1. 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

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

7. Conversion to electronic medical records

8. Data use to improve and personalize health care, and reduce costs

9. Overarching Goal:

11. Inadequate organizational readiness

12. Infrastructure-related / financial / political

13. Inadequate information standards

14. Differing terminologies, data models, data architectures

15. Inadequate technology integration

16. Differing IT systems

17. Inadequate workflow integration

19. “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”

20. 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

21. “Learn from Every Patient”Program Model With IRB oversight Data Mart Clinical + research data collection integrated into provision of care Leverage data sources, including EMR and EDW (Disease-specific data set derived from multiple data sources) Patientreceives evidence-based standardized care Translational Research Peer Reviewed Publications Systematically improve care of all patients Drive incremental improvements in standard of care Quality Improvement

22. Perspective on LFEP Program… “… inspiration is easy. Implementation is the hard part.” Bob Taylor (Taylor Guitars)

24. Small

26. Nurses / Clinical staff

27. Program administrators

28. Hospital EMR (EPIC) team

29. Enterprise Data Warehouse (EDW) team

30. Research informatics systems (RIS) team

31. Hospital informatics systems (HIS) team

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…”)

43. Research Institute Administration

44. Research Informatics / CP Program Director

46. Requires IRB application to access data (or samples) for research or QI purposes

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

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

59. ~ Reduced hospitalizations

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.

72. Development of EMR [EPIC (“Clarity”)] fields

73. Data Mart Build

74. Data Extraction

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)