This clinical trial tests whether provider and/or patient nudges improve rates of supplemental breast magnetic resonance imaging (MRI) referral and engagement in women with extremely dense breasts. Women with dense breasts have an increased risk for breast cancer compared to women without dense breasts. Dense breast tissue can mask small tumors, leading to reduced effectiveness of mammography for detecting breast cancer. Supplemental breast MRI screening has been shown to improve detection of small, invasive cancers that are not detected by mammography. However, only a small fraction of eligible women with extremely dense breasts receive supplemental breast MRI screening. This trial is testing whether provider nudges, delivered via the mammogram report, and/or patient nudges, delivered via text message after mammogram, work to increase the rates at which women with dense breasts are referred for and engage in supplemental breast MRI.
Additional locations may be listed on ClinicalTrials.gov for NCT05787249.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To develop provider-and patient-directed nudges for supplemental breast MRI screening for women with extremely dense breasts.
II. To test the effect of provider-and patient-directed nudges on ordering and/or scheduling of supplemental breast MRI screening among women with extremely dense breasts.
III. To compare the effect of nudges on utilization of supplemental breast MRI screening for Black and White women.
OUTLINE: Providers are cluster randomized by clinic group and patients are individually randomized to 1 of 4 arms.
ARM I (USUAL CARE): Patients and providers proceed with usual care as normal.
ARM II (PROVIDER NUDGE ONLY): Providers receive nudges embedded within the impression section of the patient's mammogram report in the EHR.
ARM III (PATIENT NUDGE ONLY): Patients receive nudges via text message within two weeks of receiving a mammogram.
ARM IV (PROVIDER AND PATIENT NUDGE): Providers receive nudges embedded within the impression section of the patient's mammogram report in the EHR and patients receive nudges via text message within two weeks of receiving a mammogram.
After completion of study intervention, participants are followed up for 6 months.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorAnne Marie McCarthy
