Comparing models of delivery for cancer genetics services among patients receiving primary care who meet criteria for genetic evaluation in two healthcare systems: BRIDGE randomized controlled trial.
Comparing models of delivery for cancer genetics services among patients receiving primary care who meet criteria for genetic evaluation in two healthcare systems: BRIDGE randomized controlled trial.
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DOI：
10.1186/s12913-021-06489-y
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发表时间：
2021-06-02
影响因子：
2.8
通讯作者：
BRIDGE research team
中科院分区：
文献类型：
--
作者：
Kaphingst KA;Kohlmann W;Chambers RL;Goodman MS;Bradshaw R;Chan PA;Chavez-Yenter D;Colonna SV;Espinel WF;Everett JN;Gammon A;Goldberg ER;Gonzalez J;Hagerty KJ;Hess R;Kehoe K;Kessler C;Kimball KE;Loomis S;Martinez TR;Monahan R;Schiffman JD;Temares D;Tobik K;Wetter DW;Mann DM;Kawamoto K;Del Fiol G;Buys SS;Ginsburg O;BRIDGE research team
遗传学和测序技术的进步使更多具有遗传性癌症易感性的个体能够从量身定制的筛查和预防建议中受益。虽然癌症家族史信息被用于初级保健环境中，以确定未受影响的患者谁可以受益于癌症遗传学评估，这一信息是利用不足。需要系统一级的人口健康管理战略，以协助卫生保健系统确定可能受益于遗传服务的患者。此外，由于训练有素的遗传学专家人数有限，而患者数量不断增加，因此必须制定创新和可持续的方法来提供癌症遗传服务。我们正在进行一项随机对照试验，题为扩大遗传服务的范围、影响和提供（BRIDGE），以满足这些需求。该试验比较了遗传咨询的使用，遗传检测的使用以及患者对自动化，患者导向与增强标准护理癌症遗传学服务交付模式的管理建议的依从性。一个基于算法的系统，利用电子健康记录（EHR）中可用的结构化癌症家族史数据，用于识别在研究中心接受初级护理并符合当前癌症基因检测指南的未受影响的患者。我们正在两个医疗保健系统（犹他州大学健康中心和纽约大学Langone健康中心）招募符合条件的患者，方法是在两个研究中心随机选择2780例符合条件的患者样本，并以1：1的比例随机分配至研究中心内的遗传服务提供组。研究结果通过遗传学诊所记录、EHR和最后一次遗传咨询后4周和12个月的两次随访问卷进行评估。BRIDGE正在两个具有不同临床结构和患者人群的医疗保健系统中进行。该试验的创新方面包括将基于聊天机器人的遗传服务提供模式与标准护理进行随机比较，以及通过可持续的基于EHR的系统识别风险个体。BRIDGE试验的发现将推动科学界在识别具有遗传性癌症易感性的未受影响的患者以及为这些患者提供遗传服务方面的发展。BRIDGE注册号为NCT 03985852。该试验于2019年6月6日在clinicaltrials.gov注册。在线版本包含补充材料，可在10.1186/s12913-021-06489-y获得。
Advances in genetics and sequencing technologies are enabling the identification of more individuals with inherited cancer susceptibility who could benefit from tailored screening and prevention recommendations. While cancer family history information is used in primary care settings to identify unaffected patients who could benefit from a cancer genetics evaluation, this information is underutilized. System-level population health management strategies are needed to assist health care systems in identifying patients who may benefit from genetic services. In addition, because of the limited number of trained genetics specialists and increasing patient volume, the development of innovative and sustainable approaches to delivering cancer genetic services is essential. We are conducting a randomized controlled trial, entitled Broadening the Reach, Impact, and Delivery of Genetic Services (BRIDGE), to address these needs. The trial is comparing uptake of genetic counseling, uptake of genetic testing, and patient adherence to management recommendations for automated, patient-directed versus enhanced standard of care cancer genetics services delivery models. An algorithm-based system that utilizes structured cancer family history data available in the electronic health record (EHR) is used to identify unaffected patients who receive primary care at the study sites and meet current guidelines for cancer genetic testing. We are enrolling eligible patients at two healthcare systems (University of Utah Health and New York University Langone Health) through outreach to a randomly selected sample of 2780 eligible patients in the two sites, with 1:1 randomization to the genetic services delivery arms within sites. Study outcomes are assessed through genetics clinic records, EHR, and two follow-up questionnaires at 4 weeks and 12 months after last genetic counseling contactpre-test genetic counseling. BRIDGE is being conducted in two healthcare systems with different clinical structures and patient populations. Innovative aspects of the trial include a randomized comparison of a chatbot-based genetic services delivery model to standard of care, as well as identification of at-risk individuals through a sustainable EHR-based system. The findings from the BRIDGE trial will advance the state of the science in identification of unaffected patients with inherited cancer susceptibility and delivery of genetic services to those patients. BRIDGE is registered as NCT03985852. The trial was registered on June 6, 2019 at clinicaltrials.gov. The online version contains supplementary material available at 10.1186/s12913-021-06489-y.
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