Smoyer
- 1. Translating Research into the Standard of CareWilliam E. Smoyer, M.D.C. Robert Kidder Chair,Vice President and Director,Center for Clinical and Translational ResearchThe Research Institute at Nationwide Children’s HospitalProfessor of Pediatrics,The Ohio State University
- 2. OverviewSummarize major trends and barriers to integrating clinical care and research
- 3. Describe the “Learn from Every Patient” (LFEP) Program mission, model, structure, and flow
- 4. Share NCH experience with a LFEP Pilot Program
- 5. Outline resources needed to ensure LFEP success
- 6. Share lessons learned and opportunities !BackgroundMajor trend toward merging clinical care and medical research Information
- 7. Conversion to electronic medical records
- 8. Data use to improve and personalize health care, and reduce costs
- 10. Improving patient outcomes through integration of clinical care and researchBackgroundMajor Barriers to Merging Clinical Care and Research Information
- 12. Infrastructure-related / financial / political
- 14. Differing terminologies, data models, data architectures
- 18. Differing clinical care and research processes“Learn From Every Patient” ProgramA Model for Full Integrationof Research and Clinical Care
- 19. “Learn from Every Patient”Program MissionTo fully integrate knowledge gained from clinical care with research to systematically advance the care of childrenIn other words…“We will learn from every patient at every visit and use that knowledge to improve the care of the children that follow”
- 20. Alignment of LFEP with Strategic GoalsGoal: To fully integrate knowledge gained from clinical care with research to systematically advance the care of children at NCH
- 21. “Learn from Every Patient”Program ModelWith IRB oversightData MartClinical + research data collection integrated into provision of careLeverage data sources, including EMR and EDW(Disease-specific data set derived from multiple data sources)Patientreceives evidence-based standardized careTranslationalResearchPeer Reviewed PublicationsSystematically improve care of all patientsDrive incremental improvements in standard of careQualityImprovement
- 22. Perspective on LFEP Program…“… inspiration is easy. Implementation is the hard part.”Bob Taylor (Taylor Guitars)
- 23. Building the TeamPilot Program IdentifiedCerebral Palsy Program
- 24. Small
- 25. Charged with “improving clinical care”Key Stakeholders for Pilot Program IdentifiedPhysicians
- 26. Nurses / Clinical staff
- 28. Hospital EMR (EPIC) team
- 29. Enterprise Data Warehouse (EDW) team
- 30. Research informatics systems (RIS) team
- 31. Hospital informatics systems (HIS) team
- 32. Recruited a Project ManagerSetting ExpectationsBiweekly meetings convened
- 33. Scope of LFEP program detailed for CP Program
- 34. Advantage: EMR had not yet been rolled out in program
- 35. Benefits to organization and patients emphasized
- 36. Individual expectations for roles in program clarified
- 37. Altered clinical practices required for physicians
- 38. Altered clinical practices required for nurses / staff
- 39. Altered interactions between hospital and research informatics teams
- 40. Altered rollout of EMR (“We’ve never done this…”)
- 41. “This is a lot of change !!!”Key Performance Indicators (KPIs) toTrack Success of LFEP ProgramOperationsIntegrationResearchQuality & Safety
- 42. IRB / HIPAA ComplianceWorking group developed to address issuesLegal Services / IRB Chair
- 44. Research Informatics / CP Program Director
- 45. Reviewed similar processes at other research institutionsIRB Database Protocol CreatedProvide oversight structure for IRB as “gatekeeper” of data
- 46. Requires IRB application to access data (or samples) for research or QI purposes
- 47. Ensures consultation between IRB and Legal Services regarding data use to ensure HIPAA and Human Subjects Research complianceProject ManagementRoutine clinical care-related data fields developed (per standard process)Physicians charged with several key tasks:Commit to initial standard of care (evidence + opinion-based)
- 48. Determine three high-value research questions that would advance their field
- 49. Develop research data fields to collect key info for above
- 50. Develop research data elements to populate these fields
- 51. Hospital EMR team charged with building these into EMR
- 52. Clinical team in-serviced for clinical / research data entry
- 53. Project rollout: April, 2010 Data ManagementClinical + research data fields entered at point of carePart of a billable patient encounter
- 54. Data collected in EMR migrated to Data Mart
- 55. Data extraction functional but still being refined
- 56. # of patients “enrolled” in first year already comparable to a similar NIH-funded multi-site clinical trial over three years!
- 57. Preliminary analysis suggests LFEP program implementation alone showing positive trends
- 58. ~ Reduced ER utilization
- 60. Initial manuscript being developedDevelopment of Standardized ProgramLFEP implementation created new requests for serviceTwo programs now using LFEP
- 61. 10 additional programs have expressed interest !
- 62. Opportunity to develop a standardized LFEP program
- 63. Applicable to variety of settings
- 64. Pediatric or adult programs
- 65. Medical or surgical programs
- 66. Academic or private medical centers
- 67. Able to incorporate biological sample collection
- 68. Able to incorporate multiple datasets into data mart
- 69. Clinical / Lab / Radiology / Etc.
- 70. Genomic / Proteomic / Metabolomic / Etc.LFEP Program Structure and FlowIntake form routed to LFEP Executive Committee for reviewCommittee provides follow up questions to clinician or investigator within 2 weeksClinician completes web-based intake formSelect committee members and clinician/investigator meet to discuss project, project requirements and the development/implementation processFormal presentation to LFEP Executive Committee for approvalClinician, with guidance from committee, prepares final application complete with clinical and research outcomes, financials, and overall ROI to organization and community
- 71. Resources Required for LFEP Program5 Major ComponentsOversight / Implementation
- 72. Development of EMR [EPIC (“Clarity”)] fields
- 73. Data Mart Build
- 74. Data Extraction
- 75. Reporting ToolKey Positions for LFEP ProgramLFEP Project ManagerResearch EMR SpecialistResearch EDW SpecialistReport SpecialistPoint-of-Care Support / Data Quality Specialist
- 76. SummaryBroad-based “buy-in” essential for programmatic success
- 77. Clinical / Financial / Political
- 78. “Integration” requires significant culture change !!!
- 79. Physicians (drop-down menus; radio buttons; etc.)
- 80. Nurses / Clinical Staff (documentation; etc.)
- 81. Administrators (clinic flow; charge documentation; etc.)
- 82. Among biggest challenges to realization of goals of PHC
- 83. Huge opportunities for those willing / able to change !
- 84. Systematic improvement in clinical care
- 85. Unprecedented phenotyping of biologic samples
- 86. Career advancement of academic faculty (publications)
- 87. Expected market advantage for true evidence-based carePerspective on LFEP Program…… inspiration is easy. Implementation is the hard part.Bob Taylor (Taylor Guitars)