Waddell Kimberly J, Mehta Shivan J, Liao Joshua M, Linn Kristin A, Park Saehwan, Rhodes Corinne M, Brophy Caitlin, Reitz Catherine, Cousins Deborah S, Williams Keyirah, Thatcher Esther J, Muskin Ryan, Pronovost Peter J, Navathe Amol S
Perelman School of Medicine, University of Pennsylvania, USA; Center for Health Incentives and Behavioral Economics, University of Pennsylvania, USA; Leonard Davis Institute for Health Economics, University of Pennsylvania, USA; Center for Health Care Transformation and Innovation, University of Pennsylvania, USA; Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA.
Perelman School of Medicine, University of Pennsylvania, USA; Center for Health Incentives and Behavioral Economics, University of Pennsylvania, USA; Leonard Davis Institute for Health Economics, University of Pennsylvania, USA; Center for Health Care Transformation and Innovation, University of Pennsylvania, USA.
Contemp Clin Trials. 2025 Jan;148:107753. doi: 10.1016/j.cct.2024.107753. Epub 2024 Nov 22.
Routine mammogram screening is critical for early detection of breast cancer. However, screening rates are below national targets, with persistent disparities among sub-populations. The purpose of this trial is to examine the effectiveness of a multi-component nudge intervention to increase breast cancer screening among eligible primary care patients.
This is a two-phase, multisite, pragmatic cluster randomized clinical trial. In the first phase, two concurrent trials (trial A, B) will test the effectiveness of a multi-component nudge intervention that leverages the electronic health record (EHR) for increasing mammogram screening. The second phase includes a replication trial at an additional site. In Trial A, primary care clinics (n = 30) will be randomized 2:1 to a nudge intervention or usual care. Eligible clinicians and patients within the intervention clinics will receive the intervention. Patients identified as high-risk for mammogram non-completion in the intervention arm will be further randomized 1:1 to receive an intensification nudge. In Trial B, primary care clinicians (n = 82) will be randomized 1:1 to a nudge intervention or usual care. The primary outcome is mammogram completion within three months of the eligible visit.
Outcomes will be evaluated using generalized estimating equations (GEE) to address clinic-level clustering. GEE models will also be fit to evaluate the impact of the intensification nudge on mammogram completion.
If successful, this trial provides a blueprint for leveraging scalable multi-component nudge interventions for clinicians and patients to improve cancer screening rates.
常规乳房X光筛查对于早期发现乳腺癌至关重要。然而，筛查率低于国家目标，不同亚人群之间存在持续差异。本试验的目的是检验一种多成分助推干预措施在增加符合条件的初级保健患者乳腺癌筛查方面的有效性。
这是一项两阶段、多地点、实用的整群随机临床试验。在第一阶段，两项并行试验（试验A、B）将测试一种利用电子健康记录（EHR）来增加乳房X光筛查的多成分助推干预措施的有效性。第二阶段包括在另一个地点进行的重复试验。在试验A中，初级保健诊所（n = 30）将按2:1随机分为助推干预组或常规护理组。干预诊所内符合条件的临床医生和患者将接受干预。在干预组中被确定为乳房X光检查未完成高危的患者将进一步按1:1随机分组，以接受强化助推。在试验B中，初级保健临床医生（n = 82）将按1:1随机分为助推干预组或常规护理组。主要结局是在符合条件的就诊后三个月内完成乳房X光检查。
将使用广义估计方程（GEE）评估结局，以处理诊所层面的聚类情况。GEE模型也将用于评估强化助推对乳房X光检查完成情况的影响。
如果试验成功，则可为利用针对临床医生和患者的可扩展多成分助推干预措施来提高癌症筛查率提供一个蓝图。
