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

选择戒烟的可教时刻 (TeaM OUT)：阶梯式楔形聚类随机试验

• 批准号: 10625825
• 负责人: Christopher G. Slatore
• 金额: --
• 依托单位: PORTLAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-10-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10625825
• 关键词: Abstinence; Adoption; Adult; American; Biochemical; Categories; Chest; Clinical; Cluster randomized trial; Code; Communication; Consolidated Framework for Implementation Research; Control Groups; Counseling; Data; Diagnosis; Disease; Effectiveness; Effectiveness of Interventions; Elderly; Electronic Health Record; Elements; Enrollment; Exposure to; Geography; Health Hazards; Health Professional; Health Services Research; Healthcare; Individual; Institutional Review Boards; Intervention; Interview; Knowledge; Letters; Link; Logistic Regressions; Lung nodule; Measures; Methodology; Methods; Motivation; Newly Diagnosed; Nicotine; Nodule; Notification; Outcome; Participant; Patient Outcomes Assessments; Patients; Persons; Pharmaceutical Preparations; Population; Prevalence; Publications; Randomized; Readiness; Recommendation; Registries; Research; Research Personnel; Resources; Services; Smoke; Smoker; Smoking; Smoking Cessation Intervention; Societies; Suggestion; Surveys; System; Technology; Telephone; Testing; Time; Tobacco; Tobacco Dependence; United States Preventative Services Task Force; Veterans; Voice; arm; behavior change; cancer diagnosis; cigarette smoke; cigarette smoking; clinical encounter; cost; data de-identification; design; effectiveness evaluation; experience; future implementation; high risk; implementation barriers; implementation facilitators; implementation process; innovation; novel; outreach; patient engagement; pragmatic intervention; primary outcome; quitline; repository; response; secondary outcome; smoking abstinence; smoking cessation; stakeholder perspectives; symposium; therapy design; treatment arm; treatment as usual; usual care arm

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.

背景：在美国，吸烟是可预防疾病的主要原因。 虽然吸烟率在缓慢下降，但许多老年人仍然积极吸烟。在退伍军人中，22%和17%的 2015年，50岁以上的人积极吸烟。戒烟是出了名的难，尽管广泛流行， 成年人对持续吸烟的健康危害的认识和戒烟的愿望。给定 烟草成瘾的流行和持久性，美国预防服务工作组（USPSTF） 建议医疗保健专业人员在每次医疗保健接触时提供戒烟干预。 意义/影响：选择戒烟的可教时刻（TeaM OUT）干预措施具体包括： 旨在增加戒烟的动力，减少障碍，并增加戒烟的机会 资源它特别关注将尚未准备好戒烟的老年活跃吸烟者与戒烟联系起来 服务TeaM OUT有可能导致更频繁和更长时间的禁欲， 在这个难以接触的人群中吸烟。 创新：TeaM OUT结合了一个可教的时刻和一个选择退出的主动方法来连接患者 使用交互式语音应答（IVR）技术的现有戒烟服务。IVR是一种主动的， 以负担得起的方式更频繁地接触更多的老年活跃吸烟者。 具体目的：目的1：在最近诊断为肺结节的患者中，评估 积极主动的、基于可教时刻的戒烟外展干预（TeaM OUT）的有效性 与增强的家庭护理相比，增加对戒烟资源的参与。目标二： 评价接受TeaM OUT与尼古丁戒断的相关性（7天时点患病率和 生物化学测量）和戒烟动机相比，增强的医疗保健。目标3：定性引出 关键利益攸关方的观点，以告知可接受性和效用，实施障碍和促进者， 和TeaM OUT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机构（VA 波特兰、明尼阿波利斯VA、查尔斯顿VA）。肺结节患者将在逐步- 在临床水平上进行楔形随机化。干预组的参与者由IVR Quitline呼叫， 而控制臂的参与者必须主动选择拨打退出热线。选择的选项 将记录退出线并使用逻辑回归进行分析，以测试退出线是否增加了与 戒烟服务。对于目标2，将联系目标1中的参与者子样本， 在确定结核后的56周内进行额外调查。我们将测量尼古丁的戒断率， 动机，沟通和分析的措施，使用多变量，多层次的逻辑 回归分析在目标3中，我们将通过两次访谈患者参与者来定性评估TeaM OUT， 研究-第一次在初次主动IVR联系时，第二次在入组后13个月。 还将采访临床利益相关者，重点关注当前和期望的戒烟情况， TeaM Out的经验。代码将在没有预设类别的情况下导出。 下一步/实施：我们有目的地设计了干预措施和整体研究，以最大限度地提高 干预措施的普遍性、可行性、采用性和可持续性。我们计划进行多项科学研究 演讲和出版物。研究者将参加美国胸科学会和HSRD年度会议 会议，以展示研究成果。我们将把所有去识别化的数据放在我们的IRB批准的健康 在研究结束时保存在Services Research Repository（IRB #3535）中。我们正在创建一个详细的工具包， 研究的实施过程的一部分，使IVR系统可以很容易地复制在多个设置。