PCORnet Overview Presenter Name: Betsy Shenkman, PhD Professor, - PowerPoint PPT Presentation

PCORnet Overview Presenter Name: Betsy Shenkman, PhD Professor, Health Outcomes and Biomedical Informatics, University of Florida and Director, OneFlorida Clinical Research Consortium #oneflorida Date: September 20, 2019

Betsy Shenkman • Has nothing to disclose. 2

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PCORnet Pragmatic Clinical Trials Roadmap: Engagement, Electronic Health Data, Embedded Delivery Study conduct Recruitment Study setup • Trials specific data capture Pre-study • E-consent with from care delivery • Utilize EHR to identify Incorporate screening • Assess sites’ use of EHR to • Auto-populated CRFs fields local participants criteria into EHR for facilitate research from EHR • Embed encounter Scheduling patients - • Usability of inclusion and • Extract data to facilitate instructions and site Contacting patients exclusion criteria - work of study coordinator content into EHR • EHR Health Portal • Refine protocol • Query data to identify • Alert clinician about trial • Clinician Alerts events • Community interaction • Model outcomes profiles with health system • Participant retention and education • Feasibility analysis • Return of results • Recruitment plan 5

PCORnet : Standardizing Data for Efficiency • Based on FDA Sentinel Common Data Model • Licensed under Creative PCORnet represents: Commons (open-access, more than use, and share) 68 million patients • Designed to promote multi-site, research who have had a medical encounter in the past five years • Supplemented by other *some individuals may have visited more than one partner network sources of data and would be counted more than once 6

Accomplishments: Pragmatic Clinical Trials ADAPTABLE: Aspirin 81mg vs. 325 mg. Enrollment of 14,000 participants completed eScreening, eEnrollment and eFollow-up Compare the outcomes of high versus low dose influenza vaccine in 9,300 high--risk CV patients Examining the real-world effectiveness of sacubitril/valsartan on PROVIDE - HF quality of life in 400 patients with chronic heart failure The PREVENTABLE Trial (NHLBI): PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr Adults; 15,000 adults age 75+ without dementia or disability 7

Accomplishments: Health System Demo Projects 8

Accomplishments: PCORnet Observational Study: PCSK9 Inhibitor Use in the Real World: Data From the National Patient- Centered Research Network • Less than 1% of patients were prescribed the drug • Despite evidence of effectiveness, threshold for Quality Adjusted Life Years (QALYs) may limit its use 9

Summary • PCORnet infrastructure is in place and can support a number of project types leveraging real world data • Uniquely designed to support  Pragmatic clinical trials  Observational studies  Implementation science / quality improvement studies • Projects generally characterized by:  Integration of participant and stakeholder preferences (people-centered)  Curated data with longitudinal outcomes and efficient integration of external data sources  Advanced analytics  Clinician and health system engagement  Administrative efficiencies and rapid study start-up 10

Learn More • www.pcori.org • info@pcori.org • #PCORI2019 • https://onefloridaconsortium.org 11