<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03813862</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00023648</org_study_id>
    <nct_id>NCT03813862</nct_id>
  </id_info>
  <brief_title>Observational Pharmaco-Epidemiology Research &amp; Analysis</brief_title>
  <acronym>OPERA</acronym>
  <official_title>OPERA Longitudinal Observational Database in the Study of Chronic Diseases, Treatments and Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Epividian</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Epividian</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Greater advances are needed in two separate but related areas in healthcare: 1) the Clinical&#xD;
      Decision Support Systems that complement the EHR use in support of routine patient care,&#xD;
      population management and disease management; and 2) the use of the point-of-care&#xD;
      observational data from the provider-patient encounter that support realworld medical&#xD;
      research and healthcare quality measure assessment. Real-world evaluations of treatments of&#xD;
      chronic diseases in the context of comorbid conditions and special populations (minorities,&#xD;
      women, mentally ill, and those with addiction) are limited. The purpose of the OPERA database&#xD;
      is to help address this unmet need in clinical research.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives of OPERA&#xD;
&#xD;
        1. To research numerous chronic diseases (HIV, HCV, HBV currently and IBD and RA in the&#xD;
           near future, with others as identified for further consideration) utilizing the OPERA®&#xD;
           longitudinal database that consists of de-identified EHR data from numerous clinical&#xD;
           practices in a variety of settings (e.g. solo practitioners, small groups, and&#xD;
           hospitals). Research will be ongoing and yield numerous individual analyses and reports&#xD;
           that are authored by epidemiologists, practicing physicians, pharmaco-economists, and&#xD;
           other researchers and will target scientific conferences and peer-reviewed medical&#xD;
           journals for dissemination.&#xD;
&#xD;
        2. To use epidemiological, statistical, and data analysis methods and related research&#xD;
           findings to deliver a sophisticated healthcare analytics reporting solution (CHORUS™) to&#xD;
           clinicians.†&#xD;
&#xD;
        3. To enhance patient population management as well as disease management capabilities of&#xD;
           the practicing physician.&#xD;
&#xD;
        4. To provide anonymous, nation-wide benchmarking of quality measures and key performance&#xD;
           indicators (KPI) for medical clinics.&#xD;
&#xD;
        5. To enhance patient engagement with their physicians to deliver better health outcomes.&#xD;
&#xD;
        6. To evaluate whether engagement in care by patients with their physicians results in&#xD;
           better outcomes for patients with chronic illness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2013</start_date>
  <completion_date type="Anticipated">November 2027</completion_date>
  <primary_completion_date type="Anticipated">November 2027</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Virologic response to therapy</measure>
    <time_frame>1 year</time_frame>
    <description>HIV-1 PCR laboratory value (&quot;viral load&quot;) quantifies the amount of HIV-1 copies in plasma per mL. The baseline viral load is compared to viral load after 1 year of antiretroviral therapy.</description>
  </primary_outcome>
  <enrollment type="Anticipated">2000000</enrollment>
  <condition>Chronic Disease</condition>
  <condition>HIV/AIDS</condition>
  <condition>Liver Diseases</condition>
  <condition>Inflammatory Bowel Diseases</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Rheumatic Diseases</condition>
  <condition>Neurodegenerative Diseases</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-interventional (observational only)</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patient population includes a diverse group of individuals treated in ambulatory&#xD;
        practice with a focus on those living with chronic disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are treated in the practices who enroll and participate in the study&#xD;
&#xD;
          -  Patients whose treatment is documented in the practice's electronic health record&#xD;
             system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who opt out of OPERA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Gregory Fusco, MD</last_name>
    <phone>224-632-1862</phone>
    <email>gregory.fusco@epividian.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Epividian</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27703</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rodney Mood</last_name>
      <phone>919-323-8728</phone>
      <email>rodney.mood@epividian.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>February 14, 2023</last_update_submitted>
  <last_update_submitted_qc>February 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rheumatic Diseases</mesh_term>
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    <mesh_term>Neurodegenerative Diseases</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Collagen Diseases</mesh_term>
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03813862
org study id: Pro00023648
nct id: NCT03813862
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Greater advances are needed in two separate but related areas in healthcare: 1) the Clinical
      Decision Support Systems that complement the EHR use in support of routine patient care,
      population management and disease management; and 2) the use of the point-of-care
      observational data from the provider-patient encounter that support realworld medical
      research and healthcare quality measure assessment. Real-world evaluations of treatments of
      chronic diseases in the context of comorbid conditions and special populations (minorities,
      women, mentally ill, and those with addiction) are limited. The purpose of the OPERA database
      is to help address this unmet need in clinical research.
Objectives of OPERA

        1. To research numerous chronic diseases (HIV, HCV, HBV currently and IBD and RA in the
           near future, with others as identified for further consideration) utilizing the OPERA®
           longitudinal database that consists of de-identified EHR data from numerous clinical
           practices in a variety of settings (e.g. solo practitioners, small groups, and
           hospitals). Research will be ongoing and yield numerous individual analyses and reports
           that are authored by epidemiologists, practicing physicians, pharmaco-economists, and
           other researchers and will target scientific conferences and peer-reviewed medical
           journals for dissemination.

        2. To use epidemiological, statistical, and data analysis methods and related research
           findings to deliver a sophisticated healthcare analytics reporting solution (CHORUS™) to
           clinicians.†

        3. To enhance patient population management as well as disease management capabilities of
           the practicing physician.

        4. To provide anonymous, nation-wide benchmarking of quality measures and key performance
           indicators (KPI) for medical clinics.

        5. To enhance patient engagement with their physicians to deliver better health outcomes.

        6. To evaluate whether engagement in care by patients with their physicians results in
           better outcomes for patients with chronic illness.
observational model: Cohort
time perspective: Retrospective
measure: Virologic response to therapy
time frame: 1 year
description: HIV-1 PCR laboratory value ("viral load") quantifies the amount of HIV-1 copies in plasma per mL. The baseline viral load is compared to viral load after 1 year of antiretroviral therapy.
intervention type: Other
intervention name: Non-interventional (observational only)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 0 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gregory Fusco, MD
phone: 224-632-1862
email: gregory.fusco@epividian.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Rheumatic Diseases
mesh term: Liver Diseases
mesh term: Inflammatory Bowel Diseases
mesh term: Neurodegenerative Diseases
mesh term: Cardiovascular Diseases
mesh term: Collagen Diseases
mesh term: Chronic Disease
sharing ipd: No