HERON, Frontiers, and Pioneers:
Database and Recruitment Resources to Advance
Your Research
Jeffrey M. Burns, MD, MS
Edward H. Hashinger Professor of Neurology
Director, Clinical and Translational Science Unit
Associate Director, KU Alzheimer’s Disease Center
Russ Waitman, PhD
Associate Professor, Department of Internal Medicine
Associate Vice Chancellor for Enterprise Analytics
Director of Medical Informatics
Patricia Kluding, PT PhD
Associate Professor, Dept of Physical Therap & Rehab Sciences
Director, Georgia Holland Health Exercise and Aging Lab
Associate Director, Clinical and Translational Science Unit
What is the CTSU?
• Supports research activity
• NIH-Funded
– A program of Frontiers: Heartland Institute of Clinical and
Translational Research
– Physical Infrastructure
•
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•
•
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Clinic rooms
Infusion center
Exercise physiology
Sleep lab and beds for extended stays
Metabolic kitchen
– Nursing
– Coordinators
– Recruitment Program
• Registry
• Pioneers Community Registry
– CTSU Satellite / CTSU Without Walls program
KU Clinical Research Center
http://www.youtube.com/watch?v=zsMBazY31S0
Clinical Space
Clinical Area
• 9 exam rooms for multi-purpose
outpatient research evaluations
• 2 cognitive testing rooms
• 2 Isolation exam rooms, designed
for smoking cessation or ID studies
• Workspace for up to 8 study
coordinators
Infusion Center
• 11 infusion suites for drug
administration and
pharmacokinetic studies
• Investigational pharmacy
Extended Observation Unit /
Sleep Lab
• Extended Observation
Unit (EOU) to allow
evening stays
• 3 hospital-style suites
• Study drug
administration,
observation & PK lab
draws
• Sleep Program opened
in October 2012
(Suzanne Stevens)
Exercise Physiology Laboratory
 Exercise Physiologist, ACSM Certified
 Two Parvo Medics Metabolic Carts
 Maximal Graded Exercise Testing with
Medical Monitoring
 Multiple Modalities and Protocols
 Treadmill
 Cycle
 Recumbent Stepper
 Upper Body Ergometer
Metabolic and Demonstration Kitchens
• Assessment of dietary intake
• Direct or digital photograph
observation
• 24-hour recalls
• Food records
• Food frequency questionnaires
• Screeners
• Nutrition interventions
• Recipe Development and Testing
• Research diets / Controlled feeding
protocols
• Standardized meals
CTSU Satellite Space
• Meet basic needs of investigators on
campus
• Rooms and basic supplies
– Delp – shared space with Dr. Moriarty,
overflow room.
– Hoglund Brain Imaging Center
– Swope Health Services
Research Coordinator Pool Service
 % FTE or $60 per hour
 Coordinator may provide services
including
 Regulatory processing for the trial
 Coordinating and conducting study
visits
 Performing study-required procedures
 Documentation
 Assisting with monitor visits
 Many other tasks and duties
Participant Recruitment
• Frontiers Registry
• Pioneers program
Research Participant Registry Program
 Comprehensive registry of KUMC patients willing to be
contacted for participation in research studies
 4 clinics started in 2009, now active 17 clinics
 15,000+ enrolled in registry by September 2012
 17 researchers have received participant information for 25
protocols (7 PhDs, 8 MDs, 1 PharmD and 1 MSPT)
 148 participants identified from the registry have been enrolled
in protocols
Summary of CTSU
• The purpose of the CTSU is to support
research by providing
– Space
– Nursing / coordinators
– Access to important resources
• Exercise physiology
• Overnight stay and sleep lab capabilities
• Metabolic kitchen
– Recruitment tools
• Frontiers Registry, Pioneers Program
KUMC Biomedical Informatics Resources
for your Research:
a focus on HERON
Russ Waitman, PhD
Director of Medical Informatics,
Director, Frontiers Biomedical Informatics
Assistant Vice Chancellor, Enterprise Analytics
Associate Professor, Internal Medicine
University of Kansas Medical Center
Kansas City, Kansas
This project is supported in part by NIH grant UL1TR000001
and NSF Award CNS-1258315
Overview
• “Hooking” People on Informatics
• How We Work: the technology and the team
• What’s on the Horizon
– Enhanced Registry Integration and data delivery
with REDCap
– Collaboration via CTSAs and PCORI opportunity
to generalize your research findings
Biomedical Informatics Can Help Your Research
• We have tools and expertise to manage data
and convert it into information
• REDCap and CRIS – enter and manage data
• HERON – fish for data from the hospital/clinic
• Biweekly Frontiers Clinical Informatics Clinics
– Tuesday 4-5 pm in 1028 Dykes Library.
– Next session September 17, 2013.
You’re that fisherman: wanting to land data to
answer your research hypothesis
Bennett Spring Trout Park, Lebanon Missouri
http://mdc.mo.gov/regions/southwest/bennett-spring
The Fish: Diagnoses, Demographics, Observations,
Treatments
Why so many fish?
Current Goal: Build Hatchery, Manage the Fishery
Second Goal: If you need help fishing, get a guide
Photo Credit: HuntFishGuide.com
http://www.flickr.com/photos/huntfishguide/5883317106/
Prepare and Analyze Data
Photo Credit: S. Klathill
http://www.flickr.com/photos/sklathill/505464990/
Our shared goal: a tasty publication
Photo Credit: Steve Velo
http://www.flickr.com/photos/juniorvelo/259888572/
Nightmare: looks like a nice river, but can’t catch fish
• I’ll just enter everything in Excel….
• What if I lose or accidentally sort my
spreadsheet?
• How to I let students only review deidentified data?
• Hospital/Clinic is making me use this
Electronic Medical Record and I get
nothing in return...
Little White Salmon River, Washington State, last Summer in July
Sometimes, You’re willing to enter data/buy fish:
REDCap: Research Electronic Data Capture
• https://redcap.kumc.edu
– It uses the same username
and password as your KUMC
email.
– Non-KUMC researchers can
request an affiliate account
through Frontiers CTSA
office
– Check out the training
materials under videos
• Case Report Forms
– (see left) registries, trials
• Conduct Surveys
– Similar to “SurveyMonkey”
REDCap: think Fish Tank you manage
http://www.flickr.com/photos/wiccked/185270913/lightbox/
I want to go fishing, not fill a fish tank (REDCap)
Use HERON: a managed fishery
Bonneville Hatchery: Trout, Salmon, Sturgeon, Columbia River, Oregon
Central CTSA Informatics Aim: Create a data “fishing”
platform: HERON, https://heron.kumc.edu
• Get a License: Develop business
agreements, policies, data use agreements
and oversight.
• Get a Fishing Rod and Bass Boat:
Implement open source NIH funded (i.e.
i2b2 https://www.i2b2.org/) initiatives for
accessing data.
• Know what your catching: Transform data
into information using the NLM UMLS
Metathesaurus as our vocabulary source.
• Stock Different Tasty Fish: link clinical data
sources to enhance their research utility.
HERON: Getting a Fishing License
Single sign-on
using your email
username
Real-time check
for current human
subjects training
• Fill out System Access Agreements to sponsor students/staff
• Fill out Data Use Agreement to request data export
• No Limit!!! IRB Protocol Not Required to view or pull deidentified data
• Must be on campus or use VPN or https://access.kumed.com
• Check http://frontiersresearch.org/frontiers/HERON-Introduction
for more information, status, and training videos
The i2b2 “Fishing Rod”: build Diabetes cohort
Types of “fish” in folders
Drag concepts from upper left
into panels on the right
i2b2 : AND in Frontiers Research Registry
Dragging over the second condition
i2b2: AND a high Hemoglobin A1C
When you add a numeric concept,
i2b2 asks if you want to set a constraint
i2b2 Result: 497 patients in Cohort
Run the Query
Query took 4 seconds
497 patient in cohort
I2b2: Explore Cohort, Visualize
The dream: landing the big one
Catch the data
for JAMA, NEJM
publication
http://www.oregon.com/columbia_gorge_attractions/bonneville_hatchery
Without getting bit
HERON as Central Aim to CTSA
“Signals” of Health: Think of each source electronic
system as an EKG, blood pressure cuff, arterial line
Hypothesis #2: Computer +
Clinical Process-> Better Health?
Hypothesis #1:
Admin + Clinical
-> Better Knowledge?
How the Team Works: HERON Evolves Every Month
• Goal: stable monthly process, minimal downtime
• Complete rebuild of the repository, not HL7 messaging update based.
• Two databases: create new DB while old DB is in use.
• When the new DB is ready, switch over i2b2 to serve customers fresh
data.
• Initial Files from Clinical Organizations
• Export KUH Epic Clarity relational database instead of Cache/MUMPS.
• Monthly file from clinic billing system (GE IDX).
• Demographics, services, diagnoses, procedures, and Frontiers research
participant flag.
– UHC CDB hospital quality , Tumor Registry, Biospecimens
• Extract Transform Load (ELT) processes largely SQL (Oracle)
• Wrapped in python scripts.
• Goals for a monthly release (21 months in a row so far):
– Fresh data. Example: another month of visits = millions of facts
– New types of data. Example: microbiology
– New functionality: Example: link data by encounter across clinical and
financial sources; distinguish medication administration from
prescription
Monthly Release
Blog highlights:
https://informatics.kumc.edu/work/blog - world view
https://bmi-work.kumc.edu/work/blog - internal KUMC view: latest breaking developments
- Features
- Size
- Dates of sources
HERON’s Data Sources, Types of Data
https://bmi-work.kumc.edu/work/wiki/HeronProjectTimeline#July2013Planning
- contains current plan for next several monthly releases
“Who’s Using HERON” and collaboration approaches
• Find a colleague
• Talk with hospital, clinic to
understand workflow
• Attend bi-weekly clinics
• Watch the videos:
http://frontiersresearch.org/frontie
rs/informatics-training-videos
• Request a consult
http://frontiersresearch.org
/frontiers/biomedicalinformatics
If you don’t see what you want, or you
really like things, let us know:
https://redcap.kumc.edu/surveys/?s=3S
BkPg&tool=1
HERON De-identification: Remove HIPAA 18
identifiers -> non human subjects research
• HIPAA Safe Harbor De-identification
– Remove 18 identifiers and randomly date shifting by up to 365 days back
in time
• Downside: can’t do seasonal studies without IRB approval to go back and get actual
dates
• In general, tack on 7 months when wanting volume for the last year.
– Resulting in non-human subjects research data but treated as a limited
data set from a system access perspective. System users and data recipients
agree to treat as a limited data set (acknowledging re-identification risk)
• To be addressed:
– For now, we won’t add free text such as progress notes with text
scrubbers (DeID, MITRE Identification Scrubber toolkit)
• Date Shift example:
– Patient was born August 13, 1968, had their blood pressure measured on
November 28, 2012.
– Each month dates shifted, ex: to -15 for January release: New birthday is
July 29, 1968 and the blood pressure measurement occurred on
November 13, 2012.
• For another patient, their offset might be -278. Next month the Aug 13th patient’s offset
might be -192.
Repurposing i2b2 Clinical Research Infrastructure for
Inpatient Quality Improvement
• i2b2 “largely” ambulatory or population/genomics focused
• Is i2b2 version 1.6 with same financial encounter and modifiers
now useful for inpatient research?
• Goal: understand medication
timing and antibiotic selection
• Suspect vancomycin preferred
• Validate HERON medications
– Especially administration timing
Aligning Clinical Research Informatics for Quality:
Registry Abstraction and Data Delivery
• REDCap registries into i2b2 allows intuitive exploration
– Researchers may need less abstraction as data is extracted from the EMR.
• i2b2 into REDCap: inherit security model, graphical/export tools
Next Steps: A Learning Healthcare System
• Evidence Generation: Trials post Electronic Health Records (EHR)
– Learning Healthcare System Institute of Medicine Reports: 2006 onward.
– 2011 Report: Digital Infrastructure for the Learning Health System: The
Foundation for Continuous Improvement in Health and Health Care
• “Information Technology (IT) serves as the functional engine for the
continuous learning system”
• Effective Biomedical Research Organizations will integrate Medical
Informatics and Clinical Research Informatics capabilities with
Operational Clinical Systems of the Healthcare Systems
– EHR Standardization and collection of data becomes critical to the cost
effective research capacity of the University.
– EHRs (Cerner/Epic), clinical research systems like (REDCap/Oncore/Velos),
and ultimately translational bioinformatics systems will need to be
managed holistically as opposed to siloed.
Patient-Centered Outcomes Research Institute
Clinical Data Research Network Announcement
• April 23, 2013
• Two types of
component networks:
systems-generated
and patient driven
networks
• Active involvement of
health care systems,
of clinicians and of
patients
• A commitment to
establishing interoperability and data
sharing across
networks and ready
collaboration with the
larger research
community
Scientific Advisory Board
PCORI
Steering Committee
Special Expert Group
PPRN
CDRN
Coordinating
Center
PPRN
PPRN
PPRN
PPRN
PPRN
PPRN
CDRN
CDRN
PPRN
CDRN
PPRN
PPRN
CDRN
CDRN
Selby JV, Krumholz HM, Kuntz RE, Collins FS. Network news: powering clinical research.
Sci Transl Med. 2013 Apr 24;5(182):182fs13. doi: 10.1126/scitranslmed.3006298. Epub 2013 Apr 23.
What Do They Want the Network to Do?
Capabilities:
•
Rich clinical data from electronic health records and other data sources stored in
standardized, interoperable formats.
•
Capacity to conduct both observational studies and randomized trials embedded in
clinical settings
•
Rigorous practices for data security and confidentiality
•
Appropriate IRB and human subjects oversight
•
Utility for CER, safety studies, surveillance, etiologic research, and potentially for preapproval trials
COOPERATIVE AGREEEMENT AWARD
18 MONTHS LATER
• At least two health care systems engaged
• > 1,000,000 patients enrolled
• Willingness and capacity to work toward
data standardization with other awardees
• Data standardized within network and with
other awardee networks
• Willingness to participate in collaborative
studies with data sharing as part of a national
research infrastructure
• Patients, system, and clinicians engaged in
governance & use
• Capable of implementing clinical trials
Joe V. Selby, MD, MPH, Executive Director ONC HITCP June 5, 2013
The “Greater Plains Collaborative”
Letter of Intent Submitted Tuesday
• KS, the University of Kansas
Medical Center (KUMC)
• MO, Children’s Mercy Hospital
• IA, University of Iowa Healthcare
• WI, the University of WisconsinMadison, the Medical College of
Wisconsin, and Marshfield Clinic
• MN, the University of Minnesota
Medical Center
• NE, the University of Nebraska
Medical Center
• TX, the University of Texas Health
Sciences Center at San Antonio
and the University of Texas
Southwestern Medical Center.
• Will learn in July if we can apply
in September, award in December
– $7 million total costs over 18 months
Community Research Recruitment Registry
www.pioneersresearch.org
Pioneers Development
• Frontiers / CTSU team
– Communications
– Frontiers Registry
• Bioinformatics team
– REDcap survey
– HERON search
– Active studies list
• Information technology
• Website development
• Regulatory / legal
• Ethics
• Community Partnership
for Health
– POW! paPOW!
papaPOW!
• Outreach plan for public
and researchers
– KU entities
– All Frontiers
organizations
Become a Pioneer!
• Potential research participants = Entire
community
– KUH patients
– Non-KUH patients
– Healthy individuals
• Online enrollment & informed consent
– Enroll self, children, family member/surrogate
Become a Pioneer!
• Email verification
• Brief survey (redcap)
– Demographic and contact info
– Medical history info (self report)
– Option to link to EMR if KUH patient
Pioneers: Universal Research Portal
• Currently, multiple individual databases
• Pioneers offers:
– Single sign up process for participants
– Powerful search options with EMR access
– No cost to investigators to manage database, to
search for participants, to advertise study
– Able to screen by email with study – specific
questions
Investigator Access
• Open to all Frontiers investigators
– KUH EMR access only available to KUMC
investigators
• Data Request Committee (DRC) approval
– Community Partnership for Health
– Ethics / Regulatory representative
– KU Hospital
Current Status
Accomplished:
• HSC approval
• Website / database fully developed
• Multiple rounds of user testing with community
group
• “Live” early next week?
Pending:
• Searchable list of all active trials
• Integrated study-specific surveys
Future Plans
• Spanish language consent
• Option to search EMR of other health care
organizations
• Link with biospecimen repository
• Merge with existing Frontiers participant
registry (enrollment via checkbox in EMR)
Community Research Recruitment Registry
www.pioneersresearch.org