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STEMI Acclerator Regional Systems of Care Demonstration Project Final Results of the Regional Systems of Care Demonstration Project: Mission: Lifeline™ STEMI Accelerator Study Matthew W Sherwood, Hussein R Al-Khalidi, James G Jollis, Mayme L Roettig, Peter B Berger, Claire C Corbett, Harold L Dauerman, Kathleen Fox, J Lee Garvey, Timothy D Henry, Ivan C Rokos, B Hadley Wilson, Christopher B. Granger for the Accelerator Project Study sponsored through research and educational grants by: – The Medicines Company – AstraZeneca – Philips Healthcare – Abiomed, Inc. I have no relationships with industry related to this study All Rights Reserved, Duke Medicine 2007 Organization Duke Clinical Research Institute in Collaboration with The American Heart Association Regional Leadership Study Coordinating Center DCRI AHA National and Affiliate* Central Organizing Committee Leadership Dr. Chris Granger, MD Lori Hollowell Dr. James Jollis, MD Chris Bjerke Mayme Lou Roettig, RN, MSN Tammy L. Gregory, American Heart Association- National Center 169 Primary PCI Hospitals** DCRI Project Team & Statistics Kathleen Fox, BA, RN 214 Non PCI Hospitals Hussein Al-Khalidi, PhD Joan Gu, M.S 1253 EMS Agencies Ashley Mitchell *Listed slide 4 Michael Redden **Listed at end of presentation All Rights Reserved, Duke Medicine 2007 Organization Regional Leadership Region Regional Leader Affiliation AHA Personnel Michael A. Ross, MD Emory University Jeffrey Walker Atlanta, GA Mike Jernigan, EMT-P Metro Atlanta Ambulance Service Mary Robichaux Columbus, OH Ernest Mazzaferri, Jr., MD The Ohio State University Medical Center Lory Sheeran Winland Jeb Burchenal, MD Denver, CO University of Colorado Denver Loni Denne Fred Severyn, MD Richard Kamin, MD Univ. of Conn. Health Science Center Hartford, CT Lisa Bemben C. Steven Wolf, MD John Dempsey /St Francis Care James McCarthy, MD Memorial Hermann Hospital Houston, TX Todd Caliva, MD HCA Healthcare Loni Denne Catherine Bissell SETRAC Lynn Ashbeck, MS, RD, Jeff Fariss, Hospital Council Bakersfield, Rea Anne Arcangel Kern County, CA Ross Elliott Public Health Dept Ron Loomis Louisville Jesse Adams, MD Baptist Health Louisville Alex Kuhn Norma Keller, MD; New York University Medical Center, Zainab Magdon-Ismail New York City, NY Jacqueline Tamis-Holland, MD; Mount Sinai St Lukes Hospital, Molly Perini Glenn Asaeda, MD; John Freese, MD Fire Department New York City Pamela Borg-Jensen Newark Beth Israel Medical Center, Mark Zucker, MD; Mark Merlin, DO; MONOC Control & Newark Beth Israel/Barnabas Northern NJ Samantha Cole Steven Sheris, MD Health, Overlook Medical Center Charles Bethea, MD Plaza Medical Center Oklahoma City, OK Loni Denne Tim Cathey, MD Oklahoma Department of Health Philadelphia, PA Elliot Barnathan, MD Johnson and Johnson Laurie St. Claire Pittsburgh, PA Bruce MacLeod, MD West Penn Hospital Alex Kuhn St. Louis should be Barnes-Jewish Hospital, St. Richard G. Bach, MD, Michael J. Lim, MD, St. Louis, MO Louis University Hospital, and Missouri Baptist Robin Hamann George M. Kichura MD, Stuart T. Higano, MD Hospital Dudley Wait, BBA, EMT-P, Eric Epley, Schertz EMS, Southwest Texas Regional Advisory San Antonio, TX Diana Barrett NREMT-P, Jorge Alvarez, MD Council for Trauma Robert Sanchez, MD HCA Healthcare Tampa, FL Kathy Fenelon Xavier Prida MD Bay Heart Group Steven Voyce, MD Geisinger Health System Wilkes-Barre / Scranton Alex Kuhn John Ellis, MD Commonwealth Health All Rights Reserved, Duke Medicine 2007 Organization National Faculty Physician Faculty Physician Faculty (continued) Peter Berger, MD - Interventionalist; Geisinger Clinic, Ivan Rokos, MD- Emergency Medicine; Los Angeles, CA. Danville, PA B. Hadley Wilson, MD- Interventionalist; CMC, Charlotte, Harry Dauerman, MD- Interventionalist; University of NC Vermont, Burlington, VT Emergency Medicine; CMC, Charlotte, Lee Garvey, MD- Implementation Faculty NC Claire Corbett, MS, EMT-P Christopher B. Granger, MD- Cardiologist; Duke University New Hanover Regional Medical Center, Wilmington, NC Medical Center, Durham Timothy D. Henry, MD Loni Denne, RN, BSN American Heart Association Cedar Sinai Heart Institute Russell Griffin, EMT-P James G. Jollis, MD- Cardiologist; Duke University Medical Center, Durham, NC American Heart Association William Koenig, MD- Emergency Medicine Mayme Lou Roettig, RN, MSN Los Angeles EMS Medical Director DCRI, Durham, NC Craig Manifold, DO- Emergency Medicine Stephanie Starling, MHA, BSN University of Texas, HSC San Antonio Novant Health Winston-Salem, NC Greg Mishkel, MD - Interventionalist; Prairie Heart , Springfield, IL All Rights Reserved, Duke Medicine 2007 Background • Timely reperfusion improves survival in patients with ST segment elevation myocardial infarction (STEMI) yet only half of patients are treated within guideline goals. • These delays in treatment are primarily related to fragmentation of the health system and lack of coordination among 15,000 EMS agencies and 5,200 acute care hospitals. • For example only 17% of EMS agencies can pre- activate cardiac cath. labs in all receiving hospitals. Am J Emerg Med. 2014 ;32:856-63. All Rights Reserved, Duke Medicine 2007 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction I IIaIIbIII All communities should create and maintain a regional system of STEMI care that includes assessment and continuous quality improvement of EMS and hospital-based activities. I IIaIIbIII EMS transport directly to a PCI-capable hospital for primary PCI with an ideal FMC-to-device time system goal of 90 minutes or less. I IIaIIbIII Immediate transfer to a PCI-capable hospital for primary PCI with an FMC-to-device time system goal of 120 minutes or less. All Rights Reserved, Duke Medicine 2007 Objective To increase the rate of timely coronary reperfusion by organizing coordinated STEMI care on a regional basis. All Rights Reserved, Duke Medicine 2007 Study Design Recruitment of 21 Metropolitan Statistical Regions 2012 Q2 – 2013 Q1 Gap Analyses - Strategic Planning - Regional Leadership Meetings 2012 Q3- 2013 Q1 Regional Education Intervention 2012 Q3- 2013 Q1 Focus on pre-hospital activation and common regional plans for reperfusion 16 Regions Met Study Requirements 5 Regions Continued to Recruit Quarterly data review, ongoing mentorship, Beyond Entry Deadline establish and execute protocols STUDY REQUIREMENTS 70% of PCI Hospitals in ARG 23,809 STEMI Patients with Symptoms <12 Hours Regional Leadership Oct. 2012 – March 2014 Common Protocols Goal: Improve the % patients Enter all STEMI patients for reaching guideline goals 6 consecutive quarters All Rights Reserved,Bagai Duke Medicine A. 2007 Am Heart J 2014;167:15-21.e3 Intervention OPERATIONS MANUAL Optimal system specifications by point of care – EMS – Non-PCI and PCI ED – Transfer – Catheterization lab Optimal STEMI system – Other system issues – specifications by point of care Operations manual payers, regulations – Choice of PCI or lytic reperfusion regimens available at www.dcri.org/cee/stemi/additional-resources-links/OPs%20Manual%202-12.pdf/view All Rights Reserved, Duke Medicine 2007 Intervention Sites 16 regions 484 hospitals 1,253 EMS agencies Wilkes-Barre/ Scranton Hartford New York City Pittsburgh Northern New Jersey Philadelphia Colorado Front Range St. Louis Columbus Kern County Louisville Oklahoma Atlanta Houston Tampa San Antonio All Rights Reserved, Duke Medicine 2007 Patient characteristics Direct Transfer Overall EMS Self Number 11,765 6,502 5,542 23,809 Age (median) 62 59 60 60 Female 32% 26% 27% 29% No insurance 16% 17% 16% 16% All Rights Reserved, Duke Medicine 2007 Patient characteristics Direct Transfer Overall EMS Self Diabetes 27% 27% 26% 27% Prior MI 13% 11% 11% 12% Cardiac arrest 10% 3% 10% 8% Shock 11% 3% 8% 8% All Rights Reserved, Duke Medicine 2007 Patient characteristics Direct Transfer Overall EMS Self Symptom onset to first medical 47 114 89 69 contact (median) PCI 90% 90% 89% 90% Eligible 6% 6% 6% 6% untreated All Rights Reserved, Duke Medicine 2007 Patient characteristics Direct Transfer Overall EMS Self In hospital outcomes Stroke 0.8% 0.7% 0.9% 0.8% Shock 9% 6% 8% 8% Death 8% 3% 6% 6% All Rights Reserved, Duke Medicine 2007 First medical contact and door to device 75th Percentile for Baseline Quarter (Mission:Lifeline goal) 140 120 100 90 80 Minutes 60 40 First medical contact to device 20 Door to device 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Regions All Rights Reserved, Duke Medicine 2007 ED time and Risk-adjusted in-hospital mortality Direct EMS patients 12% 10.8% P<0.001 10% 8% 7.0% 6% 4% 3.6% 2% n=4939 n=2575 n=3054 In hospital mortality In hospital 0% <= 30 min 30 - 45 min > 45 min Emergency department time All Rights Reserved, Duke Medicine 2007 Primary Outcome FMC to Device Time % Meeting Guideline Goal Direct EMS Hospital transfer n=18,271 n=11,765 n=5,542 p = 0.025 p = 0.0046 p = 0.007 <=90 min <=90 min <= 120 min 70% 65% 65% 62% 63% 63% 64% 64% 58% 58% 59% 60% 56% 56% 57% 54% 53% 53% 50% 50% 50% 50% 46% 48% 40% 30% 20% 10% 0% 2012Q3 2012Q4 2013Q1 2013Q2 2013Q3 2013Q4 2014Q1 All Rights Reserved, Duke Medicine 2007 Primary Outcome FMC to Device Time % Meeting Guideline Goal 5 Most improved regions Direct EMS patients Region 1* Region 2 Region 3* Region 4 Region 5** All 5** 80% 77% 70% 59% 61% 56% 53% 55% 55% 57% 60% 49% 50% 40% 40% 30% 25% 20% 10% 0% 2012Q3 2012Q4 2013Q1 2013Q2 2013Q3 2013Q4 2014Q1 N=4,208 *P<0.05 **P<0.01 All Rights Reserved, Duke Medicine 2007 In hospital mortality (rolling 12 months) 6.7 6.6 6.5 National 6.4 6.3 6.2 6.1 6.0 Accelerator 5.9 In mortality In hospital 5.8 2012Q3 2012Q4 2013Q1 2013Q2 2013Q3 2013Q4 2014Q1 2014Q2 All Rights Reserved, Duke Medicine 2007 Limitations • Majority of the intervention time dedicated to establishing leadership, recruiting hospitals to participate in a national database, establishing and training regional protocols. • Thus, greatest impact toward end of study period and continuing after measurement period. • This is an observational study and included the possibilities of confounded patient selection and improvement not related to the intervention.
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