Study protocol: a cluster randomized controlled trial of web-based decision support tools for increasing BRCA1/2 genetic counseling referral in primary care
Study protocol: a cluster randomized controlled trial of web-based decision support tools for increasing BRCA1/2 genetic counseling referral in primary care
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DOI：
10.1186/s12913-018-3442-x
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发表时间：
2018-08-13
影响因子：
2.8
通讯作者：
Kukafka, Rita
中科院分区：
文献类型：
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作者：
Silverman, Thomas B.;Vanegas, Alejandro;Kukafka, Rita
背景：BRCA1和BRCA2突变使携带它们的人有很大的患乳腺癌的风险。出于这个原因，美国预防服务工作组（USPSTF）建议所有妇女在初级保健机构进行筛查，以确定是否有突变家族史，有乳腺癌或卵巢癌家族史的妇女应进行遗传咨询。然而，很少有高危妇女进行常规筛查，很少有妇女进行遗传咨询。为了满足这一需求，我们开发了两种决策支持工具，并将其整合到临床护理中。方法：本研究为高危患者及其医护人员的整群随机对照试验。患者-提供者二人组将随机接受标准教育，并辅以面向患者的决策辅助，Real-Risks和面向提供者的乳腺癌风险导航工具箱（BNAV），或者单独接受标准教育。我们将评估这些工具在促进遗传咨询的吸收和关于基因检测的知情和共同决策方面的有效性。讨论：如果发现有效，这些工具可以帮助将基因组风险评估纳入初级保健，并最终帮助更多的高危妇女获得适合风险的乳腺癌预防选择。
Background: BRCA1 and BRCA2 mutations confer a substantial breast risk of developing breast cancer to those who carry them. For this reason, the United States Preventative Services Task Force (USPSTF) has recommended that all women be screened in the primary care setting for a family history indicative of a mutation, and women with strong family histories of breast or ovarian cancer be referred to genetic counseling. However, few high-risk women are being routinely screened and fewer are referred to genetic counseling. To address this need we have developed two decision support tools that are integrated into clinical care.Method: This study is a cluster randomized controlled trial of high-risk patients and their health care providers. Patient-provider dyads will be randomized to receive either standard education that is supplemented with the patient-facing decision aid, Real-Risks, and the provider-facing Breast Cancer Risk Navigation Toolbox (BNAV) or standard education alone. We will assess these tools' effectiveness in promoting genetic counseling uptake and informed and shared decision making about genetic testing.Discussion: If found to be effective, these tools can help integrate genomic risk assessment into primary care and, ultimately, help expand access to risk-appropriate breast cancer prevention options to a broader population of high-risk women.