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

Primary Purpose

Breast Cancer

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient nudge
Provider nudge
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring Breast cancer, Breast density, Mammography

Eligibility Criteria

40 Years - 74 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Usual care (no nudge)

Provider nudge only

Patient nudge only

Patient and provider nudge

Arm Description

Usual standard of care, no nudging.

Nudge sent to provider through EHR.

Nudge sent to the patient through text messaging.

Nudge sent to both provider through EHR, and to patient through text messaging.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Ordering of breast MRI
Whether an MRI is ordered within 6 months of receiving a nudge. Analyzed separately from scheduling.
Scheduling of breast MRI
Whether an MRI is scheduled within 6 months of receiving a nudge. Analyzed separately from ordering.
Completion of breast MRI
Whether an MRI is completed within 6 months of receiving a nudge
False-positive rate
False-positive rate among those women who schedule and undergo MRI
Cancer detection rate
Cancer detection rate among those women who schedule and undergo MRI

Full Information

First Posted
March 15, 2023
Last Updated
October 6, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05787249
Brief Title
Improving Utilization of Supplemental Breast MRI Screening for Women With Extremely Dense Breasts
Official Title
Improving Utilization of Supplemental Breast MRI Screening for Women With Extremely Dense Breasts
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 4, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Breast density, Mammography

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care (no nudge)
Arm Type
No Intervention
Arm Description
Usual standard of care, no nudging.
Arm Title
Provider nudge only
Arm Type
Experimental
Arm Description
Nudge sent to provider through EHR.
Arm Title
Patient nudge only
Arm Type
Experimental
Arm Description
Nudge sent to the patient through text messaging.
Arm Title
Patient and provider nudge
Arm Type
Experimental
Arm Description
Nudge sent to both provider through EHR, and to patient through text messaging.
Intervention Type
Behavioral
Intervention Name(s)
Patient nudge
Intervention Description
Nudge directed to the patient with the aim of increasing the uptake of MRI in patients with extremely dense breasts
Intervention Type
Behavioral
Intervention Name(s)
Provider nudge
Intervention Description
Nudge directed to the provider with the aim of increasing ordering of MRI in patients with extremely dense breasts
Primary Outcome Measure Information:
Title
Ordering and/or scheduling of supplemental breast MRI
Description
Whether a breast MRI is ordered and/or scheduled within 6 months of receiving a nudge.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Ordering of breast MRI
Description
Whether an MRI is ordered within 6 months of receiving a nudge. Analyzed separately from scheduling.
Time Frame
6 months
Title
Scheduling of breast MRI
Description
Whether an MRI is scheduled within 6 months of receiving a nudge. Analyzed separately from ordering.
Time Frame
6 months
Title
Completion of breast MRI
Description
Whether an MRI is completed within 6 months of receiving a nudge
Time Frame
6 months
Title
False-positive rate
Description
False-positive rate among those women who schedule and undergo MRI
Time Frame
6 months
Title
Cancer detection rate
Description
Cancer detection rate among those women who schedule and undergo MRI
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Marie McCarthy, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24816206
Citation
Pettersson A, Graff RE, Ursin G, Santos Silva ID, McCormack V, Baglietto L, Vachon C, Bakker MF, Giles GG, Chia KS, Czene K, Eriksson L, Hall P, Hartman M, Warren RM, Hislop G, Chiarelli AM, Hopper JL, Krishnan K, Li J, Li Q, Pagano I, Rosner BA, Wong CS, Scott C, Stone J, Maskarinec G, Boyd NF, van Gils CH, Tamimi RM. Mammographic density phenotypes and risk of breast cancer: a meta-analysis. J Natl Cancer Inst. 2014 May 10;106(5):dju078. doi: 10.1093/jnci/dju078.
Results Reference
background
PubMed Identifier
30206060
Citation
Bond-Smith D, Stone J. Methodological Challenges and Updated Findings from a Meta-analysis of the Association between Mammographic Density and Breast Cancer. Cancer Epidemiol Biomarkers Prev. 2019 Jan;28(1):22-31. doi: 10.1158/1055-9965.EPI-17-1175. Epub 2018 Sep 11.
Results Reference
background
PubMed Identifier
32096852
Citation
Comstock CE, Gatsonis C, Newstead GM, Snyder BS, Gareen IF, Bergin JT, Rahbar H, Sung JS, Jacobs C, Harvey JA, Nicholson MH, Ward RC, Holt J, Prather A, Miller KD, Schnall MD, Kuhl CK. Comparison of Abbreviated Breast MRI vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women With Dense Breasts Undergoing Screening. JAMA. 2020 Feb 25;323(8):746-756. doi: 10.1001/jama.2020.0572. Erratum In: JAMA. 2020 Mar 24;323(12):1194.
Results Reference
background
PubMed Identifier
33724062
Citation
Veenhuizen SGA, de Lange SV, Bakker MF, Pijnappel RM, Mann RM, Monninkhof EM, Emaus MJ, de Koekkoek-Doll PK, Bisschops RHC, Lobbes MBI, de Jong MDF, Duvivier KM, Veltman J, Karssemeijer N, de Koning HJ, van Diest PJ, Mali WPTM, van den Bosch MAAJ, van Gils CH, Veldhuis WB; DENSE Trial Study Group. Supplemental Breast MRI for Women with Extremely Dense Breasts: Results of the Second Screening Round of the DENSE Trial. Radiology. 2021 May;299(2):278-286. doi: 10.1148/radiol.2021203633. Epub 2021 Mar 16.
Results Reference
background
PubMed Identifier
32931396
Citation
Weinstein SP, Korhonen K, Cirelli C, Schnall MD, McDonald ES, Pantel AR, Zuckerman S, Borthakur A, Conant EF. Abbreviated Breast Magnetic Resonance Imaging for Supplemental Screening of Women With Dense Breasts and Average Risk. J Clin Oncol. 2020 Nov 20;38(33):3874-3882. doi: 10.1200/JCO.19.02198. Epub 2020 Sep 15.
Results Reference
background
PubMed Identifier
34794600
Citation
Expert Panel on Breast Imaging; Weinstein SP, Slanetz PJ, Lewin AA, Battaglia T, Chagpar AB, Dayaratna S, Dibble EH, Goel MS, Hayward JH, Kubicky CD, Le-Petross HT, Newell MS, Sanford MF, Scheel JR, Vincoff NS, Yao K, Moy L. ACR Appropriateness Criteria(R) Supplemental Breast Cancer Screening Based on Breast Density. J Am Coll Radiol. 2021 Nov;18(11S):S456-S473. doi: 10.1016/j.jacr.2021.09.002.
Results Reference
background
Citation
Wolf, Tom. "Insurance Company Law of 1921 - Coverage for Mammographic Examinations." The Office Website for the Pennsylvania General Assembly, Pennsylvania General Assembly, 2020, https://www.legis.state.pa.us/cfdocs/legis/li/uconsCheck.cfm?yr=2020&sessInd=0&act=52.
Results Reference
background
PubMed Identifier
32975573
Citation
Niraula S, Biswanger N, Hu P, Lambert P, Decker K. Incidence, Characteristics, and Outcomes of Interval Breast Cancers Compared With Screening-Detected Breast Cancers. JAMA Netw Open. 2020 Sep 1;3(9):e2018179. doi: 10.1001/jamanetworkopen.2020.18179.
Results Reference
background
PubMed Identifier
10943276
Citation
Monsees BS. The Mammography Quality Standards Act. An overview of the regulations and guidance. Radiol Clin North Am. 2000 Jul;38(4):759-72. doi: 10.1016/s0033-8389(05)70199-8.
Results Reference
background
PubMed Identifier
28430829
Citation
Sedrak MS, Myers JS, Small DS, Nachamkin I, Ziemba JB, Murray D, Kurtzman GW, Zhu J, Wang W, Mincarelli D, Danoski D, Wells BP, Berns JS, Brennan PJ, Hanson CW, Dine CJ, Patel MS. Effect of a Price Transparency Intervention in the Electronic Health Record on Clinician Ordering of Inpatient Laboratory Tests: The PRICE Randomized Clinical Trial. JAMA Intern Med. 2017 Jul 1;177(7):939-945. doi: 10.1001/jamainternmed.2017.1144.
Results Reference
background
PubMed Identifier
30646039
Citation
Patel MS, Kurtzman GW, Kannan S, Small DS, Morris A, Honeywell S Jr, Leri D, Rareshide CAL, Day SC, Mahoney KB, Volpp KG, Asch DA. Effect of an Automated Patient Dashboard Using Active Choice and Peer Comparison Performance Feedback to Physicians on Statin Prescribing: The PRESCRIBE Cluster Randomized Clinical Trial. JAMA Netw Open. 2018 Jul 6;1(3):e180818. doi: 10.1001/jamanetworkopen.2018.0818.
Results Reference
background
PubMed Identifier
34563227
Citation
Takvorian SU, Bekelman J, Beidas RS, Schnoll R, Clifton ABW, Salam T, Gabriel P, Wileyto EP, Scott CA, Asch DA, Buttenheim AM, Rendle KA, Chaiyachati K, Shelton RC, Ware S, Chivers C, Schuchter LM, Kumar P, Shulman LN, O'Connor N, Lieberman A, Zentgraf K, Parikh RB. Behavioral economic implementation strategies to improve serious illness communication between clinicians and high-risk patients with cancer: protocol for a cluster randomized pragmatic trial. Implement Sci. 2021 Sep 25;16(1):90. doi: 10.1186/s13012-021-01156-6.
Results Reference
background
PubMed Identifier
34266468
Citation
Jenssen BP, Schnoll R, Beidas R, Bekelman J, Bauer AM, Scott C, Evers-Casey S, Nicoloso J, Gabriel P, Asch DA, Buttenheim A, Chen J, Melo J, Shulman LN, Clifton ABW, Lieberman A, Salam T, Zentgraf K, Rendle KA, Chaiyachati K, Shelton R, Wileyto EP, Ware S, Leone F. Rationale and protocol for a cluster randomized pragmatic clinical trial testing behavioral economic implementation strategies to improve tobacco treatment rates for cancer patients who smoke. Implement Sci. 2021 Jul 15;16(1):72. doi: 10.1186/s13012-021-01139-7.
Results Reference
background

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

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