1. OneFlorida Clinical Research Consortium
Betsy Shenkman, PhD, Lead Co-PI
Bill Hogan, MD, Biomedical Informatics Co-PI
Dave Nelson, MD – Co-Chair, OneFlorida Steering Committee

2. OneFlorida: Primary Goals
To create an infrastructure to support:
Implementation science studies focused on the adoption, implementation, and sustainability of evidence-based interventions
Pragmatic trials designed to estimate intervention effects under usual conditions in health settings
Examination of treatment effects among diverse populations; requires the power of large numbers and variation

3. Statewide and Clinical Partners
9 million patients
All 67 counties
1,240 practices
More than 4,000 physician providers
22 hospitals
Patient Powered Research Networks
Duchenne Connect
Phelan McDermid Syndrome
HBCU Partners
Florida A & M University
Edward Waters College
Not all sites receive PCORI funding

4. OneFlorida Governance

5. OneFlorida Governance
Governance Policies
Steering Committee
Representation from each university and health system
Patient and community clinician representation
Programs and Teams
Varied representation from partners and stakeholders
Scientific and technical expertise
Executive Committee
Representatives from each university and clinical system

6. Stakeholder Engagement: Citizen Scientist Program
11 Citizen Scientists
Paid “OPS” employees
Support for annual stakeholder meetings and other events
Training Program
Stakeholder engagement
Ethics and human subjects
Cultural competency
Health disparities
Comparative effectiveness and patient centered outcomes research
Big data
Range of engagement from co-investigators to consultants

7. Stakeholder Engagement: Clinician Scientist Program
Clinical Champions Program
Community Practice Facilitators
On-the-Road Design Studios
Maintenance of Certification Program

8. Translation and Implementation Science Studios
Held monthly
Community clinicians, patients, citizen scientists
Academic scientists
At UF and On-the-Road

9. OneFlorida Patient Populations
Rare Disease: Duchenne Muscular Dystrophy (786 children)
Long standing partnership Parent Project Muscular Dystrophy
Duchenne Connect
Novel non-invasive techniques for evaluation of skeletal muscle
Ability to enhance muscle function using gene transfer, exercise intervention and pharmacological treatment
Bone Health (in collaboration with PedsNet)

10. OneFlorida Patient Populations
Common Disease: Hypertension (N=1.3M over three years using HEDIS “Controlling High Blood Pressure Measure”)
Levels of blood pressure control
Based on conflicting RCT results and conflicting guideline recommendations, it is not clear what the best BP treatment targets are.
Utilize data from CDRNs to ascertain adverse cardiovascular and falls outcomes among populations of hypertensive patients who have been treated to various blood pressure control levels.
Resistant hypertension – computable phenotype

11. OneFlorida Patient Populations
Common Disease: Obesity
Adults overweight and obese seen in 2014 & 2015, N=998,871
Children overweight and obese seen in 2014 & 2015 N=234,282
Rural health programs particular expertise
Rural LEAP (NHLBI)
Cognitive Behavioral Treatment to Improve Sleep in Overweight and Obese Youth (NHLBI)
Partnership with Sanford-Burnam and Florida Hospital Translational Research Institute for Metabolism and Diabetes

12. OneFlorida Data Trust Model

13. The OneFlorida Data Trust Investment
FISMA environment – NIST 800 controls
Biomedical Informatics Director and Faculty
Ontology
Governance
Data Linkage
mHealth
Programming Team
Clinical and Translational Science Institute and BMI IT Team
I2b2 interface

14. Key Informatics Capabilities
Claims data
Approx. 20 years experience as a team
Medicaid and Medicare
Texas and Florida
Data linkage
Vital statistics
Healthy start data
Florida cancer data system
Ontology, terminology, and data modeling
Entity resolution (a.k.a. record linkage)
Privacy and security
Data analytics, including network analysis

15. Quality Control Processes: Claims Data

16. OneFlorida Project Partners/Funders
PCORI Clinical Data Research Network
James and Esther King Biomedical Research Foundation Grant
Florida Node Alliance of the Drug Abuse Clinical Trials Network (University of Miami lead institution)
NCI - Maximizing HPV vaccination: Real-time Reminders, Guidance, and Recommendations
NHGRI – IGNITE Network, Genomic Medicine Implementation: The Personalized Medicine Program
NIH Southern HIV Alcohol Research Consortium (SHARC)
University of Florida contributions
Clinical partner contributions

17. Thank You. Betsy Shenkman eshenkman@ufl. edu Bill Hogan hoganwr@ufl
Thank You! Betsy Shenkman Bill Hogan OneFlorida Clinical Research Consortium