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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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 |
|
| Usual care | No Intervention | No intervention at all |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mutation arrays, NGS panels, GWAS, WES, WGS, | Genetic | DNA extracted from peripheral blood as well as genetic analysis of bacteria from feces |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gad Rennert, MD, PhD | Clalit National Cancer Control Center Carmel Medical Center, Technion, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carmel Medical Center | Haifa | 3436217 | Israel |
study comparative unit is a whole clinic and not an individual participants
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| ID | Term |
|---|---|
| D020022 | Genetic Predisposition to Disease |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D055106 | Genome-Wide Association Study |
| D000073336 | Whole Genome Sequencing |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017720 | Molecular Epidemiology |
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Paired cluster randomization of 40 clinics into 20 intervention and 20 usual care. Randomization from among a couple of similar clinics
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| wearable monitors | Device | test various technologies of sensors to measure continuously various body functions and provide information to person and to physician |
|
| D007239 | Infections |
| D056726 | Genetic Association Studies |
| D005821 | Genetic Techniques |
| D020411 | Oligonucleotide Array Sequence Analysis |
| D017421 | Sequence Analysis |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D017422 | Sequence Analysis, DNA |