Recruiting

NCT Number: NCT03813862

Observational Pharmaco-Epidemiology Research & Analysis

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.

Recruiting

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Key information

Conditions

Chronic Disease Acquired Immunodeficiency Syndrome Blood-Borne Infections Cardiovascular Diseases Communicable Diseases Connective Tissue Diseases Digestive System Diseases Disease Attributes Gastroenteritis Gastrointestinal Diseases Genital Diseases HIV Infections HIV/AIDS Immune System Diseases Immunologic Deficiency Syndromes Infections Inflammatory Bowel Diseases Intestinal Diseases Lentivirus Infections Liver Diseases Musculoskeletal Diseases Nervous System Diseases Neurodegenerative Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Rheumatic Diseases Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin and Connective Tissue Diseases Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Epividian

Durham, North Carolina, 27703, United States

Location status: Recruiting

Location contact

Rodney Mood

CONTACT

[email protected]

919-323-8728

About this study

Objectives of OPERA

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.
To use epidemiological, statistical, and data analysis methods and related research findings to deliver a sophisticated healthcare analytics reporting solution (CHORUS™) to clinicians.†
To enhance patient population management as well as disease management capabilities of the practicing physician.
To provide anonymous, nation-wide benchmarking of quality measures and key performance indicators (KPI) for medical clinics.
To enhance patient engagement with their physicians to deliver better health outcomes.
To evaluate whether engagement in care by patients with their physicians results in better outcomes for patients with chronic illness.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-interventional (observational only)

Other

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gregory Fusco, MD

CONTACT

[email protected]

224-632-1862

Sponsors and collaborators

Lead sponsor

Epividian

Industry

Registry information

Official study title

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

Acronym: OPERA

Important dates

Study start: 2013
Primary completion: 2035
Study completion: 2035
First posted: Jan 23, 2019
Registry last updated: Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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