Improving Utilization of Supplemental Breast MRI Screening for Women With Extremely Dense Breasts

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT05787249
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Study Timeline

• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-15
• Study First Posted: 2023-03-28
• Study Start: 2023-09-18
• Status Verified: 2024-08
• Primary Completion: 2025-04-04
• Study Completion: 2025-04-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1358

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Bala Cynwyd, Pennsylvania, United States