Pragmatic Trial

务实试用

• 批准号: 10453885
• 负责人: Katharine A. Rendle
• 金额: $ 19.72万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10453885
• 关键词: Address; Adult; Advanced Malignant Neoplasm; Age; American; Awareness; Benefits and Risks; Black race; COVID-19 pandemic; Communication; Complement; Complex; Data; Decision Aid; Effectiveness; Female; Geography; Goals; Guidelines; Healthcare; Individual; Inferior; Insurance Coverage; Intervention; Interview; Knowledge; Lead; Malignant neoplasm of lung; Methods; Modeling; Outcome; Patients; Pennsylvania; Persons; Population; Race; Radiation exposure; Randomized; Research; Risk; Science; Sequential Multiple Assignment Randomized Trial; Smoking History; Socioeconomic Status; Surgical complication; Testing; Time; Touch sensation; Training; Universities; Visit; arm; base; behavioral economics; black patient; cancer care; cancer health disparity; cancer survival; care coordination; care delivery; comparative; compare effectiveness; contextual factors; design; digital healthcare; effectiveness evaluation; evidence base; health equity; innovation; lens; low dose computed tomography; lung cancer screening; male; mortality; payment; pragmatic trial; preference; programs; racial disparity; screening; screening guidelines; sex; shared decision making; telehealth; trial design; uptake

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.

项目摘要/摘要（务实试验） 宾夕法尼亚大学癌症护理远程医疗研究中心（Penn TRC）的目标 务实的试验是将四种自适应远程医疗策略的有效性与共同决定进行比较 制造（SDM）进行肺癌筛查。使用低剂量计算机断层扫描的年度肺癌筛查 （LDCT）与肺癌死亡率降低有关，但也与危害有关。因此，建议您使用 报销要求，患者在筛选之前完成SDM访问，以讨论潜在 在患者价值观的背景下，风险和收益。尽管指导方针建议筛查和国家 LDCT的保险范围，SDM访问的吸收和随后的LDCT非常低。甚至在 在方法中提出了Covid-19-19的大流行，同步和异步远程医疗策略 扩展访问权限，但在现实世界中尚未对其进行严格测试。估计有1450万 现在，美国成年人有资格根据扩展的2021指南和持续的种族分布进行筛选 肺癌是紧急的公平和可持续解决方案的需求。我们旨在解决这些差距 比较务实的传播科学和行为经济学告知的远程医疗策略 使用定性完成的顺序多重任务随机试验（智能）设计（智能）设计（智能）设计 比较分析。这将使我们能够检查多层次的决定者，以促进有效性 潜水员患者的四种策略，具有健康权益镜头。在审判的第一阶段， 患者将单独使用远程医疗SDM或Active Choice SDM。 行为经济学将为患者提供两种替代方案，以完成 SDM访问：远程医疗或面对面。两个武器中不安排SDM访问的人（无反响者） 将仅使用框后的消息（低触摸策略）或 轻推与同步数字护理协调（高触摸策略）结合使用。在审判发布之前，我们 将使用快速循环方法来优化远程医疗策略的交付和内容。具体目的是 至：1）确定远程医疗策略增加符合肺部患者SDM访问的有效性 使用患者级务实的智能设计进行癌症筛查； 2）评估远程医疗策略的公平性 通过种族和性行为； 3）评估有助于有效性和公平性的多级机制 使用定性比较分析和我们综合概念框架的远程医疗策略。这 创新的务实试验将对宾夕法尼亚TRC的目标产生新的基础作用做出重大贡献 关于远程医疗的知识，有可能改变数百万的癌症护理，公平和成果 美国人特别强调肺癌筛查和 减少肺癌差异。