Genome Driven Primary Care Clinics - an RCT

• Sponsor: Carmel Medical Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04781205
• Collaborator: (none)
• Enrollment: 200,000
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 127
• Patients Per Site Per Month: 1574.2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Health Services Administration; Genetic Predisposition; Microbial Colonization	Genetic: Mutation arrays, NGS panels, GWAS, WES, WGS,; Device: wearable monitors	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 200000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Paired cluster randomization of 40 clinics into 20 intervention and 20 usual care. Randomization from among a couple of similar clinicsPaired cluster randomization of 40 clinics into 20 intervention and 20 usual care. Randomization from among a couple of similar clinics
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Operating Community Primary Care Clinics Under Personalized Medicine Paradigm and Determining Differences in Health Outcomes Between Clinics With and Without Intervention.
• Actual Study Start Date: May 1, 2019
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Dec 1, 2029

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. chronic diseases in clinic [5 years]

   whole clinic Incidence rate/100,000 of major chronic diseases (hypertension, Hyperlipidemia, DM, IHD, Cancer)

2. Mortality in clinic [5 ytears]

   whole clinic mortality rate/100,000 of major chronic diseases (DM, cancer, IHD)

3. costs in clinic [5 years]

   Total annual cost of clinic activity in NIS, including cost of diagnostic tests and hospitalization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All clinic adult population

• All diseases

Exclusion Criteria:

• Mentality unable to understand and sign consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carmel Medical Center	Haifa		Israel	3436217

Sponsors and Collaborators

• Carmel Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gad Rennert, Professor and Chairman, Dept. of Community Medicine and Epidemiology, Carmel Medical Center
• ClinicalTrials.gov Identifier: NCT04781205
• Other Study ID Numbers: CMC-16-0071-CTIL
• First Posted: Mar 4, 2021
• Last Update Posted: Mar 4, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gad Rennert, Professor and Chairman, Dept. of Community Medicine and Epidemiology, Carmel Medical Center: wearable monitors, microbiome, genomic medicine,
• Additional relevant MeSH terms: Communicable Diseases; Infections; Disease Susceptibility; Genetic Predisposition to Disease

Study Results

No Results Posted as of Mar 4, 2021