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Rethinking Clinical Research

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  1. Rethinking Clinical Research HCN Educational Session June 25, 2014

  2. RESEARCH A CEO’s Perspective ... To Research or Not to Research That is the Question?

  3. NO !@%# WAY!!!! • Not Our Mission! Our job is to take care of people NOT study them • NO Time! Already pedaling so fast we can’t keep up Can’t ask providers to do any more • NO Resources! Our $$ need to go to direct services Don’t have staff expertise • NO Difference to our patients!

  4. Changing Health Care Environment • Being forced to bend the cost/quality curve • Reduce ER visits, lower hospital re-admissions • System Integration, ACO, PCMH, CMS Innovation • Value not Volume • New payment models • Data-driven changes • ACA places CHCs front and center • “walking our talk” and let our voice to be heard Success in this environment requires we innovate and work in new ways!

  5. Benefits of Research • Use it to advocate for needs of our patients • Academic “petri dish” researchers can’t and don’t know needs of our patients • Data is an Asset -- we are data-rich • Leverage to benefit patients • Influence policy • Design evidenced-based best practices and find “Better ways to do what we do” • Generate new opportunities and revenues

  6. SOME LAST THOUGHTS…. • Be at the table when questions are asked and decisions made… • If we don’t advocate, Who will … • Prefer to “drive the bus” … • Don’t want to say “We wish we would of….” • Our Moral Obligation Opportunity to make a difference! Fulfill our Mission!

  7. Let’s not be left behind!

  8. Research at OCHIN Presented by: Abby Sears Chief Executive Officer OCHIN, Inc. 20th Annual HCN Educational Session

  9. Agenda • OCHIN and OCHIN Research: Overview • OCHIN’s Investment in Research • The Truth Behind Research ROI • Board Level: Contract Changes & Strong Data Use Policy • Our Mission: Enhanced by Research

  10. Who Is OCHIN? • As a nonprofit organization, we are a healthcare innovation organization designed to promote access to quality, affordable healthcare for all. • One of the nation’s largest and most successful Health Information Networks • In 18 states, coast to coast • Touching over 4,500 physicians

  11. OCHIN Engages in Health Research • Health Services Research . . . • examines access to health care, cost of care & patient outcomes • identifies effective ways to organize, manage, finance and deliver high quality care, reduce medical errors & improve patient safety • Epidemiology . . . • is the study of the factors determining and influencing the frequency and distribution of disease, injury, and other health-related events and their causes in a defined human population • is the sum of knowledge gained in such a study

  12. OCHIN Research: Quick Review • OCHIN Research is Unique • Our collaborative is one of only a few organizations in the nation currently capturing aggregate health care data and statistics of low income and uninsured populations • One of the nation’s most diverse patient databases of Medicaid-insured and uninsured individuals, a unique resource for researchers • Centralized expertise and a large group of innovative organizations that enables the development and testing of IT tools • Provides a “community laboratory” for conducting research at the clinic-level

  13. History of Research at OCHIN 2014: 5 grants/contracts funded; 5 papers published 2013: 6 grants funded; 5 papers published 2012: 6 grants funded; 12 papers published 2011: 3 grants funded; 9 papers published 2010: 7 grants funded; Jen DeVoe hired as Executive Director 2009: PODS grant funded; 2 papers published 2008: PASS 2 grant funded 2007: Registered with AHRQ as PBRN; ACQ grant funded; 1 paper published 2006: First formal meeting of OCHIN Practice-Based Research Network (O-PBRN, Formerly Safety Net West). Mission and purpose statement adopted. 2005: Discussions between OCHIN & Kaiser Permanente NW about data driven research. Kaiser Permanente NW Community Benefit Initiative Fund funds several research projects

  14. OCHIN Research Portfolio • 19 active projects as of June 2014 • 17 completed projects (since 2005) • More than $21.1 million dollars in total research grant and contract revenue since 2005 • Foci: • Health Policy • HIT Tools • Practice Transformation • Chronic Disease

  15. OCHIN’s Investment in Research • Our mission has always been to use data to impact policy around patient care and the delivery system reform • Research is credible and tangible way to deliver a message; provides evidence and data to support • We thought we could subsidize the running of Epic from the Research indirect money….but this has proven to be a fallacy

  16. The Truth Behind Research ROI • Brand new infrastructure required to manage research grants • Grant administration • Proposal coordination • PR and press releases Publication management • Grant accounting • Doubled compliance requirements • Research associates • PIs • Biostatisticians and SAS and SPSS analysts • Competitive environment for Research funding • Need for Principal Investigators that can win grants • Competing with Academic Health Centers for these resources • AHCs are now guaranteeing parts of their salaries to recruit

  17. Board Level: Contract Changes & Strong Data Use Policy • Started small • 2010: Asked for permission to share data for public health reporting only • Built trust • 2005 – 2011: Asked for permission from each member organization for data use and data sharing for each research project • Included clinicians from member organizations on research project teams • Created Board subcommittee (Data Stewardship Committee) to oversee data uses covered by the policy

  18. Board Level: Contract Changes & Strong Data Use Policy • Went back to Board on multiple occasions to gain more support • 2011: Asked for permission for data use and data sharing for research purposes (up to a limited data set) • 2012: Changed requirements for member approval to passive approval after set period of time • 2013: Added language that OCHIN may respond directly to requests for access to PHI on behalf of member organizations provided the member is notified, and the member may explicitly disapprove

  19. Our Mission: Enhanced by Research • Enabling moreinnovation for clinics • Advancing and strengthening our analytical capabilities • Improving national presence • Supporting clinicians and their growth and interests • Bringing issues and challenges to the forefront publicly • Increasing our need for advocacy “OCHIN is a nonprofit healthcare innovation center designed to provide knowledge solutions that promote quality, affordable healthcare to all.”

  20. Types of Research Projects RCT = Randomized Controlled Trial; CER = Comparative Effectiveness Research; D&I = Dissemination and Implementation

  21. OCHIN’s Research Partnership with HCN • Patient Centered Outcomes Research Institute (PCORI) Clinical Data Research Network Program • Goal is to improve the nation’s capacity to conduct comparative effectiveness research (CER) by creating a large, highly representative electronic data infrastructure for conducting clinical outcomes research • 18 Patient Powered Research Networks funded • 11 Clinical Data Research Networks (CDNRs) funded, including the OCHIN-led ADVANCE CDRN

  22. ADVANCE Governance Model

  23. PCORI’s Goals for the CDRNs • EHR data standardized within collaboration network (CDRN) • A minimum of 1 million patients enrolled   • Capable of implementing clinical trials • Individual network’s data in inter-operable format with other awardee networks and successfully responds to queries • Patients, system, and clinicians involved in governance and use of network • At least three patient cohorts identified, characterized, and surveyed

  24. ADVANCE: Accelerating Data Value Across a National Community Health Center Network

  25. For more information, visit ochin.org/offerings/research/

  26. My perspectiveAndrew L Brickman, PhD ?

  27. Show me the data

  28. My perspective What’s a Learning Healthcare System? Research Influences Practice Practice Influences Research

  29. It’s all aboutthe data. Brickman et al. Bradycardia during stimulation of the septum and somatic afferents in the rabbit. American Journal of Physiology, 1979 Brickman et al. Classically conditioned blood pressure decreases induced by electrical stimulation of posterior lateral hypothalamus in rabbits. Psychophysio­logy, 1977 Brickman et al. Responses of anterior hypothalamic neurons to stimulation of aortic nerve and caudate nucleus in rabbits. Experimen­tal Neurology, 1977

  30. Scientific insight: Humans are more interesting than rabbits.

  31. Memory Disorders Clinic Geriatric Psychiatry Biological Psychiatry Experimental Neurology Chronic Fatigue Syndrome Clinic Psychosomatics Clinical Infectious Disease J of Chronic Fatigue Syndrome Chronic Fatigue & Related Immune Deficiencies … research practice research practice research practice …

  32. Behavioral Medicine Psychophysiology Am J of Psychiatry J of Clinical Psychology in Medical Settings Kidney Transplant Consultation Journal of Urology Pediatric Nephrology British Journal of Urology General Hospital Psychiatry Dialysis and Transplantation

  33. University Behavioral Health Psychiatric Services Quality of Life & Pharmacoeconomics … research practice research practice research practice …

  34. Let’s look back a few years… Is this something new?

  35. … some not so obvious … 1948 -- First randomized controlled trial: Effects of streptomycin versus placebo on pulmonary tuberculosis. The GOLD Standard For Efficacy Ushered in the era of Evidence Based Medicine

  36. Fast Forward 66 years to 2005

  37. Contradicted and Initially Stronger Effects in Highly Cited Clinical Research. Loannidis JPA. JAMA. 2005;294(2):218-228 • Of 49 highly cited original clinical research studies, • NEJM, Lancet, JAMA (1990-2003) • 45 claimed that the intervention was effective. • 1000 citations in the literature • 16% were contradicted by subsequent studies • 16% found effects that were stronger than those of subsequent studies • 24% remained unchallenged Is the gold beginning to loose some of its luster?

  38. External validity of randomized controlled trials: “To whom do the results of this trial apply?” Relevance [of an RCT] depends on external validity (or generalizability). Can the results be applied to a definable group of patients in a particular clinical setting in routine practice? Can the results of an RTC be applied to the uninsured? Rothwell, PM. The Lancet, Volume 365, Issue 9453, Pages 82 - 93, 1 January 2005

  39. Fast Forward 9 Years. What is happening today?

  40. PCORnet: turning a dream into reality. Collins FS, Hudson KL, Brigg JP & Lauer MSJ Am Med Informatics Association , Editorial, May 20, 2014 …last month, Francis Collins (Director of the NIH) wrote: • The vast majority of ongoing clinical trials are too small to provide evidence relevant to patients and clinicians. • Too often, patients and caregivers seeking information on how best to improve their health or the health of their loved ones find that biomedicine does not have answers for questions they ask. • The current clinical research system does not produce high-quality evidence quickly enough to support health care decision making.

  41. By Ariana Eunjung Cha Published: April 15, 2014

  42. PCORI Awards $93.5 Million to Develop National Network to Support More Efficient Patient-Centered Research WASHINGTON, Dec. 17, 2013 PCORnet:a network of networks that originates in healthcare systems andsecurely collect “real-time,” “real-world” health information during the routine course of patient care. OCHIN / HCN Harvard University Medical School University of Pittsburgh The Children’s Hospital of Philadelphia The Chicago Community Trust Vanderbilt University Medical Center Kaiser Foundation Research Inst. Weill Medical College of Cornell U Louisiana Public Health Institute University of Kansas Medical Center University of California San Diego

  43. Patient-Centered Outcomes Research (PCOR) helps people and their caregivers communicate and make informed healthcare decisions, allowing their voices to be heard in assessing the value of healthcare options. “Given my personal characteristics, conditions and preferences, what should I expect will happen to me?” “What are my options and what are the potential benefits and harms of those options?” “What can I do to improve the outcomes that are most important to me?”

  44. Backup slidesDo Not use

  45. It is easy to read some of the signposts… 1796 Vaccines -- Dr. Edward Jenner successfully prevented a young English boy from getting smallpox. 1846 Anesthesia -- Dentist William T.G. Morton demonstrated ether. 1928 Antibiotics -- Sir Alexander Fleming left a petri dish of Staphylococci bacteria uncovered and later noted that the bacteria had been killed by a mold.

  46. Rethinking Clinical Research Moderator: Richard Taaffe Three Perspectives: The Center CEO – Richard Taaffe The Network CEO – Abby Sears The Clinician Researcher– Andrew Brickman CMODiscussant -- St. Anthony Amofah