Genome Driven Primary Care Clinics - an RCT

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Operating Community Primary Care Clinics Under Personalized Medicine Paradigm and Determining Differences in Health Outcomes Between Clinics With and Without Intervention.

Conditions
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Health Services Administration, Genetic Predisposition, Microbial Colonization

Intervention / Treatment
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* Genetic: Mutation arrays, NGS panels, GWAS, WES, WGS,
* Device: wearable monitors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All clinic adult population All diseases Exclusion Criteria: Mentality unable to understand and sign consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Paired cluster randomization of 40 clinics into 20 intervention and 20 usual care. Randomization from among a couple of similar clinics
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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 | Genetic: Mutation arrays, NGS panels, GWAS, WES, WGS,<br>* DNA extracted from peripheral blood as well as genetic analysis of bacteria from feces<br>Device: wearable monitors<br>* test various technologies of sensors to measure continuously various body functions and provide information to person and to physician<br>|
| No Intervention: Usual care<br>No intervention at all | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chronic diseases in clinic | whole clinic Incidence rate/100,000 of major chronic diseases (hypertension, Hyperlipidemia, DM, IHD, Cancer) | 5 years | 
| Mortality in clinic | whole clinic mortality rate/100,000 of major chronic diseases (DM, cancer, IHD) | 5 ytears | 
| costs in clinic | Total annual cost of clinic activity in NIS, including cost of diagnostic tests and hospitalization | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wearable monitors, microbiome, genomic medicine,