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.

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 Overview

• Status: Active, not recruiting
• Conditions: Microbial Colonization; Genetic Predisposition; Health Services Administration
• Intervention / Treatment: Genetic: Mutation arrays, NGS panels, GWAS, WES, WGS,; Device: wearable monitors

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 Type: Interventional
• Enrollment (Anticipated): 200000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 3436217
    • Carmel Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All clinic adult population
• All diseases

Exclusion Criteria:

• Mentality unable to understand and sign consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
No Intervention: Usual care; No intervention at all

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Carmel Medical Center
• Investigators: Principal Investigator: Gad Rennert, MD, PhD, Clalit National Cancer Control Center Carmel Medical Center, Technion,

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2029

Study Registration Dates

• First Submitted: February 14, 2021
• First Submitted That Met QC Criteria: February 28, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: February 28, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: wearable monitors, microbiome, genomic medicine,
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Disease Susceptibility; Genetic Predisposition to Disease
• Other Study ID Numbers: CMC-16-0071-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: study comparative unit is a whole clinic and not an individual participants

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No