Improving Utilization of Supplemental Breast MRI Screening for Women With Extremely Dense Breasts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,358
- 试验地点
- 1
- 主要终点
- Ordering and/or scheduling of supplemental breast MRI
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Usual care (no nudge)
Usual standard of care, no nudging.
Provider nudge only
Nudge sent to provider through EHR.
干预措施: Provider nudge (Behavioral)
Patient nudge only
Nudge sent to the patient through text messaging.
干预措施: Patient nudge (Behavioral)
Patient and provider nudge
Nudge sent to both provider through EHR, and to patient through text messaging.
干预措施: Patient nudge (Behavioral)
Patient and provider nudge
Nudge sent to both provider through EHR, and to patient through text messaging.
干预措施: Provider nudge (Behavioral)
结局指标
主要结局
Ordering and/or scheduling of supplemental breast MRI
时间窗: 6 months
Whether a breast MRI is ordered and/or scheduled within 6 months of receiving a nudge.
次要结局
- Ordering of breast MRI(6 months)
- Scheduling of breast MRI(6 months)
- Completion of breast MRI(6 months)
- False-positive rate(6 months)
- Cancer detection rate(6 months)