle of proactive deprescribing is an expectation of good prescribing practice, it is yet to become routine. The CompreHensive geriAtRician-led MEdication Review (CHARMER) study aims to develop and test a five-component behaviour change intervention to equip geriatricians and pharmacists to proactively deprescribe inappropriate medicines with older adults in hospital. This study aims to test the feasibility and acceptability of study processes and CHARMER implementation.

METHODS AND ANALYSIS

A two-arm purposive allocation feasibility study is being undertaken at four acute hospitals in England, UK (three intervention and one control). The target sample is 400 patients across all hospitals. Primary outcome measures are: (1) participant recruitment rate and (2) participant attrition rate. Secondary outcome measures are: (1) hospital readmission rate; (2) mortality rate and (3) quality of life. Quantitative data will be checked for completeness and quality, and practitioner and patient demographics descriptively analysed. We will undertake a rapid qualitative analysis on observations, interviews and study meeting minutes data. A subsequent thematic analysis will be undertaken with codes mapped to the Theoretical Domains Framework and Normalisation Process Theory. Triangulation of qualitative and quantitative data will be undertaken.

ETHICS AND DISSEMINATION

Ethics approval was obtained from Wales Research Ethics Committee 1 (IRAS ID 312494) and study approval from the Health Research Authority (22/WA/0087). Informed consent will be sought from all hospital staff involved in data collection activities and for patients involved in enhanced data collection activities. The findings of this study will be disseminated in peer-reviewed journals and conference presentations.

TRIAL REGISTRATION

ISRCTN11899506.

摘要

介绍

超过 50%的老年人服用的药物,其风险大于获益。在住院期间,老年人及其护理人员期望对药物进行适当性审查,并主动停用任何不适当的药物。虽然主动停药原则是良好处方实践的期望,但它尚未成为常规做法。CompreHENSive geriAtRician-led MEdication Review (CHARMER) 研究旨在开发和测试一个由老年医学专家和药剂师实施的五部分行为改变干预措施,以在医院内与老年人一起主动停用不适当的药物。本研究旨在测试研究过程和 CHARMER 实施的可行性和可接受性。

方法和分析

正在英国英格兰的四家急性医院(三家干预组和一家对照组)进行一项两臂有目的分配可行性研究。所有医院的目标样本量为 400 名患者。主要结局指标是:(1) 参与者招募率;(2) 参与者失访率。次要结局指标是:(1) 医院再入院率;(2) 死亡率;(3) 生活质量。定量数据将检查完整性和质量,并对从业人员和患者的人口统计学进行描述性分析。我们将对观察、访谈和研究会议记录数据进行快速定性分析。随后将对主题分析进行,将代码映射到理论领域框架和正常化过程理论。将对定性和定量数据进行三角分析。

伦理和传播

伦理批准已从威尔士研究伦理委员会 1(IRAS ID 312494)获得,并从健康研究管理局获得了研究批准(22/WA/0087)。将向所有参与数据收集活动的医院工作人员以及参与增强数据收集活动的患者征求知情同意。本研究的结果将在同行评议期刊和会议报告中发表。

试验注册

ISRCTN83502224。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81b1/10407388/23a9ea53cd14/bmjopen-2023-075795f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81b1/10407388/a700e06e229a/bmjopen-2023-075795f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81b1/10407388/2e339fb7fc52/bmjopen-2023-075795f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81b1/10407388/7cd99929e84b/bmjopen-2023-075795f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81b1/10407388/23a9ea53cd14/bmjopen-2023-075795f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81b1/10407388/a700e06e229a/bmjopen-2023-075795f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81b1/10407388/2e339fb7fc52/bmjopen-2023-075795f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81b1/10407388/7cd99929e84b/bmjopen-2023-075795f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81b1/10407388/23a9ea53cd14/bmjopen-2023-075795f04.jpg

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2
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Age Ageing. 2022 Nov 1;51(11). doi: 10.1093/ageing/afac241.
3
A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance.
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BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.
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Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back!确定实用型先导随机对照试验进展标准的样本量:假设检验卷土重来!
Pilot Feasibility Stud. 2021 Feb 3;7(1):40. doi: 10.1186/s40814-021-00770-x.
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Deprescribing interventions in primary health care mapped to the Behaviour Change Wheel: A scoping review.初级医疗保健中基于行为改变轮的药物减量干预措施:范围综述。
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