Comparative Effectiveness Research Key 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)

Time (ET)

11:00 AM (2 min.)

CTSA CER Key Function Committee (KFC) Monthly Meeting Agenda

Monday, August 20, 2012, 11:00 AM – 12:00 PM ET Teleconference Only Dial-in: 1 877 568 4109 Access Code: 271-247-588

Go To Meeting Registration (only) link

https://student.gototraining.com/r/1271356837225888256

Topic Presenters Welcome, Overview and Announcements

Tim Carey and Tom Concannon 11:02 AM (6 min.) • •

Activity Updates

• CCEC/CCSC/SGC4 Updates NIH Video Project (Jodi Segal’s video) • • Harry Selker ( PI Liaison to CCSC/CCEC/SGC4) Rosemarie Filart • Mick Murray PharmD, MPH, Central Indiana Innovation Network (CI-Net), University of Indiana School of Medicine

CER CTSA Presentation:

11:08 AM (8 min.) 11:16 AM (24 min.)  

Workgroup/Taskforce Reports

 Dissemination and Implementation Research  Methods Informatics Taskforce Capacity and Assessment 

Liaison Reports

11:40 AM (10 min) 11:50 AM (8 min.) 11:58 AM (2 min) 12:00 PM

Discussion, Action Items and Upcoming Meetings

 Member News and Recruitment

C4 updates Adjournment

1. Paul Meissner and Jonathan Tobin 2. Sean Tunis, Mark Helfand, Jerry Krishnan, Peter Neumann 3. Joel Saltz and Bill Hersh 4. Harold Pincus and Dan Ford Liaisons • ALL • Colleen Lawrence Tim Carey, Tom Concannon, and Rosemarie Filart

Structure of Comparative Effectiveness Research KFC (CER KFC)

Co- Chairs: Tim Carey and Tom Concannon CER KFC PI Liaison of the SGC & CCSC, Harry Selker NIH Coordinator, Rosemarie Filart Project Manager, Colleen Lawrence, C4 Project Assistant, Diane Rohrer, C4 C4 Faculty Liaison, Bob Dittus, C4

Operations Group

(Co-Chairs, Workgroup and Taskforce Co-Leads, PI Liaison, NIH Coordinator, and C4)

Dissemination and Implementation Research (newly merged) Leads:

Paul Meissner and Jonathan Tobin

KFC Chair:

Tom Concannon

CER Methods Workgroup Lead:

Mark Helfand, Sean Tunis, Jerry Krishnan, and Peter Neumann

KFC Chair:

Tom Concannon

Capacity and Needs Assessment Lead:

Dan Ford and Harold Pincus

CER Informatics Taskforce Co-Leads

: Joel Saltz and Bill Hersh

KFC Chair:

Tim Carey

All Members invited to participate in any group

NIH Updates

Rosemarie Filart 11:02 AM

Seeking Your Input for Productive Outcomes of Day 1: PCTi Workshop

SGC4 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

CER SCIENTIFIC PRESENTATION

Central Indiana Innovation Network (CI-Net)

Presented by: MICHAEL MURRAY, PHARMD, MPH INDIANA UNIVERSITY SCHOOL OF MEDICINE

11:08AM

Central Indiana Innovation Network (CI-Net)

CTSA CER/HIT KFC

Michael D. (Mick) Murray, PharmD, MPH Regenstrief Institute Purdue University College of Pharmacy

Project Objectives

1. Develop the mechanism to facilitate and expand engagement of physicians throughout Indiana in CER.

2. Test and evaluate the developed CER recruiting mechanism in large and small practices.

3. Package the components for dissemination to CTSA members who wish to implement similar participant recruitment programs for CER trials within their networks.

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.

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

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)

• • • • • 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

Labs Outpatient RX

INPC Data Management and Services

Data Management Hospital Health Information Exchange Data Repository Payers Network Applications Physician Office Ambulatory Centers Public Health Hospitals Physicians Data Access & Use

• • • • •

Results delivery Secure document transfer Shared EMR Credentialing Eligibility checking

• • • • • •

Results delivery Secure document transfer Shared EMR CPOE Credentialing Eligibility checking

•

Results delivery Labs Public Health Payer Researchers

• • • •

Surveillance Reportable conditions Results delivery De-identified, longitudinal clinical data

• •

Secure document transfer Quality Reporting

•

De-identified, longitudinal clinical data

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.

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.

Evaluation Using 4 Mock Studies

1.

Open-label Randomized Trial of Torsemide Compared with Furosemide Therapy for Patients with Heart Failure 2.

Estimate the incidence of long-term opioid initiation among older patients with chronic non-cancer pain and estimate the incidence of various drug effects 3.

Comparative Effectiveness Research Trial of Alzheimer’s disease [COMET-AD] 4.

Intervening Now in Diabetes to Encourage Healthy Eating, Activity and Linkages to Healthcare [INDE-HEALTH]

Variable Information Needs and Availability

Study 1 Study 2 • Information contained in INPC • Information collected by ResNet or interviewers • Information collected by practice personnel

Cover Letter and Teleform

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.

2013+ Vision

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

• Project Management  Patty McGuire  Sarah Hoover  Corey Whitley • ResNet – Jane French – Brenda Hudson • Data Core – Evgenia Teal – Faye Smith

Project Team

• Software Engineering

– Jeremy Leventhal – Mike Barnes, MD – Hui Xiao • Biomedical Informatics – Bill Tierney, MD – Paul Dexter, MD • Administration – Anantha Shekhar, MD

UPCOMING CER SCIENTIFIC PRESENTATION

STATISTICAL INFRASTRUCTURE FOR COMBINING MULTIPLE DATA SOURCES IN CER October 15 th Presented by: Trivellore Raghunathan, PHD UNIVERSITY OF MICHIGAN, SCHOOL OF PUBLIC HEALTH WELCOME VOLUNTEERS or SUGGESTIONS

WORKGROUP REPORTS 11:16AM

October 2011

DIR Workgroup co-Leads: Paul Meissner and Jonathan Tobin

Fall –Winter 2011 2012

Merged Collaboration and Dissemination and Implementation Workgroups launched into one WG: newly named as Dissemination and Implementation Research WG 1. 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 3. Identification of variables of interest for D&I research from EHRs and other data sources.

Completed To be Completed 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 1.

2.

3.

Tufts EPC (5) PPP KFC (1) Other 3.

Variables of interest for D&I research – link with NCI GEM initiative 4. Rapid D&I Network / Pilot DIR demonstrations - Needs leadership

Methods Workgroup co-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.

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) 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 Completed To be Completed

CER Informatics Taskforce

Open Discussion: *Projects *In-person CER KFC Informatics Taskforce meeting with the CER KFC Co-Leads: Joel Saltz and Bill Hersh

LIAISON REPORTS 11:40AM

Academy Health

Committee

AHRQ DARTnet (Distributed Ambulatory Research in Therapeutics Network) AHRQ CER T32 Program AHRQ PBRN Biostatistics / Epidemiology / Research Design (BERD) KFC Novartis DIA CER Bayesian statistical methods grp Clinical Research Management (CRM) KFC Community Engagement KFC-- Education, Scholarship and Engagement (ESE) WG CTSA Consortium Child Health Oversight Committee (CC-CHOC) Education & Career Development Key Function Committee Evaluation KFC         

Liaison Member Reports Liaison

• Erin Holve and Lisa Simpson     Jeanne-Marie Guise ,Doug Landsittel , Wilson Pace, David West Tim Carey Paul Meissner Frank Harrell and Chang Yu Chang Yu Jeffrey Silverstein

TBA: Seeking Additional Volunteer(s) TBA: Seeking Volunteers

Jill Herndon Daphne Hsu Wishwa Kapoor Pam Mitchell Harold Pincus, Arthur Blank, and Jodi Segal Informatics Key Function Committee

(NOTE: This is distinct from the CER Informatics Taskforce)

IOM Public-Private Partnerships (PPP)KFC New York CER Regional Group Midwestern and Chicago CER Regional Groups      Joel Saltz, Bill Hersh, Stephen Pauker Lucy Savitz, Harry Selker, Rosemarie Filart Caren Heller Harold Pincus Jerry Krishnan, Neil Barroos, Gavin Hougham                

CTSA

OHSU, UPMC, Denver University of North Carolina Albert Einstein Vanderbilt University Vanderbilt University Mount Sinai University of Florida Albert Einstein UPMC University of Washington Columbia U, Albert Einstein and JHU Atlanta CTSI (GA Tech),Tufts University, Oregon HSC Utah University, Tufts University, NIH Cornell University Columbia UIC, UC

MEMBERSHIP UPDATES, IDEAS, SUGGESTIONS, AND NEWS ALL 11:50AM

C4 UPDATES Colleen Lawrence, CER PM 11:58 AM

CER KFC UPCOMING MEETING SCHEDULE

CER KFC Monthly Meeting: Monday, September 10 th from 11 AM-12PM EDT Capacity and Needs Assessment Workgroup: Monday, August 20 th from 4-5 PM EDT Dissemination and Implementation Research Workgroup: Tuesday, September 25 th EDT from 11AM-12 PM Methods Workgroup: Thursday, August 23 rd from 12-1 PM EDT Informatics Taskforce: Thursday, September 6 th from 12 - 1 PM EDT Operations Group: Tuesday, August 28 th 4-5 PM EDT

* attended by Co-Chairs /WG-TF Leads/ KFC Coordinator/PI Liaison

SGC #4 Bi-Monthly Meeting : Monday, September 24 th from 11 AM- 12 PM EDT

*attended by CER and Comm. Eng. KFC Co-Chairs /WG-TF Leads/ KFC Coordinator/PI Liaison

APPENDIX

(PROCEED IF NEEDED)

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.

CER KFC MISSION AND VISION STATEMENTS

HTTPS://WWW.CTSAWIKI.ORG/WIKI/DISPLAY/CER/COMPARATIVE+EFFECTIVENESS+RESEARCH-+HOME 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.