Breakout 2: Informatics, including support of Clinical ...€¦ · Study Design and implementation 2. Access to public, private EHRs 3. ... A. Feasibility and Cohort Exploration for

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


December 6, 2018External Advisory Committee


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


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


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


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


3. Translational Informatics Core

1. Study Design and implementation

2. Access to public, private EHRs3. Education/tutorials on EHR

access and analytical tools


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.


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)



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


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)


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


Informatics Common MetricAnnual Characterization of Patient Data Set to be Submitted


Educational Activities

1. Clinical Informatics Fellowship1. 2 slots (Metrohealth)

2. Programs in Health Informatics1. Approved 2018

2. Certificate

3. Master’s

4. Ph.D.

3. Integration into CWRU UP medical education



Questions for DiscussionInformatics, 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?


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?

Questions for DiscussionInformatics, including support of Clinical Trials and Hub Liaison Team (TIN)

Documents

Breakout 2: Informatics, including support of Clinical ...€¦ · Study Design and implementation 2. Access to public, private EHRs 3. ... A. Feasibility and Cohort Exploration for