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初级保健中针对吸烟者的激励性短期干预措施的效果(COSMOS试验):一项整群随机对照试验的研究方案

Efficacy of motivating short interventions for smokers in primary care (COSMOS trial): study protocol for a cluster-RCT.

作者信息

Grischott Thomas, Senn Oliver, Rosemann Thomas, Frei Anja, Cornuz Jacques, Martin-Diener Eva, Neuner-Jehle Stefan

机构信息

Institute of Primary Care, University and University Hospital of Zurich, Pestalozzistrasse 24, CH-8091, Zurich, Switzerland.

Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Hirschengraben 84, CH-8091, Zurich, Switzerland.

出版信息

Trials. 2019 Jan 25;20(1):81. doi: 10.1186/s13063-018-3071-z.

DOI:10.1186/s13063-018-3071-z
PMID:30683155
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6347802/
Abstract

BACKGROUND

Tobacco abuse is a frequent issue in general practitioners' (GPs') offices, with doctors playing a key role in promoting smoking cessation to their patients. However, not all smokers are ready and willing to give up smoking. Thus, a GP focusing on smoking cessation alone might waste the opportunity to improve his patient's health by supporting a change in another harmful behaviour pattern. The aim of this study is to determine whether multi-thematic coaching will lead to higher overall health benefits without resulting in a reduced rate of successful smoking cessations, compared with a monothematic smoking cessation approach.

METHODS

The study is designed as a two-armed, double-blinded, cluster-randomised trial. GPs will be randomly assigned to the intervention or control group. In the intervention group, GPs will undergo training in patient-centred coaching, shared decision-making and motivational interviewing. The control group will be trained in a state-of-the-art smoking cessation algorithm. GPs will approach adult cigarette-smoking patients and advise those included according to the GP's group affiliation. The primary outcome is the between-group difference in the proportion of participants who achieve a beneficial change in at least one of seven different health-related behavioural dimensions, 12 months post baseline. Secondary outcomes include smoking cessation rates and the patients' self-perceived smoking-related motivation, self-efficacy and planning behaviour. Additionally, covariates describing both GPs and patients will be collected before the start of the intervention, and process outcome measures in compliance with the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) framework will be recorded during the ongoing study.

DISCUSSION

Tobacco consumption is still highly prevalent in the general population and often goes hand in hand with other behaviour patterns with adverse health effects. This study will add to the literature regarding effective strategies available to GPs to address unhealthy behaviour among their smoking patients beyond mere smoking cessation counselling. The study will also establish a basis for decisions about further promotion and dissemination of the coaching under study.

TRIAL REGISTRATION

ISRCTN, ISRCTN38129107 . Registered on 2 October 2017.

摘要

背景

在全科医生(GP)诊所中,烟草滥用是一个常见问题,医生在促使患者戒烟方面发挥着关键作用。然而,并非所有吸烟者都准备好且愿意戒烟。因此,仅专注于戒烟的全科医生可能会浪费通过支持改变另一种有害行为模式来改善患者健康的机会。本研究的目的是确定与单一主题的戒烟方法相比,多主题辅导是否会带来更高的整体健康益处,同时不会导致成功戒烟率降低。

方法

本研究设计为双臂、双盲、整群随机试验。全科医生将被随机分配到干预组或对照组。在干预组中,全科医生将接受以患者为中心的辅导、共同决策和动机性访谈方面的培训。对照组将接受最先进的戒烟算法培训。全科医生将接触成年吸烟患者,并根据全科医生所属组对纳入的患者提供建议。主要结局是基线后12个月时,在七个不同的与健康相关的行为维度中至少有一个实现有益改变的参与者比例的组间差异。次要结局包括戒烟率以及患者自我感知的与吸烟相关的动机、自我效能和计划行为。此外,将在干预开始前收集描述全科医生和患者的协变量,并在研究进行期间记录符合RE-AIM(覆盖、效果、采用、实施、维持)框架的过程结局指标。

讨论

烟草消费在普通人群中仍然非常普遍,并且常常与其他对健康有不良影响的行为模式同时存在。本研究将为全科医生提供有效策略的文献增添内容,这些策略可用于解决吸烟患者的不健康行为,而不仅仅是戒烟咨询。该研究还将为决定进一步推广和传播正在研究的辅导方法奠定基础。

试验注册

ISRCTN,ISRCTN38129107。于2017年10月2日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4332/6347802/7a64ef0a3b0d/13063_2018_3071_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4332/6347802/e1d2005defc5/13063_2018_3071_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4332/6347802/7a64ef0a3b0d/13063_2018_3071_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4332/6347802/e1d2005defc5/13063_2018_3071_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4332/6347802/7a64ef0a3b0d/13063_2018_3071_Fig2_HTML.jpg

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