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2013 Summit on Clinical Research Informatics
Citation preview
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)