유방이 매우 치밀한 여성을 위한 유방 MRI 보조 검사의 활용도 향상
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Pennsylvania
-
Bala-Cynwyd, Pennsylvania, 미국, 19004
- University of Pennsylvania
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
간섭 없음: Usual care (no nudge)
Usual standard of care, no nudging. |
|
|
실험적: Provider nudge only
Nudge sent to provider through electronic health record (EHR). |
Nudge directed to the provider with the aim of increasing ordering of MRI in patients with extremely dense breasts |
|
실험적: Patient nudge only
Nudge sent to the patient through text messaging. |
Nudge directed to the patient with the aim of increasing the uptake of MRI in patients with extremely dense breasts |
|
실험적: Patient and provider nudge
Nudge sent to both provider through EHR, and to patient through text messaging. |
Nudge directed to the provider with the aim of increasing ordering of MRI in patients with extremely dense breasts Nudge directed to the patient with the aim of increasing the uptake of MRI in patients with extremely dense breasts |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Patients for Whom Breast MRI Was Ordered and/or Scheduled
기간: 6 months
|
Whether a breast MRI is ordered and/or scheduled within 6 months of the mammogram date |
6 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Patients for Whom Breast MRI Was Ordered
기간: 6 months
|
Whether an MRI is ordered within 6 months of the mammogram date. Analyzed separately from scheduling. |
6 months
|
|
Number of Patients Who Scheduled a Breast MRI
기간: 6 months
|
Whether an MRI is scheduled within 6 months of the mammogram date. Analyzed separately from ordering. |
6 months
|
|
Number of Patients Who Completed a Breast MRI
기간: 6 months
|
Whether an MRI is completed within 6 months of the mammogram date |
6 months
|
|
False-positive Rate
기간: 6 months
|
False-positive rate among those women who schedule and undergo MRI, defined as the number of patients who received a positive MRI result (i.e., BIRADS score of 4 or 5) but did not have a subsequent cancer diagnosis |
6 months
|
|
Cancer Detection Rate
기간: 6 months
|
Cancer detection rate among those women who schedule and undergo MRI |
6 months
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Anne Marie McCarthy, PhD, University of Pennsylvania
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- McCarthy AM, Fernandez Perez C, Beidas RS, Bekelman JE, Blumenthal D, Mack E, Bauer AM, Ehsan S, Conant EF, Wheeler BC, Guerra CE, Nunes LW, Gabriel P, Doucette A, Wileyto EP, Buttenheim AM, Asch DA, Rendle KA, Shelton RC, Fayanju OM, Ware S, Plag M, Hyland S, Gionta T, Shulman LN, Schnoll R. Protocol for a pragmatic stepped wedge cluster randomized clinical trial testing behavioral economic implementation strategies to increase supplemental breast MRI screening among patients with extremely dense breasts. Implement Sci. 2023 Nov 24;18(1):65. doi: 10.1186/s13012-023-01323-x.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- UPCC 03123
- P50CA244690 (미국 NIH 보조금/계약)
- 852666 (레지스트리 식별자: University of Pennsylvania Institutional Review Board)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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