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,

Children’s 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

systems—lab, 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, Children’s 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

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.

Guiding Principles

Options Evaluated

Option Advantages Disadvantages

1. Create CRS functions

in the EMR

One system (actually 3!) Would require custom

programming.

Prioritization with

regards to other EMR

projects.

2. Create EMR functions

in the CRS

One system for some

researchers, but not all.

Duplication of existing

effort. Additional

training requirements for

clinicians and others.

3. Integrate existing

EMR and CRS

Takes advantage of

strengths of each

systems.

Interface would be a

Beta project for 2

vendors!

High Level Workflow

CRS to EMR Integration (clinical services required for screening)

EM

REM

RC

RS

CR

S

Register Study, Create Calendar

(CPT Coded Svcs) & Get Approvals*

Schedule Research Visit 3. Associate Vist to Study

Recruit Participants

Screen Potential

Participants

Arrive for Visit

Patient Completes

Study

Pay Bill (OPAA)

1. Create Study

Get Clinical Bill (IDR)

Consent Eligible

Participants

Identify Existing Patient or

Create Patient (MRN)

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

Enroll Participants

to Study

Conduct Visit/ Collect

Data

Check off Visit/

Milestone(CRS)

Get Order Results

BillingRelease

HIM

Document (Research

Note)

Recruitment BestPractice Advisories

My Chart

Enrolling Patient to Study Occurs for each Research Visit

Place Orders

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”

Note the Patient Study Status “Associated with Study in

EMR”

Implementation

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)

• Consent Signed

• Pre-Screening

• Eligible/Screen

Successful

Active

(visit can be associated with

study)

• Enrolled

• Active/On Treatment

• Off Treatment

• In Follow-up

Inactive

(visit can no longer be

associated with study)

• 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 Children’s Medical Center EMR live

EMR/CRS

Data integration status summary

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

Use of Research Patient Flag

Source: UTSW EMR audit trail

Use in clinical care

04/2012 - 09/2012: 836

09/2012 - 03/2013: 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 “high-availability”. By integrating the CRS into the clinical workflow we raised the bar on up-time needed for the CRS.

End user training is typically divided between the clinical world and the research world – knowing how to effectively use both mechanisms takes care and constant attention.

Existing governance structures around EMR updates and changes do not always include individuals knowledgeable regarding clinical research who can assist in prioritizing work.

Conclusions1. 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.

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

Acknowledgements (a few)