Genome Driven Primary Care Clinics - an RCT

Not Applicable

Active, not recruiting

• Conditions: Genetic Predisposition; Health Services Administration; Microbial Colonization
• Interventions: Genetic: Mutation arrays, NGS panels, GWAS, WES, WGS,; Device: wearable monitors

• Registration Number: NCT04781205
• Lead Sponsor: Carmel Medical Center

Brief Summary

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

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

1. 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.

2. Examine whether the public has an interest in extensive genetic testing.

3. Examine whether the medical staff has an interest and ability to assimilate a genomic approach in the routine clinic work.

4. Identify links between genetic markers (mutations, variants) and different diseases (incidence or clinical behavior) or different drug responses (resistance, effectiveness, side-effects).

5. Examine whether the implementation of prolonged personal monitoring devices will lead to improved morbidity and mortality indices.

6. Examine whether measuring genomic variability in the microbiome has implications on health status or means of coping with different diseases and different health conditions.

Study Timeline

• Study Start: 2019-05-01
• Status Verified: 2021-02
• Study First Submitted: 2021-02-14
• Study First Submitted QC: 2021-02-28
• Last Update Submitted: 2021-02-28
• Study First Posted: 2021-03-04
• Last Update Posted: 2021-03-04
• Primary Completion: 2025-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200000

Inclusion Criteria

• All clinic adult population
• All diseases

Exclusion Criteria

• Mentality unable to understand and sign consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Mutation arrays, NGS panels, GWAS, WES, WGS,	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
Intervention	wearable monitors	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Carmel Medical Center; 🇮🇱 Haifa, Israel