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Improving Adherence to PALS Septic Shock Guidelines abstract BACKGROUND AND OBJECTIVES: Few studies have demonstrated im- provement in adherence to Pediatric Advanced Life Support guide- lines for severe sepsis and septic shock. We sought to improve adherence to national guidelines for children with septic shock in a pediatric emergency department with poor guideline adherence. METHODS: Prospective cohort study of children presenting to a tertiary care pediatric emergency department with septic shock. Quality im- provement (QI) interventions, including repeated plan-do-study-act cycles, were used to improve adherence to a 5-component sepsis bundle, including timely (1) recognition of septic shock, (2) vascular access, (3) administration of intravenous (IV) uid, (4) antibiotics, and (5) vasoactive agents. The intervention focused on IV uid delivery as a key driver impacting bundle adherence, and adherence was mea- sured using statistical process control methodology. RESULTS: Two-hundred forty-two patients were included: 126 subjects before the intervention (November 2009 to March 2011), and 116 patients during the QI intervention (October 2011 to May 2013). We achieved 100% adherence for all metrics, including (1) administration of 60 mL/kg IV uid within 60 minutes (increased from baseline adherence rate of 37%), (2) administration of vasoactive agents within 60 minutes (baseline rate of 35%), and (3) 5-component bundle adherence (baseline rate of 19%). Improvement was sustained over 9 months. The number of septic shock cases between each death from this condition increased after implementation of the QI intervention. CONCLUSIONS: Using QI methodology, we have demonstrated improved adherence to national guidelines for severe sepsis and septic shock. Pediatrics 2014;133:e1358e1366 AUTHORS: Raina Paul, MD, a Elliot Melendez, MD, b,c Anne Stack, MD, b Andrew Capraro, b Michael Monuteaux, ScD, b and Mark I. Neuman, MD, MPH b a Department of Emergency Medicine, Pediatric Section, Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina; and b Division of Emergency Medicine, and c Medicine Critical Care Program, Boston Childrens Hospital, Boston, Massachusetts KEY WORDS sepsis, severe sepsis, septic shock, PALS, quality improvement, adherence, guidelines ABBREVIATIONS EDemergency department IQRinterquartile range IVintravenous LOSlength of stay PALSPediatric Advanced Life Support PIM2Pediatric Index of Mortality Score, version 2 QIquality improvement SPCstatistical process control Dr Paul conceived and designed the study, supervised the conduct of the trial and data collection, undertook acquisition of data of included patients and managed the data, including quality control, drafted the manuscript, including all revisions, and takes responsibility for the paper as a whole; Dr Melendez conceived and designed the study as well as supervised the conduct of the trial and data collection, undertook acquisition of data of included patients and managed the data, including quality control, assisted with drafting of the manuscript, including all revisions, and approved the manuscript as submitted; Dr Stack conceived and designed the study and undertook acquisition of data of included patients and managed the data, drafted the manuscript, including all revisions, and approved the manuscript as submitted; Dr Capraro conceived and designed the study and undertook acquisition of data of including patients and managed the data, assisted with drafting of the manuscript, including all revisions, and approved the manuscript as submitted; Dr Monuteaux provided statistical advice on study design and analyzed the data, assisted with drafting of the manuscript, including all revisions, and approved the manuscript as submitted; and Dr Neuman conceived and designed the study as well as supervised the conduct of the trial and data collection, undertook acquisition of data of included patients and managed the data, including quality control, assisted with drafting of the manuscript, including all revisions, and approved the manuscript as submitted. (Continued on last page) e1358 PAUL et al by guest on May 19, 2018 http://pediatrics.aappublications.org/ Downloaded from

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Page 1: Improving Adherence to PALS Septic Shock Guidelines abstractpediatrics.aappublications.org/content/pediatrics/133/5/e1358.full.pdf · Improving Adherence to PALS Septic Shock Guidelines

Improving Adherence to PALS Septic Shock Guidelines

abstractBACKGROUND AND OBJECTIVES: Few studies have demonstrated im-provement in adherence to Pediatric Advanced Life Support guide-lines for severe sepsis and septic shock. We sought to improveadherence to national guidelines for children with septic shock ina pediatric emergency department with poor guideline adherence.

METHODS: Prospective cohort study of children presenting to a tertiarycare pediatric emergency department with septic shock. Quality im-provement (QI) interventions, including repeated plan-do-study-actcycles, were used to improve adherence to a 5-component sepsisbundle, including timely (1) recognition of septic shock, (2) vascularaccess, (3) administration of intravenous (IV) fluid, (4) antibiotics, and(5) vasoactive agents. The intervention focused on IV fluid delivery asa key driver impacting bundle adherence, and adherence was mea-sured using statistical process control methodology.

RESULTS: Two-hundred forty-two patients were included: 126 subjectsbefore the intervention (November 2009 to March 2011), and 116patients during the QI intervention (October 2011 to May 2013). Weachieved 100% adherence for all metrics, including (1) administrationof 60 mL/kg IV fluid within 60 minutes (increased from baselineadherence rate of 37%), (2) administration of vasoactive agentswithin 60 minutes (baseline rate of 35%), and (3) 5-component bundleadherence (baseline rate of 19%). Improvement was sustained over 9months. The number of septic shock cases between each death fromthis condition increased after implementation of the QI intervention.

CONCLUSIONS: Using QI methodology, we have demonstrated improvedadherence to national guidelines for severe sepsis and septic shock.Pediatrics 2014;133:e1358–e1366

AUTHORS: Raina Paul, MD,a Elliot Melendez, MD,b,c AnneStack, MD,b Andrew Capraro,b Michael Monuteaux, ScD,b

and Mark I. Neuman, MD, MPHb

aDepartment of Emergency Medicine, Pediatric Section, WakeForest University Baptist Medical Center, Winston-Salem, NorthCarolina; and bDivision of Emergency Medicine, and cMedicineCritical Care Program, Boston Children’s Hospital, Boston,Massachusetts

KEY WORDSsepsis, severe sepsis, septic shock, PALS, quality improvement,adherence, guidelines

ABBREVIATIONSED—emergency departmentIQR—interquartile rangeIV—intravenousLOS—length of stayPALS—Pediatric Advanced Life SupportPIM2—Pediatric Index of Mortality Score, version 2QI—quality improvementSPC—statistical process control

Dr Paul conceived and designed the study, supervised theconduct of the trial and data collection, undertook acquisition ofdata of included patients and managed the data, includingquality control, drafted the manuscript, including all revisions,and takes responsibility for the paper as a whole; Dr Melendezconceived and designed the study as well as supervised theconduct of the trial and data collection, undertook acquisition ofdata of included patients and managed the data, includingquality control, assisted with drafting of the manuscript,including all revisions, and approved the manuscript assubmitted; Dr Stack conceived and designed the study andundertook acquisition of data of included patients and managedthe data, drafted the manuscript, including all revisions, andapproved the manuscript as submitted; Dr Capraro conceivedand designed the study and undertook acquisition of data ofincluding patients and managed the data, assisted with draftingof the manuscript, including all revisions, and approved themanuscript as submitted; Dr Monuteaux provided statisticaladvice on study design and analyzed the data, assisted withdrafting of the manuscript, including all revisions, and approvedthe manuscript as submitted; and Dr Neuman conceived anddesigned the study as well as supervised the conduct of the trialand data collection, undertook acquisition of data of includedpatients and managed the data, including quality control,assisted with drafting of the manuscript, including all revisions,and approved the manuscript as submitted.

(Continued on last page)

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Severe sepsis and septic shock areassociated with high rates of mortalityin children (10%), and death rates areeven higher among those with comor-bid conditions (12%).1,2 The AmericanHeart Association, in 2010, updatedthe Pediatric Advanced Life Support(PALS) septic shock guidelines, althoughthe standards for sepsis care haveremained essentially unchanged formore than a decade.3–5 Five algorithmcomponents include timely recognitionof septic shock and vascular accesswithin 5 minutes, and antibiotic andvasoactive agent delivery within 60minutes.5 The fifth PALS time pointrecommends 60 mL/kg of intravenous(IV) fluids administered within 60minutes of meeting the definition ofseptic shock.5,6

In adults, timely fluid resuscitation andantibiotic administration, componentsof early goal-directed therapy, havebeen shown to decrease mortality.7,8

Pediatric studies in the community, in-tensive care, and international settingshave demonstrated that timely fluidresuscitation is associated with de-creased morbidity and mortality.9–12

Three recent studies conducted in ter-tiary pediatric emergency department(ED) settings have demonstrated bar-riers to the care of children with sep-sis, resulting in poor adherence to therapid administration of IV fluids, vaso-active agents, and antibiotics.13–15

Preliminary Institutional Study

From November 2009 to March 2011, weconducted a prospective cohort study atBoston Children’s Hospital ED to evalu-ate adherence rates to the PALS guide-lines for children with septic shock.15

We observed that adherence to all al-gorithm time points as a bundle waslow (19%), with particularly low adher-ence to timely administration of IV fluids(37%) and vasoactive agents (35%).

Adjusting for severity of illness at pre-sentation using the Pediatric Index of

Mortality score, version 2 (PIM2),16 weobserved in previous work thatpatients who received 60 mL/kg of IVfluid within 60 minutes had a 57%shorter hospital length of stay (LOS),and a 42% shorter ICU LOS. We alsoobserved that adherence to the 5-stepbundle was associated with a 57%shorter hospital LOS and a 59% shorterICU LOS.15

There have been 2 studies in a tertiarycare pediatric ED that examined ad-herence to national guidelines forpatients with sepsis after a quality im-provement (QI) intervention.13,14 Thesestudies demonstrated improved timeto delivery of 20 mL/kg of fluids butnot 60 mL/kg of fluids per the PALSrecommendation. Based on our observation that a minority of patients withseptic shock at our institution receivedtimely IV fluids, and that rapid fluidadministration and bundle adherencewere associated with improved out-comes, we instituted a QI interventionto improve adherence to PALS guide-lines.

METHODS

Study Design and Setting

ThiswasaprospectivecohortQI study forpatients presenting to the ED with septicshock between November 2009 andMarch 2011 (preintervention period) andOctober 2011 and May 2013 (QI period).The ED treats ∼60 000 patients per yearand has 15 pediatric emergency medi-cine fellows, 120 rotating pediatric resi-dents, and 90 emergency medicineresidents annually. This study was ap-proved by the institutional review boardat Boston Children’s Hospital.

Planning the Intervention

QI interventions were first initiated inOctober 2011. The improvement teamconsisted of 5 physicians from the pe-diatric ED and medical ICU, 3 nurses, 1pharmacist, 1 information technologyspecialist, and 3 research assistants. APareto diagram was developed to de-termine the components of the bundlethat were the most integral to im-proving adherence to the PALS sepsisguideline (Fig 1). We focused on the

FIGURE 1Pareto diagram of algorithm time points. The primary y-axis depicts percent adherence to eachcomponent of the PALS algorithm (green bars). The secondary y axis depicts the cumulative percentageforwhich nonadherenceof each step contributes to overall bundle adherence (blue line). The dotted redlinedemonstrates that 80%ofbundlenonadherence isdue to3bundlecomponents (vasoactiveagentsat60 minutes, 60 mL/kg IV fluids in 60 minutes, and vascular access within 60 minutes of recognition ofsevere sepsis or septic shock).

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timely administration of IV fluid as aprimary driver of bundle adherence, asadherence to this parameter was par-ticularly low. An Ishikawa fishbone di-agram was then developed with inputfrom all stakeholders involved in thedelivery of fluid, including nurses, clin-ical assistants, the phlebotomy team,pharmacists, and physicians (Fig 2). Itwas determined that use of an IV pumpfor fluid delivery was a major contrib-utor to poor adherence, as IV pumpcharacteristics limit the administra-tion of 60 mL/kg of IV fluid within 60minutes to children weighing#16 kg.17

Interventions

Several plan-do-study-act cycles wereimplemented over the course of the

intervention by using varying levels ofreliability.18 Reliability is measured asthe inverse of the system’s failure rate;a system that has a defect rate of 1 in10, or 10%, performs at a level of 1021

(a level 1 system).

The first cycle of interventions included1021 reliability measures. Level 1 sys-tems have no common process andfocus on training and retrospectivereminders.18 We educated all stake-holders through every-other-montheducational meetings, hospital-wideInternet-based learning modules, andskills days for nursing staff, empha-sizing use of an IV fluid pressure bag.Weekly e-mails were sent to individualproviders involved in the care of

a specific patient with septic shock,detailing adherence to the 5 compo-nents of the sepsis bundle and pro-viding recommendations if there wereany observed barriers to timely care.Additionally, for each patient seen, a 10-question electronic survey was com-pleted, allowing the caregiver to givefeedback regarding barriers to care.Finally, midway through the intervention,we conducted a second department-wide staff meeting where group feed-back was elicited and reference mate-rials were revised.

Level 2 reliability strategies were in-corporated during the first and sub-sequent plan-do-study-act cycles. Level2 systems have intentionally designed

FIGURE 2Ishikawa fishbone diagram for fluid delivery. The barriers to delivery of 60mL/kg of IV fluids within 60minutes can be divided into 4 key contributors; each hassubcomponents outlining barriers and potential solutions. CA, clinical assistant; MD, medical doctor; RN, registered nurse; IO, intraosseous device.

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tools that aim to error-proof a system,ensuring ease of performing in thedesired standard way.18 The PALS al-gorithm with local modifications wasposted prominently in the resuscita-tion rooms, charting areas, officeareas, and break rooms. The algorithm,including details of care, specific defi-nitions of septic shock, and dosing ofmedications, was included in a pocketcard that was created and distributedto all members of the health care team.We also incorporated a standardizedorder set into the electronic medicalrecord to assist providers at the bed-side. This order set included guidanceon IV fluid bolus volume and infusiontime, recommended laboratory tests,and antibiotic and vasoactive agentchoices. Every time the order set wasused, a lightning bolt symbol automat-ically appeared on the ED trackingboard, notifying nurses and ancillarystaff of a patient likely to requireadditional personnel and resources(which became known as “firing thebolt”). This lightning bolt also helped toaddress a nursing concern over lim-ited resources by alerting the chargenurse to redirect additional nursingresources to the bedside. The bolt alsoalerted the pharmacist that all medi-cations and fluids were needed emer-gently for that patient.

Level 3 reliability strategies includedredesigning the process throughwhicha child with septic shock wasmanaged.A large clock, the “shock clock,” wasplaced in all resuscitation areas, anda portable clock was located in thephysician charting area, designed to beused in any nonresuscitation room. Weinstructed physicians or nurses tostart the shock clock for any patientwith concern for severe sepsis orseptic shock. This visual cue allowedproviders and parents to be aware ofthe 60-minute time goal to complete allthe components of the algorithm. Theshock clock was large and centrally

located in the resuscitation areas, toallow for maximal visibility by the clin-ical staff during a critical care process.Based on feedback from physicians,a smaller clock was later introduced,to allow caregivers to feel more com-fortable bringing it into the room.

Planning the Study of theIntervention and Evaluation

We evaluated the effectiveness of ourinterventions on a monthly basis, byusing 5 process, 3 outcome, and 3 bal-ancing measures. The process mea-sures included adherence to the timegoals for the 5 components of the al-gorithm.Theprimaryoutcomemeasurewas adherence to the total algorithmbundle (all 5 components), and thesecondary outcome was change inrates of mortality. Balancing measuresincluded ED length of stay (for allpatients) to evaluate whether the re-direction of personnel and resourcesaffected ED throughput. We also ana-lyzed cases for which the lightning boltwas fired inappropriately (ie, for a pa-tient notmeeting our case definition forseptic shock) and thus resources mayhave been excessively diverted.

Each month, patients with septic shockwere identified by using admission logsfrom the ED to the ICUs, intermediatecare unit, and bone marrow transplantandoncology units. In our institution, allpatients who have septic shock areadmitted to 1 of these units. Patientswere classified as having either severesepsis or septic shock by using defi-nitions from the 2005 InternationalPediatric Sepsis Consensus Confer-ence.19 Measures were then manuallyabstracted from the electronic medicalrecord as described in our previousstudy.15 Appropriate recognition, with-in 5 minutes from the definition ofseptic shock, was determined by doc-umentation of severity of illness,transfer to an ED resuscitation room,additional IV placement, or second

fluid bolus initiation. Abstraction oftime points was duplicated in 10% ofpatients by another physician to en-sure reliability.15

Analysis

We tracked all measures by using sta-tistical process control (SPC) charts toallow for immediatedetectionof specialcause variation that could be in-vestigated. Control limits were set at 3SDs fromthemean.Multivariate logisticregression, controlling for severity ofillness using the PIM2 score, was usedto determine whether the use of anappropriate fluid-delivery apparatus(pressurebag, rapid-infuser, ormanualpush) was associated with improvedadherence to the guidelines.16 We alsoascertained how often laboratory testswere obtained to establish the di-agnosis of septic shock, such as co-agulation profiles, lactic acid, and liverfunction tests. x2 tests were used tocompare categorical variables. Thet-test and Wilcoxon rank sum test wereused to compare normally and non-normally distributed continuous datarespectively; P , .05 was consideredstatistically significant. The StatisticalPackage for the Social Sciences, ver-sion 21.0 (IBM SPSS Statistics, IBMCorporation, Chicago, IL) and Stataversion 11 (Stata Corp, College Station,TX) were used for statistical analysis.

RESULTS

Our cohort consisted of 242 patients:126 patients with septic shock beforethe intervention, and 116 patientsduring the QI intervention. Overall, 47(19%) had severe sepsis and 195 (81%)ultimately developed septic shock (Ta-ble 1). The median ED LOS for includedchildren was 4 hours and 10 minutes(interquartile range [IQR] 2 hours 46minutes to 5 hours 56 minutes). Thirty-one percent of patients met the defi-nition for severe sepsis or septic shockat the time of triage in the ED. Among

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all patients, the median time to de-velopment of severe sepsis or septicshock was 52 minutes (IQR 0–140).There were no differences between thebaseline and QI intervention cohortswith regard to PIM2 score (10.3 vs 8.2,P = .06), percent with comorbidities(60.0% vs 61.2%, P = .85), or age (9.2 vs12.3 years, P = .14).

Process Measures

Percent adherence to process mea-sures, including fluid and vasoactiveagent delivery, is detailed in SPC charts(Fig 3). There was a significant im-provement, initially attaining 80% ad-herence for the administration of IVfluids in February 2012, and 60% ad-herence for the administration of va-soactive agents in April 2012. Theseinitial improvements were demon-strated after feedback e-mails andthe process of “firing the bolt” were

initiated. Further improvements werenoted after the second group meetinggenerated the idea for use of a smaller,more portable shock clock and revisedpocket reference cards. By August2012, adherence to fluid and vasoactiveagent time goals reached 100%. Ad-herence to these measures remainednear 100% for the last 9 months of thestudy period. Median time to adminis-tration of IV fluid decreased from 83minutes (IQR 43–145) in the baselinegroup, to 33 minutes (IQR 0–68) in theQI group. Additionally, median time todelivery of vasoactive agents de-creased from 90 minutes (IQR 51–164)to 35 minutes (IQR 14–86). Adherenceto other process measures is detailedin Table 2.

Outcome Measures

Adherence to the total PALS bundleshowed initial significant improvement

to 50% in December 2011 (Fig 4A), andreached 100% by September 2012.Sustainability was demonstrated forthe last 9 months of the study period.Use of the appropriate fluid-deliveryapparatus was associated with adher-ence to the fluid guidelines (odds ratio4.8 [confidence interval 2.3–10.1]) andthe total bundle (odds ratio 4.4 [confi-dence interval 2.1–9.1]). The number ofcases of septic shock between eachdeath from this condition increased,demonstrating significant outcomeimprovement (Fig 4B).

Balancing Measures

Overall ED LOS for all patients did notincrease over the course of the studyperiod. The septic shock pathway and“firing of the bolt” was inappropriatelyinitiated in patients who did not meetcriteria for septic shock in fewer than 5cases per month on average.

DISCUSSION

Although national guidelines for pedi-atric septic shockhave existed formorethan a decade, several studies haveshown that they have not been trans-lated into practice.11–13 One ICU-basedstudy conducted in the United Kingdomdemonstrated 38% adherence to 2002PALS guidelines, citing inexperienceand a delay in the administration ofvasoactive agents until central venouscatheter placement as the major bar-riers to guideline adherence.11 Twopediatric EDs have attempted to im-prove care of patients with sepsisthrough QI interventions.13,14 One EDfocused on improving awareness andearly recognition of children with sep-tic shock in addition to alleviatinga barrier of limited resources.13 Theydemonstrated an improvement in thetime to administration of IV fluidsand antibiotics.13 Despite these gains,they fell short of guideline recom-mendations, with fluids and antibiotics

TABLE 1 Demographics of Study Population

Patient Characteristicsa Preintervention,n (%), n = 126

Postintervention,n (%), n = 116

% boys 68 (54.0) 58 (50.0)Category of sepsisSeptic shock 108 (86.5) 89 (76.0)Severe sepsis 18 (14.3) 27 (23.0)

Age, y, median (IQR) 9.2 (3–16) 12.3 (6–16),1 y 15 (11.9) 4 (3.4)

Mortality 6 (4.8) 2 (1.7)Comorbidites 75 (60.0) 71 (61.2)Hematologic malignancy 8 (6.3)b 5 (7.0)b

Solid tumor malignancy 7 (5.6)b 9 (12.7)b

Bone marrow transplantation 5 (4.0)b 1(1.4)b

Solid organ transplantation 5 (4.0)b 3 (4.2)b

Short gut 11 (8.7)b 8 (11.3)b

Immunosuppression from chronic therapy(Crohn disease, rheumatoid arthritis)

15 (11.9)b 5 (7.0)b

Neurodegenerative disorder 5 (4.0)b 10 (14.3)b

Other 25 (19.8)b 30 (42.2)b

PIM2 score, mean (SD) 10.3 (12.9) 8.2 (11.5)Intubated/noninvasive ventilation in ED 26 (20.6) 26 (22.4)Vasopressor administered 58 (46.0) 63 (54.3)Dopamine 52 (41.3) 55 (47.4)Epinephrine 4 (3.2) 2 (1.7)Norepinephrine 1 (0.8) 5 (4.3)

Catecholamine refractory shock 20 (15.9) 7 (6.0)Indwelling vascular catheter 33 (26.2) 16 (17.8)Central venous catheter placement in ED 30 (23.8) 20 (17.0)Intraosseous placement in ED 10 (7.9) 5 (4.0)a All parameters reflect occurrences during the entire ED course.b Does not add up to 100% due to overlapping comorbidities.

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being delivered after the 1-hour goal.Another pediatric ED also engaged ina successful QI endeavor, citing diffi-culties with recognition but also diffi-

culties with vascular access as majorbarriers.14 This group demonstratedimproved delivery of 20 mL/kg of IVfluids and antibiotics within 3 hours,

but did not address the PALS recom-mendation to administer 60 mL/kg IVfluid and antibiotics within 60 minutesof recognition.

FIGURE 3Statistical process control charts for key process measures. A: fluid adherence pre- and postintervention. B: Vasoactive agent adherence pre- andpostintervention. aNo patients received vasoactive agents in July–August 2012.

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We demonstrated improved adherenceto all 5 components of the PALS septicshock algorithm. We learned from les-sons identified in previous studies andfrom the detailed stakeholder-driven

knowledge gained at our own in-stitution regarding the barriers ofimplementing the PALS sepsis guide-lines.13–15 Rapid IV fluid administrationwas the most common barrier to

guideline adherence and we observedthat this was due to the use of an IVpump in most cases. Much of our in-tervention focused on educating clini-cians regarding the limitations of thismethod of fluid administration. Aspredicted from reliability theory, edu-cation alone was not effective in im-proving our process.18 Level 2 and 3reliability strategies, such as “firing thebolt” and individual feedback e-mailswere needed to achieve statistical im-provement in all process and outcomemeasures. By the end of the study pe-riod, as evident from the SPC chart(Fig 4B), there was an increase in thenumber of cases of septic shock be-tween each death, possibly associatedwith our improvement measures. Thiswill need to be followed over time todetermine if there is sustained re-duction in mortality. More than half ofthe patients did not meet the definitionof septic shock on arrival in the ED, butrather, had their condition evolve overthe course of their ED stay. This dem-onstrates the importance of continualmonitoring of vital signs and frequentreassessment of a patient’s clinicalstatus throughout their ED course to beable to identify more subtle pre-sentations of sepsis.

Through continual assessment andfeedback from clinicians, we becameaware of physician hesitancy in usingthe larger shock clock, particularly ata time when a child needed acute careand resources. Based on this feedback,we introduced a smaller clock, yet stillplaced it in a strategically apparentlocation, ultimately resulting in dra-matically improved measure adher-ence. We also recommended that theclock count forward rather than beinga “countdown” clock, because of pa-rental concern and perception of time“running out.” However, when we ac-commodated providers’ concern fur-ther by allowing caregivers to not usethe clock, but rather use a sepsis time-

TABLE 2 Adherence to Key Algorithm Time Points Pre- and Postintervention

Care Element Preintervention Adherence,n (%)

Postintervention Adherence,n (%)

P Value

Recognition within 5 min 180 (79) 113 (97) .011Vascular access within 5 min 84 (67) 104 (90) ,.00160 mL/kg IV fluid within 60 min 47 (37) 85 (73) ,.001Antibiotics within 60 min 88 (70) 99 (86) .02Vasoactive agents started at 60 min 44 (35) 79 (68) ,.001Overall bundle adherence 24 (19) 90 (78) ,.001Median time to IV fluids 83 (IQR, 43–145) 33 (IQR, 0–68) ,.001Median time to vasoactive agents 90 (IQR, 51–164) 35 (IQR, 14–86) ,.001Appropriate fluid mechanism used(pressure bag, rapid-infuser,manual push)

62 (49) 110 (95) ,.001

Coagulation profile obtained 35 (28) 44 (38) .092Liver function tests obtained 63 (50) 77 (66) .014Lactic acid obtained 83 (66) 96 (83) 0.003

FIGURE 4Statistical process control charts for outcome measures. A: Bundle adherence pre- and post-intervention. B: Number of cases between each death from severe sepsis and septic shock.

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out at the bedside (whereby the time ofdefinition of septic shock was verballyannounced), we saw a decrease inadherence to all measures. Within amonth, we again returned to use ofthe shock clock and subsequently re-turned to previous levels of adherence.This highlights the fluid nature of im-provement, and the continual need forfeedback mechanisms and real-timemonitoring of process-improvementefforts.

After detailed analysis of preimprove-ment practice andaPareto diagram,wewere able to focus on the key inter-ventions that drove bundle adherence,rather thandiverting resources towardremediating all barriers. From the SPCcharts (Figs 3A and 4A), we confirmedour hypothesis that use of the appro-priate fluid-delivery apparatus was in-deed significantly associated with fluidadherence and thus bundle adherence;the fluid-adherence SPC chart stronglymirrors that of total bundle adherence.This was supported through traditionallogistic regression analysis as well.

We also aimed to minimize the impacton other aspects of health care deliveryby using balancing measures. We rec-ognized that allocation of resourcestoward a child with sepsis could affectthe delivery of care for other children intheED.Weobservednochange in EDLOS

during the implementation of this QIintervention. In addition, there wasminimal use of the septic shock pathwayfor patients who did not meet sepsiscriteria throughout the study period.

Feasibility is a key component of asuccessful QI intervention. This study,although having the support of the in-stitution, did not require significantadditional resources or personnel. Weengaged nursing staff already availablein the ED to achieve timely care forpatients with septic shock. All educa-tional outreach, feedback, and datacollection were performed by existingfrontline workers. This has positiveimplications for institutions where re-sources may be limited.

This work has several limitations. Def-initions of septic shock were based onInternational Sepsis Consensus Con-ference guidelines.18 These can becumbersome to apply in real time atthe patient’s bedside and in recordreview to evaluate for guideline ad-herence. However, these are the mostrigorous criteria that exist for childrenwith sepsis, and other strategies foridentification, such as InternationalClassification of Diseases coding, haveunderestimated the true prevalence ofseptic shock.1,20 Second, without ran-domization, we were unable to ascer-tain whether improvements over time

were due solely to our interventions.Regardless, institutional change islikely multifactorial, requiring multiplesystem-level changes not amenable toa simple randomized control design.Third, based on our initial work, whichshowed good performance in recogni-tion of septic shock, we decided not tofocus on timely recognition. However,through overall education and aware-ness, we were still able to showimprovements in this regard. Finally,our study ended after demonstrating 9months of sustainability. QI interven-tions are sustainable only if embeddedinto standard practice and thus we willcontinue to monitor our progress toensure continued improvement.

CONCLUSIONS

Through implementation of a QI initia-tive,wewereable to improve the careofpatientswith septic shock in a pediatricED. Focus on a single key driver and useof reliability theory to inform ourinterventions was successful in im-proving adherence to all components ofPALS guidelines. This process waspossible without additional resourcesand has proved sustainable over time.

ACKNOWLEDGMENTSWe thank John Andrea and KaitlinMorris for their dedicated efforts indata collection for this project.

REFERENCES

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QUALITY REPORT

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(Continued from first page)

www.pediatrics.org/cgi/doi/10.1542/peds.2013-3871

doi:10.1542/peds.2013-3871

Accepted for publication Jan 22, 2014

Address correspondence to Raina Paul, MD, Wake Forest University Baptist Medical Center, Department of Emergency Medicine, Medical Center Boulevard, Winston-Salem, NC 27103. E-mail: [email protected]

PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).

Copyright © 2014 by the American Academy of Pediatrics

FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.

FUNDING: Supported by an internal Program from Patient Safety and Quality Grant at Boston Children’s Hospital.

POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose.

e1366 PAUL et al

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