TELEhealth Shared decision-making COaching for lung cancer screening in Primary care (TELESCOPE)

摘要 低剂量CT（LDCT）扫描筛查可降低肺癌死亡率。然而，潜在的危害 与筛查相关的包括假阴性和假阳性结果，偶然发现，过度诊断， 辐射暴露以及侵入性诊断程序和治疗的并发症。考虑到 肺癌筛查（LCS）的决定，美国预防服务工作组强烈 建议患者接受有关戒烟和共同决策（SDM）的咨询， 在被转介进行LDCT之前，SDM关于LCS的讨论应解决以下问题： 筛查的益处和危害，坚持每年进行肺癌LDCT筛查的重要性， 推荐的诊断测试和治疗，以及避免吸烟。然而，如何做到这一点还存在不确定性。 最有效地让患者参与到SDM for LCS中。患者和初级保健医生都认为重要的是 LCS决策和获得卫生服务的障碍。在进行筛选讨论时， 往往达不到对SDM的期望。我们建议通过实施工作流程来解决这些缺陷 感知远程医疗SDM干预，包括决策指导和患者导航， 可扩展和有效的方法，以满足国家筛选建议。这项研究的长期目标是 通过支持高质量的决策，减少重度吸烟者之间的差异和肺癌负担 关于LCS和戒烟和禁欲的文章。我们的短期目标是确定一个有效的 干预，可以很容易地在现实世界的初级保健设置，以支持高质量的SDM， 种族和民族多样化的人口。我们将进行有效性实施混合I型试验 实用、稳健的实施和可持续性模型（PRISM）。一项整群随机试验 包括40个初级保健实践，100个提供者和400名患者的设计将评估远程医疗是否 决策指导和导航干预（TELESCOPE）与增强型常规护理（EUC）相比， 提高决策质量，增加筛查和诊断检测的依从性， 更多的戒烟推荐。具体目标是：1）测试决策指导的有效性 护士导航员与EUC提供的LCS干预对患者关于LCS决策的质量， 随后的筛查和诊断测试，以及目前吸烟者的戒烟转诊; 2） 评价 导航员主导的LCS决策指导的实施潜力;以及3）确定资源， 为LCS实施导航员主导的决策指导干预所需的成本。这个极具影响力的 研究有可能极大地推进SDM实施领域，并通过以下方式提高护理质量： 为患者提供有关LCS的高质量决策支持，为忙碌的PCP测试可行的策略， 为高危患者提供SDM支持，并为政策制定者和支付者展示新的模式， 为LCS有效提供SDM。

ABSTRACT Screening with low-dose CT (LDCT) scans reduces lung cancer mortality. However, the potential harms associated with screening include false-negative and false-positive results, incidental findings, overdiagnosis, radiation exposure, and complications from invasive diagnostic procedures and treatments. Given the complexity of lung cancer screening (LCS) decisions, the United States Preventive Services Task Force strongly recommends that patients receive counseling about smoking cessation and shared decision-making (SDM) with a health care provider before being referred for LDCT. The SDM discussion about LCS should address the benefits and harms of screening, the importance of adhering to annual lung cancer LDCT screening and recommended diagnostic testing and treatment, and tobacco avoidance. Yet, there is uncertainty about how to most effectively engage patients in SDM for LCS. Both patients and primary care clinicians perceive important barriers to LCS decision making and accessing health service. When screening discussions are conducted, they often fail to meet expectations for SDM. We propose to address these deficiencies by implementing a workflow aware telemedicine SDM intervention that includes decision coaching and patient navigation that is a potentially scalable and efficient approach to meeting national screening recommendations. The study’s long-term goal is to reduce disparities and the burden of lung cancer among heavy smokers by supporting high-quality decision making about LCS and smoking cessation and abstinence. Our short-term goal is to identify an effective intervention that can readily be implemented in real-world primary care settings to support high-quality SDM in racially and ethnically diverse populations. We will conduct an effectiveness-implementation hybrid type I trial guided by the Practical, Robust Implementation and Sustainability Model (PRISM). A cluster randomized trial design including 40 primary care practices, 100 providers and 400 patients will evaluate whether a telemedicine decision coaching and navigation intervention (TELESCOPE) compared to enhanced usual care (EUC) will improve the quality of decision making, increase adherence with screening and diagnostic testing, and generate more referrals for smoking cessation. The specific aims are to: 1) Test the effectiveness of a decision coaching intervention for LCS delivered by nurse navigators vs. EUC on the quality of patient decision making about LCS, subsequent screening and diagnostic testing, and smoking cessation referrals for current smokers; 2) Evaluate the implementation potential of navigator-led decision coaching for LCS; and 3) Determine the resources and costs required to implement the navigator-led decision coaching intervention for LCS. This highly impactful research has the potential to greatly advance the field of SDM implementation and improve quality of care by providing patients with high-quality decision support about LCS, testing feasible strategies for busy PCPs to support SDM for their high-risk patients, and demonstrating for policy makers and payors new models for effective delivery of SDM for LCS.