Clinical trial NCT05787249: Improving Utilization of Supplemental Breast MRI Screening for Women With Extremely Dense Breasts
Official title: Improving Utilization of Supplemental Breast MRI Screening for Women With Extremely Dense Breasts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Breast density
Mammography
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-03-28
Enrollment: 1358
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

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.

Eligibility 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

Primary outcomes:
measure: Ordering and/or scheduling of supplemental breast MRI
timeFrame: 6 months
Secondary outcomes:
measure: Ordering of breast MRI
timeFrame: 6 months
measure: Scheduling of breast MRI
timeFrame: 6 months
measure: Completion of breast MRI
timeFrame: 6 months
measure: False-positive rate
timeFrame: 6 months
measure: Cancer detection rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Bala Cynwyd
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Anne Marie McCarthy, PhD
role: PRINCIPAL_INVESTIGATOR
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