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在全科医疗中提高长效可逆避孕方法的使用率:澳大利亚避孕选择项目(ACCORd)整群随机对照试验方案

Increasing the uptake of long-acting reversible contraception in general practice: the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomised controlled trial protocol.

作者信息

Mazza Danielle, Black Kirsten, Taft Angela, Lucke Jayne, McGeechan Kevin, Haas Marion, McKay Heather, Peipert Jeffery F

机构信息

Department of General Practice, Monash University, Notting Hill, Victoria, Australia.

Department of Obstetrics, Gynaecology & Neonatology, University of Sydney, Central Clinical School, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.

出版信息

BMJ Open. 2016 Oct 7;6(10):e012491. doi: 10.1136/bmjopen-2016-012491.

DOI:10.1136/bmjopen-2016-012491
PMID:27855100
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5073472/
Abstract

INTRODUCTION

The increased use of long-acting reversible contraceptives (LARCs), such as intrauterine devices and hormonal implants, has the potential to reduce unintended pregnancy and abortion rates. However, use of LARCs in Australia is very low, despite clinical practice guidance and statements by national and international peak bodies advocating their increased use. This protocol paper describes the Australian Contraceptive ChOice pRojet (ACCORd), a cluster randomised control trial that aims to test whether an educational intervention targeting general practitioners (GPs) and establishing a rapid referral service are a cost-effective means of increasing LARC uptake.

METHODS AND ANALYSIS

The ACCORd intervention is adapted from the successful US Contraceptive CHOICE study and involves training GPs to provide 'LARC First' structured contraceptive counselling to women seeking contraception, and implementing rapid referral pathways for LARC insertion. Letters of invitation will be sent to 600 GPs in South-Eastern Melbourne. Using randomisation stratified by whether the GP inserts LARCs or not, a total of 54 groups will be allocated to the intervention (online 'LARC First' training and rapid referral pathways) or control arm (usual care). We aim to recruit 729 women from each arm. The primary outcome will be the number of LARCs inserted; secondary outcomes include the women's choice of contraceptive method and quality of life (Short Form Health Survey, SF-36). The costs and outcomes of the intervention and control will be compared in a cost-effectiveness analysis.

ETHICS AND DISSEMINATION

The ACCORd study has been approved by the Monash University Human Research Ethics Committee: CF14/3990-2014002066 and CF16/188-2016000080. Any protocol modifications will be communicated to Ethics Committee and Trial Registration registry. The authors plan to disseminate trial outcomes through formal academic pathways comprising journal articles, nation and international conferences and reports, as well as using more 'popular' strategies including seminars, workshops and media engagements.

TRIAL REGISTRATION NUMBER

ACTRN12615001346561.

摘要

引言

长效可逆避孕法(LARC),如宫内节育器和激素植入物的使用增加,有可能降低意外怀孕和堕胎率。然而,尽管有临床实践指南以及国家和国际顶尖机构倡导增加LARC的使用,但澳大利亚LARC的使用率仍然很低。本方案文件介绍了澳大利亚避孕选择项目(ACCORd),这是一项整群随机对照试验,旨在测试针对全科医生(GP)的教育干预措施以及建立快速转诊服务是否是提高LARC使用率的一种具有成本效益的方法。

方法与分析

ACCORd干预措施改编自美国成功的避孕选择研究,包括培训全科医生为寻求避孕的女性提供“优先选择LARC”的结构化避孕咨询,并实施LARC植入的快速转诊途径。将向墨尔本东南部的600名全科医生发送邀请信。根据全科医生是否进行LARC植入进行分层随机分组,总共54个组将被分配到干预组(在线“优先选择LARC”培训和快速转诊途径)或对照组(常规护理)。我们的目标是每组招募729名女性。主要结局将是植入LARC的数量;次要结局包括女性对避孕方法的选择和生活质量(简短健康调查问卷,SF-36)。将在成本效益分析中比较干预组和对照组的成本与结局。

伦理与传播

ACCORd研究已获得莫纳什大学人类研究伦理委员会批准:CF14/3990 - 2014002066和CF16/188 - 2016000080。任何方案修改都将通报给伦理委员会和试验注册登记处。作者计划通过正式的学术途径传播试验结果,包括期刊文章、国内和国际会议及报告,以及采用更多“大众”策略,如研讨会、工作坊和媒体参与。

试验注册号

ACTRN12615001346561。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/255d/5073472/90c4c41bfb7f/bmjopen2016012491f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/255d/5073472/eef1b659987d/bmjopen2016012491f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/255d/5073472/90c4c41bfb7f/bmjopen2016012491f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/255d/5073472/eef1b659987d/bmjopen2016012491f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/255d/5073472/90c4c41bfb7f/bmjopen2016012491f02.jpg

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