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停用抗胆碱能药物和镇静药物:老年护理机构可行性试验(DEFEAT-多重用药)方案

Deprescribing anticholinergic and sedative medicines: protocol for a Feasibility Trial (DEFEAT-polypharmacy) in residential aged care facilities.

作者信息

Ailabouni Nagham, Mangin Dee, Nishtala Prasad S

机构信息

School of Pharmacy, University of Otago, Dunedin, New Zealand.

University of Otago, Christchurch and David Braley Nancy Gordon, Chair in Family Medicine, McMaster University, Hamilton, Ontario, Canada.

出版信息

BMJ Open. 2017 Apr 16;7(4):e013800. doi: 10.1136/bmjopen-2016-013800.

Abstract

INTRODUCTION

Targeted deprescribing of anticholinergic and sedative medicines can lead to positive health outcomes in older people; as they have been associated with cognitive and physical functioning decline. This study will examine whether the proposed intervention is feasible at reducing the prescription of anticholinergic and sedative medicines in older people.

METHODS AND ANALYSIS

The Standard Protocol Items: Recommendations for Interventional trials (SPIRIT checklist) was used to develop and report the protocol. Single group (precomparison and postcomparison) feasibility study design.

STUDY POPULATION

3 residential care homes have been recruited.

INTERVENTION

This will involve a New Zealand registered pharmacist using peer-reviewed deprescribing guidelines, to recommend to general practitioners (GPs), sedative and anticholinergic medicines that can be deprescribed. The cumulative use of anticholinergic and sedative medicines for each participant will be quantified, using the Drug Burden Index (DBI).

OUTCOMES

The primary outcome will be the change in the participants' DBI total and DBI PRN 3 and 6 months after implementing the deprescribing intervention. Secondary outcomes will include the number of recommendations taken up by the GP, participants' cognitive functioning, depression, quality of life, activities of daily living and number of falls.

DATA COLLECTION POINTS

Participants' demographic and clinical data will be collected at the time of enrolment, along with the DBI. Outcome measures will be collected at the time of enrolment, 3 and 6 months' postenrolment.

ETHICS AND DISSEMINATION

Ethics approval has been granted by the Human Disability and Ethics Committee. Ethical approval number (16/NTA/61).

TRIAL REGISTRATION NUMBER

Pre-results; ACTRN12616000721404.

摘要

引言

针对性地停用抗胆碱能药物和镇静药物可使老年人获得积极的健康结果;因为这些药物与认知和身体功能衰退有关。本研究将探讨所提议的干预措施在减少老年人抗胆碱能药物和镇静药物处方方面是否可行。

方法与分析

采用《干预性试验标准方案条目:建议清单》(SPIRIT清单)来制定和报告本方案。采用单组(干预前和干预后对比)可行性研究设计。

研究对象

已招募3家养老院。

干预措施

这将包括一名新西兰注册药剂师依据同行评审的减药指南,向全科医生推荐可停用的镇静药物和抗胆碱能药物。将使用药物负担指数(DBI)对每位参与者的抗胆碱能药物和镇静药物累计使用量进行量化。

结局指标

主要结局指标将是实施减药干预3个月和6个月后参与者DBI总分及按需使用DBI的变化。次要结局指标将包括全科医生采纳的建议数量、参与者的认知功能、抑郁情况、生活质量、日常生活活动能力以及跌倒次数。

数据收集时间点

在入组时收集参与者的人口统计学和临床数据以及DBI。结局指标将在入组时、入组后3个月和6个月收集。

伦理与传播

已获得人类残疾与伦理委员会的伦理批准。伦理批准号(16/NTA/61)。

试验注册号

结果待出;ACTRN12616000721404。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/62b6/5775460/3f9ac0dcfc3f/bmjopen-2016-013800f01.jpg

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