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A Case Study Transforming Research Management Systems at Mayo Clinic

A Case Study Transforming Research Management Systems at Mayo Clinic. Presented by: Steven C. Smith, Chair, Research Administration Leon G. Clark, Vice-Chair, Research Administration Gary C. Cseko, Operations Administrator, Research Administration

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A Case Study Transforming Research Management Systems at Mayo Clinic

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  1. A Case StudyTransforming Research Management Systems at Mayo Clinic Presented by: Steven C. Smith, Chair, Research Administration Leon G. Clark, Vice-Chair, Research Administration Gary C. Cseko, Operations Administrator, Research Administration Susan M. Uhlenkamp, Chair, Research Finance NCURA Annual Conference, Washington DC Washington Hilton, Washington, DC 11:00 – 12:00pm, November 7, 2012

  2. Disclosure The presenters do not have any relevant financial relationships with any commercial interests.

  3. Presentation Outline • Learning Objectives • Overview • Questions

  4. Learning Objectives • Describe the Mayo quality improvement framework and how this framework can be applied in their organizations to improve the quality and transform business processes. • Explain the transformation is a process that advances through a series of stages that build upon one another. • Describe the eight stages of changes, the critical action steps to take and the common problems to avoid.

  5. Overview • Mayo Clinic Overview • Mayo Quality Framework • Comprehensive Research Management System • Stages of Transformation

  6. ©2011 MFMER | slide-6 Mayo ClinicLocations Mayo Clinic Mayo Clinic Health System Mayo Clinic in Arizona Mayo Clinic in Florida

  7. ©2011 MFMER | slide-7 Mayo Clinic Research is… • National research program • Arizona, Florida, Minnesota • In top 20 NIH-funded AMC’s • 365 awards from 27 institutes • Over 8,000 active human studies • Over 3,000 staff employed in research

  8. Bedside Bench Population Research: Overview Translational research • Over 90% of Mayo physicians are involved in research-related activities • $600 million research budget Mayo Clinic research partnerships

  9. ©2011 MFMER | slide-9 Mayo Clinic Research is… • Enterprise-wide governance • Enterprise-wide leadership & management • Physician/administrator partnership • Committed to creating ‘world-class’ systems • Continuing growth of programs • Evolution from ‘cottage industries’ to systems approach • Infrastructure not up to Mayo standards • Recognition of risks • Commitment to implementing quality systems

  10. Mayo Clinic Quality Framework I The best care for every patient every day Culture Engineering Execution III IV V • Quality Academy Leader Training • Champions training • Articulate roles and expectations • Commitment to transparency • Communications plan • Practice (e.g. - pressure ulcers, right-site surgery) • Education (e.g. – Ask Mayo Expert) • Research (e.g. – IRB, OSPA,etc) • Demonstrate business case • Active visible leadership • Process owners • Frontline empowerment • Common scorecard + targets • 100-day discipline Infrastructure II • Quality Academy • Systems implementation • Enterprise Learning System • Spread simulation practices December 6, 2007 Adapted from Bisognano, Plsek. 10 More Powerful Ideas for Improving Patient Care.Chicago: Health Administration Press & Institute for Healthcare Improvement; 2006. ©2010 MFMER | 3065532-10

  11. Research Management System TransformationCRMS Vision • Imagine we will… • Create optimal research administrative services to advance research from knowledge generation through delivery to our patients …that is our vision

  12. CRMS Key Strategic Objectives Creating an Optimal Clinical Trials Management System Implementing Quality Management Systems across all Research Business Units Developing Scalable Infrastructure to serve MCHS, APN and clients globally

  13. Comprehensive Research Management System Pre-award Activities Study Activities Post-study Activities RESEARCH PROCESS  Concept Development  Protocol Development  ProtocolReview  Protocol Execution  Analysis& Reporting  Translation • Creation of aims • Literature search • Preliminary reviews • Create concept docs • Identify teams • Establish study plan • Create protocol • Complete/initiate docs and forms • Qualify staff and/or organizations • Meeting preparation • Meeting execution • Document/forms review • Scientific review • Assign staff/resources • Patient search, screening, scheduling • Patient treatment & education • Collect/test/track samples data analysis • End of study report • Drop out, screen failure, outcomes reporting • Produce publications • Present discoveries • New Treatments • New Lab Procedures • New Analysis Capabilities • New Care Delivery Methods Planning & Strategy Services Research Governance, Research Leadership, Strategic Planning, Operational Planning, Portfolio Management, Quality Planning, Financial Planning & Analysis, Benchmarking, Competitive Intelligence, Research Collaborations & Partnerships, Research Funding Model, Research Review Process Business Management Services Research Policy Management, Process and Procedure Management, Quality Management and Process Improvement, Administrative Support Activities, e-Research – (Research Web, Clinical Trials Management System, Lawson), New Process Design, Performance Management & Reporting, Business Analysis, Project Management Funding Services Identification of Funding Opportunities, Proposal Submission Services, Budgeting and Forecasting, Contracting, Fundraising, Intellectual Property Disclosures & Licensing ◄ Research Services  Training & Education Services Compliance Training & Education, A.H. Staff Education & Development, Leadership Development, Change Management Scientific Support Services Pharmacy Support, Study Coordination, Direct Scientific Support for Cellular-Animal-Human Studies, Biostatistics, Informatics, Computing, Epidemiology, Bio-repository, Health Services Research, Bio-specimens, Survey Research Regulatory Support Services Billing Compliance, Human Subjects Protection, Animal Care and Use, Research Safety, Conflict of Interest

  14. Research Management System TransformationCRMS Roadmap to Excellence Phase I Research Visionand Strategic Priorities Phase 2 ResearchInfrastructure Compliance Phase 3 Research Infra-structure Process Improvement Phase 4 Research InfrastructureService Excellence • Vision • Strategic priorities • Strategic initiatives • Scorecard metrics • Financial management systems • Written policies and procedures • Roles and responsibilities • Compliance training and education • NIH Response Circle Back • Management systems design • Policy system • Protocol management system • Pre-award system • Legal contracting system • IRB process • Quality Management Systems • Comprehensive Training Program • Research strategic planning • Research policy management • Research compliance • Research management system • Research contract management • Research financial management • Sponsored projects administration • Research information services • Research communication • Research web services • Human subjects protection • Animal care and use • Research career development • Science and technology • Research Service Excellence Cycles • Research Service Center

  15. Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Establishurgency Formcoalition Createvision Conveyvision Empowerstaff Short-term win Producechange Institu-tionalizeapproach The Stages of Change8 Steps to Transforming Your Organization Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.

  16. ©2011 MFMER | slide-16 Research Management System TransformationCRMS Inflection Points Create optimal research administrative services and systems Advance entrepreneurism to the benefit of our patients and society Accelerate the translation of discoveries to our patients CRMS Phase 4 2012-2017 Develop a scalable global Affiliated Research Network Optimize Clinical Trials Integrate research administrative services and systems Implement QMS in all Research business units Implemented QMS in selected Research business units Reduced pre-award cycle time by 351 days Increased federal indirect revenue by $8M annually CRMS Phases 1-3 2006-2011 Reduced administrative costs by 10% Eliminated industry research write-offs by $1.8M annually Eliminated need to outsource IRB savings $16M annually Reduced NIH annual audit findings from 14 to 0 for last 3 years Mitigated $65M in risk exposure Closed 27 major research compliance gaps Resolved 72 compliance questions raised by NIH for continued federal funding NIH Inquiry DOJ Settlement

  17. Questions

  18. Appendix

  19. Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Establishurgency Formcoalition Createvision Conveyvision Empowerstaff Short-term win Producechange Institu-tionalizeapproach Step 1 – Establish a sense of urgency • Examine market and competitiverealities • Identify and discuss crises and major opportunities Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.

  20. Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Establishurgency Formcoalition Createvision Conveyvision Empowerstaff Short-term win Producechange Institu-tionalizeapproach Step 1 – Establish a sense of urgency • Understanding difficulty of driving people from their comfort zones • Becoming paralyzed by risks Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.

  21. Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Establishurgency Formcoalition Createvision Conveyvision Empowerstaff Short-term win Producechange Institu-tionalizeapproach Step 2 – Form a powerful guiding coalition • Assemble a group with enough powerto lead change • Encourage the group to work togetheras a team Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.

  22. Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Establishurgency Formcoalition Createvision Conveyvision Empowerstaff Short-term win Producechange Institu-tionalizeapproach Step 2 – Form a powerful guiding coalition • No prior experience in teamwork at the top • Relegating team leadership to HR, quality,or strategic-planning executive rather than a senior line manager Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.

  23. Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Establishurgency Formcoalition Createvision Conveyvision Empowerstaff Short-term win Producechange Institu-tionalizeapproach Step 3 – Create a vision • Create a vision to help direct the change • Develop strategies to achieve the vision Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.

  24. Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Establishurgency Formcoalition Createvision Conveyvision Empowerstaff Short-term win Producechange Institu-tionalizeapproach Step 3 – Create a vision • Presenting a vision that’s too complicated or vague to be communicated succinctly Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.

  25. Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Establishurgency Formcoalition Createvision Conveyvision Empowerstaff Short-term win Producechange Institu-tionalizeapproach Step 4 – Communicate the vision • Use every vehicle possible to communicate • Teach new behaviors by leaders settingan example Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.

  26. Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Establishurgency Formcoalition Createvision Conveyvision Empowerstaff Short-term win Producechange Institu-tionalizeapproach Step 4 – Communicate the vision • Under communicating the vision • Behaving in ways antithetical to the vision Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.

  27. Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Establishurgency Formcoalition Createvision Conveyvision Empowerstaff Short-term win Producechange Institu-tionalizeapproach Step 5 – Empower others to act • Get rid of obstacles to change • Change systems or structures that seriously undermine the vision • Encourage risk taking and unconventional thinking Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.

  28. Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Establishurgency Formcoalition Createvision Conveyvision Empowerstaff Short-term win Producechange Institu-tionalizeapproach Step 5 – Empower others to act • Failing to remove powerful individuals who resist the change effect Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.

  29. Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Establishurgency Formcoalition Createvision Conveyvision Empowerstaff Short-term win Producechange Institu-tionalizeapproach Step 6 – Plan for and create short-term wins • Plan for visible performance improvements • Create visible performance improvements • Recognize and reward employees involved Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.

  30. Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Establishurgency Formcoalition Createvision Conveyvision Empowerstaff Short-term win Producechange Institu-tionalizeapproach Step 6 – Plan for and create short-term wins • Leaving short-term successes up to chance • Failing to achieve successes early enough (12-24 months into change effort) Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.

  31. Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Establishurgency Formcoalition Createvision Conveyvision Empowerstaff Short-term win Producechange Institu-tionalizeapproach Step 7 – Consolidate improvements • Use increased credibility to change policies, systems and structures that don’t fit new vision • Hire, promote and develop employees who can implement the vision Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.

  32. Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Establishurgency Formcoalition Createvision Conveyvision Empowerstaff Short-term win Producechange Institu-tionalizeapproach Step 7 – Consolidate improvements • Declaring victory too soon—with the first performance improvement • Allowing resistors to convince “troops” that the war has been won Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.

  33. Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Establishurgency Formcoalition Createvision Conveyvision Empowerstaff Short-term win Producechange Institu-tionalizeapproach Step 8 – Institutionalize new approaches • Articulate the connections between the new behaviors and corporate success • Develop the means to ensure leadership development and succession Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.

  34. Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Establishurgency Formcoalition Createvision Conveyvision Empowerstaff Short-term win Producechange Institu-tionalizeapproach Step 8 – Institutionalize new approaches • Not creating new social norms and shared values consistent with changes • Promoting people into leadership positions who don’t personify the new approach Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.

  35. Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Establishurgency Formcoalition Createvision Conveyvision Empowerstaff Short-term win Producechange Institu-tionalizeapproach The Stages of Changing8 Steps to Transforming Your Organization Source: “Leading Change: Why Transformation Efforts Fail”,Kotter, John P., Harvard Business Review, January, 2007.

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