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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Patient nudge
* Behavioral: Provider nudge


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care (no nudge)<br>Usual standard of care, no nudging. | |
| Experimental: Provider nudge only<br>Nudge sent to provider through EHR. | Behavioral: Provider nudge<br>* Nudge directed to the provider with the aim of increasing ordering of MRI in patients with extremely dense breasts<br>|
| Experimental: Patient nudge only<br>Nudge sent to the patient through text messaging. | Behavioral: Patient nudge<br>* Nudge directed to the patient with the aim of increasing the uptake of MRI in patients with extremely dense breasts<br>|
| Experimental: Patient and provider nudge<br>Nudge sent to both provider through EHR, and to patient through text messaging. | Behavioral: Patient nudge<br>* Nudge directed to the patient with the aim of increasing the uptake of MRI in patients with extremely dense breasts<br>Behavioral: Provider nudge<br>* Nudge directed to the provider with the aim of increasing ordering of MRI in patients with extremely dense breasts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ordering and/or scheduling of supplemental breast MRI | Whether a breast MRI is ordered and/or scheduled within 6 months of receiving a nudge. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ordering of breast MRI | Whether an MRI is ordered within 6 months of receiving a nudge. Analyzed separately from scheduling. | 6 months | 
| Scheduling of breast MRI | Whether an MRI is scheduled within 6 months of receiving a nudge. Analyzed separately from ordering. | 6 months | 
| Completion of breast MRI | Whether an MRI is completed within 6 months of receiving a nudge | 6 months | 
| False-positive rate | False-positive rate among those women who schedule and undergo MRI | 6 months | 
| Cancer detection rate | Cancer detection rate among those women who schedule and undergo MRI | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Breast density, Mammography