Breakout 2: Informatics, including support of Clinical Trials and HUB Liaison Team (TIN)

Breakout Discussion Leads: • Jonathan Haines, PhD • Serpil Erzurum, MD • David Kaelber, MD, PhD

December 6, 2018 External Advisory Committee

Louis Stokes Cleveland VA Medical Center Informatics is Key

Informatics is a primary component of the CTSA initiative, aiming to advance the use of cutting-edge informatics for research: • Data collection, data structure, data storage and best practices for data use and data sharing • Analytical methods for large data sets • Use of EHR methods for both research participant recruitment and clinical and translational research

Louis Stokes Cleveland VA Medical Center CTSC Informatics Specific Aims

Aim 1: Provide Informatics tools to support and accelerate clinical and translational research

Aim 2: Educate and train researchers, trainees, and staff in biomedical informatics tools and resources

Aim 3: Enable collaborative research and data sharing within CTSC and across the nation

Louis Stokes Cleveland VA Medical Center CWRU’s CTSA has Multiple Institutions: A Microcosm of the National Consortium Many IT systems and software in use at three hospital systems creates opportunities and challenges. EHR CTMS IRB

Epic Clic WebKit

Epic (none) Clic

Allscripts Velos Sparta*

*Note: Also used by CWRU

Louis Stokes Cleveland VA Medical Center Informatics Support in Clinical and Translational Science Discovery 1. Computational Biology Core 3. Translational Informatics 1. Experimental Design and Core Analysis 1. Study Design and 2. DNA and RNA sequence implementation 3. CHiP seq 2. Access to public, private EHRs 3. Education/tutorials on EHR 4. Single cell seq access and analytical tools 2. Data Management Core 1. SHED (Oncore, LabMatrix, APEX, SRE) 2. Data management design and expertise

Louis Stokes Cleveland VA Medical Center Informatics in Clinical Trials Research

Hub Research Capacity and the Hub Liaison Team (TIN) are responsible for developing systems and processes that enable efficient completion of a clinical research project, from concept to results dissemination.

Informatics is a key enabler toward those goals.

Louis Stokes Cleveland VA Medical Center Informatics in Clinical Research: Research Uses of EHRs that Need Further Development A. Feasibility and Cohort Exploration for proposal development B. Recruitment of patient participants into clinical research studies 1. Cohort contact list generation based on match to inclusion/exclusion criteria 2. Direct-to-Patient recruitment via MyChart® or similar portals 3. Daily EMR ‘alerts’ or weekly reports to care & study teams identifying scheduled patients that meet study inclusion criteria C. Patient-Reported data – digitally collected 1. MyChart® or similar patient portals for patient answers to any type of study instrument (e.g., diet logs, symptom trackers, questionnaires)

Louis Stokes Cleveland VA Medical Center Informatics in Clinical Research: Research Uses of EHRs that Need Further Development D. e-Consent option – compliant, on-line consenting to be in a research study E. Tracking subjects’ course throughout clinical trial (e.g, interest, consent, enrollment, retention/participation per protocol, completion, etc.) F. Physician Research Order Sets – quick, correctly detailed instructions per protocol related to research studies, biobank processing G. Data pulls from EHR for research purposes

Louis Stokes Cleveland VA Medical Center Digital Tools for Researchers Available now • ResearchMatch® – sign-up for research participation and match for research studies • Explorys® – self-service EHR feasibility review per enrollment criteria and special populations • Site-specific EHR Data pull support* – Custom requests for EHR-based participant identification or for IRB-approved research use – Different implementation approaches at each site • REDCap and REDCap Cloud (FDA compliant)

Louis Stokes Cleveland VA Medical Center Digital Tools for Researchers Being implemented/under consideration • TriNetX®evaluation – self-service components • Epic® Cosmos Research Network evaluation – self-service components • Epic® Slicer/Dicer • CLEARPATH – Regional EHR data integration – OMOP data mapping

Louis Stokes Cleveland VA Medical Center Informatics Common Metric Annual Characterization of Patient Data Set to be Submitted

Louis Stokes Cleveland VA Medical Center Educational Activities

1. Clinical Informatics Fellowship 1. 2 slots (Metrohealth) 2. Programs in Health Informatics 1. Approved 2018 2. Certificate 3. Master’s 4. Ph.D. 3. Integration into CWRU UP medical education

Louis Stokes Cleveland VA Medical Center Questions for Discussion Informatics, including support of Clinical Trials and Hub Liaison Team (TIN)

1. What stands out as achievable priorities? 2. What is an appropriate balance of service to innovation/tool development? 3. How do we expand educational activities for staff? 4. How do we balance resource availability with informatics needs? 5. How do we enable our Hub to collaborate with other Hubs, especially on Informatics projects?

Louis Stokes Cleveland VA Medical Center Questions for Discussion Informatics, including support of Clinical Trials and Hub Liaison Team (TIN)

6. What strategies would aid innovation? 7. How do we address barriers to data integration across sites? 8. What has been effective at the Advisor’s sites for furthering clinical research activities? What successes have you had? 9. Anything we have missed or overlooked?

Louis Stokes Cleveland VA Medical Center