Protocol to evaluate sequential electronic health record-based strategies to increase genetic testing for breast and ovarian cancer risk across diverse patient populations in gynecology practices.
Protocol to evaluate sequential electronic health record-based strategies to increase genetic testing for breast and ovarian cancer risk across diverse patient populations in gynecology practices.
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DOI：
10.1186/s13012-023-01308-w
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发表时间：
2023-11-06
影响因子：
7.2
通讯作者：
Domchek, Susan M.
中科院分区：
文献类型：
--
作者：
Symecko, Heather;Schnoll, Robert;Beidas, Rinad S.;Bekelman, Justin E.;Blumenthal, Daniel;Bauer, Anna-Marika;Gabriel, Peter;Boisseau, Leland;Doucette, Abigail;Powers, Jacquelyn;Cappadocia, Jacqueline;Mckenna, Danielle B.;Richardville, Robert;Cuff, Lauren;Offer, Ryan;Clement, Elizabeth G.;Buttenheim, Alison M.;Asch, David A.;Rendle, Katharine A.;Shelton, Rachel C.;Fayanju, Oluwadamilola M.;Wileyto, E. Paul;Plag, Martina;Ware, Sue;Shulman, Lawrence N.;Nathanson, Katherine L.;Domchek, Susan M.
关键词：
生殖系基因检测是由国家综合癌症网络（NCCN）推荐的个人，包括但不限于，那些有卵巢癌个人病史，年轻发病（< 50岁）乳腺癌，卵巢癌或男性乳腺癌家族史的人。基因检测总体上没有得到充分利用，而且在黑人和西班牙裔人群中的比率一直较低。针对患者和临床医生的行为经济学实施策略或推动可能会增加这种循证临床实践的使用。符合乳腺癌和卵巢癌生殖系基因检测资格的患者将使用电子表型算法进行鉴定。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，两种针对患者，一种针对临床医生，部署在不同学术医疗中心的妇产科诊所的电子健康记录（EHR）中。我们将根据相关的临床医生和患者经验、卫生公平和行为经济学，使用快速循环方法，在试验开始前优化和降低我们的策略和方法的风险。步骤1将通过卫生系统患者门户向患者发送消息。对于无应答者，第二步将通过短信联系患者。对于无应答者，步骤3将使用EHR中的新型“等待和发送”工具联系患者的临床医生。主要实施结果是参与乳腺癌和卵巢癌易感性的生殖系基因检测，定义为预定的遗传咨询预约。通过电子病历收集的患者数据（例如，种族/民族，地理编码地址）将作为策略影响的调节因子进行检查。这项研究将是第一个连续检验患者和临床指导策略对参与乳腺癌和卵巢癌基因检测的行为经济学影响的研究之一。务实和顺序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因子。这些发现可能有助于确定低成本、高度可运输的实施策略的影响，这些策略可以整合到医疗保健系统中，以改善基因组医学的使用。ClinicalTrials.gov。NCT05721326。2023年2月10日注册。https://www.clinicaltrials.gov/study/NCT05721326在线版本包含补充资料，下载地址：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.clinicaltrials.gov/study/NCT05721326 The online version contains supplementary material available at 10.1186/s13012-023-01308-w.
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影响因子：
6
作者：
Jayasinghe K;Quinlan C;Mallett AJ;Kerr PG;McClaren B;Nisselle A;Mallawaarachchi A;Polkinghorne KR;Patel C;Best S;Stark Z
通讯作者：
Stark Z
影响因子：
64.8
作者：
Green ED;Gunter C;Biesecker LG;Di Francesco V;Easter CL;Feingold EA;Felsenfeld AL;Kaufman DJ;Ostrander EA;Pavan WJ;Phillippy AM;Wise AL;Dayal JG;Kish BJ;Mandich A;Wellington CR;Wetterstrand KA;Bates SA;Leja D;Vasquez S;Gahl WA;Graham BJ;Kastner DL;Liu P;Rodriguez LL;Solomon BD;Bonham VL;Brody LC;Hutter CM;Manolio TA
通讯作者：
Manolio TA
影响因子：
25.8
作者：
Beidas RS;Buttenheim AM;Mandell DS
通讯作者：
Mandell DS
影响因子：
4.6
作者：
de Moor, Janet S.;Gray, Stacy W.;Freedman, Andrew N.
通讯作者：
Freedman, Andrew N.
影响因子：
5.1
作者：
Franck, Linda S.;Kriz, Rebecca M.;Dimmock, David
通讯作者：
Dimmock, David