Observational Pharmaco-Epidemiology Research & Analysis

Cardiovascular Diseases Clinical Trial

— OPERA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03813862
• Other study ID #: Pro00023648
• Status: Recruiting
• Start date: December 1, 2013
• Est. completion date: November 2027

Study information

• Verified date: February 2023
• Source: Epividian
• Contact: Gregory Fusco, MD
• Phone: 224-632-1862
• Email: gregory.fusco[@]epividian.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000000
• Est. completion date: November 2027
• Est. primary completion date: November 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chronic Disease
• Collagen Diseases
• HIV/AIDS
• Inflammatory Bowel Diseases
• Liver Diseases
• Neurodegenerative Diseases
• Rheumatic Diseases

Intervention

Other:
• Non-interventional (observational only)

Locations

Country	Name	City	State
United States	Epividian	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Epividian

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virologic response to therapy	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