Protocol for a pragmatic stepped wedge cluster randomized clinical trial testing behavioral economic implementation strategies to increase supplemental breast MRI screening among patients with extremely dense breasts
Authors: McCarthy Anne Marie , Fernandez Perez Claudia , Beidas Rinad S. , Bekelman Justin E. , Blumenthal Daniel , Mack Elizabeth , Bauer Anna-Marika , Ehsan Sarah , Conant Emily F. , Wheeler Bernadette C. , Guerra Carmen E. , Nunes Linda W. , Gabriel Peter , Doucette Abigail , Wileyto E. Paul , Buttenheim Alison M. , Asch David A. , Rendle Katharine A. , Shelton Rachel C. , Fayanju Oluwadamilola M. , Ware Sue , Plag Martina , Hyland Steven , Gionta Tracy , Shulman Lawrence N. , Schnoll Robert 
Published: November 2023

Abstract
Background
Increased breast density augments breast cancer risk and reduces mammography sensitivity. Supplemental breast MRI screening can significantly increase cancer detection among women with dense breasts. However, few women undergo this exam, and screening is consistently lower among racially minoritized populations. Implementation strategies informed by behavioral economics (“nudges”) can promote evidence-based practices by improving clinician decision-making under conditions of uncertainty. Nudges directed toward clinicians and patients may facilitate the implementation of supplemental breast MRI.

Methods
Approximately 1600 patients identified as having extremely dense breasts after non-actionable mammograms, along with about 1100 clinicians involved with their care at 32 primary care or OB/GYN clinics across a racially diverse academically based health system, will be enrolled. A 2 × 2 randomized pragmatic trial will test nudges to patients, clinicians, both, or neither to promote supplemental breast MRI screening. Before implementation, rapid cycle approaches informed by clinician and patient experiences and behavioral economics and health equity frameworks guided nudge design. Clinicians will be clustered into clinic groups based on existing administrative departments and care patterns, and these clinic groups will be randomized to have the nudge activated at different times per a stepped wedge design. Clinicians will receive nudges integrated into the routine mammographic report or sent through electronic health record (EHR) in-basket messaging once their clinic group (i.e., wedge) is randomized to receive the intervention. Independently, patients will be randomized to receive text message nudges or not. The primary outcome will be defined as ordering or scheduling supplemental breast MRI. Secondary outcomes include MRI completion, cancer detection rates, and false-positive rates. Patient sociodemographic information and clinic-level variables will be examined as moderators of nudge effectiveness. Qualitative interviews conducted at the trial’s conclusion will examine barriers and facilitators to implementation.

Discussion
This study will add to the growing literature on the effectiveness of behavioral economics-informed implementation strategies to promote evidence-based interventions. The design will facilitate testing the relative effects of nudges to patients and clinicians and the effects of moderators of nudge effectiveness, including key indicators of health disparities. The results may inform the introduction of low-cost, scalable implementation strategies to promote early breast cancer detection.

Trial registration
ClinicalTrials.gov NCT05787249. Registered on March 28, 2023.