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

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

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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

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Presenter Name: Betsy Shenkman, PhD

PCORnet Overview

Professor, Health Outcomes and Biomedical Informatics, University of Florida and Director, OneFlorida Clinical Research Consortium #oneflorida Date: September 20, 2019

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Betsy Shenkman

  • Has nothing to disclose.
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PCORnet Pragmatic Clinical Trials Roadmap: Engagement, Electronic Health Data, Embedded Delivery

Pre-study

  • Assess sites’ use of EHR to

facilitate research

  • Usability of inclusion and

exclusion criteria

  • Refine protocol
  • Community interaction

profiles with health system

  • Feasibility analysis
  • Recruitment plan

Study setup Recruitment

  • Utilize EHR to identify

local participants

  • Embed encounter

instructions and site content into EHR

  • Alert clinician about trial
  • Model outcomes

Study conduct

  • E-consent with

Incorporate screening criteria into EHR for

  • Scheduling patients
  • Contacting patients
  • EHR Health Portal
  • Clinician Alerts
  • Trials specific data capture

from care delivery

  • Auto-populated CRFs fields

from EHR

  • Extract data to facilitate

work of study coordinator

  • Query data to identify

events

  • Participant retention and

education

  • Return of results
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PCORnet : Standardizing Data for Efficiency

PCORnet represents:

more than

68 million patients

who have had a medical encounter in the past five years

*some individuals may have visited more than one partner network and would be counted more than once

  • Based on FDA Sentinel

Common Data Model

  • Licensed under Creative

Commons (open-access, use, and share)

  • Designed to promote

multi-site, research

  • Supplemented by other

sources of data

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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 quality of life in 400 patients with chronic heart failure

PROVIDE - HF

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

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Accomplishments: Health System Demo Projects

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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

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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
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Learn More

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