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干预措施以减少初级保健中的苯二氮䓬类药物处方,一项混合 1 型集群随机对照试验的研究方案:BENZORED 研究。

Intervention to reduce benzodiazepine prescriptions in primary care, study protocol of a hybrid type 1 cluster randomised controlled trial: the BENZORED study.

机构信息

Son Serra-La Vileta Healthcare Centre, Balearic Health Service Ib-Salut, Palma, Spain.

Instituto de Investigación Sanitaria de Baleares (IdISBa), Palma, Spain.

出版信息

BMJ Open. 2019 Jan 30;9(1):e022046. doi: 10.1136/bmjopen-2018-022046.

DOI:10.1136/bmjopen-2018-022046
PMID:30705235
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6359733/
Abstract

INTRODUCTION

Benzodiazepines (BZDs) are mainly used to treat anxiety and sleep disorders, and are often prescribed for long durations, even though prescription guidelines recommend short-term use due to the risk of dependence, cognitive impairment, and falls and fractures. Education of general practitioners (GPs) regarding the prescription of BZDs may reduce the overuse and of these drugs.The aims of this study are to analyse the effectiveness of an intervention targeted to GPs to reduce BZD prescription and evaluate the implementation process.

METHODS AND ANALYSIS

The healthcare centres in three regions of Spain (Balearic Islands, Catalonia and Community of Valencia) will be randomly allocated to receive a multifactorial intervention or usual care (control). GPs in the intervention group will receive a 2-hour workshop about best-practice regarding BZD prescription and BZD deprescribing, monthly feedback about their BZD prescribing practices and access to a support web page. Outcome measures for each GP are the defined daily dosage per 1000 inhabitants per day and the proportion of long-term BZD users at 12 months. Data will be collected from the electronic prescription database of the public health system, and will be subjected to intention-to-treat analysis. Implementation will be evaluated by mixed methods following the five domains of the Consolidated Framework For Implementation Research.

ETHICS AND DISSEMINATION

This study was approved by the Balearic Islands Ethical Committee of Clinical Research (IB3065/15), l'IDIAP Jordi Gol Ethical Committee of Clinical Research (PI 15/0148) and Valencia Primary Care Ethical Committee of Clinical Research (P16/024). The results will be submitted for publication in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

ISRCTN28272199.

摘要

简介

苯二氮䓬类药物(BZDs)主要用于治疗焦虑和睡眠障碍,通常开具长期处方,尽管由于依赖、认知障碍、跌倒和骨折的风险,处方指南建议短期使用。教育全科医生(GP)开具 BZD 处方可以减少这些药物的过度使用。本研究的目的是分析针对全科医生的干预措施减少 BZD 处方的有效性,并评估实施过程。

方法和分析

西班牙三个地区(巴利阿里群岛、加泰罗尼亚和巴伦西亚社区)的医疗中心将随机分配接受多因素干预或常规护理(对照)。干预组的全科医生将参加关于 BZD 处方和 BZD 停药最佳实践的 2 小时研讨会,每月收到关于他们 BZD 处方实践的反馈,并访问支持网页。每位 GP 的结果衡量指标是每 1000 居民每天的定义日剂量和 12 个月时长期 BZD 用户的比例。数据将从公共卫生系统的电子处方数据库中收集,并将进行意向治疗分析。实施将通过混合方法进行评估,遵循实施研究综合框架的五个领域。

伦理和传播

这项研究已获得巴利阿里群岛临床研究伦理委员会(IB3065/15)、IDIAP Jordi Gol 临床研究伦理委员会(PI 15/0148)和巴伦西亚初级保健临床研究伦理委员会(P16/024)的批准。结果将提交给同行评议的期刊发表。

试验注册号

ISRCTN28272199。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6124/6359733/e40cb50f002b/bmjopen-2018-022046f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6124/6359733/561e475d72f1/bmjopen-2018-022046f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6124/6359733/5a46ac0fdcff/bmjopen-2018-022046f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6124/6359733/e40cb50f002b/bmjopen-2018-022046f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6124/6359733/561e475d72f1/bmjopen-2018-022046f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6124/6359733/5a46ac0fdcff/bmjopen-2018-022046f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6124/6359733/e40cb50f002b/bmjopen-2018-022046f03.jpg

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