NCT04781205

Genome Driven Primary Care Clinics - an RCT

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200,000 (estimated)
• Sponsor: Carmel Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Health Services Administration
• Genetic Predisposition
• Microbial Colonization

Interventions

Type	Name	Description
GENETIC	Mutation arrays, NGS panels, GWAS, WES, WGS,	DNA extracted from peripheral blood as well as genetic analysis of bacteria from feces
DEVICE	wearable monitors	test various technologies of sensors to measure continuously various body functions and provide information to person and to physician

Timeline

• Start date: 2019-05-01
• Primary completion: 2025-12-01
• Completion: 2029-12-01
• First posted: 2021-03-04
• Last updated: 2021-03-04

Locations

1 site across 1 country: Israel