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Translating Research into the Standard of Care<br />William E. Smoyer, M.D.<br />C. Robert Kidder Chair,<br />Vice Preside...
Overview<br /><ul><li>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 !</li></li></ul><li>Background<br /><ul><li>Major trend toward merging clinical ca...
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</li></li></ul><li>Background<br /><ul><li>Maj...
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</li></li></ul><li>“Learn From Every Patient” ProgramA Model for Full Integ...
“Learn from Every Patient”Program Mission<br />To fully integrate knowledge gained from clinical care with research to sys...
Alignment of LFEP with Strategic Goals<br />Goal:  To fully integrate knowledge gained from clinical care with research to...
“Learn from Every Patient”Program Model<br />With IRB oversight<br />Data Mart<br />Clinical + research data collection in...
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Smoyer

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Transcript of "Smoyer"

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