Clinical Pathway Produces

Sustained Improvement in
Acute Gastroenteritis Care
Lori Rutman, MD, MPH,​a,​b Eileen J. Klein, MD, MPH,​a,​b Julie C. Brown, MD, MPHa,​b

BACKGROUND AND OBJECTIVES: Despite widespread use of the rotavirus vaccine

abstract
in the last decade, dehydrating illnesses impact almost 2 billion children
worldwide annually. Evidence supports oral rehydration therapy as a first-
line treatment of mild to moderate dehydration. Ondansetron has proven to
be a safe and effective adjunct in children with vomiting. We implemented
a clinical pathway in our pediatric emergency department (ED) in January
2005 to improve care for this common condition. Our objective in this aDepartment of Pediatrics, University of Washington,
Seattle, Washington; and bDivision of Pediatric Emergency
study was to determine the long-term impact of the pathway for acute
Medicine, Seattle Children’s Hospital, Seattle, Washington
gastroenteritis (AGE) on the proportion of patients receiving intravenous
(IV) fluids and ED length of stay (LOS) for discharged patients. Dr Rutman conceptualized and designed the study,
including the selection of outcome and balancing
METHODS: Cases were identified by using International Classification of measures, was primarily responsible for the
Diseases, Ninth Revision, Clinical Modification diagnosis codes. We used analyses and creation of statistical process control
charts, and drafted the initial manuscript;
statistical process control to analyze process and outcome measures for Dr Klein obtained funding for the project, provided
2 years before and 10 years after pathway implementation. oversight on all aspects of the study design and
analyses, and critically reviewed the manuscript;
RESULTS: We included 30 519 patients. We found special cause variation with
Dr Brown provided oversight on all aspects of the
a downward shift in patients receiving IV fluids after initiation of the study design and analyses, and critically reviewed
pathway and later with addition of ondansetron to the pathway from 48% to the manuscript; and all authors approved the
26%. Mean ED LOS for discharged patients with AGE decreased from 247 to final manuscript as submitted and agree to be
accountable for all aspects of the work.
172 minutes. These improvements were sustained over time.
DOI: https://​doi.​org/​10.​1542/​peds.​2016-​4310
CONCLUSIONS: Implementation of a clinical pathway emphasizing oral
Accepted for publication Jun 15, 2017
rehydration therapy and ondansetron for children with AGE led to
Address correspondence to Lori Rutman, MD, MPH,
decreased IV fluid use and LOS in a pediatric ED. Improvements were Division of Pediatric Emergency Medicine, Seattle
sustained over a 10-year period. Our results suggest that quality- Children’s Hospital, 4800 Sand Point Way NE, Seattle,
improvement interventions for AGE can have long-term impacts on care WA 98105. E-mail: lori.rutman@seattlechildrens.org
delivery. PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online,
1098-4275).
Copyright © 2017 by the American Academy of
Pediatrics
Dehydration because of acute safe and effective therapy for mild to FINANCIAL DISCLOSURE: The authors have
gastroenteritis (AGE) is one of moderate dehydration.‍4–‍‍ 8‍ indicated they have no financial relationships
the most common problems of relevant to this article to disclose.
childhood. Despite widespread use The World Health Organization, the FUNDING: Provided by the Marco J. Heidner
of the rotavirus vaccine in the last American Academy of Pediatrics, Charitable Trust.
decade, dehydrating illnesses impact and the Centers for Disease POTENTIAL CONFLICT OF INTEREST: The authors
almost 2 billion children worldwide Control and Prevention have have indicated they have no potential conflicts of
annually and cause more than 700 000 promoted the use of evidence- interest to disclose.
deaths.‍1–‍ 3‍ Treatment options include based guidelines emphasizing
intravenous (IV) fluids, nasogastric ORT since the mid-1990s.‍9,​10
‍ Our To cite: Rutman L, Klein EJ, Brown JC. Clinical
fluids, and oral rehydration therapy institution first implemented an Pathway Produces Sustained Improvement in
Acute Gastroenteritis Care. Pediatrics. 2017;140(3):
(ORT). Since the 1980s, researchers emergency department (ED)-based e20164310
have demonstrated that ORT is a clinical pathway for AGE in 2005 to

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PEDIATRICS Volume 140, number 3, September 2017:e20164310 Quality Report
standardize and improve the care of
children presenting with dehydration
because of simple AGE with vomiting.
The pathway emphasizes the
use of ORT for mild to moderate
dehydration and includes the use
of ondansetron for children with
vomiting. Our aim in this project was
to determine the short- and long-
term impacts of implementing this
evidence-based pathway for children
with mild to moderate dehydration
on ED length of stay (LOS), IV fluid
use, and 72-hour unplanned returns.

Methods
Context
The setting was a tertiary, university-
affiliated, 323-bed pediatric hospital
with a dedicated pediatric ED
(43 000 annual visits). Since 2002,
the institution has developed and
implemented clinical standard
work (CSW) pathways for common
conditions. CSW is an evidence-
based approach to the management
of particular patient populations
or diagnoses. Clinical pathways are
designed as flowcharts or algorithms
to guide provider decision-making
and provide education to learners
on the evidence behind the FIGURE 1
recommendations. They are linked AGE clinical pathway (2005). BP, blood pressure; CIS, clinic information system; D/C, discharge; NPO,
to diagnosis-specific electronic order nothing by mouth; q, every; RR, respiratory rate.
sets. Currently, more than 50 CSW
pathways have been implemented. physician stakeholders rated the well as clinical nursing specialists.
Pathways are formally reviewed on a quality of the evidence and generated Multiple strategies were used to
regular basis to ensure they remain a series of recommendations. When support uptake and adherence.
consistent with current medical evidence was not available from Before implementation, the pathway
literature and national guidelines. the literature, recommendations was discussed at ED provider
were made on the basis of local meetings. E-mail notifications
Intervention expert consensus. The team used including physician and nurse job
A multidisciplinary stakeholder these recommendations to develop aids were sent. Copies of the pathway
group developed the clinical pathway the content of the pathway and were placed outside patient rooms
for children presenting to the ED with electronic order set. The original AGE and in provider work areas to insure
AGE. This group included physicians pathway and electronic order sets visibility and access.
and nurses from the ED and inpatient were launched in January 2005 (‍Fig
units as well as pharmacists and 1). Subsequent re-evaluation of the In March 2006, changes were made
information technology specialists. literature resulted in minimal change to ondansetron access and use. These
Pathway development began with to the pathway over time (‍Fig 2).‍11 changes included the following: (1)
a literature review of Embase, hospital formulary, the addition of
PubMed, and national guideline The implementation of the pathway gastroenteritis as an indication for
clearinghouses. The team of was led by the ED physicians as the use oral ondansetron with dosage

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2 Rutman et al
FIGURE 2
AGE clinical pathway (2015). HUS, hemolytic uremic syndrome; MCC, medically complex children.

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PEDIATRICS Volume 140, number 3, September 2017 3
recommendations; (2) AGE pathway,
recommendations for ondansetron
use for patients with vomiting in the
past 6 hours were added; and (3)
medication stocking, ondansetron
was located in ED Omnicell for easy
accessibility.
Measures
This was a quality-improvement
(QI) study to assess outcomes
related to the implementation of
the AGE pathway. We considered
process, outcome, and balancing
measures. Process measures were
selected to reflect adherence to the
recommendations of the pathway,
specifically the proportion of AGE
patients receiving IV fluids. The
outcome measure used was LOS
for patients discharged from the
ED and was selected to determine
the efficiency of care provided. The
balancing measure of unplanned
returns to the ED within 72 hours
of discharge, for symptoms related
to gastroenteritis, was selected to
monitor and identify any unintended
consequences of the AGE pathway;
an increase in 72-hour returns could
signal inappropriate discharge or
inadequacy of care provided during
the initial ED visit.
Analysis
We analyzed data for 2 years
before and 10 years after the
implementation of our AGE pathway.
We included children aged 3 months
to 18 years who presented to our ED
with AGE from January 2003 through
April 2015 and who were eligible
for the AGE pathway. We defined the
population of patients “who were
eligible for the AGE pathway” as
those having a primary International
Classification of Diseases, Ninth
Revision, Clinical Modification (ICD-
9-CM) diagnosis code associated with
both AGE and vomiting. Patients were
excluded from the analysis if they
were <3 months old or assigned ICD-
9-CM or International Classification
of Diseases, 10th Revision discharge
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4 Rutman et al
TABLE 1 Demographic Characteristics of the AGE Population
Characteristic
Sample size
Sex
  Female
  Male
Age, y
  <2
  2–4
  5–12
  13–18
Race/ethnicity
  Asian
  Black or African American
  Other
  White
Insurance type
  Commercial
  Public
diagnosis codes associated with
bloody diarrhea or comorbid
conditions (eg, medical complexity,
renal failure, cardiac disease,
neurologic disease, and sepsis) that
would have excluded their eligibility
for the pathway (Supplemental
Tables 2 and 3).
Descriptive statistics were used to
compare demographics of the pre-
and postpathway groups. Statistical
process control (SPC) was used
to analyze process, outcome, and
balancing measures.‍12,​13
‍ All control
charts were created by using the QI
Charts 2.0 add-in for Microsoft Excel
(Process Improvement Products,
Austin, TX).
Ethical Considerations
This study was approved under
expedited review by our institution’s
Internal Review Board.
Results
During the 12-year study period,
30 519 patients met eligibility
criteria. There were no statistically
significant differences between the
pre- and postpathway groups with
regard to age, sex, or race/ethnicity.
The postpathway group included a
larger percentage of children with
commercial insurance (‍Table 1).
Prepathway (%), January Postpathway (%), January
2003–December 2004 2005–April 2015
4147 26 372
2076 (50) 12 464 (47)
2071 (50) 13 908 (53)
1925 (46) 10 283 (39)
1174 (28) 7926 (30)
833 (20) 6604 (25)
215 (6) 1559 (6)
298 (7) 1861 (7)
416 (10) 3718 (14)
1292 (31) 9367 (36)
2141 (52) 11 462 (43)
1891 (46) 18 752 (71)
2256 (54) 7620 (29)
There were challenges associated
with the initial implementation of
the pathway. First, many referring
primary care providers, ED providers
(doctors and registered nurses), and
some families believed that IV fluids
were more efficient and effective
than ORT, and there was hesitation
to forego IV placement. Sharing
initial process metrics with the
care team led to increased provider
buy-in. Second, ondansetron was
a relatively new medication in the
pediatric ED. Limited experience
with the medication led to pharmacy
concerns about appropriate dosing
and physician concerns that surgical
pathologies may be masked. With
time and ongoing provider education,
many of these initial concerns
dissipated. Despite these challenges,
the pathway underwent minimal
modification over time (‍Figs 1 and ‍2).
Process Measure
We noted special cause variation
with a downward shift (8 points
below the centerline) in the
percentage of patients receiving
IV fluids from 48% to 44% after
pathway implementation. Special
cause variation occurred again, with
an additional downward shift of the
centerline to 26%, after changes
were made related to ondansetron
use and accessibility (‍Figs 3 and
‍ ). The decrease in IV fluid use was
4
sustained for the entirety of the
10-year postpathway period. We
also measured oral ondansetron use
for patients with AGE in the ED over
the same study period. We found an
increase from a baseline of 4% to
20% after pathway implementation.
The proportion of patients receiving
ondansetron in the ED steadily
increased after it was more readily
available and was sustained at
∼65% by the end of the study period
(Supplemental Fig 6).

Outcome Measure
Similar to the pattern of decreased FIGURE 3
IV fluid use, we noted special cause P-chart for the proportion of AGE patients receiving IV fluids in the ED over time. LCL, lower control
limit; UCL, upper control limit.
variation with a clinically significant
decrease in ED LOS for discharged
patients by ∼60 minutes immediately
after the pathway was implemented.
We noted further improvement with
an additional 20-minute decrease
in ED LOS after oral ondansetron
recommendations were added to the
pathway.

Balancing Measure
Unplanned 72-hour returns to the ED
for AGE patients did not change over
this time frame (‍Fig 5).

Discussion
In this study, we used SPC analyses
to examine the long-term impact of a
clinical pathway for AGE on IV fluid
use and efficiency (regarding LOS)
in the ED of a single free-standing,
tertiary-care, pediatric hospital. We
found that pathway implementation,
including provider education
regarding the use of ORT for patients
with mild to moderate dehydration,
decreased IV fluid use and ED LOS
for discharged patients. Further
improvements in IV fluid use and ED
LOS were achieved once the hospital
formulary and the pathway included
recommendations for the use of
FIGURE 4
ondansetron in gastroenteritis and X-bar (A) and s chart (B) for the mean ED LOS and the SD of ED LOS over time. LCL, lower control limit;
the medication was readily available UCL, upper control limit.
for use in our ED. Importantly, our

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PEDIATRICS Volume 140, number 3, September 2017 5

FIGURE 5
A, T-chart for the days between 72-hour ED returns for AGE over time. B, T-chart for the days between
72-hour ED returns for AGE (with admission) over time.
analysis included 12 years of data,
and our results were sustained
for the duration of the 10-year
postpathway period.
There is a wealth of published
data supporting the use of ORT in
children. One randomized controlled
trial sought to demonstrate the
noninferiority of ORT for successful
rehydration of moderately
dehydrated children. This study
showed that ORT was as effective
as IV fluids for rehydration in
the ED and demonstrated that
time to treatment was shorter for
those patients receiving ORT.‍14 In
a retrospective, cross-sectional,
provincial study of pediatric AGE
patients, the use of a medical
directive for ORT was associated with
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6 Rutman et al
fewer unplanned ED returns.‍15 Our
results similarly demonstrate that
the standardization of care with an
emphasis on ORT was temporally
related to a decreased use of IV
fluids and improved ED throughout,
without a significant change in
unplanned returns.
The adjunctive use of ondansetron
in AGE has also been well studied.
The benefits of ondansetron include
a reduction in the likelihood and
frequency of vomiting, an increase
in oral intake, and a decrease in the
need for IV fluids.‍16–‍‍‍ 21
‍ A cost analysis
of ondansetron use estimated
that routine administration of the
medication to eligible children in
the United States would save both
society and health care payers >$60
million annually.‍22 Although we did
not perform a cost-effectiveness
analysis as part of this study, we did
demonstrate improved outcomes
once ondansetron became readily
available.
Despite more than 2 decades of
evidence supporting ORT and
ondansetron as the standard of care
for treatment of mild to moderate
dehydration, gaps remain in current
clinical practice. A survey comparing
practice patterns of United States
and Canadian providers found that
76% of Canadian physicians reported
initiating ORT in moderately
dehydrated children compared
with 47% of their US colleagues.
American physicians were found to
administer larger IV fluid boluses
over shorter time periods and
repeated boluses more frequently.‍23
Although we were able to achieve
and sustain significant reduction in
our IV fluid use, from 44% to 26%,
it is important to note that our new
baseline is still higher than what is
reported in Canadian EDs.‍24 This
might reflect differences in patient,
family, and provider expectations
between the 2 countries. A survey
of US pediatric emergency medicine
program directors revealed that they
do not routinely use ORT because
they believe it takes longer than
IV hydration, and they feel parents
and referring providers expect IV
fluids.‍25 Our findings support the use
of ORT with ondansetron, rather than
IV fluids, as an efficient treatment
modality for most children with mild
to moderate dehydration.
The utility of ED-based clinical
pathways for dehydration secondary
to AGE has been suggested by
researchers in studies from Australia
and Canada, but no studies to
date have been published from
US-pediatric EDs‍15,​26,​
‍ 27
‍ and none
have demonstrated the long-term
sustainability of QI efforts. There
is a gap in the literature regarding
how to achieve provider buy-in and
maintain adherence or if results
can be sustained over long periods
of time. This study adds to this
knowledge base, demonstrating that
the maintenance of a well-established
clinical pathway is a successful
approach to producing ongoing
improvements in provider practice
and patient outcomes that are
similarly sustained over time.
This study has limitations. First,
patients were identified for
analysis primarily by using ICD-
9-CM discharge diagnosis codes.
This method can lead to the
misclassification of patients, although
we expect any bias to be similar in
the pre- and postpathway period.
Second, secular trends, including
the use of the rotavirus vaccine,
may have had an impact on our
results. Notably, rotavirus vaccine
was licensed in 2008 and in regular
use in Washington state by 2010.
Although we did not note special
cause variation on any of our SPC
charts at that time, we do not know if
widespread vaccine use changed the
makeup of pediatric gastroenteritis
patients (potentially resulting in
an overall less-sick population of
patients) and thereby contributed to
the long-term sustainability of our
results. Furthermore, although we
assume that reduced resource use (ie,
fewer IV starts and IV fluid boluses)
and improved efficiency (reduced
LOS) were cost-effective, we did not
have cost data available for analysis.
Future studies of the sustainability of
QI interventions should include cost
measures.
Finally, our institution was an early
adopter of care standardization and
has implemented clinical pathways
since 2002. Over time, our culture
has shifted such that providers
are familiar with clinical pathway
use. This infrastructure and level
of provider buy-in may limit the
generalizability of this intervention
to other institutions.
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PEDIATRICS Volume 140, number 3, September 2017
Conclusions
The implementation of a clinical
pathway emphasizing ORT and
ondansetron for children with
AGE led to sustained decreases
in IV fluid use and ED LOS over a
10-year period. Our results suggest
QI interventions, such as clinical
pathways for AGE, can have long-
term impacts on care delivery.
Contextual factors, including
institutional culture and leadership
support for such interventions,
are important considerations for
implementation success and long-
term sustainability.
Abbreviations
AGE: acute gastroenteritis
CSW: clinical standard work
ED: emergency department
ICD-9-CM: International
Classification of
Diseases, Ninth
Revision, Clinical
Modification
IV: intravenous
LOS: length of stay
ORT: oral rehydration therapy
QI: quality improvement
SPC: statistical process control
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 Clinical Pathway Produces Sustained Improvement in Acute Gastroenteritis
Care
Lori Rutman, Eileen J. Klein and Julie C. Brown
Pediatrics 2017;140;
DOI: 10.1542/peds.2016-4310 originally published online September 7, 2017;

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Clinical Pathway Produces Sustained Improvement in Acute Gastroenteritis
Care
Lori Rutman, Eileen J. Klein and Julie C. Brown
Pediatrics 2017;140;
DOI: 10.1542/peds.2016-4310 originally published online September 7, 2017;

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located on the World Wide Web at:
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