Lung Cancer Screening Protocol

Study Overview
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Brief Summary
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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.

Official Title
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I-STEP: Increasing Screening Through Engaging Primary Care Providers

Conditions
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Lung Cancer Screening

Intervention / Treatment
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* Other: Toolbox for Lung Cancer Screening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lung Cancer Screening Toolbox<br>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. | Other: Toolbox for Lung Cancer Screening<br>* -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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of initial low-dose CT (LDCT) scan screenings per month per screening center | -Screening will be defined as completed initial screen for lung cancer | Completion of study (estimated to be 21 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of primary care providers who refer at least two patients per month for LDCT |  | Completion of study (estimated to be 21 months) | 
| Percent of patients referred who are screen-eligible | Defined as the number of screen-eligible patients divided by the total of screening procedures performed | Completion of study (estimated to be 21 months) | 
| Percent of patients referred who complete screening | Defined as the number of patients referred for screening divided by the total number of screening procedures performed. | Completion of study (estimated to be 21 months) |