A Randomized Trial of Internet Access to Nicotine Patches

互联网访问尼古丁贴片的随机试验

• 批准号: 8136106
• 负责人: Lawrence Chin-I An
• 金额: $ 117.29万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-01 至 2014-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8136106
• 关键词: Abstinence; Address; Affect; American; Attitude; Behavior Therapy; Behavioral; Coping Skills; Costs and Benefits; Counseling; Dependence; Development; Evaluation; Evidence based intervention; Future; Gender; Grant; Health; Health Planning; Hybrids; Income; Individual; Internet; Intervention; Investigation; Investments; Lead; Life; Link; Literature; Measures; Mediator of activation protein; Online Systems; Patient Self-Report; Pharmaceutical Preparations; Pharmacological Treatment; Population; Process; Randomized; Randomized Controlled Trials; Recruitment Activity; Reporting; Research Personnel; Self Efficacy; Services; Smoker; Smoking; Subgroup; Telephone; Tobacco; Tobacco Use Cessation; Withholding Treatment; Work; base; cost; cost effective; cost effectiveness; evidence base; follow-up; help-seeking behavior; improved; innovation; intervention effect; medication compliance; nicotine patch; peer; primary outcome; programs; prospective; psychologic; randomized trial; self help; smoking cessation; success; web services; web site

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.

描述（由申请人提供）：每年超过800万美国人在线搜索戒烟方面的帮助。当前的证据表明，现代互动式戒烟网站的使用仅导致短期禁欲的增加。除了作为提供援助的直接渠道外，互联网还可以用作将寻求帮助的个人与更确定的基于证据的行为和药理学治疗联系起来的手段。接受咨询和药物结合的吸烟者增加了两倍的成功可能性，但事先研究了以在线戒烟计划的一部分来增加使用基于证据的干预措施的策略。我们提出了一项3组随机对照试验，以确定提供免费的尼古丁补丁的功效和成本效益，无论是否有任何联系以主动电话咨询，作为互联网辅助烟草治疗的辅助手段。在线搜索帮助退出的吸烟者（n = 2,475）将被招募并随机分配，以接收（1）在线戒烟服务，（2）在线戒烟服务以及访问免费的尼古丁补丁，或（3）在线戒烟服务，并在积极参与积极的电话咨询中访问免费补丁。主要结果将是在9个月评估随访中衡量的6个月延长节制的自我报告。成本效益分析将检查拟议的干预措施的每次退出成本，挽救的每年质量年份成本（质量）以及雇主投资回报率（ROI）。这项研究的探索目的是检查干预效果的潜在介体和主持人。对潜在调解人的检查将确定关键的心理和行为过程（即药物依从性，自我效能感等），这是干预措施如何影响退出过程的基础，并就未来研究的关键目标提供指导。对潜在主持人的检查（即依赖水平，收入，性别）至关重要，因为这将确定候选子群体的候选子组可能更有效且具有成本效益。这项研究将回答有关州卫生部门，卫生计划，大型雇主和其他正在寻求具有成本效益策略的实体以改善烟草治疗服务提供的重要问题。这项研究的发现有可能影响未来的美国国家烟草行动计划的实施，该计划目前要求普遍访问药理学烟草治疗，这是基于电话但基于网络的戒烟计划的一部分。