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

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

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

OneFlorida Governance

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

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

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

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

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)

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

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

OneFlorida Data Trust Model

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

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

Quality Control Processes: Claims Data

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

Thank You. Betsy Shenkman eshenkman@ufl. edu Bill Hogan hoganwr@ufl Thank You! Betsy Shenkman eshenkman@ufl.edu Bill Hogan hoganwr@ufl.edu OneFlorida Clinical Research Consortium https://onefloridaconsortium.org/ https://www.ctsi.ufl.edu/research-initiatives/projects/oneflorida/