ECOST = Economic and Clinical Outcomes of (Whole Exome) Sequencing in Tapestry
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 100,000
- 试验地点
- 3
- 主要终点
- Change in costs measured by disease related and all-cost related costs.
研究概览
简要总结
The purpose of this research is to learn more about the impact of genetic testing on healthcare costs, clinical care, and quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Tapestry patients who have received genetic results, regardless of positive or negative testing results.
- •Age of 18 and older.
- •Patients with an established Mayo Clinic provider prior to their enrollment in Tapestry.
排除标准
- •Individuals less than 18 years old.
- •Patients without capacity to consent (i.e., needing legal authorized representatives).
- •Prisoners.
- •Subjects eligible for chart review, without a Minnesota Research Authorization on record.
结局指标
主要结局
Change in costs measured by disease related and all-cost related costs.
时间窗: Every 12 months for 5 years after enrollment.
Cost Composite of: Disease-related costs. Disease-related costs by utilization category. All-cause costs. All-cause costs by utilization category.
Change in quality of life measured through adjusted years.
时间窗: Every 12 months for 5 years after enrollment.
Measuring quality of life through adjusted years due to learning Tapestry test results.
Disease incidence measured by disease count per 100 participants.
时间窗: 12 months
Number of disease incidences per 100 participants.
Change in utilization measured by total number of office visits, hospital stays, ER visits, and length of visits.
时间窗: Every 12 months for 5 years after enrollment.
Composite of: Number of Office-based visits. Number of Hospital stays and length of visits. Number of ER visits.
次要结局
- Change in utilization from different scenarios.(Every 12 months for 5 years after enrollment.)
- Change in quality of life measured through adjusted years from subgroups.(Every 12 months for 5 years after enrollment.)
- Change in quality of life measured through adjusted years from different scenarios.(Every 12 months for 5 years after enrollment.)
- Disease incidence from subgroups.(12 months)
- Disease incidence from different scenarios..(12 months)
- Change in utilization from subgroups.(Every 12 months for 5 years after enrollment.)
- Change in costs from subgroups.(Every 12 months for 5 years after enrollment.)
- Change in costs from different scenarios.(Every 12 months for 5 years after enrollment.)