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

为 MedStar Health 接受肺癌筛查的患者提供烟草治疗：一项随机试验

• 批准号: 10654115
• 负责人: Kathryn L Taylor
• 金额: $ 66.03万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10654115
• 关键词: Abstinence; Acceleration; Accounting; Address; Bupropion; Caring; Cessation of life; Cigarette; Clinical; Collaborations; Cost Analysis; Counseling; Data; Disease; Disparity; Effectiveness; Effectiveness of Interventions; Elderly; Electronic Health Record; Electronic Mail; Eligibility Determination; Enrollment; Ethnic Origin; Future; Goals; Guidelines; Health; Health system; Individual; Insurance Coverage; Intervention; Leadership; Life; Lung; Malignant neoplasm of lung; Mediator; Methods; Nurse Practitioners; Outcome; Participant; Patient Schedules; Patient-Focused Outcomes; Patients; Population Heterogeneity; Practical Robust Implementation and Sustainability Model; Provider; Race; Randomized; Readiness; Recommendation; Research; Site; Smoke; Smoker; Smoking Cessation Intervention; Specialist; Subgroup; Systems Integration; Telephone; Text; Tobacco; Training; Translations; Treatment Effectiveness; Underinsured; Underserved Population; Work; acceptability and feasibility; arm; barrier to care; budget impact; care delivery; clinical practice; compare effectiveness; contextual factors; cost; cost effective; design; disparity reduction; economic evaluation; economic outcome; effectiveness outcome; effectiveness testing; ethnic minority population; evidence base; flexibility; future implementation; high risk; implementation framework; implementation strategy; improved; incremental cost; innovation; intervention cost; lung cancer screening; models and simulation; motivational enhancement therapy; nicotine replacement; outreach; participant enrollment; primary outcome; quitline; racial minority population; randomized trial; recruit; relapse prevention; routine practice; screening; screening guidelines; smoking cessation; sustainability framework; therapy design; trial enrollment; uptake; varenicline

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.

据估计，与单独进行肺部筛查相比，结合最近扩大的肺癌筛查指南提供戒烟治疗可大幅降低肺癌死亡率并增加生命年。虽然CMS建议目前正在接受肺部筛查的吸烟者接受戒烟治疗，但治疗提供有多种障碍。改善接受肺部筛查的患者的戒烟治疗的证据基础，以及促进戒烟治疗系统性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 R 01207228）。我们提出了一项卫生系统层面的、务实的、随机试验，以比较两种循证戒烟治疗的有效性，实施策略旨在解决接触和参与的障碍，特别是在服务不足的群体中（例如，种族和少数民族群体、保险不足的患者和不准备戒烟的患者），他们不太可能接受戒烟治疗。为了最大限度地推广到其他卫生系统，并提高异质群体的覆盖率，计划在MedStar Health（大西洋中部最大和最多样化的卫生系统）的10个肺部筛查中心之一进行筛查的所有患者将通过EHR进行识别，使用选择退出方法联系入组，并随机分配至：1）Quitline E-referral（QL-E; N=594）通过EHR和戒烟热线集成系统，包括主动外展和标准电话咨询+戒烟热线提供的尼古丁替代品vs. 2）MedStar Health System（MHS; N=594），这是一种集中的、基于电话的+ NRT干预措施，根据我们先前的试验进行调整和改进，对那些在3个月内没有禁欲的人进行随机阶梯式护理干预。具体目标是：1。比较电子转诊与戒烟热线和集中卫生系统干预措施。主要结局是：3个月和6个月时的生物等效戒烟率。我们将评估干预中介（例如，治疗参与）和调节器（例如，6个月时准备退出）。2.评估总体和子组的覆盖面和参与度（例如，种族和族裔、保险不足、戒烟意愿），并使用混合方法了解与干预措施和执行战略的可行性和可接受性有关的背景因素。3.从卫生系统的角度进行经济分析，以评估每次戒烟的成本、平均成本和增量成本，以及干预措施在3个月和6个月时的预算影响。提案的优势包括测试两种戒烟干预措施的有效性和经济成果，同时为今后在本系统和其他不同的卫生系统内实施奠定基础。我们的创新方法利用EHR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。