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HMORN Member Organizations. Most sites include insurance companies and multi-specialty practices Representing 10 million covered lives Reimbursement models include managed care, FFS, Medicare & Medicaid. HMORN Collaborative Research Networks.
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HMORN Member Organizations • Most sites include insurance companies and multi-specialty practices • Representing 10 million covered lives • Reimbursement models include managed care, FFS, Medicare & Medicaid
HMORN Collaborative Research Networks • Vaccine Safety Datalink (10 sites, CDC, 1990) • Cancer Research Network (14 sites, NCI, 1999) • Developing Evidence to Improve Decisions about • Effectiveness (14 sites, AHRQ, 2005) • Cardiovascular Research Network (15 sites, NHLBI, 2007) • Mini-Sentinel Initiative (13+ sites, FDA, 2009) • Mental Health Research Network (10 sites, NIMH, 2010) • Scalable Partnering Network for Comparative Effectiveness • Research (10+ sites, AHRQ, 2010) • Surveillance, Prevention, and Management of Diabetes • Mellitus (AHRQ, 2010)
HMORN Virtual Data Warehouse (VDW) • A series of dataset standards and automated processes at each of 15 HMORN sites • Each institution’s VDW data remain at their site until a study-specific need arises • SAS programs written at one site, can be run quickly with minimal customization at others • Data from all compatible sources, including: • Legacy (pre-modern EMR) internal systems • Claims (rx, facility, professional) • EMR
HMORN Multi-site Study Tools • Multi-center IRB Review • IRB Authorization Agreements in place between HMORN sites • Lead PI submits application to lead IRB • Other sites review and decide whether to cede to lead IRB or retain local review based on perceived risk • Lead IRB assumes ongoing oversight for institutions ceding to it • Pre-negotiated sub-award agreement template • All sites sign MOU agree to use as starting place • Includes data use terms, up front • Data Sharing • HMORNDUA template is customized to fit with HMORNsubaward template • Bidirectional DUAs in use • Distributed research networks in development • Primarily designed and tested for data-only and observational studies
HMORN Strengths for Clinical Trials • The Integrated Health Systems • Representing 10 million covered lives • All sites have EMRs – most using EpicCare • Recruitment Infrastructure • Research departments are “covered entities” • VDW and other electronic data sources • Skilled & dedicated programming and informatics • Accurate feasibility assessment and efficient, targeted recruitment • Trial Conduct • Efficient electronic communication with health care providers • Excellent retention • Surveillance for events, obtaining documents, determining costs • Disseminating results • Future Innovations: Pragmatic, low-cost trials using EMR to recruit, randomize, intervene and collect follow-up data?