University of Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004, United States
NCT Number: NCT05787249
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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Notify Me40 year–74 year
Female
Interventional
Not applicable
Bala-Cynwyd, Pennsylvania, 19004, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patient participants:
Inclusion criteria
Exclusion criteria
Provider participants:
Inclusion criteria
Nudge directed to the patient with the aim of increasing the uptake of MRI in patients with extremely dense breasts
Nudge directed to the provider with the aim of increasing ordering of MRI in patients with extremely dense breasts
Time frame: 6 months
Whether a breast MRI is ordered and/or scheduled within 6 months of receiving a nudge.
Time frame: 6 months
Whether an MRI is ordered within 6 months of receiving a nudge. Analyzed separately from scheduling.
Time frame: 6 months
Whether an MRI is scheduled within 6 months of receiving a nudge. Analyzed separately from ordering.
Time frame: 6 months
Whether an MRI is completed within 6 months of receiving a nudge
Time frame: 6 months
False-positive rate among those women who schedule and undergo MRI
Time frame: 6 months
Cancer detection rate among those women who schedule and undergo MRI
Abramson Cancer Center at Penn Medicine
Other
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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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