A Randomized Trial of Internet Access to Nicotine Patches

描述(由申请者提供)：每年有超过800万美国人在网上寻找戒烟帮助。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略有增加。除了作为提供帮助的直接渠道，互联网还可以作为一种手段，将寻求戒烟帮助的个人联系到更成熟的循证行为和药物治疗。接受咨询和药物治疗的吸烟者成功戒烟的可能性会增加一倍，达到三倍，但此前很少有研究将增加循证干预措施的使用作为在线戒烟计划的一部分。我们提出了一项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，无论是否与主动电话咨询有关，作为互联网辅助烟草治疗的辅助手段。在网上寻找戒烟帮助的吸烟者(N=2,475)将被招募并随机接受(1)在线戒烟服务，(2)在线戒烟服务加上免费尼古丁贴片，或(3)在线戒烟服务，根据是否参与主动电话咨询而获得免费贴片。主要结果将是自我报告的6个月的长期戒酒，在9个月的评估跟踪中测量。成本效益分析将检查建议干预措施的每次戒烟成本、每优质寿命年成本(QUALY)和雇主投资回报率(ROI)。本研究的探索性目的是考察干预效果的潜在中介变量和调节变量。对潜在媒介的检查将确定关键的心理和行为过程(即服药依从性、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。审查潜在的主持人(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对其更有效和更具成本效益的候选子群体。这项研究将为州卫生部门、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回答重要问题。这项研究的发现可能会影响未来美国国家戒烟行动计划的实施，该计划目前呼吁普遍获得药物烟草治疗，作为基于电话的戒烟计划的一部分，而不是基于网络的戒烟计划。

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.