Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Basser Center for BRCA, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Implement Sci. 2023 Nov 6;18(1):57. doi: 10.1186/s13012-023-01308-w.
Germline genetic testing is recommended by the National Comprehensive Cancer Network (NCCN) for individuals including, but not limited to, those with a personal history of ovarian cancer, young-onset (< 50 years) breast cancer, and a family history of ovarian cancer or male breast cancer. Genetic testing is underused overall, and rates are consistently lower among Black and Hispanic populations. Behavioral economics-informed implementation strategies, or nudges, directed towards patients and clinicians may increase the use of this evidence-based clinical practice.
Patients meeting eligibility for germline genetic testing for breast and ovarian cancer will be identified using electronic phenotyping algorithms. A pragmatic cohort study will test three sequential strategies to promote genetic testing, two directed at patients and one directed at clinicians, deployed in the electronic health record (EHR) for patients in OB-GYN clinics across a diverse academic medical center. We will use rapid cycle approaches informed by relevant clinician and patient experiences, health equity, and behavioral economics to optimize and de-risk our strategies and methods before trial initiation. Step 1 will send patients messages through the health system patient portal. For non-responders, step 2 will reach out to patients via text message. For non-responders, Step 3 will contact patients' clinicians using a novel "pend and send" tool in the EHR. The primary implementation outcome is engagement with germline genetic testing for breast and ovarian cancer predisposition, defined as a scheduled genetic counseling appointment. Patient data collected through the EHR (e.g., race/ethnicity, geocoded address) will be examined as moderators of the impact of the strategies.
This study will be one of the first to sequentially examine the effects of patient- and clinician-directed strategies informed by behavioral economics on engagement with breast and ovarian cancer genetic testing. The pragmatic and sequential design will facilitate a large and diverse patient sample, allow for the assessment of incremental gains from different implementation strategies, and permit the assessment of moderators of strategy effectiveness. The findings may help determine the impact of low-cost, highly transportable implementation strategies that can be integrated into healthcare systems to improve the use of genomic medicine.
ClinicalTrials.gov. NCT05721326. Registered February 10, 2023. https://www.
gov/study/NCT05721326.
美国国家综合癌症网络（NCCN）建议对符合条件的个人进行种系基因检测，包括但不限于有卵巢癌个人病史、发病年龄较轻（<50 岁）的乳腺癌、以及有卵巢癌或男性乳腺癌家族史的个人。总体而言，基因检测的使用率较低，黑人和西班牙裔人群的使用率始终较低。以患者和临床医生为目标的行为经济学驱动的实施策略（或推动）可能会增加对这种基于证据的临床实践的使用。
将使用电子表型算法确定符合进行乳腺癌和卵巢癌种系基因检测的患者。一项实用的队列研究将测试三种促进基因检测的连续策略，其中两种针对患者，一种针对临床医生，这些策略将在跨不同学术医疗中心的妇产科诊所的电子健康记录（EHR）中部署。我们将使用基于相关临床医生和患者经验、健康公平和行为经济学的快速循环方法，在试验启动前优化和降低策略和方法的风险。第 1 步将通过健康系统患者门户向患者发送消息。对于未回复的患者，第 2 步将通过短信与患者联系。对于未回复的患者，第 3 步将使用 EHR 中的新型“挂起并发送”工具联系患者的临床医生。主要的实施结果是参与乳腺癌和卵巢癌易感性的种系基因检测，定义为安排遗传咨询预约。通过电子健康记录（例如，种族/民族、地理编码地址）收集的患者数据将作为策略影响的调节剂进行检查。
这项研究将是首批之一，将连续检查基于行为经济学的患者和临床医生导向策略对参与乳腺癌和卵巢癌基因检测的影响。实用和连续的设计将促进大量和多样化的患者样本，允许评估不同实施策略的增量收益，并允许评估策略有效性的调节剂。研究结果可能有助于确定可以整合到医疗保健系统中以改善基因组医学使用的低成本、高可移植性实施策略的影响。
ClinicalTrials.gov。NCT05721326。2023 年 2 月 10 日注册。https://www.clinicaltrials.gov/study/NCT05721326。
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