Increasing screening for breast cancer using a randomized evaluation of electronic health record nudges: Design and rationale of the I-screen clinical trial

Background: Routine mammogram screening is critical for early detection of breast cancer. However, screening rates are below national targets, with persistent disparities among sub-populations. The purpose of this trial is to examine the effectiveness of a multi-component nudge intervention to increase breast cancer screening among eligible primary care patients. Methods: This is a two-phase, multisite, pragmatic cluster randomized clinical trial. In the first phase, two concurrent trials (trial A, B) will test the effectiveness of a multi-component nudge intervention that leverages the electronic health record (EHR) for increasing mammogram screening. The second phase includes a replication trial at an additional site. In Trial A, primary care clinics (n = 30) will be randomized 2:1 to a nudge intervention or usual care. Eligible clinicians and patients within the intervention clinics will receive the intervention. Patients identified as high-risk for mammogram non-completion in the intervention arm will be further randomized 1:1 to receive an intensification nudge. In Trial B, primary care clinicians (n = 82) will be randomized 1:1 to a nudge intervention or usual care. The primary outcome is mammogram completion within three months of the eligible visit. Analysis: Outcomes will be evaluated using generalized estimating equations (GEE) to address clinic-level clustering. GEE models will also be fit to evaluate the impact of the intensification nudge on mammogram completion. Conclusion: If successful, this trial provides a blueprint for leveraging scalable multi-component nudge interventions for clinicians and patients to improve cancer screening rates.