Pragmatic Trial

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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.