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

March 28, 2016 updated by: Proove Bioscience, Inc.

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

100000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Beverly Hills, California, United States, 90211
        • Medical Clinic - Amy Weinberg M.D. Inc
      • Beverly Hills, California, United States, 90212
        • Medical Clinic - Dr. Neil Ghodadra
      • Beverly Hills, California, United States, 90212
        • Snibbe Orthopedics
      • Fresno, California, United States, 93710
        • Robert Graham, MD
      • Fresno, California, United States, 93726
        • Bautista Medical Group
      • La Jolla, California, United States, 92037
        • Torrey Pines Orthopaedic Medical Group
      • Los Angeles, California, United States, 90017
        • Soha Dolatabadi Rheumatology
      • Murrieta, California, United States, 92563
        • Summit Family Medicine
      • Rolling Hills, California, United States, 90274
        • Macer Medical
      • San Diego, California, United States, 92122
        • Medical Clinic - Paul C. Murphy, MD Inc
      • Torrance, California, United States, 90501
        • Comprehensive Pain Relief Group
      • Vista, California, United States, 92083
        • The Doctor's Office
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Medical Clinic - Dr. Kevin Monahan, MD
      • Davie, Florida, United States, 33328
        • Associates MD
      • Fort Lauderdale, Florida, United States, 33316
        • Reeders Internal Medicine
      • Fort Lauderdale, Florida, United States, 33316
        • Troutt & Associates, PSC
      • Fort Lauderdale, Florida, United States, 33334
        • Medical Clinic - Kevin Ohayon MD Family Medicine
    • Georgia
      • Macon, Georgia, United States, 31210
        • Neurology of Central Georgia
    • Idaho
      • Sandpoint, Idaho, United States, 83864
        • Idaho Pain Clinic
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Comprehensive Pain Clinic
    • Kentucky
      • Louisville, Kentucky, United States, 40214
        • Medical Clinic - Dr. Rosenberg A. Reyes
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Interventional Pain Institute
    • Massachusetts
      • Littleton, Massachusetts, United States, 01460
        • New England Center for Mental Health
    • Ohio
      • Vandalia, Ohio, United States, 45414
        • Orthopedic Associates of SW Ohio
    • Oregon
      • Portland, Oregon, United States, 97216
        • Mallik Tella MD
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16601
        • Lighthouse Medical
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Medical Clinic - Anthony Mathis, DPM
    • Tennessee
      • Chattanooga, Tennessee, United States, 37416-166
        • Personal Medicine, LLC
      • Hixson, Tennessee, United States, 37343
        • Northgate Neurology
      • Morristown, Tennessee, United States, 37813
        • Morristown Pain Consultants
    • Washington
      • Spokane, Washington, United States, 99006
        • Pain Clinic of Spokane

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pain
Patients presenting to a clinic for pain, that will be either blinded to genetic testing results or unblinded to genetic testing results
The physicians of this group of patients will be unblinded to the results of the genetic testing.
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.
Experimental: Mental Health
Patients presenting to a clinic for mental health disorders, that will be either blinded to genetic testing results or unblinded to genetic testing results
The physicians of this group of patients will be unblinded to the results of the genetic testing.
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.
Experimental: Cardiovascular
Patients presenting to a clinic for cardiovascular complications, that will be either blinded to genetic testing results or unblinded to genetic testing results
The physicians of this group of patients will be unblinded to the results of the genetic testing.
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.
Experimental: Arthritis
Patients presenting to a clinic for osteoarthritis or rheumatoid arthritis, that will be either blinded to genetic testing results or unblinded to genetic testing results
The physicians of this group of patients will be unblinded to the results of the genetic testing.
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.
Experimental: Type 2 Diabetes Mellitus
Patients presenting to a clinic for T2DM, that will be either blinded to genetic testing results or unblinded to genetic testing results
The physicians of this group of patients will be unblinded to the results of the genetic testing.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores on the Pain Numeric Rating Scale (NRS)
Time Frame: 60 days
60 days
Function/Disability assessment on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: 60 days
60 days
Number of Participants that Experience of Adverse Events
Time Frame: Up to 2 years
Up to 2 years
Type of Adverse Events Experienced by Participants
Time Frame: Up to 2 years
Up to 2 years
Severity of Adverse Events Experienced by Participants
Time Frame: Up to 2 years
Up to 2 years
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
Time Frame: Up to 2 years
Up to 2 years
Medication dosage prescribed to the participants
Time Frame: Up to 2 years
Up to 2 years
Frequency of participant urine drug screens
Time Frame: Up to 2 years
Up to 2 years
Self-rated response levels to prescribed medications
Time Frame: 60 days
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
Presence and Severity of Generalized Anxiety Disorder on the GAD-2
Time Frame: 60 days
60 days
Presence and Severity of Depression on the PHQ-2
Time Frame: 60 days
60 days
Presence of atrial fibrillation symptoms and their impact on quality of life using the Severity of Atrial Fibrillation (SAF) scale
Time Frame: 60 days
60 days
Risk of cardiovascular incidents using the AHA Heart Disease Risk Assessment
Time Frame: 60 days
60 days
Risk of stroke using the CHA2DS2-VASc Score
Time Frame: 60 days
60 days
Severity of Rheumatoid Arthritis using the Routine Assessment of Patient Index Data (RAPID-3) score
Time Frame: 60 days
60 days
BMI for patients being treated for T2DM
Time Frame: 60 days
60 days
Glucose levels for patients being treated for T2DM
Time Frame: 60 days
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine drug screen results
Time Frame: 60 days
60 days
Co-occurring disorders collected by ICD-9/10 codes
Time Frame: 60 days
60 days
Assessment of previous treatments
Time Frame: 60 days
Participants are asked to rate the benefit of previous treatments on a scale of 0 to 5.
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gregory A Smith, M.D., G.S. Medical Center Inc./Comprehensive Pain Relief Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

June 26, 2015

First Submitted That Met QC Criteria

June 29, 2015

First Posted (Estimate)

July 2, 2015

Study Record Updates

Last Update Posted (Estimate)

March 30, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

March 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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