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.

项目总结/摘要(务实试用) 宾夕法尼亚大学癌症护理远程健康研究中心(宾夕法尼亚大学)的目标 实用型实验是比较四种自适应远程保健策略对共享决策的有效性 制作(SDM)用于肺癌筛查。应用低剂量CT进行年度肺癌筛查 低密度脂蛋白(LDCT)与肺癌死亡率的降低有关，但也与危害有关。因此，我们建议， 和报销要求，患者在筛查前完成SDM访问以讨论潜在的 患者价值背景下的风险和收益。尽管指南建议筛查和国家 最不发达国家的保险覆盖率、SDM访问和随后的最不发达国家医疗保险覆盖率非常低。甚至在那之前 提出了新冠肺炎大流行、同步和异步远程保健战略作为应对 扩大接入，但它们还需要在现实世界中进行严格的测试。估计有1450万人 根据2021年扩大的指导方针和持续的种族差距，美国成年人现在有资格进行筛查 就肺癌而言，迫切需要公平和可持续的解决办法。我们的目标是通过以下方式解决这些差距 传播学和行为经济学提供的远程保健策略的语用学比较 使用序贯多分配随机试验(SMART)设计的试验，辅以定性试验 比较分析。这将使我们能够审查有助于实现以下目标的多层次决定因素 这四种战略跨越不同的患者和在不同的患者内部，具有健康公平的视角。在审判的第一阶段， 患者将被随机分为远程医疗SDM单独组或主动选择SDM组，这是一种由 在行为经济学中，患者将有两种选择来完成 SDM访问：远程医疗或面对面。未安排SDM访问的双方人员(非响应者) 将被随机化以接收仅使用成帧消息(低接触策略)的异步轻推 与同步数字护理协调相结合的轻推(高触摸策略)。在试运行之前，我们 将使用快速周期办法来优化远程保健战略的交付和内容。具体目标是 为了：1)确定远程医疗策略的有效性，以增加符合肺部疾病条件的患者的SDM就诊次数 使用患者级实用智能设计进行癌症筛查；2)评估远程医疗策略的公平性 按种族和性别分类；以及3)评价有助于实现以下目标的多层次机制： 使用定性比较分析和我们的综合概念框架的远程保健战略。这 创新的务实试验将大大促进宾夕法尼亚TRC制定新的基本原则的目标 关于远程医疗的知识，有可能改变数百万人的癌症护理提供、公平和结果 特别强调大幅增加肺癌筛查的SDM和 缩小肺癌差距。