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室外吸烟热点尼古丁替代疗法样本对启动戒烟尝试和使用戒烟服务的效果:一项集群随机对照试验方案。

Effectiveness of nicotine replacement therapy sample at outdoor smoking hotspots for initiating quit attempts and use of smoking cessation services: a protocol for a cluster randomised controlled trial.

机构信息

School of Nursing, The University of Hong Kong, Hong Kong, Hong Kong

Integrated Centre on Smoking Cessation, Tung Wah Group of Hospitals, Hong Kong, Hong Kong.

出版信息

BMJ Open. 2020 Apr 7;10(4):e036339. doi: 10.1136/bmjopen-2019-036339.

DOI:10.1136/bmjopen-2019-036339
PMID:32269028
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7170641/
Abstract

INTRODUCTION

More than half of the smoking population in Hong Kong are unmotivated to quit. Only about 2% of tobacco users in the territory have ever used cessation aids such as nicotine replacement therapy (NRT). The present study aims to assess the effectiveness of delivering 1-week free NRT sample plus brief intervention to smokers at outdoor smoking hotspots on quit attempts and use of smoking cessation services.

METHODS AND ANALYSIS

This is a two-arm, pragmatic, multisite, cluster randomised controlled trial (RCT) on the effectiveness of increasing quit attempts, use of cessation service and recruitment outcomes. Trained smoking cessation ambassadors will approach smokers at outdoor smoking hotspots, and deliver brief smoking cessation advice. Recruitment sessions are randomised to intervention or control group (allocation ratio 1:1). Participants in the intervention group (n=550) will receive 1-week free NRT sample (either patch or gum), brief medication advice from an onsite nurse and cessation service referral, whereas participants in control group (n=275) will only receive the brief advice and service referral. The primary outcomes are the proportion of participants who enrol in any cessation service in Hong Kong within 1 month of the recruitment, and the proportion of participants who report quit attempts at 1-month follow-up. Secondary outcomes include self-reported use of NRT, self-reported 7-day tobacco abstinence, 30-day abstinence at 3 months and 6 months, biochemically validated abstinence at 6 months, perceived importance, difficulty and confidence to quit (scale 0-10), and Incremental Behavior Change towards Smoking Cessation. Process outcomes include number of smokers who will be approached, will accept the brief smoking cessation advice or be recruited to participate in the RCT.

ETHICS AND DISSEMINATION

The Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster approved the trial (UW 18-118). Findings will be disseminated through funding website, publication and conference presentations.

TRIAL REGISTRATION NUMBER

NCT03717051.

摘要

简介

香港超过一半的烟民没有戒烟的意愿。本港只有约 2%的烟民曾使用过尼古丁替代疗法(NRT)等戒烟辅助工具。本研究旨在评估在户外吸烟点向吸烟者免费提供一周 NRT 样本加简短干预措施,以尝试戒烟和使用戒烟服务的效果。

方法和分析

这是一项关于增加戒烟尝试、使用戒烟服务和招募结果的有效性的两臂、实用、多地点、集群随机对照试验(RCT)。经过培训的戒烟大使将在户外吸烟点接近吸烟者,并提供简短的戒烟建议。招募会议被随机分配到干预组或对照组(分配比例为 1:1)。干预组(n=550)的参与者将获得一周免费的 NRT 样本(贴片或口香糖),由现场护士提供简短的药物建议和戒烟服务转介,而对照组(n=275)的参与者将只接受简短的建议和服务转介。主要结果是在招募后 1 个月内参加任何香港戒烟服务的参与者比例,以及报告在 1 个月随访时尝试戒烟的参与者比例。次要结果包括自我报告的 NRT 使用情况、自我报告的 7 天烟草戒断情况、3 个月和 6 个月时的 30 天戒断情况、6 个月时的生物化学验证的戒断情况、对戒烟的重要性、难度和信心(评分 0-10),以及向戒烟的行为变化增量。过程结果包括将有多少吸烟者被接触、接受简短的戒烟建议或被招募参加 RCT。

伦理和传播

香港大学/医院管理局香港西联网的机构审查委员会批准了这项试验(UW 18-118)。研究结果将通过资助网站、出版物和会议报告进行传播。

试验注册编号

NCT03717051。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b39/7170641/0548556cd90c/bmjopen-2019-036339f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b39/7170641/0548556cd90c/bmjopen-2019-036339f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b39/7170641/0548556cd90c/bmjopen-2019-036339f01.jpg

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