James G. Jollis, Hussein R. Al-Khalidi, Lisa Monk, Mayme L.... Aluko, B. Hadley Wilson, Robert J. Applegate, Greg Mears, Claire... Expansion of a Regional ST-Segment Elevation Myocardial Infarction System to...

Expansion of a Regional ST-Segment Elevation Myocardial Infarction System to an Entire State
James G. Jollis, Hussein R. Al-Khalidi, Lisa Monk, Mayme L. Roettig, J. Lee Garvey, Akinyele O.
Aluko, B. Hadley Wilson, Robert J. Applegate, Greg Mears, Claire C. Corbett and Christopher B.
Granger
Circulation. published online June 4, 2012;
Circulation is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231
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DOI: 10.1161/CIRCULATIONAHA.111.068049
Expansion of a Regional ST-Segment Elevation Myocardial
Infarction System to an Entire State
Running title: Jollis et al.; Expansion of regional STEMI System to entire state
James G. Jollis, MD1; Hussein R. Al-Khalidi, PhD1; Lisa Monk, RN, MSN1;
Mayme L. Roettig, RN, MSN1; J. Lee Garvey, MD3; Akinyele O. Aluko, MD2;
B. Hadley Wilson, MD4; Robert J. Applegate, MD5; Greg Mears, MD6; Clairee C
C.. Co
Corb
Corbett,
rbet
ett,
t,
MMS7; Christopher B. Granger, MD1 on behalf of the Race Investiga
Investigators
gaato
orss
1
Duke C
Duke
Clinical
lini
li
nica
c l Re
Rese
Research
s arch Institute, Duke Univer
University,
rsiity
ty, Durham; 2Dept of
of Ca
C
Cardiology,
rdiology, Presbyterian
Hosp
Ho
Hospital;
spital
all; 3D
Depts
ept
ptts of
o Emergency Medicine, 4Ca
Cardiology,
ard
r iology
gy, Carolina
Carolinas
n s Me
na
M
Medical
di Center, Charlotte;
dical
5
Wake
W
ake For
Forest
orres
estt He
H
Health
alth
al
th S
Sci
Sciences
cien
ci
ence
en
cess Un
ce
U
University
iver
iv
ersi
er
sity
ty W
Win
Winston-Salem;
insstoon-S
Sal
alem
em;; 6EM
em
EMS
S Pe
Perf
Performance
rfoorma
rf
maanc
ncee Im
Impr
Improvement
prov
pr
ovem
ov
emen
em
ent
en
C
Ce
Center,
nter, Univ
University
iverrsiity ooff No
North
ortth Ca
Carolina
aro
rolina
inaa at Ch
Chape
Chapel
el H
Hill,
illl,
l, C
Ch
Chapel
happel H
Hill;
ill; 7Ne
New
w Ha
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Hanover
ano
novverr R
Regional
eggion
gi nall
Medical
Medi
Me
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di
Center,
nter,, Wi
nte
W
Wilmington,
lm
min
ingt
gtoon,
on, NC
C
Correspondence:
Corr
Co
rres
espo
pond
nden
ence
ce::
James G. Jollis, MD
Duke Clinical Research Institute
Duke University
Box 3254 DUMC
Durham, NC 27710
Tel: 919-684-4015
Fax: 919-668-3575
E-mail: [email protected]
Journal Subject Codes: [4] Acute myocardial infarction; [100] Health policy and outcome
research
1
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DOI: 10.1161/CIRCULATIONAHA.111.068049
Abstract:
Background - Despite national guidelines calling for timely coronary artery reperfusion,
treatment is often delayed, particularly for patients requiring inter-hospital transfer.
Methods and Results - 119 North Carolina hospitals developed coordinated plans to rapidly treat
patients with ST segment elevation myocardial infarction (STEMI) according to presentation:
walk-in, ambulance, or hospital transfer. 6841 patients with STEMI (3907 directly presenting to
21 percutaneous coronary intervention (PCI) hospitals, 2933 transferred from 98 non-PCI
hospitals were treated between July 2008 and December 2009 (age 59 years, 30% women, 19%
uninsured, chest pain duration 91 minutes, shock 9.2%). The rate of patients not receiving
reperfusion fell from 5.4% to 4.0% (P=0.04). Treatment times for hospital transfer patients
y improved.
p
p
p
p a “transfer for
substantially
First hospital
door to device for hospitals
that adopted
PCI” reperfusion strategy fell from 117 minutes to 103 minutes (P=0.0008), wh
hille ti
time
mees at
while
times
hospitals with a mixed strategy of transfer or fibrinolysis fell from 195 minutes to 138 minutes
P=0.002). Median door to device times for patients presenting directlyy to PCI hospitals fell
(P=0.002).
fr
om 64
64 too 59
59 minutes
minu
mi
nute
tes (P<0.001).
(P<0
(P
0.001
0 ). EMS-transported
EMS-transp
EM
spor
orttedd patients
pati
tien
ents were
wer
erre most
mo
ost likely
lliikelyy to reach
ch door
doo
o r to
from
device
dev
vic goals with
wit
ithh 91%
91% treated
trreaate
tedd wi
with
thin
th
i 990
in
0 mi
inu
nutes an
nd 52
52%
% be
bei
ingg ttreated
reat
re
ateed w
itth 60 m
inut
in
uttess.
device
within
minutes
and
being
with
minutes.
Pa
ati
tieents
ents treat
ated
at
e w
ed
ithi
hinn guid
gguideline
uideelin
elin
ne go
oal
a s hhad
ad a mort
m
ortal
alit
ityy of 22.
.2%
% ccompared
omp
mpar
mp
arred
d too 5.7%
5.7% ffor
or ttho
or
hose
ho
se
Patients
treated
within
goals
mortality
2.2%
those
exce
eed
ediingg gu
gguideline
id
del
e in
ne re
recomm
mmen
enda
dati
tions (P
(P<0
<0.0
.001
01))
exceeding
recommendations
(P<0.001)
Conclusion
ns - By extending
ext
exten
endding
en
ng regional
reg
egio
iona
io
naal coordination
coor
co
ordi
dina
di
nati
na
t on
ti
o to
to ann entire
ent
ent
ntir
iree state,
ir
statte,
st
e rapid
rap
rap
apid
id diagnosis
dia
iagn
gnos
osis
os
is and
and
Conclusions
treatment of STEMI has become an established standard of care independent of health care
setting or geographic location.
Key words: acute myocardial infarction
2
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DOI: 10.1161/CIRCULATIONAHA.111.068049
Introduction
The ideal treatment of ST segment elevation myocardial infarction (STEMI) involves early
diagnosis followed by rapid reperfusion therapy.1-5 Such treatment becomes more challenging
when the activities of diagnosis and reperfusion span multiple, loosely connected hospitals and
emergency medical services (EMS). To overcome these barriers and provide ideal reperfusion as
a uniform standard of care regardless of health care setting or geographic location, we
established coordinated regional care across the entire state of North Carolina.6-8 Specifically, we
aimed to determine whether expanding our STEMI system to all hospitals and EMS agencies in
North Carolina on a voluntary and “grass roots” basis would improve the rate and speed of
Appr
prroaach
h to
to
myocardial reperfusion. According to protocols established in the Regional Approach
Cardiovascular Emergencies (RACE) project, we implemented processes to expedite care in 119
hoosp
spit
ital
it
alss across
al
acro
ac
ro
oss a state
ssta
t te with a population of 9.4 million
milllion residents and
and area
are
reaa of 53,000 square
hospitals
milees.
s 9 Hospit
Hospitals
talls aadopted
dop
oppte
tedd sy
ssynchronized
ync
nchr
nc
hron
onnize
ized sstrategies
tratteg
gies to
o ex
expedite
xpedi
pediitee rreperfusion
ep
perfu
fusi
sion
ionn ffor
or ppatients
or
atie
at
ieentts ppresenting
res
esen
es
en
ntiing
miles.
by EMS,
EM
E
MS, ho
MS,
hos
hospital
spitaal
spit
al transfer,
tra
rans
nsfe
feer, an
and
nd ““wa
nd
“walk-in.”
wallk-i
wa
lk-iin.
n.””
Methods
Our work was approved by the IRB at Duke University. Data Use Agreements for a HIPAA
defined limited data set were established with all primary percutaneous coronary intervention
(PCI) hospitals. We implemented our system by building on a model established in prior work
and by using the principles outlined in the American Heart Association Mission: Lifeline and the
American College of Cardiology D2B programs. 9-12 First, we developed leadership composed of
a state director, hospital system coordinators, and nursing, EMS, and physician leaders from
multiple institutions across the state (see Supplemental Material). This leadership team
3
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DOI: 10.1161/CIRCULATIONAHA.111.068049
conferred in weekly conference calls and numerous regional and state meetings. Next, we
instituted the Acute Coronary Treatment and Intervention Outcomes Network Registry -- Get
With The Guidelines (AR-G) as our main data collection instrument, requesting that all
participating primary percutaneous coronary intervention (PCI) hospitals participate and
contribute to state-system reports.13 These data were maintained by the leadership team and were
used to monitor and report treatment rates and times to individual hospitals, benchmarked to
state performance. The AR-G registry at PCI hospitals represented the majority of STEMI
patients in the state eligible for reperfusion during the study period, as 95% of patients treated at
non-PCI hospitals were transferred to PCI hospitals prior to discharge.9
Once leadership and data systems were established, we organized all 21 P
PCI
CII hhospitals
ospi
os
pita
pi
tals
ta
ls iin
the
he state with on-site surgery to serve as regional primary PCI centers (10 in the initial RACE
intervention,
nteerv
rven
enti
en
tion
ti
on, 11 aadditional
on
dd
dditional
for the state-wide int
intervention).
ter
ervvention).9 Thes
These
se hospitals
hosp
sppit
ital
a s agreed to collect and
share
hare
arre ARG da
data,
ata
ta,, fu
fund
undd orr co
co-f
co-fund
-ffun
undd a ho
hhospital
spiital S
sp
STEMI
TEM
MI sy
system
yst
s em co
coordinator,
oordinat
oor
ator
orr, ac
acc
accept
cept
cep
pt aall
ll S
STEMI
TEMI
TE
MI
patients
week
basis,
allow
for
pati
pa
tien
ti
en
nts
t rregardless
egar
eg
ardl
dleesss of bbed
ed ava
ed
aavailability
vaail
ilab
abil
ab
ilit
il
ityy on a 224
it
4 hhour
ou
ur 7 day
day pe
per we
w
ek bbas
asiis,, al
allo
low
lo
w fo
or
catheterization
catheterizatio
on la
llaboratory
bora
bo
r to
ra
t ry
r aactivation
ctiv
ct
i ati
iv
tion
on bbyy a si
sing
single
ngle
ng
lee ccall
alll fr
al
from
om
m eemergency
merg
me
rgen
rg
e cy pphysicians
en
hysi
hy
sici
si
c an
ci
anss or ttra
trained
r ined
ra
paramedics without the need for cardiology consultation, have the catheterization laboratory
available within 30 minutes including the presence of an interventional cardiologists at the start
of the procedure, establish a single treatment regimen agreed upon by all physicians, and provide
immediate and regular feedback to the emergency physicians and paramedics who initiated the
procedure. The 98 non-PCI centers (55 in the initial RACE intervention, 43 additional for the
state-wide intervention) designated themselves according to their reperfusion strategy for
patients presenting with STEMI: routine transfer for primary PCI, routine fibrinolytic therapy, or
a mixed strategy that consisted of transfer for primary PCI when transportation was readily
4
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DOI: 10.1161/CIRCULATIONAHA.111.068049
available (Figure 1).
Supported by the primary PCI facilities, system coordinators and their leadership
approached every hospital and EMS within their referral region to establish a single plan to
rapidly diagnose and reperfuse patients with an acute STEMI according to national time
standards and guidelines. Emergency departments were encouraged to ascertain whether patients
had potential symptoms prior to registration, designate an area and personnel to perform ECG
within 10 minutes of arrival, and choose a reperfusion plan according to local consensus and
resources that involved either primary PCI or fibrinolysis. Hospitals that selected fibrinolysis
also developed plans for rapid primary PCI for patients with contraindications. For hospitals
served
erved by more than one primary PCI center, all PCI centers were represented in
n pplanning
laannnin
ingg
meetings. Under the guidance of the North Carolina Office of EMS, emergency medical systems
were
patient
potential
STEMI
we
re eencouraged
ncou
ncou
oura
raagedd to obtain an ECG for every pa
ati
tien
ent with potenti
en
ial
a STE
TE
EMI symptoms, interpret
the
divert
PCI
he ECG
ECG and communicate
comm
co
mmun
mm
unniccat
atee the
the findings
finndin
fi
ndin
i gs of
of a possible
possiibl
ible STEMI
STEM
ST
EM
MI to receiving
recei
eivi
vinng hospitals,
vi
hos
osppit
ital
als,
al
s, ddiv
iver
iv
ertt to
er
oP
CI
centers
minutes
patients
ce
ent
nter
erss if first
er
fir
irst
st medical
med
m
ed
dic
icaal contact
con
ontaact
c to
to device
ddeevic
evicce could
couuldd reliably
co
r lia
re
liably
y be
be achieved
achi
achi
hiev
ev
ved
d within
witthiin 90 m
in
nut
utes
es oorr pa
pat
tien
tien
nts
standard
method
were ineligible
ineligibl
blle for
f r fibrinolysis,
fo
fibr
fi
brrin
nollys
ysis
i , and
and provide
p ov
pr
ovid
idee a st
id
tan
anda
dard
da
r m
rd
etho
et
hodd fo
ho
for th
thee EM
EMS
S ti
time
me ddata
ataa to be
at
available to receiving hospital personnel.
The final step of our intervention involved multiple levels of communication between
hospitals and EMS regarding system performance, immediately after PCI, within 24 hours of a
myocardial infarction admission, and in regularly scheduled hospital, EMS, regional, and state
meetings. During these meetings, we shared best practices, reviewed treatment intervals (derived
from symptom onset, first medical contact, door time, ECG time, departure time, catheterization
lab time, device time, needle time), outcomes (deaths, complications, hospital and angiography
findings) and opportunities for system improvement. Additional description of our intervention
5
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DOI: 10.1161/CIRCULATIONAHA.111.068049
can be found in the RACE Operations Manual
[http://www.nccacc.org/RACE/RACEOperationsManualOct.09.pdf].
Statistical Analysis
Descriptive statistics for continuous and categorical variables were described as median (interquartile rage) and number (percentage), respectively. Patient characteristics and process
measures were compared using Wilcoxon rank-sum test for 2 groups comparison (KruskalWallis test for more than 2 groups comparison) and chi-square tests as appropriate. The
Cochran-Armitage test for trend was used to assess changes in rates over time. To consider
whether changes in treatment time varied by hospital, mixed-effects model analyses were
conducted with PCI hospitals as a random effect. Performance data were compared
compar
arred
d inn three
thre
th
reee
re
month intervals from July 2008 through December 2009 stratified according to treatment and
presentation
pr
ressen
enta
tati
ta
tion
ti
on to
t PCI
PCI hospital (fibrinolysis orr primary
prima
maryy PCI; presentation
ma
presenta
taati
t onn to
to PCI hospital by
transfer,
ran
nsf
s er, self, or EMS).
EMS
MS).
)
For
the
objectives
RACE
intervention
were
door-toF
orr tthe
he P
PCI
CII hhospitals,
ospi
pita
pi
talss, th
he ob
obj
jecctiive
vess off tthe
hee R
ACE in
ACE
inte
teerv
r en
e ti
tion
o w
on
eree to
er
o rreduce
ed
duc
ucee do
door
or-t
-tto-presenting
medical
device
EMS
device timess ffor
or ddirectly
irec
ir
e tl
ec
t y pr
res
esen
enti
en
ting
ti
n patients
ng
pattie
i nt
n s and
and ffirst
irrstt m
med
edic
ed
ical
ic
a ccontact
al
ontaact ttoo de
on
devi
v cee ffor
vi
or E
M
MS
transported patients. For non-PCI hospitals, the objectives of RACE were to reduce the door-in
to door-out times and first door to device times for patients who were transferred to undergo PCI
elsewhere and door-to-needle times for those receiving fibrinolysis. For both hospital settings,
we also aimed to increase the rate of reperfusion among eligible patients. In cases where the first
ECG did not have diagnostic ST elevation, door or first medical contact time was reset to the
first diagnostic ECG. All tests were conducted at the 0.05 significance level. All patients with
ischemic symptoms lasting greater than 10 minutes within 24 hours prior to arrival and an ECG
with diagnostic ST segment elevation were included in the analyses. Statistical analyses were
6
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DOI: 10.1161/CIRCULATIONAHA.111.068049
carried out using SAS version 9.2 (SAS Institute INC, Cary, NC).
Results
Between July 2008 and December 2009, 6,841 patients presented with acute ST elevation
myocardial infarction including 3,907 patients who presented directly (57%) and 2,933 patients
who were transferred to PCI hospitals (43%). (Table 1) The median age of the cohort was 59
years (interquartile range 51-69), 30% of patients were women, and 15% were either black or of
Latino ethnicity. Nineteen percent of patients had no insurance and 7% were covered by
Medicaid. Median duration of chest pain from onset to ECG was 91 minutes, 20% of patients
had prior myocardial infarction or PCI, and shock was present on admission for 9% off patients.
pati
pa
tien
ti
ents
en
ts.
By medical record review, 86% of patients were felt to be reperfusion candidates and STEMI
wass ap
apparent
patients.
wa
app
pare
pare
rent
nt onn th
thee initial ECG for 89% of patie
ieent
n s.
facility
was
for
and
walk-in
Meanss of ttransport
rans
ra
nsspoort ttoo th
thee fi
ffirst
rstt fa
rs
fac
cilitty w
ass bby
y EM
EMS
S fo
or 555%
5% off ppatients
atie
ient
ntss an
nt
nd walk
w
alk
l -i
-inn fo
fforr
43%
course
was
percentage
patients
43
3% of ppatients.
attie
ient
nts.
s. Over
Over tthe
h co
he
oursse of tthe
ours
he sstudy,
he
tudy
tu
dy,, th
dy
tthere
e re w
ere
ass an iincrease
ncrreas
nc
asee in
n tthe
he pe
perc
r en
rc
ntaage off pa
atieents
en
The
inverse
pattern
presenting byy EMS
EMS to
t PCI
PCI hospitals,
hos
o pi
pita
tals
ta
lss, from
frrom 70
70 to 75%
75% (P=0.04).
(P
P=0
0.0
.04)
4).. Th
4)
he in
inve
vers
ve
rsee pa
rs
patt
tter
tt
ernn an
er
aand
d trend
were seen at non-PCI hospitals, where EMS presentation fell from 35 to 30% (P= 0.10). During
the final quarter of data collection, pre-hospital ECGs were identified for 88% of patients
presenting to PCI centers via EMS and for 32% of patients presenting to non-PCI centers
(P<0.0001). (Figure 2)
Treatment rates and times
Among the 5,888 eligible patients, the rate of patients not receiving reperfusion fell from 5.4% to
4.0% (P=0.04) largely attributable to a 4% absolute decline in eligible untreated patients at nonPCI hospitals (P<0.01) (Figure 3). During the same period, primary PCI as reperfusion mode
7
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DOI: 10.1161/CIRCULATIONAHA.111.068049
increased from 52% to 66% in non-PCI hospitals with a corresponding decrease in fibrinolysis
from 41% to 31% of eligible patients. For patients presenting directly to PCI hospitals, primary
PCI remained stable at 95%, with only 17 patients being treated with fibrinolysis during the
study period. These patients either received fibrinolysis pre-hospital or when a significant delay
to catheterization laboratory availability was anticipated due to simultaneously presenting
patients.
Corresponding with guideline goals, treatment times of interest included door to device
for patients undergoing primary PCI, first medical contact to device for patients presenting to
PCI hospitals by EMS, first hospital door to device for patients transferred between hospitals,
median
and door to needle for patients treated with fibrinolysis. Over the study period, m
edi
d an
di
n ddoor
oorr to
oo
device times for patients presenting directly to PCI hospitals fell modestly from 64 to 59 minutes
(P<0.001)
P<0
<0.0
.001
.0
01)) with
01
witth improvements
wi
imp
mprrovements in both self presenting
presen
en
nting patients from
om
m 799 to 73 minutes (P=0.01)
and
EMS
transported
patients
minutes
(P=0.06)
4).
an
nd EM
E
S tran
nsp
spoort
ortedd pa
ati
tien
ents
en
ts ffrom
rom
ro
m 58 too 55
5m
inuutees (P=
P=0.
P=
0.06
06)) ((Figure
06
Figgure
gure 44)
). The
The proportion
prroppor
orti
t on
on ooff
directly
patients
who
underwent
PCI
within
minutes
dire
di
reecttly ppresenting
reese
sent
ntin
in
ng pa
pat
tieents
ents w
ho
o un
und
derw
derw
wen
entt PC
CI w
itthin
th n 990
0 mi
minu
n tes
nu
tes increased
incr
in
crreaase
sedd from
from
m 83%
83%
% to
to 89%.
899%.
%.
For patients
pati
pa
t en
ti
e ts transported
traans
n poort
rted
e directly
ed
dir
i ec
ectlyy too PCI
PCI hospitals
hosp
ho
spit
sp
i al
it
alss by EMS,
EMS
MS, pre-hospital
prepr
e ho
ehosp
spit
sp
i all ECG
it
ECG rates
rat
a es
increased from 67% to 88% during the intervention. This improvement was accompanied by a
decline in median time from first medical contact to device from 103 to 91 minutes (P<0.0001),
with 50% of patients being treated within 90 minutes by the last quarter. The transport
component of this time interval remained stable at a median of 35 minutes (interquartile range
25, 49) from first medical contact to hospital door. The percentage of patients receiving device
activation within 90 minutes of first medical contact increased from 36% to 50% (P=0.0002).
Patients transported by EMS were most likely to reach door to device goals, with 91%
undergoing device activation within 90 minutes of hospital arrival and 52% being treated with 60
8
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minutes by the end of the study.
Treatment times for patients transferred between hospitals for primary PCI significantly
improved (Figure 5). The median time from first hospital door to device activation for 1,175
patients transferred from hospitals that adopted a “transfer for PCI” strategy (52 hospitals) fell
from 117 minutes to 103 minutes (P=0.0008) with 39% patients being treated within the 90
minute goal by the end of the intervention. A time interval of focus for these transferred patients
involved first hospital “door in door out” time, improving from 44 to 39 minutes. The 474
patients transferred from hospitals with a “mixed” strategy of transfer and fibrinolysis (15
hospitals) had substantially longer treatment time with first door to device falling from 195
varied
minutes to 138 minutes by the end of the study (P=0.002). Treatment time varie
ieed su
ssubstantially
bsta
bs
tant
ta
ntia
nt
iall
ia
llyy
by transfer distance expressed as drive times according to standard mapping software
[http://www.mapquest.com
access October 21, 2010]
htttp:
p://
//ww
//
www.
ww
w mapq
mapq
pquuest.com
ue
20110] Median first
20
firrst
s door
doo
ooor to
to device time for
hospitals
within
hospitals
hosp
p
with
hin 30
30 minutes
minu
mi
utes
tees was
was 94 minutes,
minu
inutess, 134
134 minutes
minu
mi
utees for
for hospitals
hosp
ho
spital
alls between
betw
weeen 31 aand
nd 445
5
minutes
mi
inu
n te
tess drive
driv
dr
ivee time,
iv
time
ti
me,, and
me
an
nd 192
19 minutes
minu
mi
nute
nu
tess for
te
fo
or hospitals
hosspit
ho
itaalss exceeding
it
eexc
xcee
e di
ee
dinng
ng 45
45 minutes
minu
mi
nute
nu
tees drive
driv
dr
ivee time.
iv
t me
ti
me.. Mixed
Mixe
Mixe
x d
strategy
hospitals
minute
longer
median
transfer
trategy hospi
pita
pi
tals
ta
ls hhad
a a 221
ad
1 mi
minu
ute lo
ongger m
med
edia
ed
iaan dr
ddrive
i e ti
iv
time
me ccompared
ompa
om
paare
redd to ttra
rans
ra
nssfe
ferr fo
forr PCI
strategy hospitals. Among the 903 patients treated with fibrinolysis prior to transfer, door to
needle did not significantly improve with median times of 35 minutes and 27 minutes in the first
and last quarters of the study (P=0.27) with 48% being treated within 30 minutes during the
entire study period. When treatment time analyses were stratified according to patients treated at
the initial RACE intervention hospitals or hospitals added for the full state intervention, the
findings were similar for both subgroups of patients. When treatment times were further
considered in mixed-effects models with PCI hospital as a random effect, the models were
significant, indicating that some hospitals had significantly greater improvement than others
9
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DOI: 10.1161/CIRCULATIONAHA.111.068049
(P<0.01).
Outcomes
Patients treated within times suggested by guidelines had a mortality of 2.2% compared to 5.7%
for patients whose treatment time exceeded guideline recommendations (P=0.001) Overall inhospital mortality was 5.7% (95% confidence interval 5.2 – 6.3%) during the study period
including 5.9% during the first half of the intervention and 5.5% during the second half (P=NS).
Other clinical outcomes, bleeding, stroke, hemorrhagic stroke, congestive heart failure, and
shock did not significantly vary over the study period.
Discussion
The RACE system is the largest state-wide ST elevation myocardial infarction system ever
implemented
United
intervention
systematic
mpl
plem
em
men
nte
tedd in tthe
he U
nited States. Our interven
nti
tion
onn demonstratess th
tthat
at sy
syst
s ematic barriers in
timely
overcome
imely
meel reperfusion
reperfu
usiion ccan
an
n bbee ov
over
erco
er
come
me with
wit
w
ithh a broadly
broadlly organized
bro
orga
gani
ga
nizzedd voluntary
voolu
unt
ntar
aryy effort
effo
ef
fort
fo
rt to
to fill
f ll lleadership
fi
eade
ders
de
rshi
hipp
hi
gaps
ga
ps in
in the
the health
heal
he
alth
th
h care.
car
aree. These
Thesse gaps
Th
gaps primarily
ppri
riima
mari
rilly exist
ri
exi
x st between
bettwe
ween
en competing
com
ompe
peti
pe
ting
ti
ngg institutions
innsti
nstiitu
t ti
tion
onns and
and between
betw
betw
weeen
entities
health care en
nti
t ti
t es tthat
hatt fu
ha
ffunction
ncti
nc
tion
ti
on
n iinn se
sseparate
paara
rate
te aand
nd distinct
dissti
tinc
nctt systems.
syst
sy
stem
st
ems.
em
s. By building
bbui
uild
ui
ldin
ld
i g consensus
in
cons
co
nsen
ns
ensus amongg
en
all primary PCI hospitals in the state, we were able to convince the majority of emergency
departments and EMS systems to adopt uniform and coordinated processes for rapid diagnosis
and treatment. This universal approach allowed us to establish and embed a standard of care
independent of health care setting or geographic location of the patient. By the end of our
intervention, our protocols were adopted by state regulation for all EMS agencies, and all PCI
hospitals voluntarily agreed to continue sharing data and support regional care.
http://www.ncems.org/pdf/OverviewEMSTriageandDestinationPlan.pdf
The findings identify some remarkable changes in patterns of care and improvements in
10
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DOI: 10.1161/CIRCULATIONAHA.111.068049
performance measures. Notable achievements of the RACE system include a historically low
rate of eligible but untreated of 4.0% and exceptionally fast coronary intervention for patients
presenting directly to PCI facilities with 89% being treated within 90 minutes and 52% treated
within 60 minutes. These results achieved across all 21 PCI hospitals in the state are comparable
to those achieved by 10 select systems that reported on EMS transported patients alone by Rokos
and colleagues of 86% within 90 minutes and 50% within 60 minutes.3
At the same time, this work highlights areas that need further consideration in
formulating STEMI treatment guidelines and building systems of care. Two particular areas of
interest include EMS transported patients and patient transferred between hospitals for primary
PCI. In 2007, the American College of Cardiology / American Heart Associatio
on ST
S
EMII
EM
Association
STEMI
guidelines first directed device activation to occur within 90 minutes of “first medical contact”
ath
her tth
han ho
han
hosp
pit
itaal
al ddoor
oor for patients initially trea
eate
ea
t d by emergency
te
c per
cy
errso
sonn
n el, defined as the
rather
than
hospital
treated
personnel,
1
imee tthat
hat the EM
MS cr
rew aarrives
rriv
rr
ivees
iv
es aatt th
he “s
“sc
cenee” of tthe
he pa
atient
ati
ientt.14
By
B
y aadding
dd
din
ingg sc
scen
scene
enee ti
en
time
me aand
nd
time
EMS
crew
the
“scene”
patient.
transport
ran
nsp
spor
o t ti
or
time
ime
m tto
o th
the
he 90
90 minute
min
i ute
ut go
goal
goal,
al,, th
al
this
hiss ggu
guideline
uideeli
uide
l ne eeffectively
fffect
fect
ctiv
ivel
iv
elyy ra
raised
aissed tthe
he bbar
he
arr oon
n pr
prim
primary
im
marry PC
PCII and
an
made hospita
hospitals
als aand
nd eemergency
merg
me
rgen
ency
en
c m
cy
medical
edic
ed
i all sservices
ic
ervi
er
v ce
vi
cess jo
join
jointly
intl
in
tlyy ac
acco
accountable
coun
co
unta
un
tabl
ta
blee fo
forr pa
pati
patient
tien
ti
en
nt tr
trea
treatment.
eatm
ea
tment. This
tm
work describes the first broad application of this new standard with 50% of patients treated
within 90 minutes of first medical contact (or EMS arrival on scene) by the end of our study.
Time from scene arrival to hospital door consumed a median of 36 minutes of the 90 minute goal
including 15 minute scene time and 21 minute transport time. Our findings indicate that
incremental improvements in all processes of care will allow a majority of EMS transported
patients to meet this goal. These improvements should include universal adoption of
catheterization laboratory activation by paramedics as a standard of care (median time savings 17
minutes). The 28 minute median hospital door to laboratory arrival time for EMS transported
11
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DOI: 10.1161/CIRCULATIONAHA.111.068049
patients also indicates potential for a further improvement in hospital processes such as preregistration of patients, proceeding directly to the catheterization laboratory when available, and
cross training laboratory, emergency department, and intensive care unit personnel to cover
emergent STEMI patients.
To our knowledge the 39% of patients undergoing primary PCI within 90 minutes of first
hospital door in “transfer strategy” hospitals represents the highest rate reported in a multicenter
study. For comparison, 15% of patients requiring hospital transfer in Massachusetts State were
treated within 90 minutes in 2008, the latest year data are available, and the AR-G registry
reported 24% of patients transferred for PCI in the fourth quarter of 2009 had device times
within 90 minutes of first door.14 The AR-G registry involved a select group of ap
approximately
pprrox
xim
imat
atel
at
elyy
el
220 hospitals that were submitting data and this national benchmark likely reflects above average
performance.
pe
erffor
orm
manc
manc
nce.
e The
he treatment
ttre
r atment times in RACE for tr
tran
transferred
an
nsferred patien
patients
nts
t als
also
lsso ccompare
ompare favorably to
selected
eleect
c ed singlee center
center
er oorr single
sing
si
ngle
ng
le rregion
eg
gio
on reports
repportts from
re
mA
Abbot
bbot
bbo
ot N
Northwestern
orthw
orth
wes
este
terrn ooff 32
32%,
%, M
Mayo
a o Cl
ay
Clin
Clinic
inic
nic ooff
12%,
Springfield,
Illinois
Stat
Heart
12%.
12
2%, aand
nd S
p in
pr
inggfie
gfieeld
ld,, Il
lli
linnois
is S
tatt He
ta
H
art of 12%
art
2%.. 1, 22,, 5 Wit
2%
W
With
ithh national
it
nati
na
tioonal
onal guidelines
gguuiddeli
deliine
n s for
fo
or inte
iinter-hospital
nteer--ho
hosp
spit
ittal
ransfer conti
tinu
nuin
nu
ingg to
t ccall
a l fo
al
forr de
evi
v cee aactivation
ctiv
ct
iv
vat
atio
ionn wi
io
w
thin
th
i 990
in
0 mi
minu
nute
nu
tess of ffirst
te
irst
ir
st m
med
ed
dic
ical
al ccontact
ontact as a
on
transfer
continuing
device
within
minutes
medical
“systems goal,” our inability to reach this goal in a majority of patients despite focused efforts
raises questions regarding the feasibility of achieving this benchmark on a broad scale.15 First
door to device time varied as a function of inter-hospital drive time, from 93 minutes for
hospitals within 30 minutes, 117 minutes for 31 to 45 minute drive times, and 121 minutes for
hospitals beyond 45 minutes drive time. Patients transported by air were not treated faster, with
median first door to device times of 125 minutes for hospitals in the 31 to 45 drive time range,
and 138 minutes for hospitals beyond 45 minute drive times. Thus, treatment by the 90 minute
goal for hospitals located beyond the 30 minute drive time appears less likely to occur for the
12
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DOI: 10.1161/CIRCULATIONAHA.111.068049
majority of patients using current processes. Our work supports the extension of the standard to
120 minutes in order to have relevance for the majority of patients undergoing hospital transfer
for primary PCI.16
Mortality
While there are trends toward lower STEMI mortality in North Carolina since the initiation of
our regional system, our study lacked adequate sample size to reliably identify mortality
differences. Pathological, imaging, and clinical data support a strong relationship between
earlier treatment, less myocardial necrosis and lower mortality, and we believe the significant
time improvements in coronary reperfusion resulting from our intervention represent an
mportant improvement of myocardial infarction care in North Carolina.17-19 Obs
Observations
bsserrva
v ti
tion
onss fr
on
from
om
important
our RACE data also support timely treatment according to a 2.2% mortality for those receiving
reperfusion
epe
perf
rfuusio
rf
usio
ionn according
acco
ord
rdin
ing to overall guideline time goals
goaals compare to a 5.7%
go
5.77% mortality
m rtality for those
mo
treated
reaate
ted beyondd rrecommended
ecom
ec
mmeend
nded
ed
d ttime
imee in
im
iintervals
tervalss (P
(P<0.001).
P<0
0.0
.0001).
).
Limitations
Li
imi
mita
tati
ta
tion
on
ns
This study rel
relied
ellie
iedd on the
the voluntary
vol
olun
untaary submission
un
ssub
u mi
ub
m ss
ssio
io
on of
o data
dat
ataa too the
the AR
AR-G
-G rregistry,
egis
eg
isstrry, a ssystem
yste
ys
tem
te
m that
t at lacks
th
any mechanism for auditing. Thus, it is possible that some of the observed improvements in
performance and outcome may have been due to self reporting. The extent to which our data
elements overlapped with door to device and needle measures in CMS Hospital Compare, a
subset of our data were subject to random audit, providing some impetus for accurate reporting.20
Our study design did not allow us to determine whether changes in care were directly attributable
to the RACE interventions or whether they occurred independently of the project. During the
corresponding time period from Q3 2008 to Q4 2009, the 220 hospitals submitting data to AR-G
had improved median door to device times for directly presenting patients from 66 to 62 minutes
13
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DOI: 10.1161/CIRCULATIONAHA.111.068049
compared to 64 to 59 minutes in our study, and 120 to 113 minutes for transferred patients
compared to 152 to 118 minutes in RACE. Thus, the improvements in our system were of a
similar magnitude to those seen for all AR-G hospitals for directly presenting patients, and
appear to be substantially larger for transferred patients. As hospitals participating in AR-G
represent a select group focused on improving treatment times among the 1200 to 1400 hospitals
in the United States that perform primary PCI, we believe that the improvements in North
Carolina, particularly among transferred patients, likely reflect the effect of our system.
Conclusions
entire
state
A uniform and comprehensive approach to organizing STEMI care across an en
ntiiree sta
ate oonn a
voluntary basis resulted in markedd improvements in timely coronary artery reperfusion. Patients
presenting
directly
requiring interpr
ressen
enti
ting
ti
ngg ddir
irecctl
ir
tlyy to
t PCI hospitals received thee fa
ffastest
stest treatment,
t,, while
whi
hile
le those
t
hospital
transfer
showed
improvements
time.
By
extending
hospital
hosp
p
transfe
ferr sh
how
wed
d tthe
he ggreatest
reattes
reat
estt im
mprov
vem
menntss in ttreatment
reattme
reat
ment
nt ti
ime.
e B
y ex
exte
tend
nddin
ng our
our
organization
state,
diagnosis
STEMI
or
rga
gani
niza
ni
z ti
za
tion
on to
to aan
n eentire
ntiiree st
nt
stat
te,
e rrapid
apid
ap
id ddi
iagn
iagn
gnos
osiss aand
os
nd
d ttreatment
r at
re
a me
mennt ooff S
TEM
TE
MI hhas
MI
as bbecome
ecom
ec
om
me an
n eembedded
m ed
mb
eddded
standard
care
independent
health
tandard of ca
are iind
ndep
nd
epen
ep
endeent ooff he
en
heal
alth
al
t ca
care
re ssetting
etti
et
t ng or
ti
or geographic
geeog
ogra
raph
ra
phic
ph
ic location.
loc
ocat
oc
atio
at
ion.
io
n
n.
Funding Sources: Unrestricted grants from Phillips, Sanofi Aventis, Medtronic Foundation.
Phillips, Sanofi Aventis, and the Medtronic Foundation had no role in the design and conduct of
the study, analysis and interpretation of the data, or in the preparation, review, or approval of the
manuscript
Conflict of Interest Disclosures: Jollis received research grants from Phillips, Sanofi Aventis,
Medtronic Foundation and The Medicines Company. He also acted as a consultant for United
Healthcare and Blue Cross Blue Shield North Carolina. Granger received research grants from
Astellas, Medtronic Foundation, Astra Zeneca, Merck, Boehringer Ingelheim, Bristol-Myers
Squibb, The Medicines Company, GlaxoSmithKline, and Sanofi Aventis. He also acted as a
consultant for Boehringer Ingelheim, Sanofi Aventis, Astra Zeneca, Bristol-Myers Squibb,
GlaxoSmithKline, Roche, Novarti, and The Medicines Company. Applegate acted as a
consultant for Abbott, St. Jude, and Terumo Medical Corporation. Wilson acted as a consultant
for Boston Scientific. Garvey acted as a consultant for Abbott Vascular.
14
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DOI: 10.1161/CIRCULATIONAHA.111.068049
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irccula
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.htt
ttp:
tt
p://
p:
//ww
www.
ww
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caarddio
iossouurc
urce.o
.oorgg/~/
~/me
meddia/
a/Fi
a/
Filles/
Fi
s/Sc
s/
Scie
Sc
ienc
nce%
e%20
e%
20an
20
nd%
d%20
200Qu
Quallit
ity/
y//NC
NCDR
DR
R/Sli
/Slide
dese
de
sets
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AC
TIONGWTG%20ResultsQ309_Q210.ashx
Accessed
12/18/2010.
TION
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09_Q
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cces
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e sedd 12
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20100.
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Mukherjee D, Nallamothu BK, Ting HH. 2011 ACCF/AHA/SCAI guideline for percutaneous
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17. Reimer KA, Jennings RB. The "wavefront phenomenon" of myocardial ischemic cell death.
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DOI: 10.1161/CIRCULATIONAHA.111.068049
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2009;11:38.
20. http://www.hospitalcompare.hhs.gov Accessed 12/18/2010.
Table 1. Patient characteristics, procedures, and outcomes according to direct or transfer
presentation to percutanous coronary intervention hospital.
Age (yrs)
Median (IQR)
Female (%)
Race (%)
White
Black
Other
Latino ethnicity (%)
Insurance (%)
Private / HMO
Medicaid
None
Other
Othe
Ot
herr
he
Prrio
iorr my
m
occar
arddial
di iinfarction
nfar
nf
arct
c ionn (%
(%))
Prior
myocardial
Prior
failure
Prio
or heart fa
aillur
uree (%
(%))
Prior
Priior PCI (%)
Prior
surgery
(%)
P
rio
or coronary
ry
y bbypass
yp
passs su
urgeery (%
%)
Diabetes
mellitus
Diab
Di
abet
ab
e es m
et
elli
el
litu
li
tuss (%
(%))
Chest
minutes,
median
(IQR)
Ches
Ch
estt pa
pain
in duration
ddur
u at
atio
i n in
io
in m
mi
inut
in
utes
tes, me
medi
dian
di
an ((IQ
QR))
Means
first
facility
Mean
Me
anss of transport
an
ttra
rans
ra
nspo
ns
port
po
rt to
to fi
firs
rstt fa
rs
faci
cili
ci
lity
li
ty ((%)
%)
Self
Se
lf / ffamily
amil
am
illy
Ambulance
A
b l
Other (Air/ICU)
Shock on presentation (%)
Heart failure on presentation (%)
Reperfusion candidate
STEMI first diagnosed (%)
1st ECG
Subsequent ECG
Procedures during hospitalization (%)
PCI
Coronary bypass surgery
Complications (%)
In-hospital death
Stroke
Hemorrhagic stroke
Cardiogenic shock
Congestive heart failure
Major bleeding
Re-infarction
IQR = Inter-quartile range (25th, 75%).
All
6841
59 (51, 69)
Direct
3907
60 (51, 70)
Transfer
2933
59 (51, 69)
P value
29.6
30.0
29.1
0.36
83.9
13.6
2.5
1.6
84.3
13.6
2.1
1.5
83.4
13.5
3.1
1.7
0.03
47.7
7.2
19.1
26.1
26
6.11
20.1
20.1
44.7
4.
7
19.66
6.5
22.4
22.4
4
(49,
91
1 ((4
49, 190)
49,
190)
49.7
7.0
18.2
25.2
21.8
5.33
5.
21.4
21.44
77.5
.5
221.8
1.88
1.
(42,
8833 (4
(42
2, 1181)
2,
81))
81
44.9
7.5
20.2
27.4
17
7.8
8
17.8
4.00
4.
117.3
17
7.3
.3
5.2
5.
.2
223.2
3.2
.2
(58,
205)
1000 (5
10
58,
8, 2205
05))
05
43.4
43
.4
4
55.2
55 2
1.4
9.2
8.1
86.2
226.5
65
6.
71.3
71
3
2.2
9.6
7.9
86.6
665.9
65
.9
9
33.7
33
7
0.4
8.6
8.3
85.8
<0.0001
88.6
11.4
89.3
10.7
87.5
12.5
0.03
85.6
6.7
87.1
6.4
83.5
7.0
<0.0001
0.38
5.7
1.1
0.2
6.1
6.1
5.7
0.8
5.8
0.8
0.1
6.2
5.4
5.4
0.7
5.5
1.5
0.3
5.9
6.9
6.2
0.9
0.60
0.007
0.54
0.72
0.02
0.16
0.34
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0.03
00.56
0.
56
00.002
.002
002
<
0 0001
0.
<0.0001
0.03
0.03
<0.0001
<
0.00
0.
00
0011
00.0002
.0002
02
0.16
00.1
.166
<0.0001
<0.0
<0
.0
000
0011
0.18
0.51
0.38
DOI: 10.1161/CIRCULATIONAHA.111.068049
Figure Legends:
Figure 1. North Carolina hospitals according to reperfusion strategy.
Figure 2. Pre-hospital ECG for patients presenting directly to PCI hospitals by EMS.
Figure 3. Reperfusion treatment by quarter, all eligible patients. P=0.04 for trend.
Figure 4. Hospital door to device times for patients presenting directly to PCI hospitals by
orted
ed
dP
=0.0
=0
.006.
arrival mode and quarter, median times. For trend, walk in P=0.01, EMS transpo
transported
P=0.06.
Fiigu
gure
re 55. Reperfusion
Repperf
Re
rffus
usio
i n times for patients present
tin
ingg to hospitals without
wit
i hoout PCI
P facilities by quarter,
Figure
presenting
meddian
di times. D
oor to nneedle
eeedl
dlee times
tim
ti
mes for
mes
fo
or patients
patiien
nts treated
treateed with
with
t fibrinolysis.
fib
ibrrinnoly
nolysi
s s. F
irst
ir
st hhospital
o pi
os
pita
taal do
door
or tto
o
median
Door
First
device
devi
de
v ce ttime
vi
imee fo
im
forr ppatients
attien
tientts ttransferred
ranssfe
ra
ferr
rred
rr
ed ffor
orr P
PCI
PCI.
CI.. Fo
CI
Forr ttransferred
raans
ansferrre
redd pa
pati
patients,
tien
en
nts
ts,, tr
treatment
reaatm
men
entt ti
time
times
mess aare
me
ree
cco
ord
rdin
in
ng to
o hhospital
osspi
pita
t l re
ta
repe
perf
pe
r us
usio
io
on st
stra
rate
ra
teegy
gy.. F
For
or llytic
ytic
yt
ic P
P=0
=0
0.2
.27,
7 ttransfer
7,
rans
ra
nsfe
ns
feer st
stra
rate
ra
tegy
te
g
presented ac
according
reperfusion
strategy.
P=0.27,
strategy
P=0.0008, mixed strategy P=0.002.
18
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Supplemental Material
RACE Investigators
State Project Leader
Lisa Monk, RN, MSN
Central Organizing Committee
Christopher B. Granger, MD
James G. Jollis, MD
Mayme Lou Roettig, RN, MSN
EMS Regional Coordinators
Claire Corbett, MMS, NREMT-P
Scott Starnes, NREMT-P
Nurse System Coordinators
Tracey Blevins, RN, BSN, MBA
Harriet Buss, RN, BSN, MSHA
Joanne Cary, BS, RN, CN,
Frank Castelblanco, RN, ADN, BA
Bridget Harding, RN, MSN
Cheryl Henderson, RN,BSN
Michelle Keasling, RN, MSN
Robyn Keller, RN, BSN
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Jan Matthews, RN,
Jeannie Moore, RN, BSN
Linda Newton, RN, MSN
Heather Norman, MHA, RN, BSN
Gloria Paul, RN, MSN
Mary Printz, RN, MSN, FNC
Susan Rouse, RN, BSN
Betsy Russell, RN
Stephanie Starling, BSN, RN, MHA
Jennifer Sarafin, RN, MSN
Amanda Thompson, RN, BSN, MHA
April Traxler, RN, BSN
Annette Winkler, RN, MSN
Other Systems Coordinators
Keith Pendergrass, RRT, RCP
Cathy Rabb, RRT, RCP
David Reich RCIS, BS
Charles H. Wilson, MD
Interventional Cardiology Leaders
Akinyele O. Aluko, MD
Robert J. Applegate, MD
Joseph D. Babb, MD
Christopher C. Barber, MD
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Bruce R. Brodie, MD
Brian P. Hearon, MD
R. Lee Jobe, MD
Kevin R. Kruse, MD
Michael R. Komada, MD
William T. Maddox, MD
Robert B. Preli, MD
Steven C. Rohrbeck, MD
John R. Sinden, MD
Patrick J. Simpson, MD
George A. Stouffer, III, MD
Thomas D. Stuckey, MD
Mark A. Thompson, MD
F. Scott Valeri, MD
John A. Williams, III, MD
B. Hadley Wilson, MD
Emergency Medicine Leaders
Robert L. Beaton, MD
Joshua N. Cochrane, MD
Sidney M. Fletcher, MD
J. Lee Garvey, MD
Penny Jo Hamilton-Gaertner, MD
Matthew R. Harmody, MD
James W. Hoekstra, MD
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Paul E. Horton, MD
Jonathan D. Kelly, MD
Scott T. Miekley, MD
R. Darrell Nelson, MD
Brad A. Watling, MD
Randall N. Willard, MD
Emergency Medical Service Leaders
David Cuddeback, NREMT-P
Greg Mears, MD
J. Brent Myers, MD
Drexdal R. Pratt
Dwayne R. Young, BS, REMTP
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`