Clinical trial NCT03813862: Observational Pharmaco-Epidemiology Research & Analysis
Official title: OPERA Longitudinal Observational Database in the Study of Chronic Diseases, Treatments and Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Disease
HIV/AIDS
Liver Diseases
Inflammatory Bowel Diseases
Cardiovascular Diseases
Rheumatic Diseases
Neurodegenerative Diseases
Lead sponsor: Epividian
Sponsor class: INDUSTRY
First posted: 2019-01-23
Enrollment: 2000000
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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

Primary outcomes:
measure: Virologic response to therapy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Epividian
state: North Carolina
Study officials:
References: