A Randomized Trial of Internet Access to Nicotine Patches

描述（由申请人提供）：每年有超过800万美国人在网上搜索戒烟帮助。目前的证据表明，使用现代互动戒烟网站只会导致短期戒烟率的适度增加。除了作为提供帮助的直接渠道外，互联网还可以作为一种手段，将寻求戒烟帮助的个人与更成熟的循证行为和药理学治疗联系起来。接受咨询和药物治疗的吸烟者成功的可能性增加了两倍到三倍，但之前很少有关于增加使用循证干预措施作为在线戒烟计划的一部分的策略的研究。我们建议进行一项3组随机对照试验，以确定提供免费尼古丁贴片的有效性和成本效益，与或不与主动电话咨询联系，作为互联网辅助烟草治疗的替代品。将招募在线搜索戒烟帮助的吸烟者（N= 2，475），并随机接受（1）在线戒烟服务，（2）在线戒烟服务加免费尼古丁贴片，或（3）在线戒烟服务，根据参与主动电话咨询的情况提供免费贴片。主要结局将是在9个月评价随访时测量的自我报告的6个月长期禁欲。成本效益分析将检查每次戒烟的成本，每质量生命年的成本（QEY），以及雇主对拟议干预措施的投资回报率（ROI）。本研究的探索性目的是探讨潜在的中介和调节干预效果。对潜在介质的检查将确定关键的心理和行为过程（即药物依从性，自我效能等）。这是干预措施如何影响戒烟过程的基础，并为未来研究的关键目标提供指导。审查潜在的调节因素（即依赖程度、收入、性别）至关重要，因为这将确定拟议干预措施可能更有效和更具成本效益的候选分组。这项研究将回答州卫生部门，卫生计划，大型雇主和其他实体正在寻求成本效益的战略，以改善烟草治疗服务的重要问题。这项研究的结果有可能影响美国国家戒烟行动计划的未来实施，该计划目前呼吁普及药物烟草治疗，作为基于电话而不是基于网络的戒烟计划的一部分。

DESCRIPTION (provided by applicant): Over 8 million Americans each year search online for assistance with quitting smoking. Current evidence suggests the use of modern interactive smoking cessation websites results in only a modest increase in short-term abstinence. In addition to serving as a direct channel to provide assistance, the Internet may also serve as a means to connect individuals seeking help in quitting to more established evidence-based behavioral and pharmacological treatments. Smokers who receive a combination of counseling and medications double to triple their likelihood of success, but there has been little prior study of strategies to increase use of evidence-based interventions as part of an online smoking cessation program. We propose a 3-group randomized controlled trial to determine the efficacy and cost-effectiveness of providing access to free nicotine patches, with or without linkage to proactive telephone counseling, as adjuncts to Internet-assisted tobacco treatment. Smokers searching online for help quitting (N=2,475) will be recruited and randomized to receive either (1) online smoking cessation services, (2) online cessation services plus access to free nicotine patches, or (3) online cessation services with access to free patches contingent upon participation in proactive telephone counseling. The primary outcome will be self-reported 6- month prolonged abstinence measured at 9-month evaluation follow-up. Cost-effectiveness analyses will examine the cost per quit, cost per quality year of life saved (QUALY), and employer return on investment (ROI) for the proposed interventions. The exploratory aims of this study are to examine potential mediators and moderators of intervention effects. An examination of potential mediators will identify key psychological and behavioral processes (i.e. medication adherence, self-efficacy, etc.) that underlie how the interventions affect the process of quitting and offer guidance regarding key targets for future research. An examination of potential moderators (i.e. level of dependence, income, gender) is critical because this will identify candidate subgroups for which the proposed interventions may be more effective and cost-effective. This study will answer important questions for state health departments, health plans, large employers, and other entities that are seeking cost-effective strategies for improving the delivery of tobacco treatment services. Findings from this study have the potential to influence future implementation of the U.S. National Action Plan for Tobacco Cessation that currently calls for universal access to pharmacological tobacco treatments as part of phone-based, but not web-based, cessation programs.