Providing Tobacco Treatment to Patients Undergoing Lung Cancer Screening at MedStar Health: A Randomized Trial

与单独进行肺部筛查相比，提供戒烟治疗与最近扩大的肺癌筛查指南相结合，估计可大大减少肺癌死亡并增加获得的生命年。尽管CMS建议正在接受肺部筛查的吸烟者接受戒烟治疗，但治疗的实施存在多重障碍。改善接受肺部筛查的患者的戒烟治疗的证据基础，以及促进戒烟治疗纳入常规实践的方法，特别是在不同人群中，对于实现肺部筛查的最大益处至关重要。在实用、稳健、实施和可持续性框架的指导下，我们将扩展我们之前的工作（CA R01207228）。我们建议进行一项卫生系统级、务实的随机试验，比较两种基于证据的戒烟治疗的有效性，实施策略旨在解决接触和参与的障碍，特别是在不太可能接受戒烟治疗的服务不足群体（例如，种族和少数民族群体、保险不足的患者和未准备戒烟的患者）中。为了最大限度地推广到其他卫生系统，并提高异质性群体的覆盖面，MedStar health（大西洋中部最大和最多样化的卫生系统）的10个肺筛查点之一的所有患者将通过电子病历确定，使用选择退出方法联系登记，并随机分配到：1)Quitline E-referral (QL-E；N=594)通过电子病历和戒烟热线综合系统，包括戒烟热线提供的主动外诊和标准电话咨询+尼古丁替代，2)MedStar健康系统（MHS； N=594），一种集中的、电话+ NRT干预，适应和改进了我们之前的试验，对3个月时不戒烟的患者进行随机分步护理干预。具体目标是：1.；比较电子转诊到戒断热线和集中的卫生系统干预。主要的结果是：在3个月和6个月的时间里，生物化的戒烟。我们将在6个月时评估干预调解者（例如，治疗参与）和调节者（例如，戒烟准备）。2. 评估总体和分组（如种族和民族、保险不足、戒烟意愿）的覆盖范围和参与度，并使用混合方法了解与干预措施和实施策略的可行性和可接受性相关的背景因素。3. 开展经济分析，从卫生系统角度评估干预措施在3个月和6个月时的成本、每次戒烟的平均成本和增量成本以及预算影响。建议的优势包括测试两种戒烟干预措施的有效性和经济结果，同时为今后在本系统和其他多样化卫生系统内实施奠定基础。我们的创新方法利用电子病历进行招聘，提供针对不同人群的多层次培训，并考虑干预背景，为未来的护理提供信息。

Providing smoking cessation treatment in conjunction with the recently expanded lung cancer screening guidelines is estimated to substantially reduce lung cancer deaths and increase life-years gained compared to conducting lung screening alone. Although CMS recommends that individuals undergoing lung screening who currently smoke are offered cessation treatment, there are multiple barriers to treatment delivery. Improving the evidence-base of cessation treatment for patients undergoing lung screening and methods to promote the systematic uptake of cessation treatment into routine practice, particularly among diverse populations, is essential for realizing the maximum benefit of lung screening. Guided by the Practical, Robust, Implementation & Sustainability framework, we will extend our prior work (CA R01207228). We propose a health system-level, pragmatic, randomized trial to compare the effectiveness of two evidence-based cessation treatments, with implementation strategies designed to address barriers to reach and engagement, particularly among underserved groups (e.g., racial and ethnic minority groups, underinsured patients, and patients not ready to quit) who are less likely to receive cessation treatment. To maximize generalizability to other health systems and to improve reach among heterogeneous groups, all patients scheduled at one of the 10 lung screening sites at MedStar Health, the largest and most diverse health system in the Mid-Atlantic, will be identified via the EHR, contacted for enrollment using an opt-out approach, and randomized to: 1) Quitline E-referral (QL-E; N=594) via the EHR and quitline integrated system, including proactive outreach and standard phone-based counseling+ nicotine replacement provided by the quitline vs. 2) MedStar Health System (MHS; N=594), a centralized, phone-based+ NRT intervention adapted and improved from our prior trial, with a randomized stepped care intervention for those who are not abstinent at 3 months. Specific aims are: 1. To compare e-referral to the Quitline vs. the centralized Health System intervention. Primary outcomes are: bioverified abstinence from cigarettes at 3- and 6-months. We will assess intervention mediators (e.g., treatment engagement) and moderators (e.g., readiness to quit) at 6-months. 2. To evaluate reach and engagement overall and by subgroup (e.g., race and ethnicity, underinsured, readiness to quit) and using mixed-methods to understand the contextual factors related to the feasibility and acceptability of the interventions and implementation strategies. 3. To conduct an economic analysis to evaluate costs, average and incremental cost per quit, and budget impact of the intervention at 3- and 6-months from the health system perspective. Proposal strengths include testing the effectiveness and economic outcomes of two cessation interventions while simultaneously laying the groundwork for future implementation within this and other diverse health systems. Our innovative approach capitalizes on the EHR for recruitment, provides multilevel training focused on diverse populations, and accounts for intervention context to inform future care delivery.