Clinical trial NCT04781205: Genome Driven Primary Care Clinics - an RCT
Official title: Operating Community Primary Care Clinics Under Personalized Medicine Paradigm and Determining Differences in Health Outcomes Between Clinics With and Without Intervention.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Health Services Administration
Genetic Predisposition
Microbial Colonization
Keywords: wearable monitors, microbiome, genomic medicine,
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 200000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Paired cluster randomization of 40 clinics into 20 intervention and 20 usual care. Randomization from among a couple of similar clinics
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* All clinic adult population
* All diseases

Exclusion Criteria:

* Mentality unable to understand and sign consent

Primary outcomes:
measure: chronic diseases in clinic
timeFrame: 5 years
measure: Mortality in clinic
timeFrame: 5 ytears
measure: costs in clinic
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Clalit National Cancer Control Center Carmel Medical Center, Technion,
name: Gad Rennert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: