Clinical Trials Directory

Trials / Completed

CompletedNCT05787249

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
1,358 (actual)
Sponsor
Abramson Cancer Center at Penn Medicine · Academic / Other
Sex
Female
Age
40 Years – 74 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPatient nudgeNudge directed to the patient with the aim of increasing the uptake of MRI in patients with extremely dense breasts
BEHAVIORALProvider nudgeNudge directed to the provider with the aim of increasing ordering of MRI in patients with extremely dense breasts

Timeline

Start date
2023-10-04
Primary completion
2025-04-04
Completion
2025-04-04
First posted
2023-03-28
Last updated
2026-01-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05787249. Inclusion in this directory is not an endorsement.