A Study of the Impact of Genetic Testing on Clinical Decision Making and Patient Care

Pain Clinical Trial

— REVOLUTION  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02487888
• Other study ID #: PB008
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 26, 2015
• Last updated: March 28, 2016
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: Proove Bioscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100000
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Arthritis
• Cardiovascular Diseases
• Chronic Pain
• Diabetes Mellitus, Type 2
• Mental Disorders
• Pain
• Psychotic Disorders

Intervention

Other:
• Unblinded to Genetic Testing Results
The physicians of this group of patients will be unblinded to the results of the genetic testing.
• Blinded to Genetic Testing Results
The physicians of this group of patients will be blinded to the results of the genetic testing. They will be un-blinded to the results of each patient once that patient has completed the study.

Locations

Country	Name	City	State
United States	Lighthouse Medical	Altoona	Pennsylvania
United States	Interventional Pain Institute	Baltimore	Maryland
United States	Medical Clinic - Amy Weinberg M.D. Inc	Beverly Hills	California
United States	Medical Clinic - Dr. Neil Ghodadra	Beverly Hills	California
United States	Snibbe Orthopedics	Beverly Hills	California
United States	Medical Clinic - Dr. Kevin Monahan, MD	Boca Raton	Florida
United States	Personal Medicine, LLC	Chattanooga	Tennessee
United States	Associates MD	Davie	Florida
United States	Medical Clinic - Kevin Ohayon MD Family Medicine	Fort Lauderdale	Florida
United States	Reeders Internal Medicine	Fort Lauderdale	Florida
United States	Troutt & Associates, PSC	Fort Lauderdale	Florida
United States	Comprehensive Pain Clinic	Fort Wayne	Indiana
United States	Bautista Medical Group	Fresno	California
United States	Robert Graham, MD	Fresno	California
United States	Medical Clinic - Anthony Mathis, DPM	Greer	South Carolina
United States	Northgate Neurology	Hixson	Tennessee
United States	Torrey Pines Orthopaedic Medical Group	La Jolla	California
United States	New England Center for Mental Health	Littleton	Massachusetts
United States	Soha Dolatabadi Rheumatology	Los Angeles	California
United States	Medical Clinic - Dr. Rosenberg A. Reyes	Louisville	Kentucky
United States	Neurology of Central Georgia	Macon	Georgia
United States	Morristown Pain Consultants	Morristown	Tennessee
United States	Summit Family Medicine	Murrieta	California
United States	Mallik Tella MD	Portland	Oregon
United States	Macer Medical	Rolling Hills	California
United States	Medical Clinic - Paul C. Murphy, MD Inc	San Diego	California
United States	Idaho Pain Clinic	Sandpoint	Idaho
United States	Pain Clinic of Spokane	Spokane	Washington
United States	Comprehensive Pain Relief Group	Torrance	California
United States	Orthopedic Associates of SW Ohio	Vandalia	Ohio
United States	The Doctor's Office	Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Proove Bioscience, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores on the Pain Numeric Rating Scale (NRS)		60 days	No
Primary	Function/Disability assessment on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)		60 days	No
Primary	Number of Participants that Experience of Adverse Events		Up to 2 years	Yes
Primary	Type of Adverse Events Experienced by Participants		Up to 2 years	Yes
Primary	Severity of Adverse Events Experienced by Participants		Up to 2 years	Yes
Primary	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		Up to 2 years	No
Primary	Medication dosage prescribed to the participants		Up to 2 years	No
Primary	Frequency of participant urine drug screens		Up to 2 years	No
Primary	Self-rated response levels to prescribed medications	Subjects are ask to rate the ability of their medication, on a scale of 0 to 5, to treat their condition and/or relieve their symptoms.	60 days	No
Primary	Presence and Severity of Generalized Anxiety Disorder on the GAD-2		60 days	No
Primary	Presence and Severity of Depression on the PHQ-2		60 days	No
Primary	Presence of atrial fibrillation symptoms and their impact on quality of life using the Severity of Atrial Fibrillation (SAF) scale		60 days	No
Primary	Risk of cardiovascular incidents using the AHA Heart Disease Risk Assessment		60 days	No
Primary	Risk of stroke using the CHA2DS2-VASc Score		60 days	Yes
Primary	Severity of Rheumatoid Arthritis using the Routine Assessment of Patient Index Data (RAPID-3) score		60 days	No
Primary	BMI for patients being treated for T2DM		60 days	No
Primary	Glucose levels for patients being treated for T2DM		60 days	No
Secondary	Co-occurring disorders collected by ICD-9/10 codes		60 days	No
Secondary	Assessment of previous treatments	Participants are asked to rate the benefit of previous treatments on a scale of 0 to 5.	60 days	No
Secondary	Urine drug screen results		60 days	No