Building a National Clinical Research Infrastructure OneFlorida 3 rd Annual Stakeholder Meeting University of Florida Joe Selby, MD MPH Executive Director, PCORI November 28, 2016
Evolving Vision of a Research Infrastructure History of PCORnet – from the beginning! PCORnet Today The Future – Changing the Research Culture
Our national clinical research system is well-intentioned but flawed! • High percentage of decisions are not supported by evidence We are not generating the evidence we need to support the healthcare • Health outcomes and disparities are not improving decisions that patients and their doctors have to make every day. • Current clinical research system faces several problems: Doesn’t answer Too Too questions that slow expensive matter most to people 3
PCORnet’s Mission • Faster, easier, and less costly clinical and health system research, both observational studies and randomized trials • Harness the power of large amounts of electronic health record data and patient partnerships, and by making contracting negotiations and IRB approval/oversight more efficient . • To embed the research within health systems and use data and research findings to facilitate health system improvement . • And in the process, transform the culture of clinical research from one directed by researchers acting as entrepreneurs to one driven by collaboration, data sharing, and the needs of patients, clinicians, systems and payers.
The Vision of a National Research Infrastructure FDA ONC AHRQ NIH IOM VA • DRNs • Sentinel Initiative • Meaningful Use 2011 Report: Digital • SEER Registries • VistA • PBRNs • Nationwide Health • OMOP • CTSA Infrastructure for the • iEHR (2017) • Registries • Reagan-Udall Information • Collaboratory Learning Health • SPAN • NEST Network System: The • CRN, CVRN • PROSPECT • Federal Health • ClinicalTrials.gov Foundation for • EDM Forum Architecture Continuous • eMERGE • EHR Certification Improvement in Network Standards & • PROMIS/ NIH - Health and Health Interoperability Care Snomed-CT, Framework LOINC Specialty Innovators Societies Industry Payers and Entrepreneurs
A PCORI Workshop to Advance the Use of Electronic Data in Conducting PCOR at Stanford University PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Bringing together more than 70 national leaders Featuring with expertise in : Exploration of • Outcomes Research Research Models • Informatics including : • Methods • Soliciting action items in the C3N • Privacy and Ethical Issues • DARTNet following areas: • Patient-centeredness • • HMORN Governance • SCANNER • Data standards and interoperability • • Sentinel and mini- System architecture and data exchange Sentinel models • Registry of • Privacy and ethical issues, • Registries Methods • Electronic capture of patient reported outcomes (PROs) • Unconventional approaches, for example the opportunities to leverage activated Live-streaming at pcori.org July 2-3, 2012 patient networks for research
Two Distinct (and Complementary) Approaches Emerge from Palo Alto PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE PCORI National Workshop to Advance Use of Electronic Data Patient-Powered Clinical Data Research Network Network 7
PCORnet Investment Timeline 2014-2016 January 2014 : Phase I In July 2012, PCORI set out to fill 2014 in a large gap in the US national – 11 CDRNs research infrastructure that was – 18 PPRNs Phase I slow, costly, and often produced – Coordinating Center results that were not meaningful to patients. August 2015: Governance in place October 2015: Phase II begins 2015 – 13 CDRNs Phase II – 20 PPRNs – Coordinating Center 8
PCORnet Clinical Data Research Networks (CDRNs) – Phase II • The Chicago Community Trust (CAPriCORN) • The Children’s Hospital of Philadelphia Health (PEDSnet) systems • Harvard University (SCILHS) • Kaiser Foundation Research Institute (PORTAL) • Louisiana Public Health Institute (REACHnet) Claims • Mayo Clinic (LHSNet) PCORnet data • Oregon Community Health Information Network (ADVANCE) • University of California, San Diego (pSCANNER) • University of Florida (OneFLorida) Other • University of Kansas Medical Center (GPC) data • University of Pittsburgh (PaTH) • Vanderbilt University (Mid-South CDRN) • Weill Medical College of Cornell University (NYC-CDRN) 9
PCORnet Patient-Powered Research Networks (PPRNs) – Phase II Cincinnati Children’s Hospital Medical Center University of South Florida (ImproveCareNow) (ABOUT Breast Cancer Network) Kennedy Krieger Institute (IANv- autism) Global Health Living Foundation Massachusetts General Hospital (MOOD) (AR-PoWER) Accelerated Cure Project for Multiple Mayo Clinic ( Alzheimer’s PCPRN ) Sclerosis (MS-PPRN) Crohn’s and Colitis Foundation of Arbor Research Collaborative for Health (NephCure) America (CCFA Partners) Duke University (PARTNERS) University of California Los Angeles (CPPRN) Phelan-McDermid Syndrome Foundation (PMS_DN) Genetic Alliance (CENA) Immune Deficiency Foundation (PI- CONNECT) COPD Foundation (COPD PPRN) University of California San Francisco Parent Project Muscular Dystrophy (PRIDEnet) (DuchenneConnect) Epilepsy Foundation (REN) University of California San Francisco University of Pennsylvania (The (Health eHeart Alliance) Vasculitis PPRN)
PCORnet Achievements 2014-2016 From vision of a strong involvement of participants in all phases of research and use electronic health data in conducting comparative effectiveness research…. ….to implementation in two Phases: Phase II focused on Phase I focused on: completing remaining building blocks: • building the network, with • developing sustainability plans; focus on governance; • administrative simplicity; • developing individual CDRNs • implementing the Distributed and PPRNs; Research Network for • laying out a common data observational studies and infrastructure for distributed pragmatic randomized trials; research. • launching demonstration projects. 11
130 health systems across the country Over 80 data marts Data on >100 million patients
Supported by a Data domains in the CDM Common Data Model Domains that can be added Socio- Prescribing/ economic Dispensing Status Condition Claims Encounters Patient- Vital reported Status Outcomes Lab Procedures Results Biospecimen & Genomic Demographic Sexual Data Orientation and Gender Identity
Spotlight on Demographics Data 2014 PCORnet Population 2014 PCORnet Characteristics Population N Overall (N) 41,216,568 Age* 0-20 11,361,889 Based on individuals who 21-44 11,589,633 received care during 2014 at any 45-64 10,951,968 of the 50 Network Partner 65-74 4,156,901 institutions that contributed data 75+ 3,156,017 Sex* available as of August 1, 2015. Female 23,537,224 Male 17,667,683 Other/Missing 11,661 Race* Black/African American 4,979,389 White 25,669,541 Other/Missing 10,537,665 Hispanic Yes 5,870,400 No 23,357,500 Other/Missing 9,988,694 *Some stratified counts may not equal the total N counts because of low cell count masking. 16
Overall Counts 17
PCORnet Research Demonstration Projects: Funded by PCORI Study Study Design Areas of focus Network Goals ADAPTABLE (1) RCT - Comparing two doses of Aspirin in To pilot approaches to e- persons with pre-exisiting CVD identification, e-consent and e-follow up Obesity Studies (2) Observational - Comparing outcomes for 3 common To develop DRN and bariatric surgery techniques governance to run rapid - Effect of antibiotic use in children on queries in large scale weight gain network PPRN Projects (6) RCT, - Depression To answer research Observational, - Autoimmune and inflammatory diseases questions driven by N-of-1 - Cardiovascular disease patients, using PCORnet - Chronic Obstructive Pulmonary Disease resources (COPD) - Obstructive Sleep Apnea Cross-PPRN (1) RCT - 100+ chronic conditions in PPRNs To engage all PPRN communities and test rapid recruitment Health Systems (4) Observational - High utilization To provide rapid answers to - Automating Quality and Safety health systems of research Benchmarking for Children institutions - Case Management 18
ADAPTABLE: Enabling Pragmatic Research: eScreening, eEnrollment and eFollowup OR Portal FOLLOW-UP Call FOLLOW-UP • Patient Reported Outcomes • Patient Reported Outcomes • Medication use • Medication use • Health outcomes • Health outcomes ADAPTABLE 20 …. 12 16 30 8 4 Enrollee PCORNet Coordinating Center FOLLOW-UP Baseline Data • Via Common Data Model • Longitudinal health outcomes CMS & Payer Virtual Data Warehouse FOLLOW-UP • Longitudinal health outcomes http://adaptablepatient.com
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