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

Sponsor

University of Pennsylvania (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05787249

Collaborator

(none)

2,000

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Behavioral: Patient nudge Behavioral: Provider nudge	N/A

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 (<8%) of eligible women with extremely dense breasts at Penn Medicine 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 multilevel randomized 2x2 factorial pilot 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2000 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Number of women who schedule an MRI [6 months]
Whether a woman schedules supplemental breast MRI screening within 6 months of the nudge.
Number of women who undergo an MRI [6 months]
Whether a woman receives supplemental breast MRI screening within 6 months of the nudge.

Secondary Outcome Measures

Cancer detection rate [12 months]
Cancer detection rate among those women who schedule and undergo MRI
False-positive rate [12 months]
False-positive rate among those women who schedule and undergo MRI

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 74 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Patient participants:

Inclusion Criteria:

Women aged 40-74
Recent negative mammogram of less than 6 months
Mammogram performed at Penn Medicine

Exclusion Criteria:

Prior history of breast cancer
No breast MRI within the past 2 years

Provider participants:

Inclusion Criteria:

Provider needs to have ordered the screening mammogram

Exclusion Criteria:

Not employed by Penn Health System and no access to Penn Chart

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Pennsylvania

Investigators

Principal Investigator: Anne Marie McCarthy, PhD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT05787249

Other Study ID Numbers:

852666

First Posted:

Mar 28, 2023

Last Update Posted:

Mar 31, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Pennsylvania

Breast cancer

Breast density

Mammography

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Mar 31, 2023