a multifaceted approach to improving outcomes in the nicu ...cdw data set. to maximize validity,...
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A Multifaceted Approach to Improving Outcomes in the NICU: The Pediatrix 100 000 Babies CampaignDan L. Ellsbury, MD, Reese H. Clark, MD, Robert Ursprung, MD, MMSc, Darren L. Handler, BS, Elizabeth D. Dodd, BA, Alan R. Spitzer, MD
The Center for Research, Education and Quality, Pediatrix
Medical Group, Sunrise, Florida
Dr Ellsbury contributed to the conception and
design of the study and leads our quality programs,
wrote the fi rst draft of the article, and wrote and
edited the fi rst to fi nal draft with the help of his co-
authors who offered suggestions for improvement;
Dr Clark contributed to the conception and design
of the study as well as the fi nal approval of the
version to be published, and provided extensive
editorial input to the writing of the fi nal article; Dr
Ursprung contributed to the conception and design
of the study as well as the fi nal approval of the
version to be published, is the associate director
of our quality programs, and provided extensive
editorial input to the writing of the fi nal article;
Mrs Dodd played a pivotal role in helping our
medical directors access and review their quality
reports and to set up quality improvement projects
in their NICUs, and provided editorial input to the
writing of the fi nal article; Mr Handler is the lead
developer who updates and improves our clinical
data warehouse reporting system, which supports
all of our quality improvement efforts, and provided
editorial input to the writing of the fi nal article; Dr
Spitzer contributed to the conception and design of
the study, analysis and interpretation of data, and
critical revisions for important intellectual content;
and all authors approved the fi nal manuscript as
submitted.
DOI: 10.1542/peds.2015-0389
Accepted for publication Aug 3, 2015
Address correspondence to Dan L. Ellsbury, MD,
Pediatrix Medical Group, Inc, 1301 Concord Ter,
Sunrise, FL 33323. E-mail: dan_ellsbury@pediatrix.
com
Despite advances in neonatal
medicine, infants requiring neonatal
intensive care continue to incur
substantial morbidity and mortality.1,
2 Unexplained variations in outcome
between individual NICUs remain
a dilemma for neonatal networks
seeking to uniformly improve
outcomes.3 Single-center and
collaborative quality improvement
(QI) initiatives have sought to decrease
variation and improve outcomes, but
results have been mixed.4–6
QI collaboratives commonly focus on a
single clinical problem, rather than the
most common group of problems that
drive poor health outcomes.5, 7, 8 Such
collaboratives often require expensive
data collection and reporting systems
that may not be readily available.
These limitations create significant
abstractBACKGROUND AND OBJECTIVE: Despite advances in neonatal medicine, infants
requiring neonatal intensive care continue to experience substantial
morbidity and mortality. The purpose of this initiative was to generate
large-scale simultaneous improvements in multiple domains of care in
a large neonatal network through a program called the “100, 000 Babies
Campaign.”
METHODS: Key drivers of neonatal morbidity and mortality were identified.
A system for retrospective morbidity and mortality review was used to
identify problem areas for project prioritization. NICU system analysis and
staff surveys were used to facilitate reengineering of NICU systems in 5 key
driver areas. Electronic health record–based automated data collection and
reporting were used. A quality improvement infrastructure using the Kotter
organizational change model was developed to support the program.
RESULTS: From 2007 to 2013, data on 422 877 infants, including a subset
with birth weight of 501 to 1500 g (n = 58 555) were analyzed. Key driver
processes (human milk feeding, medication use, ventilator days, admission
temperature) all improved (P < .0001). Mortality, necrotizing enterocolitis,
retinopathy of prematurity, bacteremia after 3 days of life, and catheter-
associated infection decreased. Survival without significant morbidity
(necrotizing enterocolitis, severe intraventricular hemorrhage, severe
retinopathy of prematurity, oxygen use at 36 weeks’ gestation) improved.
CONCLUSIONS: Implementation of a multifaceted quality improvement program
that incorporated organizational change theory and automated electronic
health record–based data collection and reporting program resulted in
major simultaneous improvements in key neonatal processes and outcomes.
QUALITY REPORTPEDIATRICS Volume 137 , number 4 , April 2016 :e 20150389
To cite: Ellsbury DL, Clark RH, Ursprung R, et al. A
Multifaceted Approach to Improving Outcomes in
the NICU: The Pediatrix 100 000 Babies Campaign.
Pediatrics. 2016;137(4):e20150389
by 1440450 on February 20, 2018http://pediatrics.aappublications.org/Downloaded from
ELLSBURY et al
barriers to large-scale improvement
in neonatal care and outcomes.
The objective of this initiative was to
pragmatically reengineer the delivery
of neonatal intensive care in a large
neonatal network with the goal of
simultaneous multidimensional
improvements in process and
outcome. We hypothesized that
a structured approach to system
evaluation and reengineering of
neonatal intensive care in multiple
key process areas would yield
sustained improvement in neonatal
morbidity and mortality.
METHODS
Setting
Pediatrix Medical Group (PDX) is
a national group of clinicians that
provides neonatal intensive care
services for ∼20% of the newborns
in the United States who require
intensive care. These clinicians
practice in a diverse group of
settings, from small community
hospitals to large children’s hospitals,
and reside in 34 states plus Puerto
Rico.
Ethics and Data Collection
This analysis is a descriptive review
of data from infants in the PDX
network, composed of 330 NICUs that
feed data into the PDX Clinical Data
Warehouse (CDW). PDX clinicians
used a proprietary software system
(BabySteps; MEDNAX, Inc, Sunrise,
FL). Infant data are added and
modified by providers in BabySteps
during their daily assessments.
These data are used to generate
the medical documentation (eg,
admission, progress, and discharge
notes), billing worksheets, and the
CDW data set. To maximize validity,
data for the CDW are extracted
at the end of the infant’s NICU
stay, so providers have multiple
opportunities to review and verify
the documentation. These data are
deidentified, stored in a consolidated
national data set, and are compliant
with the Health Insurance
Portability and Accountability Act
of 1996 regulations.9 The Western
Institutional Review Board approved
the use of this deidentified data
warehouse for this study.
Model Development
From 2007 to 2009, the authors
defined key driver processes
based on literature review and
use of nominal group technique
methods.10 Emphasis was placed on
identifying clinical processes that
were modifiable and had substantial
impact on the primary drivers of
poor health outcomes8, 11–20 (Fig 1).
John Kotter’s 8-step model for
leading organizational change
was used for the design and
implementation of our campaign
(Fig 2).21, 22 The term “100 000
Babies Campaign” was used because
of its similarity to the Institute for
Healthcare Improvement’s “100 000
Lives Campaign, ” which successfully
targeted key problem areas in care
with the goal of saving 100 000
lives.23, 24 We sought to reengineer
the care of 100 000 infants with the
hope that the simultaneous targeting
of key driver processes would
translate into improved outcomes.
Intervention
Engagement of Practices
Various aspects of the 100 000
Babies Campaign were introduced
informally from 2007 to 2009, with
formal launch of the program in
2009. The program built on our
previous QI successes in improving
growth and reducing retinopathy of
prematurity (ROP).25, 26 Participation
was not mandated, but was strongly
encouraged. A key theme of the
intervention was a flexible and
adaptable approach to improving
care within the context of the
individual NICU’s microsystem. A
variety of approaches to problems
were provided, with the expectation
that each NICU would adapt the
interventions to their specific
environment. Reliance on automated
e2
FIGURE 1Driver diagram of the 100 000 Babies Campaign identifying the aims, outcomes, key drivers, and process changes targeted in the program. CPAP, continuous positive airway pressure; IV, intravenous.
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PEDIATRICS Volume 137 , number 4 , April 2016
central data collection via the
electronic health record (EHR) rather
than extensive local data collection
was emphasized to remove barriers
to participation in the program and
to ensure the most reliable and
reproducible outcome information.
Outcome Review
NICUs were asked to review their
outcomes for several years to assess
their performance in the driver areas
and in clinical outcomes. The CDW
was used for NICU self-assessment
and for comparison with PDX
network benchmarks.
System Analysis
NICUs were provided with a
system analysis worksheet to
guide analysis of their system’s
ability to support the targeted
project goals.
Staff Survey
NICUs were provided with a survey
to assess the attitudes, knowledge
base, and biases of their clinical
staff. Comparison of responses from
physicians, nurse practitioners, and
NICU nurses was emphasized to
detect variation in knowledge gaps
and attitudes within a NICU. These
knowledge gaps and variations
were used to inform their specific
educational needs and project
strategies.
Project Prioritization
After review of surveys, outcomes,
and system analysis, the NICU team
used a project prioritization matrix
to determine specific target areas
for ongoing improvement efforts.
Multidisciplinary project teams were
then designated, with preference for
multiple small teams rather than 1
large team that did all projects.
Implementation
A project management tool
(QualityStepsTM MEDNAX,
Sunrise, FL) was used to facilitate
tracking of each project, to help
coordinate the QI team efforts,
and to enable documentation
that allow participants to obtain
American Board of Pediatrics Part 4
Maintenance of Certification (MOC)
credit. It contained project progress
notes, educational materials, and
templates.
QI Culture
To facilitate a culture of
improvement and to provide peer
support, PDX provided “Quality
Summit” conferences 3 times per
year. The curriculum covered project
selection, Pareto charts, root cause
analysis, multidisciplinary team
building, change concepts, plan-do-
study-act cycles, basic data analysis,
and use of run charts. Workshops
included small group exercises
that provided opportunity to apply
QI methods to specific clinical
problems and emphasized shared
problem solving with clinicians
from diverse backgrounds.27, 28 QI
project presentations were a major
feature of the program, and were
used to show multiple approaches
to clinical problems and to create
a setting that highlighted the work
of high-performing NICUs. To
remove barriers to participation
and to emphasize the organization’s
commitment to improving patient
care, funding for travel and meeting
costs was provided by PDX with
the expectation that participants
would take the acquired skills
back to their practices and apply
them within their own NICU’s QI
infrastructure.
CDW
The CDW was used as the primary
mechanism for project data
reporting at the local level. Data
from the BabySteps EHR system
were automatically extracted and
transformed into near real-time
clinical quality reports of multiple
processes and outcomes. Data
reports included network level
comparisons to NICUs of similar
volume. These reports did not
require any specific data collection or
extraction.
e3
FIGURE 2Adaption of the Kotter organizational change model to the structure of the 100 000 Babies Campaign.
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ELLSBURY et al
Defi nitions
Demographic Data
Estimated gestational age (EGA)
was defined as the best estimate
of the neonatologist of EGA, based
on obstetric history, prenatal
ultrasound, and postnatal physical
examinations.
Process Measures
For each medication reported in all
tables, we defined exposure to that
specific medication as any report at
any time during the NICU stay. Early
ampicillin was defined as exposure
to ampicillin on the day of birth
(day 0) or day 1 or 2 after birth.
Ampicillin duration of >3 days with
negative cultures was the proportion
of infants in whom the blood culture
was negative who were treated with
ampicillin for >3 days’ duration.
Daily data on nutrition were captured
by using a nutritional support pick
list. Any report of human milk (donor
or maternal) during the hospital stay
was considered exposure to human
milk. Human milk at discharge was
any report of human milk in the day
of discharge feedings.
The care provider is required to
report the degree of oxygen support
and the type of support each day.
We counted the total number of days
each patient was on a ventilator
and calculated the median days of
ventilatory support for each year.
Hypothermia was defined as a NICU
admission temperature of >36°C.
Outcome Measures
In infants who had head imaging
reported, we calculated the
proportion of infants who had
a grade 3 or 4 intraventricular
hemorrhage (IVH). The highest
degree of severity was based on
the following: grade 3, ventricles
are enlarged by the accumulated
blood; and grade 4, bleeding extends
into the brain tissue around the
ventricles. In infants with a report of
an eye examination, we calculated
the proportion with severe (stage
3, 4, or 5) ROP. The highest degree
of severity was used based on the
following: stage 3, severely abnormal
blood vessel growth; stage 4, partially
detached retina; stage 5 completely
detached retina.
The guidance definition for
necrotizing enterocolitis (NEC) is
that infants with NEC should have
≥1 of the following clinical signs:
bilious gastric aspirate or emesis,
abdominal distention, or blood in
stool without evidence of a rectal
fissure; and had ≥1 of the following
radiographic findings: pneumatosis
intestinalis, hepatobiliary gas, or
pneumoperitoneum. NEC-medical
is treatment with antibiotics, bowel
rest, and supportive care and NEC-
surgical is when surgery is also
required. Chronic lung disease (CLD)
was defined as being on more than
room air at 36 weeks postmenstrual
age (PMA). The rates of NEC and
CLD were based on the denominator
of all infants (survived to discharge
or died). We defined late-onset
sepsis as any positive blood culture
reported after 3 days of age. Infants
were considered to have survived
with no morbidity if they were
discharged from the hospital with no
report of severe IVH (grade 3 or 4),
severe ROP (stages 3, 4, or 5), NEC
(medical or surgical), or CLD. Weight
gain (g/day) over the hospital stay
was calculated (discharge minus
birth weight divided by the age at
discharge for survivors).
Data Analysis
Infants were categorized by year
of discharge for the descriptive
tables. The P values reported in the
tables are based on trend analyses
over the entire time period and are
not simple comparisons of 2007
with 2013. For discrete categorical
variables, we used Cochran-Armitage
trend tests to determine if there
were significant changes over time.
Continuous variables (EGA, birth
weight, maternal age, ventilator days,
age at discharge) were evaluated by
using a 1-way analysis of variance
(ANOVA) and linear regression to
determine if there were significant
changes over time. If the P value was
<.01, we compared each year to 2007
(control) by using Dunnett’s method
in JMP. Nonparametric data were
assessed with Kruskal-Wallis ANOVA.
Statistical analyses were performed
by using JMP 11 (SAS Institute, Cary,
NC).
For catheter-associated bloodstream
infection calculations, an algorithm
that is similar to the 2012 Centers
for Disease Control and Prevention
definition for central line–associated
bloodstream infection (CLABSI) was
developed and applied to the entire
data set for consistent description
of CLABSI over the study period.
This algorithm did not include
provider-driven interpretation of
the algorithm, but was based on
objective data components, such as
culture results, timing, and presence
of a central line relative to time of
positive cultures. This model likely
overestimates the CLABSI rate to a
small degree, as other primary causes
of infection may not have been
identified and could be misattributed
as a CLABSI.29
A statistical process control chart
analysis was done by using standard
rules to detect special cause
variation. The mean (center line) and
upper and lower control limits were
calculated and displayed as ±3 SD
of the mean by using QI Macros for
Excel (KnowWare International, Inc,
Denver, CO).30, 31
RESULTS
Between January 1, 2007, and
December 31, 2013, we provided
care to 574 158 infants admitted
for neonatal intensive care; 490 539
(85%) were inborn and 422 877
(74%) were cared for at a single
hospital. Tables 1 and 2 report on
e4 by 1440450 on February 20, 2018http://pediatrics.aappublications.org/Downloaded from
PEDIATRICS Volume 137 , number 4 , April 2016
the subset of this population that had
birth weights between 501 and 1500
g (n = 58 555, 14%). A data table
on the entire population is in the
Supplemental Information.
Results for Infants 501 to 1500 g
Demographics
There was no change over time in
median gestational age (29 weeks),
birth weight (1.1 kg), proportion
of male infants (50%), delivery
by cesarean (76%), or multiple
gestations (28%). There was a
slight increase in median maternal
age from 27 to 28 years old (P <
.001). Antenatal corticosteroid use
significantly increased over time
from a 2007 baseline of 78.8% to
85.0% in 2013 (P < .001).
Process Measures
Exposure to human milk and use
of human milk use at discharge
increased (Table 1). Exposure to
medications that were targeted
for reduction (dexamethasone,
H2 blockers, metoclopramide, and
cefotaxime) was decreased. The
total proportion of infants treated
with early empirical ampicillin and
the proportion of infants
with negative cultures who were
treated for >3 days decreased.
The proportion of infants treated
with mechanical ventilation
decreased as did the median
days of ventilator support.
Hypothermia at admission to the
NICU decreased.
Outcome Measures
Mortality, NEC, severe and surgical
ROP, and bacteremia after 3 days
of life decreased (Table 2). Use of
more than room air support at 36
weeks’ PMA decreased slightly.
Severe IVH showed a nonsignificant
decrease. Survival without significant
morbidity (NEC, severe IVH, severe
ROP, oxygen use at 36 weeks)
improved. The weight at time of
discharge and growth velocity birth
to discharge was slightly increased.
e5
TABL
E 1
Res
ult
s fo
r P
roce
ss M
easu
res
for
Infa
nts
Wit
h B
irth
Wei
ght
of 5
01–
1500
g
2007
2008
2009
2010
2011
2012
2013
P
Any
hu
man
milk
, n (
%)a
6217
(77
.3)
6648
(78
.5)
6910
(82
.3)
7184
(85
.2)
7239
(85
.9)
7326
(86
.9)
7351
(87
.9)
<.0
001
Any
hu
man
milk
at
dis
char
ge in
su
rviv
ors,
n
(%)a
3057
(42
.5)
3199
(42
)34
77 (
45.4
)37
12 (
48.4
)37
79 (
49)
3889
(50
.3)
4043
(52
.7)
<.0
001
Dex
amet
has
one,
n (
%)a
645
(8)
644
(7.6
)61
2 (7
.3)
571
(6.8
)57
6 (6
.8)
568
(6.7
)56
2 (6
.7)
.003
5
H2
blo
cker
s, n
(%
)a13
86 (
17.2
)12
86 (
15.2
)11
99 (
14.3
)93
2 (1
1.1)
885
(10.
5)69
4 (8
.2)
589
(7)
<.0
001
Met
oclo
pra
mid
e, n
(%
)a16
60 (
20.6
)14
15 (
16.7
)10
97 (
13.1
)41
1 (4
.9)
181
(2.1
)14
2 (1
.7)
90 (
1.1)
<.0
001
Cef
otax
ime,
n (
%)a
1152
(14
.3)
940
(11.
1)76
9 (9
.2)
692
(8.2
)67
9 (8
.1)
677
(8)
599
(7.2
)<
.000
1
Pat
ien
ts r
ecei
vin
g ea
rly
(on
day
0, 1
, 2)
amp
icill
in, n
(%
)a
6432
(80
)67
45 (
79.7
)66
03 (
78.7
)67
02 (
79.5
)64
04 (
76)
6361
(75
.4)
6197
(74
.1)
<.0
001
Earl
y am
pic
illin
du
rati
on o
f >
3 d
wit
h n
egat
ive
cult
ure
s, n
(%
)a
2138
/607
6 (3
5.2)
2226
/639
8 (3
4.8)
2110
/627
2 (3
3.6)
2096
/639
1 (3
2.8)
1968
/611
1 (3
2.2)
1832
/606
5 (3
0.2)
1671
/589
3 (2
8.4)
<.0
001
Pat
ien
ts v
enti
late
d in
fi rs
t 3
d a
fter
bir
th, n
(%)a
4831
(60
.1)
4875
(57
.6)
4677
(55
.7)
4625
(54
.9)
4400
(52
.2)
4280
(50
.7)
3899
(46
.6)
<.0
001
Ven
tila
tor
day
s in
ven
tila
ted
pat
ien
ts, m
edia
n
(10–
90th
)b
6 (1
–46
)6
(1–
45)
6 (1
–43
)5
(1–
42)
5 (1
–41
)5
(1–
40)
5 (1
–42
)<
.000
1
Hyp
oth
erm
ia (
adm
it t
emp
erat
ure
<36
°C),
n
(%)a
1869
(23
.2)
1762
(20
.8)
1619
(19
.3)
1446
(17
.2)
1180
(14
)10
70 (
12.7
)96
8 (1
1.6)
<.0
001
H2
blo
cker
(fa
mot
idin
e, c
imet
idin
e, r
anit
idin
e).
a D
iscr
ete
cate
gori
cal v
aria
ble
s w
ere
eval
uat
ed b
y u
sin
g a
Coc
hra
n-A
rmit
age
tren
d t
est
to d
eter
min
e if
th
ere
wer
e si
gnifi
can
t ch
ange
s ov
er t
ime.
b C
onti
nu
ous
vari
able
s w
ere
eval
uat
ed b
y u
sin
g a
1-w
ay A
NO
VA a
nd
lin
ear
regr
essi
on t
o d
eter
min
e if
th
ere
wer
e si
gnifi
can
t ch
ange
s ov
er t
ime.
by 1440450 on February 20, 2018http://pediatrics.aappublications.org/Downloaded from
ELLSBURY et al
Age at discharge of survivors was
increased.
Results for All Infants, All Weights
Human milk use increased, and use
of targeted medications decreased
(Supplemental Table 4). Early use
of ampicillin decreased. Treatment
with ampicillin for more than 3
days in infants with negative blood
cultures decreased. Fewer infants
were treated with mechanical
ventilation. Admission hypothermia,
late onset sepsis, mortality, and NEC
decreased.
Statistical process control chart
analysis (Fig 3) showed a continued
decrease in CLABSI rate from a
baseline of 6 CLABSI/1000 line
days to 2.6 CLABSI/1000 line
days. The continued improvement
triggered special cause variation
and recalculation of control limits 2
additional times, indicating continued
improvement throughout the study
period.31
DISCUSSION
In this large network of NICUs, the
implementation of the 100 000
Babies Campaign was associated
with simultaneous improvement
in the key driver processes and
outcomes. Late onset sepsis, catheter
associated infections, ROP, NEC,
and mortality decreased. Survival
without morbidity increased. Growth,
severe IVH, and oxygen use at 36
weeks’ PMA were stable or slightly
improved.
Our findings are similar to previous
analyses of NICU networks. Stoll et
al32 showed an increase in antenatal
corticosteroid use and decreased
use of intubation and surfactant
in similar subgroups of premature
infants from 2003 to 2007.
Horbar et al2 showed a decrease
in morbidity and mortality in
infants weighing 501 to 1500 g in
the Vermont Oxford Network from
2000 to 2009. It is possible our
e6
TABL
E 2
Res
ult
s fo
r O
utc
ome
Mea
sure
s fo
r In
fan
ts W
ith
Bir
th W
eigh
t of
501
–15
00 g
2007
2008
2009
2010
2011
2012
2013
P
Die
d, n
(%
)a83
6 (1
0.4)
838
(9.9
)72
8 (8
.7)
750
(8.9
)71
4 (8
.5)
702
(8.3
)68
1 (8
.1)
<.0
001
IVH
gra
de
3 or
4 in
pat
ien
ts w
ith
neu
roim
agin
g, n
(%
)a47
1 (7
.2)
466
(6.5
)49
3 (6
.9)
474
(6.6
)47
1 (6
.6)
452
(6.3
)42
2 (5
.8)
.1
NEC
med
ical
or
surg
ical
/All,
n (
%)a
529
(6.6
)54
2 (6
.4)
454
(5.4
)46
3 (5
.5)
410
(4.9
)33
8 (4
)32
3 (3
.9)
<.0
001
Med
ical
NEC
/All,
n (
%)a
351
(4.4
)36
3 (4
.3)
301
(3.6
)32
9 (3
.9)
296
(3.5
)23
6 (2
.8)
220
(2.6
)<
.000
1
Su
rgic
al N
EC/A
ll, n
(%
)a17
8 (2
.2)
179
(2.1
)15
3 (1
.8)
134
(1.6
)11
4 (1
.4)
102
(1.2
)10
3 (1
.2)
<.0
001
RO
P 3
, 4, o
r 5
in p
atie
nts
wit
h a
n e
ye e
xam
inat
ion
rep
orte
d, n
(%
)a
346
(5.9
)37
3 (5
.8)
373
(5.7
)35
3 (5
.3)
304
(4.6
)29
5 (4
.4)
272
(4.1
)<
.000
1
RO
P t
reat
ed (
lase
r or
Ava
stin
)/Al
l, n
(%
)a23
6 (2
.9)
237
(2.8
)22
4 (2
.7)
193
(2.3
)16
2 (1
.9)
175
(2.1
)15
3 (1
.8)
<.0
001
CLD
(al
ive
on >
roo
m a
ir a
t 36
wk
PM
A)/A
ll, n
(%
)a18
16 (
22.6
)18
03 (
21.3
)17
56 (
20.9
)17
42 (
20.7
)17
44 (
20.7
)17
60 (
20.9
)16
80 (
20.1
).0
1
Late
-on
set
sep
sis
(pos
itiv
e b
lood
cu
ltu
re o
bta
ined
>3
d
afte
r b
irth
)/Al
l, n
(%
)a
1579
(19
.6)
1499
(17
.7)
1360
(16
.2)
1150
(13
.6)
983
(11.
7)88
8 (1
0.5)
754
(9)
<.0
001
Su
rviv
ed w
ith
no
mor
bid
ity/
All,
n (
%)a
5092
(63
.3)
5491
(64
.9)
5545
(66
.1)
5563
(66
)56
51 (
67.1
)56
74 (
67.3
)57
33 (
68.5
)<
.000
1
Age
at d
isch
arge
in s
urv
ivor
s, m
edia
n (
10–
90th
)b52
(26
–98
)52
(26
–10
0)54
(27
–10
2)55
(27
–10
3)55
(28
–10
3)56
(28
–10
5)55
(28
–10
4)<
.000
1
Dis
char
ge w
eigh
t, k
g in
su
rviv
ors,
med
ian
(10
–90
th)b
2.23
(1.
82–
3.08
)2.
25 (
1.83
–3.
16)
2.30
(1.
85–
3.25
)2.
34 (
1.86
–3.
31)
2.37
(1.
88–
3.32
)2.
38 (
1.89
–3.
41)
2.39
(1.
89–
3.4)
<.0
001
Wei
ght
gain
(g/
d)
in s
urv
ivor
s, m
edia
n (
10–
90th
)b21
(16
–27
)22
(16
–27
)22
(16
–28
)22
(17
–28
)23
(17
–28
)23
(17
–28
)23
(18
–28
)<
.000
1
a D
iscr
ete
cate
gori
cal v
aria
ble
s w
ere
eval
uat
ed b
y u
sin
g a
Coc
hra
n-A
rmit
age
tren
d t
est
to d
eter
min
e if
th
ere
wer
e si
gnifi
can
t ch
ange
s ov
er t
ime.
b C
onti
nu
ous
vari
able
s w
ere
eval
uat
ed b
y u
sin
g a
1-w
ay A
NO
VA a
nd
lin
ear
regr
essi
on t
o d
eter
min
e if
th
ere
wer
e si
gnifi
can
t ch
ange
s ov
er t
ime.
by 1440450 on February 20, 2018http://pediatrics.aappublications.org/Downloaded from
PEDIATRICS Volume 137 , number 4 , April 2016
improvements mirror improvements
seen in non-Pediatrix NICUs;
however, we targeted and showed
sustained improvement in multiple
key process measures.
Our findings are consistent
with NICU QI collaboratives that
report improvement when a
systemwide application of
evidence-based practices is
enacted and supported over
time.4, 5, 7, 8, 14, 33, 34 The 100 000
Babies Campaign was unique in
that it was successfully conducted
within a large neonatal network
with automated data collection, and
improved multiple processes and
outcomes simultaneously, rather
than targeting a single process or
morbidity.
The structure of our campaign has
limitations. No contemporaneous
control group was used. We
acknowledge that statistical
associations are not equivalent to
establishing causality. The pragmatic
approach to our patient population
limited the ability to directly collect
some data, such as central line
maintenance bundle compliance.
The details of project selection,
prioritization, modification, and
implementation were left to the
discretion of the individual
practices and may have been
suboptimal. Some clinical
results could have been affected
by inconsistent electronic
documentation. To combat this
deficiency, educational sessions
were provided to standardize
documentation and BabySteps was
enhanced to include reminders and
forced functions to enhance
accurate documentation.
Multiple factors contributed to the
success of our campaign. Use of
Kotter’s model21 for leading change
was an important determinant of
successfully changing behavior
in a diverse neonatal network.
An important step to creating
e7
transformative change is to “create
urgency.” We produced this
environment through the provision
of a CDW that enabled clinicians to
objectively see and compare their
outcomes against other NICUs. Large,
collaborative quality conferences
were used to highlight these
differences and create peer groups.
Clinical practices that demonstrated
the “quality chasm” in neonatology
were emphasized, to show evidence-
based practices that were not being
fully implemented. Attendance
at the Quality Summit (Table 3)
demonstrates increasing participation
in the meetings and use of the CDW
during the study period. The American
Board of Pediatrics’ requirement to
complete QI projects for MOC created
additional urgency. From March 2011
to December 2013, American Board of
Pediatrics MOC credit for QI work was
given for 414 projects.
We speculate that our campaign
will have downstream positive
effects on general health outcomes.
The improvements in human milk
utilization and antibiotic stewardship
have important ramifications for
public health and disease prevention.
Unneeded drug exposure increases
the risk of adverse drug events,
opportunities for error, and
consumes additional nursing and
pharmacy resources.35 Compared
FIGURE 3Statistical process control chart, CLABSI per 1000 line days, monthly data from 2007 through 2013. Sustained decrease in CLABSI rate with special cause variation shown over 3 time periods after implementation of the initiative. Control limits were adjusted with each special cause event. CTL, center line (mean); LCL, lower control limit; UCL, upper control limit.
TABLE 3 Quality Summit Attendance and CDW Utilization
Activity 2007 2008 2009 2010 2011 2012 2013
Quality summit attendance 263 331 447 414 425 456 468
CDW unique visitors 391 513 547 648 690 638 659
CDW visits 1626 2568 3274 4190 4094 4049 4579
CDW reports viewed 6511 10 132 12 859 15 326 15 443 16 148 17 522
by 1440450 on February 20, 2018http://pediatrics.aappublications.org/Downloaded from
ELLSBURY et al
with baseline utilization in 2007,
∼1 000 000 fewer doses of ampicillin,
metoclopramide, and H2 blockers
were given than expected. We
estimate a cumulative cost savings
of $58 000 000 associated with the
reduction in catheter-associated
blood stream infection.36 Based on
changes in mortality, we estimate
that over the course of our campaign
there were 1885 fewer deaths than
expected.
CONCLUSIONS
Implementation of the 100 000
Babies Campaign resulted in major
improvements in key processes
and outcomes. The structured
reengineering of NICU care, with a
supportive infrastructure to affect
large scale organizational change
was successfully used in a large
and diverse neonatal network. We
speculate that use of organizational
change theory, targeting of key
drivers of adverse health outcomes,
automated data collection, and
reporting by using a specialty-
specific EHR system could be widely
used in health care to enable large
scale improvements in patient
health and improve the value of
clinical care.
e8
ABBREVIATIONS
ANOVA: analysis of variance
CDW: Clinical Data Warehouse
CLABSI: central line–associated
bloodstream infection
CLD: chronic lung disease
EGA: estimated gestational age
EHR: electronic health record
IVH: intraventricular hemorrhage
MOC: maintenance of
certification
NEC: necrotizing enterocolitis
PDX: Pediatrix Medical Group
PMA: postmenstrual age
QI: quality improvement
ROP: retinopathy of prematurity
PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).
Copyright © 2016 by the American Academy of Pediatrics
FINANCIAL DISCLOSURE: The authors have indicated they have no fi nancial relationships relevant to this article to disclose.
FUNDING: This work was supported by Pediatrix Medical Group. No outside honorarium, grant, or other form of payment was given to anyone to produce the
manuscript.
POTENTIAL CONFLICT OF INTEREST: All authors are employed by Pediatrix and work within The Center for Research, Education and Quality. Dr Ursprung also
reports he serves as a member of the Vermont Oxford Network Database Advisory Committee.
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DOI: 10.1542/peds.2015-0389 originally published online March 2, 2016; 2016;137;Pediatrics
Dodd and Alan R. SpitzerDan L. Ellsbury, Reese H. Clark, Robert Ursprung, Darren L. Handler, Elizabeth D.
000 Babies Campaign 100A Multifaceted Approach to Improving Outcomes in the NICU: The Pediatrix
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