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.

All Rights Reserved, Duke Medicine 2007 Conclusions • Our results highlight the opportunity to shift the focus from hospital door to first medical contact to improve regional STEMI care. • Emergency department time is an important indicator of coordination of care between paramedics and hospitals and is associated with improved survival. • Organizing regional STEMI care results in significant improvements in the percent of patients achieving national reperfusion goals. • We identified numerically lower mortality among participating regions compared with national rates, suggesting that regional STEMI programs can provide important improvements to public health.

All Rights Reserved, Duke Medicine 2007 Region PCI Centers (Acknowledgement)

New York City Northern New Jersey Hartford Bellevue Hospital Center Bayonne Medical Center Hartford Hospital Bronx Lebanon Hospital Center Chilton Hospital Saint Francis Hospital & Medical Center The Hospital of Central Connecticut Brookdale Hospital & Medical Center Christ Hospital Clara Maass Medical Center University of Connecticut Health Center/ Jamaica Hospital Medical Center Englewood Hospital and Medical Center John Dempsey Hospital Lenox Hill Heart and Vascular Institute of Hackensack University Medical Center New York Hackensack UMC - Mountainside Lutheran Medical Center Holy Name Medical Center Montefiore Medical Center Jersey City Medical Center Mount Sinai Beth Israel JFK Medical Center Mount Sinai St. Luke’s Morristown Medical Center New York Hospital Medical Center of Newark Beth Israel Medical Center Queens Overlook Medical Center New York Methodist Hospital Raritan Bay Medical Center New York Presbyterian/Weill Cornell Robert Wood Johnson University Medical Center Hospital Rahway New York Presbyterian/Columbia Saint Barnabas Medical Center University Medical Center Saint Clare’s Hospital/Denville St. Joseph Regional Medical Center NYU Langone Medical Center St. Mary’s Hospital St. Barnabas Hospital Saint Michaels Medical Center St. Luke's Roosevelt Hospital Center - The Valley Hospital St. Luke's Trinitas Regional Medical Center The University Hospital

All Rights Reserved, Duke Medicine 2007 Region PCI Centers (Acknowledgement)

Pittsburgh Philadelphia Wilkes- Barre/Scranton Butler Memorial Hospital Albert Einstein Medical Center Geisinger Community Medical Center Geisinger Medical Center Excela Health Westmoreland Hospital Aria Health Hahnemann University Hospital - Hazleton Forbes Regional Hospital Holy Redeemer Hospital and Medical Wyoming Valley Health Care System Jefferson Regional Medical Center Center Monongahela Valley Hospital Hospital of the University of Sharon Regional Health System The Uniontown Hospital Jeanes Hospital Lankenau Hospital UPMC Passavant Hospital Mercy Fitzgerald Hospital UPMC Presbyterian Hospital Nazareth Hospital Washington Health System Penn Presbyterian Medical Center West Penn Allegheny Health System Pennsylvania Hospital Temple University Hospital Thomas Jefferson University Hospital

All Rights Reserved, Duke Medicine 2007 Region PCI Centers (Acknowledgement)

Colorado Front Range St. Louis Avista Adventist Hospital Barnes-Jewish Hospital Louisville Baptist Health Louisville Denver Health Medical Center Barnes-Jewish St. Peters Hospital Clark Memorial Hospital Exempla Good Samaritan Medical Center Christian Hospital Floyd Memorial Hospital and Health Littleton Adventist Hospital SSM DePaul Health Center Services McKee Medical Center Des Peres Hospital Hardin Memorial Hospital Medical Center of Aurora Mercy Hospital Jefferson Jewish Hospital Medical Center of the Rockies Mercy Hospital St. Louis Norton Audubon Memorial Health System Missouri Baptist Medical Center Norton Hospital North Colorado Medical Center Progress West Healthcare Center University of Louisville Hospital Parker Adventist Hospital Saint Louis University Hospital Parkview Medical Center SSM St. Clare Health Center Penrose Hospital SSM St. Joseph Health Center Porter Adventist Hospital SSM St. Joseph Hospital West Presbyterian/St. Luke's Medical Center SSM St. Mary’s Health Center Saint Mary’s Hospital and Regional St. Anthony’s Medical Center Medical Center Sky Ridge Medical Center St Anthony North Hospital St. Anthony Hospital St. Francis Medical Center Swedish Medical Center University of Colorado Hospital Authority

All Rights Reserved, Duke Medicine 2007 Region PCI Centers (Acknowledgement)

San Antonio Houston North Central Oklahoma Baptist Medical Center Bayshore Medical Center Deaconess Hospital CHRISTUS Santa Rosa Hospital - New CHI/Baylor St. Luke's Medical Center Hillcrest Hospital South Braunfels Clear Lake Regional Medical Center Hillcrest Medical Center CHRISTUS Santa Rosa Hospital – Conroe Regional Medical Center INTEGRIS Baptist Medical Center Westover Hills Cypress Fairbanks Medical Center Integris Bass Baptist Health Center CHRISTUS Santa Rosa Medical Center Houston Northwest Medical Center Jane Phillips Memorial Medical Center Kingwood Medical Center Norman Regional Health System Methodist Hospital Mainland Medical Center Oklahoma State University Medical Center Methodist Stone Oak Hospital Memorial Hermann SouthWest OU Medical Center Methodist Texsan Hospital Memorial Hermann Hospital TMC St. Anthony Hospital Metropolitan Methodist Hospital Memorial Hermann Memorial City Stillwater Medical Center Mission Trail Baptist Hospital Hospital North Central Baptist Hospital Memorial Hermann Northeast Northeast Baptist Hospital Memorial Hermann Northwest Hospital Kern County Bakersfield Heart Hospital Northeast Methodist Hospital Memorial Hermann Southeast Hospital Memorial Hermann The Woodlands Bakersfield Memorial Hospital St. Luke's Baptist Hospital Hospital San Joaquin Community Hospital Southwest General Hospital St. Lukes Patients Medical Center University Hospital St. Luke's Sugar Land Hospital ST. Luke's The Woodlands Hospital St. Luke's Vintage West Houston Medical Center

All Rights Reserved, Duke Medicine 2007 Regional Systems of Care Demonstration Project

All Rights Reserved, Duke Medicine 2007