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

Abstract

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.