Lung Cancer Screening Protocol (I-STEP)

BJC HealthCare, Barnes-Jewish St. Peters Hospital, Decatur Memorial Hospital, Memorial Health System, Sarah Bush Lincoln Health System, Southern Illinois Healthcare, Cox Health Systems

The successful implementation of lung cancer screening across diverse setting requires working with the community and primary care practices. Collaborating across diverse community-based sites will employ local knowledge and culture in the understanding of the health problem and identifying and implementing solutions that are appropriate for all partners (patients, primary care, referral centers). Enhanced, culturally-competent communication with patients at high risk for lung cancer can narrow inequities in screening awareness, referral, and utilization, as well as improve lung cancer outcomes across diverse patients and communities. Promoting partnerships among physicians, staff, and patients; creating routines; and tailoring materials to each clinician's situation have been show to increase the proportion of patients receiving screening.

This is a stepped wedge cluster randomized trial in which the intervention condition (toolbox) is sequentially assigned to participating hospitals (screening centers) in 6 clusters at different time-delays and where pre-intervention data serves as the control. By the end of the study, all clusters have been exposed to the intervention and each cluster has provided data for the control and intervention conditions. Independent samples of primary care providers are enrolled at each period within a cluster, thus, it is a repeated cross-sectional study. The order of the entry into the intervention phase is randomized based on levels of readiness

WU Staff will train local screening staff using a train-the-trainer model three months prior to the intervention and will provide technical assistance on an ongoing basis. During the 3 hour train-the-trainer session, the selected staff from the referral sites will learn about the program, receive an orientation to the toolbox elements, and discuss how to adapt the elements of the toolbox to their referral sites.

-Toolbox of evidence-based elements that a primary care or referral site could implement to address known barriers to screening and referral, as well as required elements for screening. These elements will be designed to be adaptable to the unique needs and screening processes of the participating practices. Patient education materials Primary care practice educational materials Pack-years/eligibility calculator Local referral process guide Smoking cessation materials and support Shared decision-making guide LDCT best practice guidelines

Defined as the number of screen-eligible patients divided by the total of screening procedures performed

Defined as the number of patients referred for screening divided by the total number of screening procedures performed.

Inclusion Criteria: To be eligible to participate in the trial, screening centers have to be existing members of the BJC Collaborative. Primary Care Providers have to have a referral relationship with the screening center; serve adult patients who may be screening-eligible, and are willing to interact with the referral site to implement referral for LDCT. Exclusion Criteria: There are not any exclusion criteria for the study

Practice level and screening center aggregate numbers may be made available to investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose

Proposals should be directed to aimeejames@wustl.edu. To gain access, data requestors will need to sign a data access agreement.

Salazar AS, Sekhon S, Rohatgi KW, Nuako A, Liu J, Harriss C, Brennan E, LaBeau D, Abdalla I, Schulze C, Muenks J, Overlot D, Higgins JA, Jones LS, Swick C, Goings S, Badiu J, Walker J, Colditz GA, James AS. A stepped-wedge randomized trial protocol of a community intervention for increasing lung screening through engaging primary care providers (I-STEP). Contemp Clin Trials. 2020 Apr;91:105991. doi: 10.1016/j.cct.2020.105991. Epub 2020 Mar 14.

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine