Brief, Novel Smoking Cessation in Primary Care: A Comparative Effectiveness Trial

描述（由申请人提供）：大多数吸烟者在任何一年都不会尝试戒烟。对于那些这样做的人，使用循证治疗，包括使用尼古丁替代疗法（NRT）充其量是适度的。基于5A/5 R模型的简短的医生戒烟建议，虽然提供了一些疗效，但管理不一致，因此对人群的影响有限。显然需要更有效的方法，特别是在临床上， 设置，以促进戒烟。我们的团队最近完成了一项大型的全国性NRT临床试验 采样，即，测试短暂提供NRT是否促进戒烟行为的进一步吸收、戒烟尝试的更高发生率和更高的戒烟率。该试验的结果对所有结果都是有希望的，并表明NRT抽样通过增加戒烟的动机和信心以及增加对NRT产品的熟悉度来实现戒烟。 NRT采样，当添加到医生的建议退出，是唯一适合于忙碌繁忙的初级保健设置有几个原因。首先，初级保健是大量吸烟者的一个突出的医疗保健接触点。其次，采样干预很简单，只需几分钟即可完成，并且需要的说明很少。第三，与其他基于诊所的策略（如动机建议）不同，NRT抽样是基于行为的，并为提供者和患者提供了一种催化戒烟的具体体验，他们都经常对有说服力的信息感到沮丧。第四，抽样得到了许多戒烟热线研究的支持，这些研究表明，免费药物显著增加了呼叫量和戒烟率。最后，抽样有很强的理论基础，表明短暂接触一种产品会促进其更广泛的可接受性。这一竞争性更新提出了一项转化的比较有效性试验，测试标准护理（询问、建议、参考）与标准护理+ NRT抽样（尼古丁贴片和含片均供应2周）。在已建立的初级保健提供者网络（基于我们的机构）内工作，这些提供者具有协调临床研究的所有已建立的基础设施，吸烟者将直接在临床实践中招募。干预措施将B诊所人员提供，前瞻性随访将由我们的研究团队集中协调，使用产生高保留率的既定程序。虽然我们跟踪了一些结果，但我们的主要目的是检查NRT采样对吸烟行为的影响：戒烟，戒烟尝试，接受额外的循证治疗。 长期、强化的治疗结合联合收割机的行为和药物治疗有很强的经验支持。然而，它们只提供部分效用，因为它们不容易适用于真实的世界初级保健环境，在这些环境中，提供者解决烟草依赖问题的时间和专门知识有限。提高初级保健中的短期干预的有效性和覆盖面，如NRT抽样所能实现的，可能对人口戒烟率产生重大影响。

DESCRIPTION (provided by applicant): Most smokers do not make a quit attempt in any given year. For those who do, use of evidence-based treatment, including the use of nicotine replacement therapy (NRT) is modest at best. Brief physician advice to quit, based on the 5As/5Rs model, while offering some efficacy, is inconsistently administered and thus has limited population impact. There is a clear need for more efficacious methods, particularly in the clinical setting, to promote quitting. Our team recently completed a large, nationwide clinical trial of NRT sampling, i.e., testing whether brief provision of NRT promotes further uptake of cessation behavior, higher incidence of quit attempts, and higher rates of abstinence. The results of that trial were promising for all outcomes, and suggested that NRT sampling works by increasing both motivation and confidence to quit and increasing familiarity with NRT products as an option for quitting. NRT sampling, when added to physician advice to quit, is uniquely suited to busy primary care settings for several reasons. First, primary care represents a prominent point of healthcare contact for a large number of smokers. Second, the sampling intervention is simple, takes only a few minutes to deliver, and requires minimal instructions. Third, unlike other clinic-based strategies such as motivational advice, NRT sampling is behaviorally based, and offers providers and patients, both of whom are often frustrated by persuasive messaging, a concrete experience to catalyze quitting. Fourth, sampling is supported by numerous quit line studies that show that free medications significantly increase call volume and cessation. Finally, sampling has a strong theoretical foundation to suggest that brief exposure to a product promotes wider acceptability of it. This competing renewal proposes a translational comparative effectiveness trial, testing standard care (Ask, Advise, Refer) vs. standard care + NRT sampling (2wk supply of both nicotine patch and lozenge). Working within an established network (based at our institution) of primary care providers who have all established infrastructure for coordinating clinical research, smokers will be recruited directly within clinic practices. Interventions will b delivered by clinic personnel, and prospective follow-up will be centrally coordinated by our research team, using established procedures that yield high rates of retention. Though we track a number of outcomes, our primary aims are to examine the impact of NRT sampling on smoking behavior: cessation, quit attempts, uptake of additional evidence-based treatment. Long, intensive treatments that combine behavioral and pharmacologic treatment have strong empirical support. However, they offer only partial utility because they do not readily lend themselves to real world primary care settings, where providers have limited time and expertise to address tobacco dependence. Improving the effectiveness and reach of brief intervention within primary care, as could be accomplished by NRT sampling, could have a major impact on population quit rates.