ITALCS: Integrating Telehealth to Advance Lung Cancer Screening

While annual lung cancer screening (LCS) using low-dose computed tomography (LDCT) has been associated with a 20% reduction in lung cancer mortality, it has also been associated with potential harms including risks of false positives, radiation exposure, and potential downstream procedural complications. In 2013, the United States Preventive Services Task Force (USPSTF) recommended annual LDCT for asymptomatic adults who are aged 55-80 years, currently smoke or have quit within the past 15 years, and have smoked heavily. In 2021, the USPSTF released updated LCS guidelines that expanded recommended eligibility criteria from previous guidelines and increased the number of US adults who are eligible for screening by approximately 6 million. Since 2015, the Centers for Medicare and Medicaid Services provides national coverage for annual LCS for eligible patients yet requires that a shared decision-making (SDM) visit occur prior to ordering LDCT. SDM visits are a collaborative discussion of the benefits and risks of screening intended to take into account the patient’s values and preferences before ordering LDCT. Despite national coverage, lung cancer screening completion rates are low, and SDM visit rates are exceptionally low at less than 10% completion. Additionally, when these visits do occur, they are often low quality due to clinician time or training barriers, leading to lower patient awareness of the potential outcomes of LDCT.

Some evidence suggests that telehealth strategies can increase both SDM visit and lung cancer screening rates due to convenience and standardized communication. While centralized approaches to identify screening-eligible patients and conduct SDM visits can result in improved outcomes, the best ways to design and scale telehealth remains unclear because of complexities of clinical pathways, payment models, and patient preferences. Lacking evidence surrounding the percentage of patients who prefer telehealth over in-person SDM visits or what resources are needed to help patients overcome potential barriers, health care systems cannot yet equitably and sustainably integrate telehealth into the lung cancer screening process.

A team of researchers at Penn Medicine, led by PC3I Director Katharine Rendle, aims to determine the effectiveness and equity of telehealth strategies to increase SDM visits for lung cancer screening. To inform both the design and determinants of these adaptive telehealth strategies, the project team developed and will utilize an overarching conceptual framework, the Framework for Integrating Telehealth Equitably (FITE). As the signature pragmatic trial for the University of Pennsylvania Telehealth Research Center of Excellence (Penn TRACE), Integrating Telehealth to Advance Lung Cancer Screening (ITALCS) is using a Sequential Multiple Assignment Randomized Trial (SMART) design to evaluate each strategy and assess equity by race and biological sex. During Stage 1, participants will be randomized to receive either the active choice SDM, which offers both in-person and telehealth options, or telehealth-only SDM. All participants who have not scheduled a SDM visit within 30 days will be randomized to receive either low touch (asynchronous text messages) or high touch (synchronous digital care coordination) interventions in Stage 2, which will include support for reducing barriers to telehealth use. A mixed methods data assessment will then be used to determine the quality of SDM in-person visits versus telehealth visits. LDCT completion within 6 months of the first intervention will be measured as a secondary outcome.

Findings of this trial will determine the effectiveness and equity of telehealth strategies to increase SDM visits and LDCT screening completion rates. By identifying underlying mechanisms facilitating or hindering telehealth and SDM for lung cancer screening, this project will provide insights into improving lung cancer screening rates across the population. Additionally, this work will help advance causal theory in behavioral economics and communication science by evaluating underlying multilevel mechanisms that contribute to the success or failure of care delivery strategies in real-world care.

National Institutes of Health