Pragmatic Trial

项目总结/摘要（实用试验） 宾夕法尼亚大学癌症护理远程医疗研究中心（Penn TRC） 语用试验是比较四种适应性远程医疗策略对共享决策的有效性 用于肺癌筛查。每年使用低剂量计算机断层扫描进行肺癌筛查 （LDCT）与降低肺癌死亡率有关，但也有危害。因此，建议， 并要求报销，患者在筛选前完成SDM访视， 患者价值观背景下的风险和获益。尽管指南建议筛查和国家 LDCT的保险覆盖率、SDM访问和随后的LDCT的使用率非常低。甚至在 提出了COVID-19大流行、同步和异步远程医疗战略， 扩大访问，但它们尚未在现实世界中进行严格的测试。估计有1450万 美国成年人现在有资格根据扩大的2021年指南和持续的种族差异进行筛查 肺癌，迫切需要公平和可持续的解决方案。我们的目标是通过以下方式弥补这些差距： 在一个实用的远程医疗战略比较通信科学和行为经济学 试验采用序贯多重分配随机试验（SMART）设计，辅以定性分析 比较分析这将使我们能够检查有助于有效性的多层次决定因素， 从健康公平透镜的角度，在不同患者之间和内部实施四种策略。在审判的第一阶段， 患者将被随机分配到单独的远程医疗SDM或主动选择SDM，这是一种由以下信息告知的方法： 行为经济学，患者将在两种选择中选择一种来完成治疗。 SDM访问：远程保健或亲自访问。两组中未安排SDM访视的个体（无应答者） 将随机接受单独使用框架消息的异步轻推（低接触策略），或 轻推与同步数字护理协调相结合（高接触策略）。在试运行之前，我们 将使用快速循环方法优化远程保健战略的提供和内容。具体目标是 目的：1）确定远程医疗战略的有效性，以增加符合肺结核患者的SDM就诊率。 癌症筛查使用患者层面的务实SMART设计; 2）评估远程医疗战略的公平性 3）评估有助于提高有效性和公平性的多层次机制， 远程保健战略使用定性比较分析和我们的综合概念框架。这 创新的实用试验将大大有助于宾夕法尼亚州TRC的目标，产生新的基本 远程医疗知识有可能改变数百万人的癌症护理提供、公平性和结果 特别强调大幅增加SDM用于肺癌筛查， 减少肺癌的差异。

PROJECT SUMMARY/ABSTRACT (PRAGMATIC TRIAL) The objective of the University of Pennsylvania Telehealth Research Center in Cancer Care (Penn TRC) Pragmatic Trial is to compare the effectiveness of four adaptive telehealth strategies on shared decision making (SDM) for lung cancer screening. Annual lung cancer screening using low-dose computed tomography (LDCT) is associated with decreased lung cancer mortality but also with harms. As such, it is recommended, and required for reimbursement, that patients complete an SDM visit prior to screening to discuss potential risks and benefits in the context of patient values. Despite guidelines recommending screening and national insurance coverage of LDCT, uptake of SDM visits and subsequent LDCT is remarkably low. Even prior to the COVID-19 pandemic, synchronous and asynchronous telehealth strategies were proposed as approaches to expand access, but they have yet to be rigorously tested in real-world settings. With an estimated 14.5 million US adults now eligible for screening based on expanded 2021 guidelines and persistent racial disparities in lung cancer, the need for equitable and sustainable solutions is urgent. We aim to address these gaps by comparing telehealth strategies informed by communication science and behavioral economics in a Pragmatic Trial using a Sequential Multiple Assignment Randomized Trial (SMART) design, complemented by qualitative comparative analysis. This will allow us to examine multilevel determinants contributing to the effectiveness of the four strategies across and within diverse patients, with a health equity lens. In the first stage of the trial, patients will be randomized to either telehealth SDM alone or active choice SDM, an approach informed by behavioral economics in which patients will be presented with a choice of two alternatives to complete the SDM visit: telehealth or in-person. Individuals in both arms who do not schedule an SDM visit (non-responders) will be randomized to receive asynchronous nudges using framed messages alone (low touch strategy) or nudges in combination with synchronous digital care coordination (high touch strategy). Prior to trial launch, we will use rapid-cycle approaches to optimize delivery and content of telehealth strategies. The specific aims are to: 1) Determine the effectiveness of telehealth strategies to increase SDM visits for patients eligible for lung cancer screening using a patient-level pragmatic SMART design; 2) Assess the equity of telehealth strategies by race and sex; and 3) Evaluate multilevel mechanisms contributing to the effectiveness and equity of telehealth strategies using qualitative comparative analysis and our integrated conceptual framework. This innovative Pragmatic Trial will contribute substantially to the Penn TRC’s goal of producing new fundamental knowledge on telehealth with the potential to transform cancer care delivery, equity, and outcomes for millions of Americans, with a particular emphasis on dramatically increasing SDM for lung cancer screening and reducing lung cancer disparities.