Comparison of 3 Modes of Genetic Counseling in High-Risk Public Hospital Patients

公立医院高危患者3种遗传咨询模式比较

• 批准号: 9755002
• 负责人: RENA Joy PASICK
• 金额: $ 5.94万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-12 至 2021-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9755002
• 关键词: Affect; BRCA1 gene; Breast Cancer Risk Factor; Breast Cancer gene; Cancer Gene Mutation; Caring; Clinical Practice Guideline; Communication; Communications Media; Complex; Conflict (Psychology); Counseling; Data; Decision Making; Distress; Documentation; Ensure; Family; Family Cancer History; Family history of; Foundations; Funding; Gene Mutation; Genetic Counseling; Genetic screening method; Goals; Grant; Healthcare; Hereditary Breast and Ovarian Cancer Syndrome; Hospitals; Income; Individual; Interview; Knowledge; Language; Linguistics; Literature; Low income; Malignant Neoplasms; Malignant neoplasm of ovary; Measures; Medicaid; Medical; Medical Technology; Medical center; Methods; Nature; Outcome; Outcome Study; Participant; Patient Preferences; Patient-Focused Outcomes; Patients; Perception; Persons; Population Dynamics; Positioning Attribute; Practice Guidelines; Process; Professional counselor; Public Hospitals; Quality of Care; Randomized; Reporting; Research; Resources; Risk; Rural; Rural Population; Sampling; Services; Socioeconomic Status; Surveys; Telephone; Testing; Training; Translating; Utah; Variant; Videoconferences; Woman; burden of illness; cancer risk; community clinic; comparative effectiveness; compare effectiveness; cost; editorial; experience; forging; genetic counselor; genetic risk assessment; health disparity; health literacy; high risk; improved outcome; lifetime risk; literacy; malignant breast neoplasm; mutation carrier; patient population; perceived stress; precision medicine; preference; risk perception; safety net; satisfaction; social; symposium; trial comparing

BACKGROUND: Hereditary breast and ovarian cancer is rare but serious. Practice guidelines call for counseling by a certified genetic counselor for those at risk to determine if a genetic test is appropriate and to assist in making an informed decision about testing. For more than two decades, genetic counseling (GC) has been widely available to those with the means to cover the high cost, but has only recently become financially accessible to low-income income patients through Medicaid and foundation grants. As a result, GC is concentrated in elite medical centers and is not offered in most safety net hospitals. Overall, there are too few Genetic Counselors to meet the growing demand. This inequity represents an early and ominous example of how advances in precision medicine can exacerbate health disparities – by leaving further behind those who already experience an excess burden of disease. GC may be extended to the underserved remotely by phone or video conference, but the benefits and harms of these delivery modes for safety net patients are not known. While recent research compared phone and in-person counseling in insured and rural populations, the dynamics are different in the safety net, and video conference and patient preference were not assessed. The complex and highly personal nature of this interaction, along with the importance of culture and health literacy, inform our research questions: i) what is the comparative effectiveness of GC delivered face to face, by phone, or via videoconference for public hospital patients with regard to knowledge, cancer distress, decisional conflict, perceived stress, risk perception, satisfaction, recall, and patient centeredness? ii) how do culture and health literacy influence these outcomes? iii) do safety net patients have a preference for mode of counseling and how does preference affect outcomes? AIMS: 1. Compare 3 modes of genetic counseling with patients at high risk for HBOC in 3 public hospitals. 2. Explore inductively and qualitatively variation in patients’ genetic counseling experiences and understandings; genetic counselors’ satisfaction and perceptions; and counseling session similarities and differences. METHODS: Using mixed methods, we will conduct a multicenter partially randomized preference noninferiority trial with high-risk English-, Spanish-, and Cantonese-speaking patients assigned by (1) patients´ preference or (2) randomization to three counseling modes: (a) in-person; (b) phone; or (c) video conference. A total of 600 patients will complete counseling and 540 will complete the final survey. Baseline and post-counseling surveys will use validated measures (adapted for literacy and language) of study outcomes. All counseling sessions will be audio-taped. A sample of 90 tapes will be analyzed for counseling content and to identify 30 participants for in-depth interviews and analysis triangulating all forms of data. Genetic counselors will be interviewed in depth to elicit their perceptions of the strengths and limitations of each counseling mode.

背景：遗传性乳腺癌和卵巢癌是罕见但严重的疾病。实践指南呼吁 由注册遗传顾问为有风险的人提供咨询，以确定基因测试是否合适，并 协助做出有关测试的明智决定。二十多年来，遗传咨询(GC)一直 对那些有能力支付高额费用的人来说是广泛可用的，但直到最近才变得经济上 低收入患者可通过医疗补助和基金会赠款获得。因此，GC是 集中在精英医疗中心，在大多数安全网医院不提供。总体而言，数量太少了。 基因咨询师满足了日益增长的需求。这种不平等是一个早期和不祥的例子 精准医学的进步如何通过进一步落后于那些 已经经历了过度的疾病负担。GC可以通过电话远程扩展到服务不足的人 或视频会议，但这些交付方式对安全网患者的好处和危害尚不清楚。 虽然最近的研究比较了电话咨询和面对面咨询在参保人口和农村人口中的作用，但 安全网中的动态是不同的，视频会议和患者的偏好没有得到评估。这个 这种互动的复杂性和高度个人化的性质，以及文化和健康素养的重要性， 告知我们的研究问题：i)面对面、电话、 或通过视频会议为公立医院的患者提供关于知识、癌症痛苦、决策 冲突、感受到的压力、风险感知、满意度、回忆和以病人为中心？二)文化和文化如何 健康素养会影响这些结果吗？三)安全网患者是否偏爱咨询方式 偏好是如何影响结果的？ 目的：1.比较3所公立医院针对高危人群的3种遗传咨询模式。 2.探索患者遗传咨询经历的诱导性和定性差异 理解；遗传咨询师的满意度和认知；以及咨询会话的相似性 和差异。 方法：采用混合方法，进行多中心部分随机偏好非劣势检验 对讲英语、西班牙语和粤语的高危患者进行的试验，根据(1)患者的喜好或 (2)随机分为三种咨询模式：(A)面对面；(B)电话；或(C)视频会议。总共600个 患者将完成咨询，540人将完成最终调查。基线和咨询后调查 将使用经过验证的研究结果的衡量标准(根据识字和语言进行调整)。所有的咨询课程 都会被录下来。将对90盘磁带的样本进行分析，以确定30名参与者的咨询内容 对所有形式的数据进行深入访谈和分析。遗传咨询师将在#年接受采访 深入了解他们对每种咨询模式的优点和局限性的看法。