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OpenTrials
Completed

NCT Number: NCT05787249

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

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.

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Key information

Age range

40 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Bala-Cynwyd, Pennsylvania, 19004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Nudge

Behavioral

Nudge directed to the patient with the aim of increasing the uptake of MRI in patients with extremely dense breasts

Provider nudge

Behavioral

Nudge directed to the provider with the aim of increasing ordering of MRI in patients with extremely dense breasts

Primary outcomes

  1. Ordering and/or scheduling of supplemental breast MRI

    Time frame: 6 months

    Whether a breast MRI is ordered and/or scheduled within 6 months of receiving a nudge.

Secondary outcomes

  1. Ordering of breast MRI

    Time frame: 6 months

    Whether an MRI is ordered within 6 months of receiving a nudge. Analyzed separately from scheduling.

  2. Scheduling of breast MRI

    Time frame: 6 months

    Whether an MRI is scheduled within 6 months of receiving a nudge. Analyzed separately from ordering.

  3. Completion of breast MRI

    Time frame: 6 months

    Whether an MRI is completed within 6 months of receiving a nudge

  4. False-positive rate

    Time frame: 6 months

    False-positive rate among those women who schedule and undergo MRI

  5. Cancer detection rate

    Time frame: 6 months

    Cancer detection rate among those women who schedule and undergo MRI

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 28, 2023
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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