Comparative Effectiveness Research Key Function Committee (CER KFC) Monday, August 20 2012, 11:00 AM-12:00 PM ET

1. Comparative Effectiveness ResearchKey Function Committee(CER KFC)Monday, August 20 2012, 11:00 AM-12:00 PM ET Co-Chairs, Tim Carey and Tom Concannon PI Liaison, Harry Selker NIH Coordinator, Rosemarie Filart PM, Colleen Lawrence (C4)

2. CTSA CER Key Function Committee (KFC) Monthly Meeting AgendaMonday, August20, 2012, 11:00 AM – 12:00 PM ETTeleconference Only Dial-in: 1 877 568 4109 Access Code: 271-247-588Go To Meeting Registration (only) link https://student.gototraining.com/r/1271356837225888256

3. All Members invited to participate in any group

4. NIH Updates Rosemarie Filart 11:02 AM

5. Seeking Your Input for Productive Outcomes of Day 1: PCTiWorkshopSGC4 Day 1 Planning Committee Schedule for Use Case Development and Selection • July-August: Proposed “Use Case” identification and development • KFCs members and stakeholders nominate proposed use cases • Planning Committee works with nominators to develop proposed use cases • Methods, CE, PBRN, Informatics, Evaluation, DIR, and other workgroups identify infrastructure capacity and needs of proposed use cases • September: “Use Case” selection (Planning Committee) • ~4 use cases will be selected to provide learning ground for the CTSA community about PCT infrastructure • September-November: Continued “Use Case” development • November 19:PCTi Workshop • 2012 – 2014: PCT development, Leadership by CTSAs, investigators and stakeholders

6. Central Indiana Innovation Network (CI-Net) CER SCIENTIFIC PRESENTATION Presented by:Michael Murray, Pharmd, Mphindiana university school of medicine11:08AM

7. Central Indiana Innovation Network (CI-Net) CTSACER/HIT KFC Michael D. (Mick) Murray, PharmD, MPH Regenstrief Institute Purdue University College of Pharmacy

8. Project Objectives • Develop the mechanism to facilitate and expand engagement of physicians throughout Indiana in CER. • Test and evaluate the developed CER recruiting mechanism in large and small practices. • Package the components for dissemination to CTSA members who wish to implement similar participant recruitment programs for CER trials within their networks.

9. INTRODUCTION • The Indiana CTSI is committed to creating a world-class infrastructure to promote the conduct of randomized clinical trials, CER, pragmatic trials, and a variety of observational study designs. • The Central Indiana Innovation Network (CI-Net) and its Research Planning Team (RPT) was established in 2009 to create several key components of necessary infrastructure.

10. History of Data Resources Regenstrief tasked in 1972 to “stitch” silos of medical information together -> the Regenstrief Medical Record System at Wishard Memorial Hospital In 1994, began merging information across institutions and expanded to statewide coverage called the Indiana Network for Patient Care (INPC) In 2004, the Indiana Health Information Exchange (IHIE) formed as a data services organization

11. INPC Data Volume • 28 million registration events • 13 million unique patients • 57 institutions and growing • > 712 million encounter events • > 4.4 billion clinical observations • > 580 million claims observations (Procedures, prescriptions, etc.) • 2 million ED visits per year • 78 million text reports (e.g., chest x-rays, operative notes)

12. Founded in February 2004 • Based on the technology, knowledge, and experience of Regenstrief Institute • 70 employees • Providing services to over hospitals, 19,000 clinicians, and 3 payers • Serving a growing area with a current population of 13 million people

13. Results delivery • Secure document transfer • Shared EMR • Credentialing • Eligibility checking Hospitals Hospital Payers • Results delivery • Secure document transfer • Shared EMR • CPOE • Credentialing • Eligibility checking Health Information Exchange Physicians Labs • Results delivery Labs Data Repository Network Applications • Surveillance • Reportable conditions • Results delivery • De-identified, longitudinalclinical data Public Health Outpatient RX • Secure document transfer • Quality Reporting Payer • De-identified, longitudinalclinical data Physician Office Public Health Researchers Ambulatory Centers INPCData Management and Services Data Management Data Access & Use

14. CI-NET Practice and Subject Recruitment • Trial Recruitment from Large Practices • Large health systems such as Wishard Health System and Indiana University Health have advanced information systems and strong research interests and missions. We have developed software to facilitate subject recruitment. • Recruitment from Small Practices • We are actively exploring using Docs4Docs as a mechanism to reach into smaller practices to recruit subjects. Docs4Docs delivers millions of messages to practices including electronic copies of discharge summaries, operative notes, EKGs, and radiology reports.

15. Engaging Smaller Practices • DOCS4DOCS® developed by Regenstrief Institute is an electronic results delivery service offered by IHIE. • Receives results and clinical messages from the participating data sources such as a hospital’s laboratory. • Converts these results into a consistent, easy to use report format, and delivers them to a secure, web-based inbox for the intended responsible provider. • Can also be transmitted via HL7 directly to a physician practice’s EMR.  • Delivers lab results, hospital admission, discharge and transfer summaries, transcriptions, EKGs, radiology reports, and others. • Provides Regenstrief/IHIE with a direct connection to over 19,000 physicians and their patients.

17. Evaluation Using 4 Mock Studies • Open-label Randomized Trial of Torsemide Compared with Furosemide Therapy for Patients with Heart Failure • Estimate the incidence of long-term opioid initiation among older patients with chronic non-cancer pain and estimate the incidence of various drug effects • Comparative Effectiveness Research Trial of Alzheimer’s disease [COMET-AD] • Intervening Now in Diabetes to Encourage Healthy Eating, Activity and Linkages to Healthcare [INDE-HEALTH]

18. Variable Information Needs and Availability Study 1 Study 2 • Information contained in INPC • Information collected by ResNet or interviewers • Information collected by practice personnel

19. Cover Letter and Teleform

20. SUMMARY • To enhance the informatics infrastructure in Indiana to conduct clinical research, Regenstrief Institute has created several programs to support subject recruitment from the networks of large practices and is creating the capacity to reach into smaller clinical practices. • CI-Net is supported by the CTSI and has become a key connection between the practitioners throughout Indiana and researchers at Indiana, Purdue, and Notre Dame. • We envision CI-Net as a valuable resource for CER involving drugs, devices, diagnostics, and services and pragmatic trials.

21. Public Health Informatics 2013+ Vision Natural Language Processing Health Geographics Health System Redesign Clinical Epidemiology CTSI Informatics and Data Analysis Center Research Planning and Infrastructure Data Mining Bioinformatics Clinical Decision Support and QI Visual Analytics Security and Privacy High Performance Computing

22. Project Team • Project Management • Patty McGuire • Sarah Hoover • Corey Whitley • ResNet • Jane French • Brenda Hudson • Data Core • Evgenia Teal • Faye Smith • Software Engineering • Jeremy Leventhal • Mike Barnes, MD • Hui Xiao • Biomedical Informatics • Bill Tierney, MD • Paul Dexter, MD • Administration • Anantha Shekhar, MD

24. UPCOMING CER SCIENTIFIC PRESENTATIONStatistical Infrastructure for combining multiple data sources in CEROctober 15thPresented by: TrivelloreRaghunathan, PHDUniversity of Michigan, school of public healthWELCOME VOLUNTEERS or SUGGESTIONS

25. WORKGROUP REPORTS11:16AM

26. DIR Workgroup co-Leads: Paul Meissner and Jonathan Tobin October 2011 Fall –Winter 2011 2012 • Merged Collaboration and Dissemination and Implementation Workgroups launched into one WG: newly named as Dissemination and Implementation Research WG • White Paper on Stakeholder Engagement • - Working paper on CTSA wiki • - Submitted for peer review • 2. Best Practices in Translational Research • 7 interviews completed • Developed preliminary results • 15 interviews proposed & scheduled • Identification of variables of interest for D&I research from EHRs and other data sources. • 1. White Paper on Stakeholder Engagement – published JGIM May 2012 • 2. CTSA Structured Interviews Dissemination Research –interviews completed, summary presented, presentations and manuscript on best practices in progress • 3. Stakeholder engagement demonstrations • Tufts EPC (5) • PPP KFC (1) • Other • Variables of interest for D&I research – link with NCI GEM initiative • 4. Rapid D&I Network / Pilot DIR demonstrations • - Needs leadership Completed To be Completed

27. Methods Workgroupco-Leads: Sean Tunis , Mark Helfand, Jerry Krishnan and Peter Neumann October 2011- Jan 2012 Feb 2012-October 2012 June – October 2011 Fall 2012 Develop and conduct an Methods WG Mini-Workshop of the October 2011 CER KFC Annual meeting with stakeholders. Focus on specific ways to advance methods research as detailed in the forthcoming CER Methods Agenda Paper. Discuss WG projects in light of the current CER/PCOR environment. • Dec 2011– Jan 2012:   • Key informant interviews on current consortium efforts to expand national infrastructure for conducting community-based PCTs • Jan 2012: Compile findings from key informant interviews Feb-May 2012: Create prioritized list of projects/ topics for discussion at CTSA PCTi workshop. Establish a planning committee with CER and CE KFC workgroup leaders. October 2012: Workshop to convene individuals and groups from CTSA program and other initiatives with shared interest in expanding national infrastructure for community-based PCTs • Fall 2012:   Produce white paper with strategic plans for CTSA CER methods workgroup to contribute to expansion of national infrastructure for community based PCTs (CTSA PCTi) Completed To be Completed

28. CER Informatics TaskforceOpen Discussion:*Projects*In-person CER KFC Informatics Taskforce meeting with the CER KFCCo-Leads: Joel Saltz and Bill Hersh

29. LIAISON REPORTS11:40AM

30. Liaison Member Reports

31. Membership Updates, Ideas, Suggestions, and NewsALL11:50AM

32. C4 UpdatesColleen Lawrence, CER PM11:58 AM

33. CER KFC Monthly Meeting: Monday, September 10th from 11 AM-12PM EDT Capacity and Needs Assessment Workgroup: Monday, August 20thfrom 4-5 PM EDT Dissemination and Implementation Research Workgroup: Tuesday, September 25th from 11AM-12 PM EDT Methods Workgroup: Thursday, August 23rd from 12-1 PM EDT Informatics Taskforce: Thursday, September 6th from 12 - 1 PM EDT Operations Group: Tuesday, August 28th 4-5 PM EDT *attended by Co-Chairs /WG-TF Leads/ KFC Coordinator/PI Liaison SGC #4 Bi-Monthly Meeting : Monday, September 24thfrom 11 AM- 12 PM EDT *attended by CER and Comm. Eng. KFC Co-Chairs /WG-TF Leads/ KFC Coordinator/PI Liaison CER KFC Upcoming meeting schedule

34. APPENDIX (Proceed If needed)

35. CTSA Consortium Executive Committee Three Objectives for SGC #4 Objective 1: (Recognized as the Priority Objective by CCEC) :Develop a CTSA Consortium-wide strategy for community-engaged and comparative effectiveness research that leads to improvements in the access, quality, and efficiency of healthcare delivery and the health of diverse communities and the public. (*Metric followed by CCEC). Objective 2: Collaborate and create synergies with a wide range of stakeholders (i.e., communities, health departments, CTSA and other academic medical centers, NIH Institutes and Centers and other DHHS Federal Partners) in planning and implementing community-engaged and comparative effectiveness research and in disseminating the research findings. Objective 3: Facilitate collaborations across CTSA institutions, PBRNs, and a broad cross-section of practice settings that increase the nation’s capacity for innovative community-engaged and comparative effectiveness research leading to the development of novel methodologies for both conducting research and for implementing and disseminating the findings of that research.

36. Mission Statement The Comparative Effectiveness Research (CER) Key Function Committee builds the field of comparative effectiveness research (CER) and patient-centered outcomes research by creating a learning community across CTSA institutions, spurring the development of methods, expanding training and education, promoting community and public engagement, applying CER findings and sharing successes and lessons learned. Vision Statement Through collaborative work products, the Comparative Effectiveness Research (CER) Key Function Committee facilitates the generation and synthesis of evidence about alternative interventions that results in actionable findings for policymakers, clinicians, patients, and purchasers to use in improving the quality and outcomes of patient-centered health care. CER KFC Mission and Vision Statements https://www.ctsawiki.org/wiki/display/CER/Comparative+Effectiveness+Research-+Home