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Clinical Research Informatics: Scope transformation of clinical exchange

Clinical Research Informatics: Scope transformation of clinical exchange. Education. Research. Alistair Erskine, MD (Chief Medical Information Officer). Technology. Benefits of Health IT. Saving Cost $77B savings/year 1 CBO cost/benefits 2.

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Clinical Research Informatics: Scope transformation of clinical exchange

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  1. Clinical Research Informatics:Scope transformation of clinical exchange Education Research Alistair Erskine, MD (Chief Medical Information Officer) Technology

  2. Benefits of Health IT • Saving Cost • $77B savings/year1 • CBO cost/benefits2 1 Hillestad et al. Can EMR systems transform health care? potential health benefits, savings, and costs. Health Aff (Millwood). 2005;24(5):1103-1117 2 Peter R. Orszag, Congressional Budget Office, “Evidence on the Costs and Benefits of Health Information Technology,” Testimony before Congress 7/24/08

  3. Benefits of Health IT • Saving Lives • IOM reports1, CPOE with CDS2 • EMR Maturity correlates positive outcomes3 • Evidence from handful of health systems4 1 Institute of Medicine, Crossing the Quality Chasm: A New Health System for the 21st Century, The National Academies Press, Washington, D.C., 2005 2 Kaushal et al “Effects of CPOE and CDSS on Medication Safety: A Systematic Review,” Arch Intern Med 163, no. 12 (2003): 1409–1416 3 Chaudhry et al. “Systematic review: Impact of health IT on quality, efficiency, and costs of medical care” Ann Intern Med. 2006;144(10):742-752 4 Amarasingham R et al. “Clinical Information Technologies and Inpatient Outcomes”  Arch Intern Med. 2009; 169 (2): pp108-114

  4. e-Iatrogenesis1  Do no harm? Adverse events2 Reduced efficiency3 Physicians rejectsystem4 1 Weiner et al “e-Iatrogenesis”: The Most Critical Unintended Consequence of CPOE and other HIT J Am Med Inform Assoc.2007;14:387–388 2 Han et al. Unexpected increased mortality after implementation of a commercially sold CPOE system. Pediatrics. 2005;116(6):1506-1512 3 Poissant et al “The Impact of EHRs on Time Efficiency of Physicians and Nurses: A Systematic Review” J Am Med Inform Assoc. 2005;12:505–516 4 Ornstein C. Hospital heeds doctors, suspends use of software: Cedars-Sinai …called it unsafe. Los Angeles Times, January 22, 2003: B1

  5. Office of Clinical Transformation • Better Clinical Input Architecture • Focus on Process and Practice Transformation • Drive Innovation and Optimization – forever…

  6. Informatics Transformation Cube Analytics Intelligence Education Research Finance Technology Patient Information Exchange

  7. Categories of Clinical Research • As defined by National Institute of Health: • Patient-oriented research.Research conductedwith human subjects (or on material of human origin such astissues, specimens and cognitive phenomena) for which an investigatordirectly interacts with human subjects. • Epidemiologic and behavioral studies. • Outcomesresearch and health services research. NIH Director's Panel on ClinicalResearch ReportBethesda, MD: National Institutes of Health; 1997

  8. Components of Clinical Research Embi PJ, Payne PR, Clinical Research Informatics…JAMIA. 2009;16:316-327

  9. Data Standards in Clinical Research • Gaps exist between clinical care and research, but there also exist significant overlaps in the types of data • Harmonization of information models for clinical care/research ought to occur in tandem • Data Standards remain the critical foundation Richesson RL, Krischer J, Data Standards in Clinical Research … JAMIA. 2007;14:687-696

  10. Healthcare Standards Development Hammond WE, Jaffe C, Kush, RD, Healthcare Standards Development, JAHIMA 80, No7 (July 2009)

  11. Health IT Standards Panel “The Healthcare Information Technology Standards Panel (HITSP) is a cooperative partnership between the public and private sectors. The Panel was formed for the purpose of harmonizing and integrating standards that will meet clinical and business needs for sharing information among organizations and systems.” http://www.hitsp.org/default.aspx

  12. HITSP – for Public Comment • Clinical Research Requirements, Design and Standards Selection • July 30, 2009 – version 1.0 • RDSS 144 (Req Design and Stds Selection) • http://www.hitsp.org/public_review.aspx until August 28th • Document Use cases: • Protocol-driven sponsored research info exchange • Registry Reporting scenario • Research Network scenario

  13. Clinical Data Xchange Stds Consort. “CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.” http://www.cdisc.org/

  14. CDSIC –Data Models

  15. CDISC Interoperability Office of Clinical Transformation

  16. Integrating the Healthcare Enterprise “IHE is a global initiative that creates the framework for passing vital health information seamlessly – from application to application, system to system, and setting to setting – across multiple healthcare enterprises. IHE does not create new standards, but rather drives the adoption of standards to address specific clinical needs.” http://www.ihe.net/

  17. IHE - Process

  18. Health Level 7 “This Work Group supports the HL7 mission to create and promote HL7 standards by developing RCRIM standards to improve or enhance information management during clinical research and regulatory evaluation of the safety, efficacy and quality of therapeutic products and procedures worldwide.” http://www.hl7.org

  19. HL7 - RCRIM • Standards Development Organization (SDO) • Accredited by ANSI – American National Standard Institute • Gradual evolution since 2002 of an EHR-TC (Technical Committee) special interest • Global EHR/CR Functional Profile began development in 2006 through collaboration of PhRMA/eSource Taskforce and eClinical Forum. http://www.hl7.org/Special/committees/rcrim/index.cfm

  20. EHR/CR (Clinical Research) http://www.ehrcr.org/index.html

  21. Consortium for Health IT Progress • First meeting April 17th 2009 • Catalyzed by Aneesh Chopra • Representatives from 10 academic and academic medical centers • Goal to collaborate on eminent NIST RFP for “Research Center” to: • Study healthcare delivery models • Study the application of Health IT to enable better healthcare

  22. Consortium for Health IT Progress • Rapidly emerging RFPs from the Recovery Act prompted the need for Program Manager • Funding identified ($300k from Commonwealth Technology Research Fund) • Job description created, vetted and circulated • UVA facilitated development of collaborative virtual space for members: https://collab.itc.virginia.edu

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