Observational Pharmaco-Epidemiology Research & Analysis (OPERA)

February 14, 2023 updated by: Epividian

OPERA Longitudinal Observational Database in the Study of Chronic Diseases, Treatments and Outcomes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

2000000

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

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27703
        • Recruiting
        • Epividian

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

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The patient population includes a diverse group of individuals treated in ambulatory practice with a focus on those living with chronic disease.

Description

Inclusion Criteria:

  • Patients who are treated in the practices who enroll and participate in the study
  • Patients whose treatment is documented in the practice's electronic health record system

Exclusion Criteria:

  • Patients who opt out of OPERA

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Virologic response to therapy
Time Frame: 1 year
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.
1 year

Collaborators and Investigators

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

Sponsor

Epividian

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 (Actual)

December 1, 2013

Primary Completion (Anticipated)

November 1, 2027

Study Completion (Anticipated)

November 1, 2027

Study Registration Dates

First Submitted

January 11, 2019

First Submitted That Met QC Criteria

January 22, 2019

First Posted (Actual)

January 23, 2019

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00023648

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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