a multifaceted approach to improving outcomes in the nicu ...cdw data set. to maximize validity,...

11
A Multifaceted Approach to Improving Outcomes in the NICU: The Pediatrix 100 000 Babies Campaign Dan 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 first draft of the article, and wrote and edited the first to final 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 final approval of the version to be published, and provided extensive editorial input to the writing of the final article; Dr Ursprung contributed to the conception and design of the study as well as the final 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 final 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 final 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 final 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 final 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 abstract BACKGROUND 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 REPORT PEDIATRICS Volume 137, number 4, April 2016:e20150389 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, 2018 http://pediatrics.aappublications.org/ Downloaded from

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Page 1: A Multifaceted Approach to Improving Outcomes in the NICU ...CDW data set. To maximize validity, data for the CDW are extracted at the end of the infant’s NICU stay, so providers

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

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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

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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.

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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.

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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

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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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000 Babies Campaign 100A Multifaceted Approach to Improving Outcomes in the NICU: The Pediatrix

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