Increasing lung cancer screening effectiveness and access through regional networks (I-LEARN) - the objective of the I-LEARN study is to compare the effectiveness of selection approaches and tailoring…

The University of Pennsylvania received a $1.59 million Cooperative Agreement from the National Cancer Institute under the 21st Century Cures Act - Beau Biden Cancer Moonshot program (CFDA 93.353) to conduct the Increasing Lung Cancer Screening Effectiveness and Access Through Regional Networks (I-LEARN) study. Awarded September 15, 2025, with completion scheduled for August 31, 2027, this research initiative will compare the effectiveness of tailored versus generalized implementation strategies for scaling and sustaining high-quality lung cancer screening (LCS) across diverse clinical settings. The study employs a pragmatic Sequential Multiple Assignment Randomized Trial (SMART) design guided by participatory implementation science and the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework to identify effective, sustainable approaches that combine trusted community messengers within primary care clinics with centralized programs to ensure equitable identification, referral, and screening of eligible adults.

The project is being conducted as a collaborative research network spanning Pennsylvania and New York through partnerships with Geisinger Health Group and New York University School of Medicine as sub-awardees. During the development phase (UG3), the team will establish infrastructure for the pragmatic trial, measure outcomes across the LCS continuum, and assess clinic readiness and contextual factors. The implementation phase (UH3) will randomize at least 60 clinics across the three institutions to receive either tailored or generalized implementation strategies, with robust causal inference and mixed methods analysis employed to evaluate equity, effectiveness, and mechanisms of implementation and sustainment. This work directly addresses persistent inequities in LCS uptake and adherence across the United States and seeks to fulfill the promise of LCS at scale through evidence-based strategies.

Increasing lung cancer screening effectiveness and access through regional networks (I-LEARN) - the objective of the I-LEARN study is to compare the effectiveness of selection approaches and tailoring of implementation strategies on the scale and sustainment of lung cancer screening (LCS). Uptake and adherence to lung cancer screening (LCS) remains low and variable across the united states, driven in large part by the challenges of implementing the multiple steps required to achieve high-quality LCS. Amid these challenges, there is growing evidence that centralized programs, often managed by pulmonary or radiology centers, are more effective at increasing LCS, but these programs require substantial resources to implement and sustain and thus are not often accessible to all settings or patients. Additionally, while centralized approaches are effective once patients are referred, they are less effective at increasing reach and adoption in patients not yet integrated into care. There is a critical need to identify effective and sustainable strategies that couple the power of trusted messengers within community and primary care clinics with centralized programs to ensure all adults eligible for LCS are identified, referred, and screened if they desire. Without this fundamental knowledge, persistent differences in outcomes will continue and the promise of LCS at scale will remain unfulfilled. Guided by participatory implementation science and RE-aim, we aim to address these gaps by comparing the effectiveness of selection approaches and tailoring on increasing the implementation and sustainment of high-quality LCS using a pragmatic sequential multiple assignment randomized trial (SMART) design complemented by mixed methods analysis. This will allow US to examine multilevel determinants contributing to the effectiveness of the strategies across and within all patients. Following the exploration, preparation, implementation, and sustainment (EPIS) framework, our specific aims are to: 1) assess and confirm clinic readiness to scale LCS by implementing a common data model and conducting rapid contextual inquiry to identify local barriers and existing workflows related to LCS; 2) finalize list of recommended implementation strategies using the cfir-eric matching tool; 3) using a cluster-randomized pragmatic trial design, determine the effectiveness of selection approaches and tailoring on reach, adoption, effectiveness, and maintenance/sustainment of LCS programs; 4) assess effectiveness of selected strategies across groups using robust causal inference methods; 5) evaluate multilevel mechanisms of effectiveness and reach using mixed methods analysis. The primary implementation outcome is effectiveness (LCS completion) and secondary outcomes include reach, adoption, maintenance/sustainment, and implementation costs. By combining the strengths of trusted messengers at community and primary care clinics to identify and refer patients to existing centralized LCS programs, this innovative study has the potential to dramatically increase scale and sustainment of LCS and have broad implications for implementation science and practice.