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DIAS 4 US Clinical Coordinating Center Overview

DIAS 4 US Clinical Coordinating Center Overview. Philip B. Gorelick, MD MPH FACP Director, US DIAS Clinical Coordinating Center (prepared for US DIAS Investigator Mtg, July 15-16, 2011, Chicago, Ill 30 minutes). Welcome to Chicago US DIAS 4 Investigators We look forward to a

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DIAS 4 US Clinical Coordinating Center Overview

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  1. DIAS 4US Clinical Coordinating CenterOverview Philip B. Gorelick, MD MPH FACP Director, US DIAS Clinical Coordinating Center (prepared for US DIAS Investigator Mtg, July 15-16, 2011, Chicago, Ill 30 minutes)

  2. Welcome to Chicago US DIAS 4 Investigators We look forward to a productive collaboration!

  3. Introduction of UIC Staff US DIAS 4 Trial Clinical Coordinating Center

  4. Philip B. Gorelick, MD MPH John S Garvin Professor and Head Director, US DIAS Clinical Coord. Cntr Prior Federally Funded Grants: -PI of AAASPS (NINDS) -PI of Risk Markers for Dementia after Stroke (NIA) -PI of Studies of Dementia in the Black Aged (NIA) • Teaching Awards • AOA • Golden Apple • Langendorf • Other Awards • AHA Feinberg • NSA Visionary • Women’s Home • Journal: Top Stroke • Neurologist • 4. Mayo Clinic • Gainey Prof. • 5. Henry Barnett • Prof. Canadian • Stroke Network • 6. Stopplemoor • Lecturer, Univ of • Iowa Consultancies -Korean CDC -CMS MEDCAC -Alaskan Native Stroke Registry -AHA/ASA -WFN (applied research) -Goddess Fund for Stroke in Women -NSA

  5. UIC Dept. of Neurology Stroke Networking Experience Co-PI US DIAS Clinical Coordinating Center Director, Neuroepidemiology, Clinical Trials, & Outcomes Research Unit Consultancies -Korean CDC -National Stroke Association (NSA) -Lundbeck, Inc • Federally Funded • Grants: • TTP Surveillance • (NIH) • Recent Networking • Efforts: • 2. Paul Coverdell • National Stroke • Registry (CDC) and • Great Lakes Stroke • Network • Medicare Part D • Data Base & DRG • 559 Project Dilip K. Pandey, MD PhD

  6. Other UIC CCC Team Members • 1. Rebecca Grysiewicz, DO:Local Site PI, junior faculty member, past Chief Resident & Stroke Fellow, interests in acute stroke treatment & prevention • 2. Maureen Hillmann, RN:Nurse Manager, >15 years of experience as a stroke study nurse • 3. Yvonne Harris, MPA:Administrator, >23 years experience as stroke study project manager & administrator; Asst to Head at UIC • 4. Vidas Simkus:IT Support, >10 yrs experience in internet support services; programmer, trouble shooter, and builds servers

  7. Unique Features of the Current DIAS Trials • Desmoteplase Theoretical properties making it a unique agent for thrombolysis • Study Design 1. Answers an important question 2. Does so in a practical way (CT/CTA or MRI/MRA) 3. Potentially cost effective and practicable application of a thrombolytic in many hospital settings

  8. Clinical Coordinating Center (CCC) Model

  9. Background & Concept for Model Prior Experience AAASPS Recruitment Challenge

  10. African-American Antiplatelet Stroke Prevention Study (AAASPS) Networking experience with over 60 sites across US Source: JAMA, June 11, 2003-vol 289:2947-2957

  11. What We Learned About Networking from AAASPS • 1. Expect the unexpected • 2. Be nimble and be prepared to change recruitment strategies depending on the trial circumstances & if opportunity presents itself

  12. Dr. Pandey’s Networking Experience • 1. CAPTURE STROKE, Illinois CDC-Illinois Department of Public Health-funded Coverdell Stroke Registry Project of >60 hospitals in Illinois • 2. Great Lakes Stroke Network Quality improvement project for all hospitals in Great Lakes/Midwest region

  13. Concept for RecruitmentA Hub-Spoke Model

  14. US DIAS Recruitment ModelHub and Spoke System by 6 Regions 6 US Regions NE West MW MA SW SE MA=Mid-Atlantic SE=Southeast MW=Midwest SW=Southwest NE=Northeast Slide courtesy of David Hess, MD

  15. Hub DirectorsNationally Recognized US Stroke Experts • Midwest: Phil Gorelick/Dilip K. Pandey (UIC) • Northeast: Lee Schwamm (Harvard) • West: Greg Albers (Stanford) • Southwest: Tim Ingall (Mayo Clinic) • Southeast: David Hess (GHS) • Mid-Atlantic: Max Hammer (U of Pitt) Hub Directors with well-developed networks for stroke treatment

  16. Advantages of Model • Hub Directors 1. Know their regions & capabilities of local hospitals/PIs/Coordinators 2. Have trained stroke physicians in the area 3. Have telemedicine capability and ready-made networks to step into 4. Are experienced and well respected • Local Spoke Sites 1. Have the option to treat at site, ‘drip & ship’, or transfer to hub for treatment

  17. Strategies for US Local Site Selection • 1. Large systems of care in which interventionalists agree to randomize to DIAS study • 2. Mid-sized systems of care without interventionalists or ones who agree to randomize to DIAS • 3. Smaller systems of care as part of a network of treatment under a major hub study hospital

  18. Clinical Coordinating Center Goals Summary

  19. Clinical Coordinating Center Goals 1. Recruit 6 regional Hub Directors 2. Hub Directors/CCC/Lundbeck collaborate to recruit 15-20 local sites per regional hub 3. Work closely with Local Sites, Hub Directors & Lundbeck to recruit patients and successfully conduct US DIAS 4 4. Support Local Sites in recruitment efforts

  20. Current Status of Local Site Recruitment • 1. # of active sites:39 • 2. # of sites in process of being activated: 40 • Total #:79 • Site Locations by Hub 1. Midwest 28 4. West 9 2. Southeast 17 5. Mid-Atlantic 6 3. Northeast 14 6. Southwest 3* *An additional 4-5 sites pending in Southwest Hub; as of June 30, 2011

  21. Clinical Coordinating Center Activities to Stimulate Recruitment

  22. CCC Activities to Stimulate Recruitment • 1. Develop hub-spoke model & help recruit local sites • 2. Monthly webinars or teleconferences (DIAS MRI/A & CT/CTA inclusion criteria, importance of DIAS in light of thrombolytic and device therapies) • 3. Email announcements to coordinators & local principal investigators • 4. Assist in newsletter development • 5. Coordinate regional hub face-to-face & teleconference meetings moderated by Hub Directors

  23. What We Ask For in Relation to Recruitment… • 1. Your Commitment & Readiness • 2. Your Enthusiasm • 3. Your Vigilance • 4. Your Patience

  24. What We Are Striving For… • 1. Timely and successful US DIAS RECRUITMENT & STUDY CONDUCT • 2. Establishment of the US as the world leader in the DIAS trials • 3. The personal satisfaction of working on an important trial that will potentially lead to an important new treatment option for stroke patients in the US and worldwide

  25. Q and AHow Can We Help You to Be Successful? Alaskan Sea Otter says: “Enroll in US DIAS 4!” Enrollment to Date:17* Target Enrollment: 200 (*as of July 11 2011) Seldovia, Alaska - 2005 Photo courtesy of H. Powell

  26. Questions/Answers& Transition into the compelling story of DIAS recruitment success Dr. Thomas Devlin & Dr. George Lopez

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