3.01.16 himss- duke rfd
TRANSCRIPT
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Retrieving Form Data from Epic Using RFD Standard Enhancement
Amy Harris Nordo RN/BSN, CPHQ, LNC, MMCi 2016
Duke Office Of Research Informatics
Supported in part by Duke’s CTSA grant (UL1TR001117)
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▪ 3 Integrated hospitals using Epic 2014 (16,513 employees)– Duke University Hospital 957 beds– Duke Raleigh Hospital 186 beds – Duke Regional Hospital 369 beds
• Duke School of Medicine Ranked 8th 2015
• Duke Clinical Research Institute is the largest Academic CRO in the world with over 900 employees
• Duke is the Coordinating Center for PCORI, NIH CollaboratoryGrants
• Our CTSA was renewed in 2013
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• 2015 Clinical revenues $2.98B
– 1.35m outpatient visits
• 2014 NIH funding $293.2m
• 2013 Industry funded research $177m
• 1462 investigators, 400+ coordinatorsin site based research
• ~2100 open enrolling IRB studiesduring FY15
• ~300 NEW clinical trial studies/yearopen at Duke University Hospital
• 7,000 simultaneous users of Epic(Epic’s largest big bang go-live)
– Integrated clinical researchmanagement into Epic.
• Duke’s REDCap approximately 4000projects and 4000 users
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What can we put in between EHR and EDC that’s not a person to facilitate data migration?
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What about RFD?
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RFD – What is it?
• Integration profile co-developed by Integrating the Healthcare Enterprise (IHE) and CDISC
• A standard for research data collection from EHRs
• Allows EHR platform to display a data collection form sourced from an EDC platform
• Pre-populates form with data sourced from Continuity of Care Document (CCD)
• CCD contains snapshot of patient chart (XML format)
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Value Proposition – Why RFD?
1- Facilitates Data Provenance• Specification dictates archiving/auditing – RFD Form Archiver
• Archive Viewer Web Application… stay tuned
2- Improve Data Quality Minimize transcription errors
3- Time: More efficient use of Clinical Research Coordinator time
Provides the opportunity to change workflow process
4- SecuritySecure, single-point registration of study participants data into EDC database from Epic context
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What is it?
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Why Integrate REDCap?• Significant Duke & CTSA adoption
• Duke ~4000 active projects; ~4000 users
• Investigator initiated studies – less barriers to adoption
• Integrate Duke enterprise EHR with Duke enterprise EDC
• (
• Enterprise level services, resources, expertise for Duke site-based research
• Epic for Research @ Duke services
• REDCap @ Duke services – eCRF design, Data Management, etc.
• Existing delivery channel for RFD services…
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– Consortium Partners
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Key
EHR and EDC must be RFD Capable
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Architecture – How?
• Epic supports the RFD specification – REDCap DOES NOT support RFD
specification
• Was not on product roadmap for Vanderbilt – feature priority, funding, demand,
etc…
• Early “Proof-of-Concept” in collaboration with Epic – confident we could “make it
work” with REDCap
• Developed middleware – makes REDCap “RFD aware”
• Messaging – Brokers RFD messages between Epic & REDCap
• Data Mapping – CCD data elements to REDCap data elements
• We call it the “RFD-REDCap Adapter”…
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Research Use Case
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Architecture – Messaging
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Duke has Winning Teams on the Court…..
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And in Research Application Development
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RFD Workflow Demo
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Initiate RFD
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REDCap Forms Menu
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Populated REDCap Form
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Populated REDCap Form
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Populated REDCap Form
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Form Saved to REDCap via RFD
Saved
!
Other study
Specific forms
that perhaps
don’t use the
CCD
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Architecture – Archive ViewerData Provenance
• Comprehensive audit trail for RFD workflow
• Track snapshot of CCD
• Track form state transitions
• “Retrieved”, “Pre-populated”, “Submitted”, etc.
• Track parsed CCD data elements
• eCRF data elements populated/CCD redaction
• Mapping rules utilized
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Archive Viewer Demo
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Value Proposition – Why RFD?
1- Facilitates Data Provenance• Specification dictates archiving/auditing – RFD Form Archiver
• Archive Viewer Web Application… stay tuned
2- Improve Data Quality Minimize transcription errors
3- Time: More efficient use of Clinical Research Coordinator time
Provides the opportunity to change workflow process
4- SecuritySecure, single-point registration of study participants data into EDC database from Epic context
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Observational Comparative Effectiveness Study
Evaluation of the effect of RFD functionality on completion of Clinical
Research data collection
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Continuing Challenges, Lessons learned, & Next Steps
• Extend data mapping coverage for maximum utility
• Exhaust what is in the standard Epic CCD
• Work with Epic on strategy to extend the current CCD, create a research CCD v2.0, view & parse a subject's CCD archive to find extended history
• The RFD source document does NOT have to be CCD
• Connect with additional EDCs
• Publish Results of Observational Comparative Effectiveness Study
• Multi-Center Trial
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In Conclusion:
• Auto-populate data transmission
• Surface forms within EHR
• Redact the CCD
• Audit Trail
• Security
Time, Data Provenance, Quality and
Security