Pragmatic Trial

务实试用

• 批准号: 10663338
• 负责人: Katharine A. Rendle
• 金额: $ 19.36万
• 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/10663338
• 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; Disparity; Effectiveness; Eligibility Determination; Equity; Female; Geography; Goals; Guidelines; Healthcare; Individual; Inferior; Insurance Coverage; Intervention; Interview; Knowledge; Malignant neoplasm of lung; Methods; Modeling; Outcome; Patients; Pennsylvania; Persons; Policy Maker; Population; Race; Radiation exposure; Randomized; Recommendation; Research; Risk; Science; Sequential Multiple Assignment Randomized Trial; Smoking History; Socioeconomic Status; Surgical complication; Testing; Time; Touch sensation; Training; Universities; Visit; arm; 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; 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.

项目概要/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 务实试验旨在比较四种自适应远程医疗策略对共同决策的有效性 每年使用低剂量计算机断层扫描进行肺癌筛查。 (LDCT) 与肺癌死亡率降低相关，但也存在危害，因此建议： 并且需要报销，患者在筛查之前完成 SDM 就诊以讨论潜在的可能性 尽管推荐了筛查指南和国家标准，但仍考虑了患者价值观的风险和益处。 即使在 LDCT 之前，LDCT 的保险覆盖率、SDM 就诊和随后的 LDCT 的接受率也异常低。 提出了 COVID-19 大流行、同步和异步远程医疗策略作为解决问题的方法 扩大访问范围，但尚未在现实​​环境中经过严格测试，估计有 1450 万。 根据 2021 年扩大的指导方针和持续存在的种族差异，美国成年人现在有资格接受筛查 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解决这些差距。 以务实的方式比较传播科学和行为经济学提供的远程医疗策略 试验采用序贯多重分配随机试验 (SMART) 设计，并辅以定性试验 这将使我们能够研究有助于有效性的多层次决定因素。 在试验的第一阶段，从健康公平的角度，对不同患者进行四种策略。 患者将被随机分配到单独的远程医疗 SDM 组或主动选择 SDM 组，这种方法由 行为经济学，其中患者将有两种选择来完成 SDM 就诊：远程医疗或现场未安排 SDM 就诊的个人（无应答者）。 将被随机地单独使用框架消息接收异步推送（低接触策略）或 在试验启动之前，我们将推动与同步数字护理协调（高接触策略）相结合。 将使用快速周期方法来优化远程医疗战略的实施和内容。 1) 确定远程医疗策略的有效性，以增加适合肺病患者的 SDM 就诊次数 使用患者层面的实用 SMART 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) 评估有助于有效性和公平性的多层次机制 使用定性比较分析和我们的综合概念框架的远程医疗策略。 创新的务实试验将为宾夕法尼亚州 TRC 的目标做出重大贡献，即产生新的基本原理 有关远程医疗的知识有可能改变数百万人的癌症护理服务、公平性和结果 的美国人，特别强调大幅增加肺癌筛查的 SDM 和 减少肺癌差异。