Teachable Moment to Opt-Out of Tobacco (TeaM OUT): A Stepped Wedge Cluster Randomized Trial

背景：吸烟是美国可预防疾病的主要原因，尽管几十年来 随着香烟使用量的缓慢下降，许多老年人仍在积极吸烟。在退伍军人中，22%的人总体上和17%的人 2015年，50岁以上的人经常吸烟。戒烟是出了名的难，尽管普遍存在 成年人对持续吸烟和经常戒烟的健康危害的认识。vt.给出 烟草成瘾的流行率和持久性，美国预防服务工作组(USPSTF) 建议卫生保健专业人员在每一次卫生保健接触时提供戒烟干预。 重要性/影响：选择退出烟草(团队退出)干预的可教时刻是明确的 旨在增强戒烟动力，减少路障，增加戒烟途径 资源。它特别侧重于将尚未准备戒烟的老年活跃吸烟者联系起来 服务。团队合作有可能导致更频繁和更长时间的禁欲 在这个难以接触到的人群中吸烟。 创新：Team Out将可教的时刻与选择退出、主动联系患者的方法结合在一起 使用交互式语音应答(IVR)技术提供现有的戒烟服务。IVR是一种主动的和 以负担得起的方式更频繁地接触到更年长的活跃吸烟者。 具体目标：目标1：在最近诊断为肺结节的患者中，评估 主动的、可教的、基于时刻的戒烟外展干预的有效性(团队外) 与加强日常护理相比，增加戒烟资源的参与度。目标2： 评估接受Team Out与尼古丁戒断(七天点流行率和 生化测量)和戒烟动机与增强的日常护理相比。目标3：定性引出 主要利益攸关方的观点，以了解可接受性和实用性、实施障碍和促进者， 和团队合作的可扩展性。 方法：在目标1中，我们使用肺结节登记来识别来自三个VA设施(VA)的参与者 波特兰、明尼阿波利斯、弗吉尼亚州查尔斯顿)。对患有肺结节的患者进行阶梯式手术后将进行接触 临床水平的楔形随机化。介入手臂的参与者被IVR Quitline呼叫， 而参与者的控制臂必须主动选择拨打电话。在上选择的选项 Quitline将被记录并使用Logistic回归进行分析，以测试Quitline是否增加了与 戒烟服务。对于目标2，将联系目标1中的参与者的一个子样本以完成 在发现结核后进行56周的额外检查。我们将测量尼古丁戒断率，戒烟 运用多变量、多层次逻辑分析方法对激励、沟通和措施进行分析 回归。在目标3中，我们将通过两次访问患者参与者来定性地评估团队成员 这项研究-第一次是在最初积极主动的IVR接触时，第二次是在注册后13个月。 临床利益相关者也将接受采访，重点是当前和期望的戒烟和 团队出局干预的经验。代码将在没有预先设定的类别的情况下派生。 下一步/实施：我们特意设计了干预措施和整体研究，以最大限度地 干预的概括性、可行性、采纳性和可持续性。我们计划多项科学研究 演讲和出版物。调查人员将参加美国胸科学会和HSRD年度会议 会议介绍研究成果。我们将把所有未识别的数据放入我们的IRB批准的健康报告中 研究结束时的服务研究库(IRB#3535)。我们正在创建一个详细的工具包，如下 这是这项研究实施过程的一部分，以便IVR系统可以在多种环境中轻松复制。

Background: Cigarette smoking is the leading cause of preventable disease in the U.S. Despite decades of slowly declining cigarette use, many older adults still actively smoke. Among Veterans, 22% overall and 17% of those over 50 years old actively smoked in 2015. It is notoriously difficult to quit, despite widespread knowledge among adults about the health hazards of persistent smoking and a frequent desire to quit. Given the prevalence and persistence of tobacco addiction, the U.S. Preventive Services Task Force (USPSTF) recommends that health care professionals offer cessation interventions at every health care encounter. Significance/Impact: The Teachable Moment to Opt-Out of Tobacco (TeaM OUT) intervention is specifically designed to increase motivation to quit, reduce roadblocks, and increase access to smoking cessation resources. It is especially focused connecting older active smokers not yet ready to quit to smoking cessation services. TeaM OUT has the potential to result in more frequent and longer periods of abstinence from smoking in this hard-to-reach population. Innovation: TeaM OUT combines a teachable moment with an opt-out, proactive approach to connect patients to existing cessation services using interactive voice response (IVR) technology. IVR is a proactive and affordable way to reach more older active smokers more frequently. Specific Aims: Aim 1: Among patients recently diagnosed with a pulmonary nodule, evaluate the effectiveness of a proactive, teachable moment-based, smoking cessation outreach intervention (TeaM OUT) on increasing engagement with smoking cessation resources compared to Enhanced Usual Care. Aim 2: Evaluate the association of receipt of TeaM OUT with nicotine abstinence (seven-day point prevalence and biochemically-measured) and quit motivation compared to Enhanced Usual Care. Aim 3: Qualitatively elicit perspectives from key stakeholders to inform acceptability and utility, implementation barriers and facilitators, and scalability of TeaM OUT. Methodology: In aim 1, we use pulmonary nodule registries to identify participants from three VA facilities (VA Portland, Minneapolis VA, Charleston VA). Patients with pulmonary nodules will be contacted after a stepped- wedged randomization at the clinical level. Participants in the intervention arm are called by the IVR Quitline, whereas participants the control arm must proactively choose to call the quitline. Options selected on the quitline will be recorded and analyzed using logistic regression to test if the quitline increases engagement with smoking cessation services. For aim 2, a subsample of participants in aim 1 will be contacted to complete additional surveys for 56 weeks after nodule identification. We will measure nicotine abstinence, quit motivation, and communication and analyze the measures using multivariable, multi-level hierarchical logistic regression. In aim 3, we will qualitatively assess TeaM OUT by interviewing patient participants twice during the study – first at the time of the initial Proactive IVR contact and second at 13 months after enrollment. Clinical stakeholders will also be interviewed, with a focus on current and desired smoking cessations and experiences with the TeaM OUT intervention. Codes will be derived without preconceived categories. Next Steps/Implementation: We have purposely designed the intervention and overall study to maximize generalizability, feasibility, adoption, and sustainability of the intervention. We plan multiple scientific presentations and publications. Investigators will attend annual American Thoracic Society and HSRD conferences to present the research findings. We will place all de-identified data in our IRB-approved Health Services Research Repository (IRB #3535) at the conclusion of the study. We are creating a detailed toolkit as part of the study's implementation process so that the IVR system can be easily replicated in multiple settings.