Clinical trial NCT02487888: A Study of the Impact of Genetic Testing on Clinical Decision Making and Patient Care
Official title: Randomized, Blinded, Controlled Trial to EValuate the EcOnomic and ClinicaL Outcomes of Utilizing Genetic Testing to Improve Therapeutic Decision-Making COmpared to Empiric Prescribing as the StaNdard of Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Chronic Pain
Mental Disorders
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Arthritis
Keywords: Genetic Variation
Genetic Polymorphism
Polymorphism, Single Nucleotide
Genetic Association Studies
Healthcare Utilization
Lead sponsor: Proove Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-02
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the impact of genetic testing on healthcare decisions and patient outcomes for patients suffering from pain, cardiovascular problems, Arthritis, Type II Diabetes, and/or Mental Health disorders. Results of genetic testing will also be compared with the clinical outcome measures collected to discover novel genetic factors that may influence patient care.

Detailed description: The molecular basis of many pharmacogenetic polymorphisms has now been elucidated, with genetic variations resulting in alteration of expression or function of receptors, enzymes, and transporters relevant to the safety and efficacy of a medical treatment. Genetics has been shown to be a significant factor in the variability of responses of medication choices and doses. With the rapid development of cost-effective high throughput molecular genotyping methods, pharmacogenetics has become increasingly important because of its potential to identify patients with increased risk of adverse drug reactions or decreased likelihood of response at standard dosage of drug. By identifying the genetic risks and the most effective therapy for an individual patient, clinicians may improve the efficacy of treatment and decrease the risk of adverse drug events. The addition of pharmacogenetic testing to routine clinical practice may also be extremely helpful because of the cost reduction associated with the identification of patients that will not respond to expensive drugs or with the identification of patients likely to suffer from severe adverse events. There are also tremendous efforts in the pharmaceutical industry to lower the cost for drug development; pharmacogenetics may fulfill the need to provide the right drug to the right patient and to increase the likelihood of success of large phase II and phase III clinical trials.

The purpose of this study is to evaluate how currently available genetic tests are being implemented in various clinics around the United States, and whether this information results in benefits to patient care. Patients presenting to clinics with pain, cardiovascular conditions, Arthritis, Type II Diabetes, and/or Mental Health disorders that are receiving Proove Bioscience's genetic testing will complete validated questionnaires to measure specific outcomes related to their treatment at each clinical visit, including medication efficacy, reduction in adverse drug events, and healthcare utilization. Physicians will document any changes made to treatment regimens, including adjustments to medications or non-pharmacological treatments, and any improvements in the outcome measures. Statistical analysis will be performed to calculate relationships between genotypic and phenotypic data points collected in this study.

The results of this study will provide a measurable understanding of the medical and economic value of implementing genetic testing into clinical care. Furthermore, data points collected will be used to examine novel correlations and associations between single nucleotide polymorphisms and longitudinal clinical outcome measures.

Eligibility criteria: Inclusion Criteria:

* Provide signed and dated informed consent form
* Willing to comply with all study procedures and be available for the duration of the study
* Male or Female, at least 18 years of age
* Currently taking or a candidate for medication
* Documented or recent complaint within 90 days with initial date of onset

Exclusion Criteria:

* Severe hepatic or renal disease (where current pharmaceutical dosing is affected and/or requires adjustment of standard dosing prior to PGx testing)
* Significant diminished mental capacity that is unable to understand the protocol, surveys and questionnaires; unable to read/write English or Spanish.
* Recent febrile illness that precludes or delays participation by more than 1 month
* Pregnancy or lactation
* Participation in a clinical study that may interfere with participation in this study
* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Primary outcomes:
measure: Pain Scores on the Pain Numeric Rating Scale (NRS)
timeFrame: 60 days
measure: Function/Disability assessment on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 60 days
measure: Number of Participants that Experience of Adverse Events
timeFrame: Up to 2 years
measure: Type of Adverse Events Experienced by Participants
timeFrame: Up to 2 years
measure: Severity of Adverse Events Experienced by Participants
timeFrame: Up to 2 years
measure: Type of medication or alternative therapy prescribed for participants, as listed on the Medication Efficacy Differentiation (MED) Scale or on the investigator's evaluation form
timeFrame: Up to 2 years
measure: Medication dosage prescribed to the participants
timeFrame: Up to 2 years
measure: Frequency of participant urine drug screens
timeFrame: Up to 2 years
measure: Self-rated response levels to prescribed medications
timeFrame: 60 days
measure: Presence and Severity of Generalized Anxiety Disorder on the GAD-2
timeFrame: 60 days
measure: Presence and Severity of Depression on the PHQ-2
timeFrame: 60 days
measure: Presence of atrial fibrillation symptoms and their impact on quality of life using the Severity of Atrial Fibrillation (SAF) scale
timeFrame: 60 days
measure: Risk of cardiovascular incidents using the AHA Heart Disease Risk Assessment
timeFrame: 60 days
measure: Risk of stroke using the CHA2DS2-VASc Score
timeFrame: 60 days
measure: Severity of Rheumatoid Arthritis using the Routine Assessment of Patient Index Data (RAPID-3) score
timeFrame: 60 days
measure: BMI for patients being treated for T2DM
timeFrame: 60 days
measure: Glucose levels for patients being treated for T2DM
timeFrame: 60 days
Secondary outcomes:
measure: Co-occurring disorders collected by ICD-9/10 codes
timeFrame: 60 days
measure: Assessment of previous treatments
timeFrame: 60 days
measure: Urine drug screen results
timeFrame: 60 days
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Medical Clinic - Amy Weinberg M.D. Inc
state: California
city: Beverly Hills
country: United States
facility: Medical Clinic - Dr. Neil Ghodadra
state: California
city: Beverly Hills
country: United States
facility: Snibbe Orthopedics
state: California
city: Fresno
country: United States
facility: Robert Graham, MD
state: California
city: Fresno
country: United States
facility: Bautista Medical Group
state: California
city: La Jolla
country: United States
facility: Torrey Pines Orthopaedic Medical Group
state: California
city: Los Angeles
country: United States
facility: Soha Dolatabadi Rheumatology
state: California
city: Murrieta
country: United States
facility: Summit Family Medicine
state: California
city: Rolling Hills
country: United States
facility: Macer Medical
state: California
city: San Diego
country: United States
facility: Medical Clinic - Paul C. Murphy, MD Inc
state: California
city: Torrance
country: United States
facility: Comprehensive Pain Relief Group
state: California
city: Vista
country: United States
facility: The Doctor's Office
state: California
city: Boca Raton
country: United States
facility: Medical Clinic - Dr. Kevin Monahan, MD
state: Florida
city: Davie
country: United States
facility: Associates MD
state: Florida
city: Fort Lauderdale
country: United States
facility: Reeders Internal Medicine
state: Florida
city: Fort Lauderdale
country: United States
facility: Troutt & Associates, PSC
state: Florida
city: Fort Lauderdale
country: United States
facility: Medical Clinic - Kevin Ohayon MD Family Medicine
state: Florida
city: Macon
country: United States
facility: Neurology of Central Georgia
state: Georgia
city: Sandpoint
country: United States
facility: Idaho Pain Clinic
state: Idaho
city: Fort Wayne
country: United States
facility: Comprehensive Pain Clinic
state: Indiana
city: Louisville
country: United States
facility: Medical Clinic - Dr. Rosenberg A. Reyes
state: Kentucky
city: Baltimore
country: United States
facility: Interventional Pain Institute
state: Maryland
city: Littleton
country: United States
facility: New England Center for Mental Health
state: Massachusetts
city: Vandalia
country: United States
facility: Orthopedic Associates of SW Ohio
state: Ohio
city: Portland
country: United States
facility: Mallik Tella MD
state: Oregon
city: Altoona
country: United States
facility: Lighthouse Medical
state: Pennsylvania
city: Greer
country: United States
facility: Medical Clinic - Anthony Mathis, DPM
state: South Carolina
city: Chattanooga
country: United States
facility: Personal Medicine, LLC
state: Tennessee
city: Hixson
country: United States
facility: Northgate Neurology
state: Tennessee
city: Morristown
country: United States
facility: Morristown Pain Consultants
state: Tennessee
city: Spokane
country: United States
facility: Pain Clinic of Spokane
state: Washington
Study officials:
affiliation: G.S. Medical Center Inc./Comprehensive Pain Relief Group
name: Gregory A Smith, M.D.
role: PRINCIPAL_INVESTIGATOR
References: