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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Patient nudge | Nudge directed to the patient with the aim of increasing the uptake of MRI in patients with extremely dense breasts |
| BEHAVIORAL | Provider nudge | Nudge 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.