In this study, personalized nudges to clinicians and patients will be evaluated to help increase breast cancer screening rates in accordance with USPSTF guidelines among women with a primary care visit, with a particular emphasis on those at high risk for non-completion of cancer screening. In partnership with Penn Medicine (Penn) and Case Western Reserve University-University Hospitals (UH), two complementary, concurrent, 6-month, cluster-randomized, pragmatic trials will be conducted. Those assigned to the intervention arm will receive the following clinician and patient level nudge interventions: clinicians will receive a default pended order for a mammogram in the visit encounter in the EHR (Penn and UH), and patients will receive post-visit text message reminders to encourage them to schedule their mammogram (Penn). Patients identified as high risk for noncompletion will be individually randomized to receive an additional bidirectional text message nudge or the standard text messaging (Penn).

Cancer is a leading cause of mortality in the United States. While strong USPSTF guideline recommendations support appropriate screening for early detection and to avoid preventable deaths, breast cancer screening is often underutilized. Increasing breast cancer screening rates is challenging, in part, because it requires complementary decisions from clinicians (e.g., recommend and counsel patients about screening) and patients (e.g., to internalize risks and choose to complete screening). Presently, the lack of interventions directly targeting both clinicians' and patients' decision-making may underscore the relatively stagnant screening rates in the United States. There is a significant need to develop and scale low-cost interventions that increase breast cancer screening while simultaneously addressing the needs of high-risk patients and reducing disparities. Building upon prior work, the investigators propose to develop and test EHR-based clinician and patient nudges, with an additional intensified nudge to high-risk patients, to help increase screening mammography rates.

This study consists of two complementary and concurrent, cluster-randomized, pragmatic trials to be conducted at Penn and UH.

Inclusion Criteria:

All patients must meet the following criteria to be eligible:

1. Women between 40 and 74 years of age
2. A scheduled new or return (non-urgent/sick) primary care visit at one of the study practices (Penn Trial) or with one of the study primary care providers (UH Trial)
3. Are overdue and eligible for a mammogram per Health Maintenance
4. Does not have a future scheduled mammogram appointment

For the Penn Trial patient intensification nudge, at least one of the following criteria must be met to be considered high risk and randomized to receive the intensification nudge:

1. Medicare Insurance
2. Medicaid Insurance
3. No EHR patient portal account
4. Zero log-ins to EHR patient portal in the previous year

Exclusion Criteria:

Patients will be excluded from the study if:

1. History of bilateral mastectomy
2. Have a mammogram exclusion modifier in Health Maintenance
3. Have no phone number (home or mobile) listed in their chart (Penn Trial only)

Baseline characteristics are reported for the Main Study Period only - Cluster Level Randomization (Control and Intervention). Patients in the Penn High Risk arms are accounted for in the Intervention arm as a whole, but were additionally randomized at the Individual Level, as noted in the Participant Flow. At UH, clinicians were randomized but no clinicians were individually enrolled as participants. All analyses were done at the participant level at both Penn and UH.

Each patient was monitored for adverse events for 6 months. Adverse events were collected mid-way through the trial at 3 months for all participants enrolled through March 18, 2024 and again at the end of the trial follow up period, 6 months after enrollment ended for both sites (April 2025), for all enrolled participants.

Per our DSMP, severe adverse events will not include death as no reasonable evidence exists to suggest death or serious injury would result from outreach to encourage standard clinical care for breast cancer screening. Therefore, All-Cause Mortality and Serious AEs was not assessed. AEs are assessed for the Main Study Period arms only - Control (except Messaging, see footnote) and Intervention - as the patients in the High Risk arms are already accounted for in the Intervention arm total.