Breast Cancer
Conditions
Keywords
Breast cancer, Breast density, Mammography
Brief summary
The goal of this study is to increase MRI utilization among women with extremely dense breasts. The main question it seeks to answer is whether nudging of the provider, patient, or both increases the uptake of MRI among this group, and whether this effect differs between Black and White women.
Detailed description
Women with dense breasts have 3-5-fold increased risk for breast cancer as women without dense breasts. Dense breast tissue can mask small tumors, leading to reduced mammography sensitivity. Recent randomized controlled trials demonstrate that supplemental breast MRI screening improves detection of small, invasive cancers that are not detected by mammography. In January 2022, a Pennsylvania law went into effect mandating insurance coverage of supplemental screening for women with extremely dense breasts. Currently only a small fraction of eligible women with extremely dense breasts are receiving supplemental breast MRI screening. Clinical pathways to identify patients who are eligible for insurance coverage of supplemental breast MRI screening and communicate this option to patients and providers are needed to ensure equitable access to supplemental screening. This study therefore proposes a stepped wedge cluster randomized clinical trial to determine whether electronic health record (EHR) and secure text message nudges increase utilization of supplemental breast MRI screening among eligible women with extremely dense breasts.
Interventions
BEHAVIORALPatient nudge
Nudge directed to the patient with the aim of increasing the uptake of MRI in patients with extremely dense breasts
BEHAVIORALProvider nudge
Nudge directed to the provider with the aim of increasing ordering of MRI in patients with extremely dense breasts
Sponsors
National Cancer Institute (NCI)
Abramson Cancer Center at Penn Medicine
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
Patient participants: Inclusion Criteria: * Women aged 40-74 * Recent non-actionable mammogram of less than 6 months * Mammogram performed at Penn Center for Advanced Medicine, Penn Presbyterian Hospital, Pennsylvania Hospital, or Radnor * Valid mobile phone number
Exclusion criteria
* Prior history of breast cancer * No breast MRI within the past 2 years * No prior actionable mammogram within 6 months * No recent or concurrent ultrasound Provider participants: Inclusion Criteria: * Provider needs to have ordered the initial screening mammogram * Employed by Penn Health System and access to Penn Chart
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ordering and/or scheduling of supplemental breast MRI | 6 months | Whether a breast MRI is ordered and/or scheduled within 6 months of receiving a nudge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ordering of breast MRI | 6 months | Whether an MRI is ordered within 6 months of receiving a nudge. Analyzed separately from scheduling. |
| Scheduling of breast MRI | 6 months | Whether an MRI is scheduled within 6 months of receiving a nudge. Analyzed separately from ordering. |
| Completion of breast MRI | 6 months | Whether an MRI is completed within 6 months of receiving a nudge |
| False-positive rate | 6 months | False-positive rate among those women who schedule and undergo MRI |
| Cancer detection rate | 6 months | Cancer detection rate among those women who schedule and undergo MRI |
Countries
United States
Outcome results
None listed