Genome Driven Primary Care Clinics - an RCT

Israel Healthcare Foundation

Status: Active, not recruiting

Conditions: Genetic Predisposition; Microbial Colonization; Health Services Administration

Treatments: Device: wearable monitors; Genetic: Mutation arrays, NGS panels, GWAS, WES, WGS,

Study type: Interventional

Funder types: Other

Identifiers

NCT04781205

CMC-16-0071-CTIL

Details and patient eligibility

About

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).

Full 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.

Enrollment: 200,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All clinic adult population
• All diseases

Exclusion criteria

• Mentality unable to understand and sign consent

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200,000 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Genetic: Mutation arrays, NGS panels, GWAS, WES, WGS,

Device: wearable monitors

Usual care

No Intervention group

Description:

No intervention at all