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土著咨询和尼古丁 (ICAN) 戒烟妊娠试验研究方案:改善健康提供者在妊娠期间管理吸烟行为的可行性阶梯式整群随机试验。

The Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy Pilot Study protocol: a feasibility step-wedge cluster randomised trial to improve health providers' management of smoking during pregnancy.

机构信息

The University of Newcastle, Newcastle, New South Wales, Australia.

Hunter Medical Research Institute, Newcastle, New South Wales, Australia.

出版信息

BMJ Open. 2017 Aug 4;7(8):e016095. doi: 10.1136/bmjopen-2017-016095.

Abstract

INTRODUCTION

Indigenous women have the highest smoking prevalence during pregnancy (47%) in Australia. Health professionals report lack of knowledge, skills and confidence to effectively manage smoking among pregnant women in general. We developed a behaviour change intervention aimed to improve health professionals' management of smoking in Indigenous pregnant women-the Indigenous Counselling And Nicotine (ICAN) QUIT in Pregnancy. This intervention includes webinar training for health professionals, an educational resources package for health professionals and pregnant women, free oral nicotine replacement therapy (NRT) for pregnant women, and audit and feedback on health professionals' performance.The aim of this study is to test the feasibility and acceptability of the ICAN QUIT in Pregnancy intervention to improve health professionals' provision of evidence-based culturally responsive smoking cessation care to Australian Indigenous pregnant smokers.

METHODS AND ANALYSIS

This protocol describes the design of a step-wedge cluster randomised pilot study. Six Aboriginal Medical Services (AMSs) are randomised into three clusters. Clusters receive the intervention staggered by 1 month. Health professionals report on their knowledge and skills pretraining and post-training and at the end of the study. Pregnant women are recruited and followed up for 3 months. The primary outcome is the recruitment rate of pregnant women. Secondary outcomes include feasibility of recruitment and follow-up of participating women, and webinar training of health professionals, measured using a designated log; and measures of effectiveness outcomes, including quit rates and NRT prescription rates.

ETHICS AND DISSEMINATION

In accordance with the Aboriginal Health and Medical Research Council guidelines, this study has been developed in collaboration with a Stakeholder and Consumer Aboriginal Advisory Panel (SCAAP). The SCAAP provides cultural consultation, advice and direction to ensure that implementation is acceptable and respectful to the Aboriginal communities involved. Results will be disseminated to AMSs, Aboriginal communities and national Aboriginal bodies.

REGISTRATION DETAILS

This protocol (version 4, 14 October 2016) is registered with the Australian and New Zealand Clinical Trials Registry (Ref #: ACTRN12616001603404).

摘要

介绍

在澳大利亚,土著妇女在怀孕期间的吸烟率(47%)最高。卫生专业人员报告说,他们普遍缺乏知识、技能和信心来有效管理孕妇吸烟问题。我们开发了一种行为改变干预措施,旨在提高卫生专业人员对土著孕妇吸烟问题的管理能力,即土著咨询和尼古丁(ICAN)戒烟在怀孕期间。该干预措施包括为卫生专业人员提供网络培训、为卫生专业人员和孕妇提供教育资源包、为孕妇提供免费的口服尼古丁替代疗法(NRT),以及对卫生专业人员绩效进行审核和反馈。本研究的目的是测试 ICAN 戒烟在怀孕期间干预措施的可行性和可接受性,以改善卫生专业人员为澳大利亚土著孕妇吸烟者提供循证文化响应的戒烟护理。

方法和分析

本方案描述了一项逐步楔形集群随机试点研究的设计。六个土著医疗服务中心(AMS)被随机分为三组。各组按 1 个月的时间间隔接受干预。卫生专业人员在培训前后和研究结束时报告他们的知识和技能。招募孕妇并随访 3 个月。主要结果是孕妇的招募率。次要结果包括参与妇女的招募和随访的可行性,以及卫生专业人员的网络培训,使用指定的日志进行测量;以及有效性结果的测量,包括戒烟率和 NRT 处方率。

伦理和传播

根据土著卫生和医学研究委员会的指导方针,这项研究是与利益相关者和消费者土著咨询小组(SCAAP)合作开发的。SCAAP 提供文化咨询、建议和指导,以确保实施是可以接受的,并尊重所涉及的土著社区。研究结果将分发给 AMS、土著社区和国家土著机构。

注册详情

本方案(第 4 版,2016 年 10 月 14 日)已在澳大利亚和新西兰临床试验注册中心注册(注册号:ACTRN12616001603404)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5878/5629642/01c6d029ead7/bmjopen-2017-016095f01.jpg

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