Creating a Research and Clinical Care Partnership through EMR and Clinical Research System Integration

Dipti Ranganathan MS, Melody Bell, DuWayne Willett MD and Ronald M. Peshock, MD

University of Texas Southwestern Medical Center

4 hospitals

UTSW, Parkland Hospital,

Childrens Medical Center

3 EMRS, all Epic

One IRB
~6000 clinical research
protocols

Participants could be
recruited from multiple hospitals

One clinical research

system

Why a clinical research system?

Electronic medical records (EMR) Fundamentally patient centric Workflow optimized for clinical care Implementation is clinically and billing driven Internally integrated and tightly interfaced to other clinical
systemslab, radiology, PACS, scheduling, etc. Participation in research is in some ways an attribute which is added to a patient

Clinical research systems (CRS) Study or research program centric Facilitate participant management and recruitment Linked to grant, contract management, and IRB systems Accommodate a broad range of types of clinical research:
clinical trials, surveys, population based studies, etc.

Governance The Main Ingredient

Govern Clinical Research Technology including related policy Meets twice a month at 7am very well-attended Members: Senior Associate Dean, Academic Affairs Professor, Pediatrics, IRB Chair Associate Vice President, Health System IT Assistant Vice President, Academic IT Senior Faculty/Director, Center for Human Genetics Pediatric Faculty Member/Research Medical Director, Childrens Hospital CIO Chief Medical Officer, University Hospitals Associate Professor, Internal Medicine/IRB Board Member Assistant Dean, Informatics Chair, Family and Community Medicine Chief Medical Officer, County Hospital Chair, Psychiatry Faculty/Principal Investigator, CTSA Chief Medical Informatics Officer Director, Simmons Cancer Center

Guiding Principles
To insure participant safety and improve clinical research workflow All research studies will be registered in the CRS. All participants will be registered in the CRS (with the exception of some
surveys).

The CRS is the source of truth for all human research studies,
participants and protocol calendars.

All research participants receiving research related services (lab, etc.)

will be registered in the local EMR (with exceptions for studies that are of a sensitive nature).

Study participants will be flagged in the EMR and associated with each
specific study.

Information specific to clinical services or items provided to an individual

research patient may be documented in the appropriate EMR medical record system.

Clinical research information contained in EMR will not be disclosed

under a release of information request for studies with Certificates of Confidentiality.

Options Evaluated
Option Advantages Disadvantages

1. Create CRS functions One system (actually 3!) Would require custom in the EMR programming. Prioritization with regards to other EMR projects. 2. Create EMR functions One system for some in the CRS researchers, but not all. Duplication of existing effort. Additional training requirements for clinicians and others. Interface would be a Beta project for 2 vendors!

3. Integrate existing EMR and CRS

Takes advantage of strengths of each systems.

High Level Workflow

CRS to EMR Integration
(clinical services required for screening)

Enrolling Patient to Study

Register Study, Create Calendar (CPT Coded Svcs) & Get Approvals*

Occurs for each Research Visit

Enroll Participants to Study Conduct Visit/ Collect Data Check off Visit/ Milestone (CRS) Get Clinical Bill (IDR) Pay Bill (OPAA) Patient Completes Study

CRS

Recruit Participants

Screen Potential Participants

Consent Eligible Participants

My Chart

EMR

1. Create Study

Recruitment BestPractice Advisories

Identify Existing Patient or Create Patient (MRN)

2. Associate Patient to Study (Reg Pt. Flag)

Schedule Research Visit 3. Associate Vist to Study

Arrive for Visit

Place Orders

Document (Research Note)

Get Order Results

Billing

Release HIM

Phase 1 Integration

Technical Specifications
Environment EMR: Epic 2010 CRS: Velos version 8.10 Real-time interfaces

IHE - Retrieve Protocol for Execution and the HL7 v2

Study Participation

All messages are in XML

Technical Specifications
Study Creation in EPIC
Velos Epic (Create Study)
Data: ID (PI) ,Title, Description (Short Description, Contact
Information, ClinicalTrials.gov number/hyperlink), Certificate of Confidentiality

Epic Velos
Confirmation that study creation was successful or failed

Participant Registration in Velos

Velos Epic (check for patient in Epic) Epic Velos
Data: First name, Last name, Address, Date of birth, Gender

Technical Specifications
Patient Association to Study Velos Epic
Data: MRN

Epic Velos
Confirmation that association was successful or failed

Demographic updates
Epic Velos Done on 24 hr. cycle due to frequent demographic updates

Separate participant phone number fields are kept for

research contacts

Implementation

Note the Study Status Study Created in EMR

Implementation

Note the Patient Study Status Associated with Study in

EMR

Velos Data Fields for Epic

Research Flag and Study Detail

Status Mapping
EMR Research Flags Categories CRS Patient Statuses

Pre-Enrollment (visit can be associated with study)

Active (visit can be associated with study) Inactive (visit can no longer be associated with study)

Consent Signed Pre-Screening Eligible/Screen Successful

Enrolled Active/On Treatment Off Treatment In Follow-up

Consent Refused Not Eligible/Screen Failure Off Study

Rollout
April 2010
Enterprise Study registration in Velos

July 2010
Cancer center patient registration
Migrated study and patient data from prior CRS Began NCI reporting from Velos

February 2012
CRS to EMR interface for study and patient registration No requirement that all study participants be entered

Rollout
September 2012 Requirement that all study participants be entered in
CRS Unable to schedule visits or lab/radiology unless the participant exists in CRS Facilitated creation of billing queues

September 2012 CRS interface to Parkland Health and Hospital EMR

live

March 2013 CRS interface to Childrens Medical Center EMR live

EMR/CRS Data integration status summary

Sept 2012 March 2013 Number of studies in CRS Number of studies sent to EMR Number of studies with Certificate of Confidentiality Number of studies with ClinicalTrials.gov number Number of patients in CRS Number of patients with Research Flag in EMR 5,154 1,411 69 351 10,411 5,295 5,625 1,744 89 411 14,590 11,034

Use of Research Patient Flag

Source:
UTSW EMR audit trail

Use in clinical care

04/2012 - 09/2012: 09/2012 - 03/2013:
836 2251

Users

Residents and faculty physicians Other clinical and hospital staff Health information management Research coordinators

Why it worked
Governance Communication Design that included stakeholders (faculty and
research coordinators)

Committed IT resources from both the clinical and the

research organizations

Lessons learned
Research systems are typically not designed for highavailability. By integrating the CRS into the clinical workflow we raised the bar on up-time needed for the CRS.
world and the research world knowing how to effectively use both mechanisms takes care and constant attention.

End user training is typically divided between the clinical

Existing governance structures around EMR updates

and changes do not always include individuals knowledgeable regarding clinical research who can assist in prioritizing work.

Conclusions
1. Working with two commercial vendors we developed a real-time,
standards-based, reusable interface between an EMR and CRS to facilitate both clinical care and the clinical research processes.

2. The research flag alerts physician, nurses and other staff that the
patient is on a research study, providing them fundamental information to assist with their care.

3. From the standpoint of the CRS this lays the foundation for taking
advantage of ordering, resulting, auditing, billing and reporting functions which are already well established in the EMR. In addition, it can fit well with workflow that exists in the EMR for clinical processes such as the routing of images or laboratory samples.

4. The use of an xml message to transfer the information to different

EMRs is well established. Thus, our use of xml to transfer study information should be generalizable to facilitate interoperability with other EMR systems as long as they support the concepts of a research study and research participant.

Acknowledgements (a few)
Kirk Kirksey, CIO, UTSW

Suresh Gunasekaran, CIO, UTSW Health Systems

Dr. Dennis Pfeiffer, CTO Interface teams at UTSW, PHHS, and CMC Karen Schifter, EMR Director Tom Cutler, CRS Director Executive Team, PHHS Executive Team, CMC Clinical Research coordinators, Investigators Epic and Velos interface teams