Observational Pharmaco-Epidemiology Research & Analysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-interventional (observational only).
- Who it may be relevant to
- Registry conditions: Chronic Disease, HIV/AIDS, Liver Diseases, Inflammatory Bowel Diseases. Basic parameters: from 0 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
OPERA Longitudinal Observational Database in the Study of Chronic Diseases, Treatments and Outcomes
Overview
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.
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.
Interventions
- Other Non-interventional (observational only)
Primary outcome measures
- Virologic response to therapy [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Epividian — Durham
Identifiers
NCT: NCT03813862 · Pro00023648