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，使用现代互动式戒烟网站只会导致短期戒烟的适度增加。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基于证据的行为和药物治疗联系起来。接受咨询和药物治疗相结合的吸烟者成功的可能性会增加一倍到三倍，但在此之前，很少有研究表明，作为在线戒烟计划的一部分，应该增加循证干预措施的使用。我们建议进行一项三组随机对照试验，以确定提供免费尼古丁贴片的疗效和成本效益，是否与主动电话咨询联系起来，作为互联网辅助烟草治疗的辅助手段。在线搜索戒烟帮助的吸烟者（N= 2475）将被招募并随机接受(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，在参与主动电话咨询的情况下获得免费贴片。主要结果将是自我报告的6个月延长禁欲，在9个月的评估随访中测量。成本效益分析将检查每个戒烟的成本、每个质量生命年的成本（quality）和雇主对拟议干预措施的投资回报率（ROI）。本研究的探索目的是探讨干预效果的潜在中介和调节因子。对潜在中介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），这些过程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。检查潜在的调节因素（即依赖程度、收入、性别）是至关重要的，因为这将确定提议的干预措施可能更有效和更具成本效益的候选亚群体。这项研究将回答州卫生部门、卫生计划、大型雇主和其他正在寻求成本效益战略以改善烟草治疗服务提供的实体的重要问题。这项研究的发现有可能影响美国国家戒烟行动计划的未来实施，该计划目前呼吁将烟草药物治疗作为基于手机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.