Operating Community Primary Care Clinics Under Personalized Medicine Paradigm and Determining Differences in Health Outcomes Between Clinics With and Without Intervention.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200,000
- 试验地点
- 1
- 主要终点
- Mortality in clinic
研究概览
简要总结
A cluster randomized controlled study of 40 primary care clinics in Northern Israel (20 intervention clinics, 20 usual care clinics) to evaluate the value of introducing a precision medicine/genomic approach/paradigm on the clinical and economical outcomes of the clinics. Intervention includes 3 elements: 1. DNA extraction and evaluation (up to the level of WGS); 2. Feces sample for microbiome study, 3. Wearable devices for continuous monitoring of body functions. Expected number of participants is 100,000 in each arm. Results will be calculated for a clinic as a unit and not for individuals (each clinic to be compared to "twin" selected clinic).
详细描述
Study major aim:
Assess whether employing a paradigm of genomic/precision medicine in primary care clinics can lead to an improvement in the medical or economic outcomes of the clinic as a unit.
Specific and secondary aims
- Study differences in morbidity, mortality, quality of life or the cost of medical service indicators between clinics operating under a genome driven paradigm compared to usual care clinics.
- Examine whether the public has an interest in extensive genetic testing.
- Examine whether the medical staff has an interest and ability to assimilate a genomic approach in the routine clinic work.
- Identify links between genetic markers (mutations, variants) and different diseases (incidence or clinical behavior) or different drug responses (resistance, effectiveness, side-effects).
- Examine whether the implementation of prolonged personal monitoring devices will lead to improved morbidity and mortality indices.
- Examine whether measuring genomic variability in the microbiome has implications on health status or means of coping with different diseases and different health conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All clinic adult population
- •All diseases
排除标准
- •Mentality unable to understand and sign consent
研究组 & 干预措施
Intervention
Members of clinics randomized into intervention arm will be consented on a blood test for DNA evaluation (up to WGS), a single feces sample for microbiome analysis and tentative agreement to ware monitors of various vital signs of body function
干预措施: wearable monitors (Device)
Intervention
Members of clinics randomized into intervention arm will be consented on a blood test for DNA evaluation (up to WGS), a single feces sample for microbiome analysis and tentative agreement to ware monitors of various vital signs of body function
干预措施: Mutation arrays, NGS panels, GWAS, WES, WGS, (Genetic)
Usual care
No intervention at all
结局指标
主要结局
Mortality in clinic
时间窗: 5 ytears
whole clinic mortality rate/100,000 of major chronic diseases (DM, cancer, IHD)
costs in clinic
时间窗: 5 years
Total annual cost of clinic activity in NIS, including cost of diagnostic tests and hospitalization
chronic diseases in clinic
时间窗: 5 years
whole clinic Incidence rate/100,000 of major chronic diseases (hypertension, Hyperlipidemia, DM, IHD, Cancer)
次要结局
未报告次要终点
研究者
Gad Rennert
Professor and Chairman, Dept. of Community Medicine and Epidemiology
Carmel Medical Center