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Translating Research into the Standard of Care
William E. Smoyer, M.D.
C. Robert Kidder Chair,
Vice President and Director,
Center for Clinical and Translational Research
The Research Institute at Nationwide Children’s Hospital
Professor of Pediatrics,
The Ohio State University
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Overview
• Summarize major trends and barriers to integrating clinical care and research
• Describe the “Learn from Every Patient” (LFEP) Program mission, model, structure, and flow
• Share NCH experience with a LFEP Pilot Program
• Outline resources needed to ensure LFEP success
• Share lessons learned and opportunities !
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Background
• Major trend toward merging clinical care and medical research Information
• Conversion to electronic medical records
• Data use to improve and personalize health care, and reduce costs
• Overarching Goal:
• Improving patient outcomes through integration of clinical care and research
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Background
• Major Barriers to Merging Clinical Care and Research Information
• Inadequate organizational readiness
• Infrastructure-related / financial / political
• Inadequate information standards
• Differing terminologies, data models, data architectures
• Inadequate technology integration
• Differing IT systems
• Inadequate workflow integration
• Differing clinical care and research processes
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“Learn From Every Patient” Program
A Model for Full Integrationof Research and Clinical Care
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“Learn from Every Patient”Program Mission
To fully integrate knowledge gained from clinical care with research to systematically advance the care of children
In other words…
“We will learn from every patient at every visit
and use that knowledge to improve the care of the children that follow”
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Alignment of LFEP with Strategic Goals
Goal: To fully integrate knowledge gained from clinical care with research to systematically
advance the care of children at NCH
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“Learn from Every Patient”Program Model
Data Mart
TranslationalResearch
QualityImprovement
Patient receives evidence-based
standardized care
Clinical + research data collection integrated into provision of care
Leverage data sources, including EMR and EDW
With IRB oversight
Drive incremental improvements in standard of care
Systematically improve care of all patients
Peer Reviewed
Publications
(Disease-specific data set derived from multiple data sources)
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Perspective on LFEP Program…
“… inspiration is easy. Implementation is the hard part.”
Bob Taylor (Taylor Guitars)
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Building the Team
• Pilot Program Identified• Cerebral Palsy Program
• Small
• Charged with “improving clinical care” • Key Stakeholders for Pilot Program Identified
• Physicians• Nurses / Clinical staff• Program administrators• Hospital EMR (EPIC) team • Enterprise Data Warehouse (EDW) team• Research informatics systems (RIS) team• Hospital informatics systems (HIS) team
• Recruited a Project Manager
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Setting Expectations
• Biweekly meetings convened• Scope of LFEP program detailed for CP Program
• Advantage: EMR had not yet been rolled out in program
• Benefits to organization and patients emphasized• Individual expectations for roles in program clarified
• Altered clinical practices required for physicians• Altered clinical practices required for nurses / staff• Altered interactions between hospital and research
informatics teams• Altered rollout of EMR (“We’ve never done this…”)
• “This is a lot of change !!!”
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Volume Growth
% increase in unique
CP patients to NCH
% of CP patients at NCH with a
completed Comprehensive Team Evaluation
n = 1,023 17%
1% 20%
2% 20%
3% 40%
4% 60%
5% 75%
KPIs Improved Patient Care
Metric
% decrease in NCH hospitalizations among CP
team clinic patients for:1) Failure to Thrive2) Psychosocial Issues3) Aspiration Pneumonia
Current 0%
2011
2012
2013
2014
2015 25%
Standard of Care
Evidence-Based
Written Standard of
Care
% of team evaluation
patients follow written standard
of care
Completed 90%
100%
Operations
Key Performance Indicators (KPIs) toTrack Success of LFEP Program
IntegrationResearchQuality & Safety
Increased Academic Productivity
Increase in number of peer-
reviewed abstracts
presented at national meetings
Increase in number of
publications in peer-
reviewed journals
Increase in number of CP Program team
members participating in
national committees
related to CP research
6 abstracts per year
2 papers per year
2 members per year
12 abstracts per year
4 papers per year
4 members per year
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IRB / HIPAA Compliance
• Working group developed to address issues• Legal Services / IRB Chair
• Research Institute Administration
• Research Informatics / CP Program Director
• Reviewed similar processes at other research institutions
• IRB Database Protocol Created• Provide oversight structure for IRB as “gatekeeper” of data
• Requires IRB application to access data (or samples) for research or QI purposes
• Ensures consultation between IRB and Legal Services regarding data use to ensure HIPAA and Human Subjects Research compliance
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Project Management
• Routine clinical care-related data fields developed (per standard process)
• Physicians charged with several key tasks:• Commit to initial standard of care (evidence + opinion-based)• Determine three high-value research questions that would
advance their field • Develop research data fields to collect key info for above• Develop research data elements to populate these fields
• Hospital EMR team charged with building these into EMR• Clinical team in-serviced for clinical / research data entry• Project rollout: April, 2010
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Data Management
• Clinical + research data fields entered at point of care• Part of a billable patient encounter
• Data collected in EMR migrated to Data Mart• Data extraction functional but still being refined• # of patients “enrolled” in first year already
comparable to a similar NIH-funded multi-site clinical trial over three years!
• Preliminary analysis suggests LFEP program implementation alone showing positive trends• ~ Reduced ER utilization• ~ Reduced hospitalizations• Initial manuscript being developed
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Development of Standardized Program
• LFEP implementation created new requests for service• Two programs now using LFEP• 10 additional programs have expressed interest !
• Opportunity to develop a standardized LFEP program• Applicable to variety of settings
• Pediatric or adult programs• Medical or surgical programs• Academic or private medical centers
• Able to incorporate biological sample collection• Able to incorporate multiple datasets into data mart
• Clinical / Lab / Radiology / Etc.• Genomic / Proteomic / Metabolomic / Etc.
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Clinician completes web-based intake form
Intake form routed to LFEP Executive Committee for review
Committee provides follow up questions to clinician or investigator within 2 weeks
Select committee members and clinician/investigator meet to discuss project, project requirements and the development/implementation process
Clinician, with guidance from committee, prepares final application complete with clinical and research outcomes, financials, and overall ROI to organization and community
Formal presentation to LFEP Executive Committee for approval
LFEP Program Structure and Flow
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Resources Required for LFEP Program
5 Major Components
• Oversight / Implementation
• Development of EMR [EPIC (“Clarity”)] fields
• Data Mart Build
• Data Extraction
• Reporting Tool
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Key Positions for LFEP Program
• LFEP Project Manager
• Research EMR Specialist
• Research EDW Specialist
• Report Specialist
• Point-of-Care Support / Data Quality Specialist
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Summary
• Broad-based “buy-in” essential for programmatic success• Clinical / Financial / Political
• “Integration” requires significant culture change !!!• Physicians (drop-down menus; radio buttons; etc.)• Nurses / Clinical Staff (documentation; etc.)• Administrators (clinic flow; charge documentation; etc.)• Among biggest challenges to realization of goals of PHC
• Huge opportunities for those willing / able to change !• Systematic improvement in clinical care• Unprecedented phenotyping of biologic samples • Career advancement of academic faculty (publications)• Expected market advantage for true evidence-based care
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Perspective on LFEP Program…
… inspiration is easy. Implementation is the hard part.
Bob Taylor (Taylor Guitars)
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