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 Louis Stokes Cleveland VA Medical Center December 6, 2018 External Advisory Committee
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Breakout 2: Informatics, including support of Clinical ...€¦ · Study Design and implementation 2. Access to public, private EHRs 3. ... A. Feasibility and Cohort Exploration for
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Louis StokesCleveland VA Medical Center
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
Louis StokesCleveland VA Medical Center
December 6, 2018External Advisory Committee
Louis StokesCleveland 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 StokesCleveland 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 StokesCleveland 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 StokesCleveland VA Medical Center
Informatics Support in Clinical and Translational Science Discovery
1. Computational Biology Core1. Experimental Design and
Analysis
2. DNA and RNA sequence
3. CHiP seq
4. Single cell seq
2. Data Management Core1. SHED (Oncore, LabMatrix,
APEX, SRE)
2. Data management design and expertise
Louis StokesCleveland VA Medical Center
3. Translational Informatics Core
1. Study Design and implementation
2. Access to public, private EHRs3. Education/tutorials on EHR
access and analytical tools
Louis StokesCleveland VA Medical Center
Informatics in Clinical Trials Research
Louis StokesCleveland VA Medical Center
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 StokesCleveland 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 portals3. Daily EMR ‘alerts’ or weekly reports to care & study teams
identifying scheduled patients that meet study inclusion criteriaC. 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 StokesCleveland VA Medical Center
Louis StokesCleveland VA Medical Center
Informatics in Clinical Research:Research Uses of EHRs that Need Further
DevelopmentD. e-Consent option – compliant, on-line consenting to
be in a research studyE. 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 StokesCleveland VA Medical Center
Digital Tools for ResearchersAvailable 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 StokesCleveland VA Medical Center
Digital Tools for ResearchersBeing 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 StokesCleveland VA Medical Center
Informatics Common MetricAnnual Characterization of Patient Data Set to be Submitted