Broadening the Reach, Impact, and Delivery of Genetic Services
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,073
- 试验地点
- 3
- 主要终点
- Completion of Genetic Testing From Electronic Health Record
研究概览
简要总结
The purpose of this study is to compare the uptake of genetic testing among patients randomized with two different models of genetic services delivery (a patient-directed model and an enhanced standard of care model) and examine whether the impact on uptake differs by race/ethnicity and rurality. This study will also compare the effect of these delivery models on adherence to cancer prevention and screening recommendations and other patient responses.
详细描述
Patient Screening: A comprehensive screening algorithm will identify patients with family history data in various sections of the electronic health record (EHR) who meet current genetic testing criteria. Randomization to study arm (Enhanced Standard of Care or Patient-Directed Standard of Care) will be at the level of the primary care clinic.
Enhanced Standard of Care Patients will be offered the opportunity to schedule a pre-test genetic counseling visit. Pre-test counseling includes review of the family history, risk assessment, discussion of the purpose of genetic testing and possible outcomes, implications for insurance coverage, costs, and assessment of psychosocial needs. Patients can opt to proceed with genetic testing during this session. All test results are returned by a genetic counselor by phone or in person based on the patient preference. A copy of the results and a letter with tailored screening recommendations are returned to the primary care provider and patient via the patient portal or mail.
Patient-Directed Standard of Care The pre-test genetic counseling visit will be conducted through access to an automated genetics education assistant accessed through the patient portal of the electronic health record. The automated approach will address all the components of the pre-test counseling and contains content designed by the genetic counselors at the University of Utah and NYU (New York University). Patients will have the option to contact genetic counselors through the patient portal, by phone, or in person but this will not be required. All results will be reviewed by a genetic counselor. Negative results will be returned by the automated genetics education assistant. Genetic counselors will return results for pathogenic variants and variants of uncertain significance via phone. A copy of the results and a letter with tailored screening recommendations will be provided to the patient and primary care provider via the patient portal.
All patients will be offered the option to schedule follow-up appointments in the genetics clinics.
Genetic Testing:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Speaks English or Spanish
- •First degree relative or second degree relative diagnosed with the following regardless of age: Ovarian Cancer, Pancreas Cancer
- •First degree relative or second degree relative diagnosed with the following <50 years of age: Breast Cancer, Colorectal Cancer, Endometrial Cancer.
- •Three of more relatives on the same side of the family diagnosed with the following clusters of cancer regardless of age:
- •Breast Cancer, Ovarian Cancer, Pancreas Cancer, Prostate Cancer
- •Colorectal Cancer, Endometrial Cancer, Ovarian Cancer, Pancreas Cancer, Urinary tract, Brain, Small intestine
- •Melanoma, Pancreas Cancer
- •Ashkenazi Jewish ancestry and family history of Breast Cancer, Ovarian Cancer, Pancreas Cancer, Prostate Cancer.
排除标准
- •Patients with a prior cancer diagnosis, other than non-melanoma skin cancer, and/or prior genetic counseling or testing related to hereditary cancer.
- •Patients unable to access the patient portal
结局指标
主要结局
Completion of Genetic Testing From Electronic Health Record
时间窗: 1 month following pre-test genetic counseling
Percentage of patients who decide to receive genetic testing
次要结局
- Completion of Pre-test Genetic Counseling From Electronic Health Record(1 month after study invitation)
- Adherence to Colonoscopy: Questionnaire(8 weeks and 13 months from pre-test counseling)
研究者
Kimberly Kaphingst
Professor
University of Utah