Observational Pharmaco-Epidemiology Research & Analysis

RECRUITING

I'm interested ...!!

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.

Conditions:

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

🗓️ Study Start (Actual) 1 December 2013

🗓️ Primary Completion (Estimated) November 2027

✅ Study Completion (Estimated) November 2027

👥 Enrollment (Estimated) 2000000

🔬 Study Type OBSERVATIONAL

📊 Phase N/A

Locations:

📍 Durham, North Carolina, United States

📋 Eligibility Criteria

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

Ages Eligible for Study: 0 Years to N/A (CHILD, ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ 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 Registration Dates

First Submitted 11 January 2019
First Submitted that Met QC Criteria 22 January 2019
First Posted 23 January 2019

Study Record Updates

Last Update Submitted that Met QC Criteria 14 February 2023
Last Update Posted 15 February 2023
Last Verified February 2023