Curr Treat Options Peds (2015) 1:347–358DOI 10.1007/s40746-015-0026-4

Quality Improvement (E Alessandrini, Section Editor)

Standardizing Care Processesand Improving Quality UsingPathways and ContinuousQuality ImprovementJane Lavelle, MD1,2,*

Aileen Schast, PhD2

Ron Keren, MD, MPH2,3

Address1Division of Emergency Medicine, The Perelman School of Medicine at theUniversity of Pennsylvania, 34th and Civic Center Blvd, Philadelphia, PA,19104-4399, USA*,2Children’s Hospital of Philadelphia, Office of Continuous Quality Improvement,The Children’s Hospital of Philadelphia, 34th and Civic Center Blvd, Philadelphia, PA,19104-4399, USAEmail: lavellej@email.chop.edu3Department of Pediatrics, The Perelman School of Medicine at the University ofPennsylvania, 34th and Civic Center Blvd, Philadelphia, PA, 19104-4399, USA

Published online: 26 October 2015* Springer International Publishing AG 2015

This article is part of the Topical Collection on Quality Improvement

Keywords Clinical pathways I Algorithms I Variation I Continuous quality improvement I Standardization I Qualitymeasurement I Pediatrics

Opinion statement

Health care providers have an opportunity to improve the quality of care provided by reducingunnecessary variation. Current evidence and expert consensus can be used to develop astandardized mental model that can be used by all members of a clinical team. Processmanagement and continuous quality improvement can be applied to measure process, health,and patient satisfaction outcomes. Clinical pathways represent one method to accomplishthese goals. When combined with targeted education, electronic clinical decision support, androbust measurement, this methodology can help to create the dynamic learning health caresystem that will support the health of the next generation of our children.

Introduction

The need for standardizationClinical standard work aims to reduce unnecessary var-iation that exists in health care delivery today with the

goal of improving health care quality. Many examples ofvariation in care and its effects on quality exist in thepediatric literature [1–5, 6••]. The reason for this

variation is complex and multifaceted. For generations,the craft of medicine has been transmitted from expertto novice through mentoring relationships in medicalschool, residency, and fellowship. Where one wastrained and the approach to care taught by one’s men-tors influences providers many years into their indepen-dent practice. However, the last 50 years has broughtexponential growth of new evidence, challenging thisapprenticeship model of training. In 2012, there were1.9 million articles published in 21,800 peer-reviewedjournals. The number of articles and peer-reviewedjournals continue to grow at a steady rate of 3–3.5 %annually [7]. The sheer volume of new medical knowl-edge makes it extremely difficult for clinicians to stay upto date and incorporate new best practices into patientcare. In addition, application of this published evidenceto direct patient care is often of uncertain value. Due tothe growing complexity of patient conditions and treat-ments, evidence may not directly translate to individualpatients or populations. In fact, for much of routineclinical practice, high-quality evidence that supportsclinical decision is available only 20 % of the timeleaving most medical decisions to clinician experienceand opinion [8]. Even when evidence-based guidelinesare available, it is estimated that only two thirds ofpatients receive the recommended care and another25 % receive care that is not necessary and may in factbe harmful [9]. Growing complexity demands strongcollaboration and coordination between multiple phy-sician subspecialists and allied health professionals toassure that the patient receives the care that is required.Systems to support this needed coordinated approachare currently lacking [10]. In 2012, the IOM publishedrecommendations to develop a continuously learninghealth care system. The creation of standard clinicalprocesses using process management in conjunc-tion with robust, targeted measurement, andteam-based care is the platform upon which sucha dynamic learning health care system can be cre-ated, in which measurement informs practice andpractice informs evidence and further improvement[11]. With the development of electronic medicalrecord systems and the availability of real-timedata, health care systems must embrace this oppor-tunity to reform health care and create a new sys-tem that emphasizes coordinated care delivered bya team of clinicians that standardizes processes,utilizes principles of continuous quality improve-ment with continued measurement to improve thehealth of children.

What is a clinical pathway?A pathway is a detailed plan of care for a well-definedgroup of patients, which translates guidelines, evidence,and expert consensus opinion into local care and is aresult of multidisciplinary work. Pathways are typicallyrepresented as flow charts. The hierarchical algorithm isa snapshot of the process at its highest level; it focusesthe user’s attention on the main decision nodes. It pro-vides amental model for themultidisciplinary team andhelps to manage complexity. Each decision node on theflow chart represents a process and an outcome; supple-mental guidance is linked to these nodes; these aresubprocesses, each having their own outcomes. Thisguidance can be as detailed as needed to support stan-dardization. These flow charts also provide an effectiveplatform for teamwork and team communication stan-dardizing team expectations and communication [12•,13, 14].

Pathways as a tool for standardization in health carePathways can be viewed as one ofmany tools that can beused to standardize health care processes. When we talkabout pathways in health care, too often the first reac-tion from providers is alarm that we are advocatingBcookbook^ medicine and fear loss of autonomy andoversimplification. In fact, professional societies andadvocacy groups have been calling for standardizationthrough the use of best practices and evidenced-basedguidelines for years. Clinical practice guidelines (CPG)have been in existence for the last four decades. Tradi-tionally, they were directed at disseminating new knowl-edge. AHRQ defines CPGs as Bsystematically developedstatements to assist practitioner and patient decisionsabout appropriate health care for specific clinicalcircumstances.^ The Institute of Medicine recently up-dated this definition—CPGs are statements that includerecommendations intended to optimize patient carethat are informed by a systematic review of evidenceand an assessment of the benefits and harms of alterna-tive care options. CPG goals have broadened to includedecreasing variation and increasing standardization, re-ducing cost, and enhancing patient education to supportshared decision making [15–17]. The challenge withmany CPGs is actually implementing the guidance theycontain. The documents are lengthy and provide high-level information, which lack detail about specific situ-ations and processes required to support implementa-tion. Clinical pathways represent one strategy to de-crease this gap in knowledge translation by convertingCPG recommendations into explicit actions providing

348 Quality Improvement (E Alessandrini, Section Editor)

guidance for patient care to be used by the clinical teamat the bedside.

Pathways are not meant to be cookbook medicine.They are designed to guide care for the majority ofpatients with a given clinical condition; 20 % will de-mand different clinical decisions. Standardizing careand assuring smooth processes frees up clinician timeto address more difficult and complex issues for the20 % of patients who do not fit neatly into a pathwayalgorithm. Well-designed pathways enhance the clini-cian’s ability to deliver complex, multistep care consis-tently, helping to reduce error, and allows them to focuscognitive efforts on the situational, interpersonal, andintuitive aspects of medical care [18].

Quality improvement theoryDeming’s quality improvement theory provides a pow-erful framework for both the development and the im-plementation of clinical pathways. Health care deliveryis a complex series of processes that are linked andinteract together to achieve specified outcomes. Throughdesigning explicit clinical processes using pathways, andthen testing changes and measuring outcomes, qualityimprovement theories can be applied to health care inmeaningful ways. Pathways promote standardizationallowing for more meaningful measurement so im-proved patient outcomes result over time. Applicationof continuous quality improvement takes the currentstate of provider generated variability in health careand through iterative measurement informs future prac-tice of patient-generated variability with appropriate re-source utilization thus increasing value [19•].

Many children’s hospitals have recognized the needfor standardization andmeasurement. Seattle Children’shas developed a Pathway Program which is available atht tp : / /www.seat t lechi ldrens .org/heal thcare -professionals/gateway/pathways/. Cincinnatti Chil-dren’s publishes evidence-based care recommendationsand embraces transparency by publishing the organiza-tions progress in national measures such as patient flowand central line infection rates on their website (JamesM. Anderson Center for Health Systems Excellence,http://www.cincinnatichildrens.org/service/j/anderson-center/default/?WT.mc_id=101018&utm_campaign=Anderson-Center&utm_content=james-m-anderson-center&utm_medium=Print&utm_source=Multiple).Texas Children’s Hospital has also created an Evidence-Based Outcomes Center and is incorporating clinicalpathways as a tool to improve care. Boston Children’sHospital is a founding member of The Institute for

Relevant Clinical Data Analytics (IRCDA) and uses Stan-dardized Clinical Assessment Management Plans(SCAMPS). The SCAMP includes a care pathway andseeks to test the validity of the decision nodes bycollecting data at the point of care. When a cliniciandisagrees with a specific action, they record the reasonfor this disagreement. This information is collected andanalyzed, reviewed by the SCAMP owners and used tofurther refine the care algorithm http://www.scamps.org[8, 20, 21••]. The process of clinical pathway develop-ment and implementation used at The Children’s Hos-pital of Philadelphia will be described below.

Developing a Clinical Pathway (see Table 1)

Deciding where to invest time and effort in developmentof clinical pathways is the first step in beginning thework of standardization. Table 1 suggests some prioriti-zation criteria that may be useful and become moreimportant as the desire for pathway development in-creases. Early on in the process, identifying areas wherethere is a will for change may actually be more impor-tant than working on a high-volume condition as stan-dardizing workflows requires a significant culturechange. Pathways may focus on a disease, a chief com-plaint, or a common process, such as sedation or nutri-tion practice in the ICU setting, bronchodilator weaningfor asthma patients, or radiology imaging and reportdocumentation.

Once the area of need is identified, it is critical tochoose the right clinician leadership team. A strong,committed physician and nurse dyad who are workingclinically are invaluable in recruiting stakeholder sup-port to drive change. The enthusiasm and satisfactionfrom a successful team is needed to move the needle onchange. All relevant clinician stakeholders should berepresented in the multidisciplinary team. Importantadditional team members include a senior improve-ment advisor and a clinical data analyst. The improve-ment advisor brings improvement theory and practicesto the table, clarifies the aims, project scope andmetrics,organizes and facilitates discussion, presents actionabledata to the team and drives the project to completion.The data analyst extracts patient data and creates a datamanagement system to track the processes and out-comes of the current state and after subsequent tests ofchanges.

The pathway team leaders, the improvement advi-sors, and other physician content experts review existingliterature and existing guidelines and pathways from

Standardizing Care Processes and Improving Quality Using Pathways Lavelle et al. 349

Table 1. Components of pathway development and implementation

Prioritization criteria High cost conditionHigh volume conditionStrong existing evidence, local expert consensusKnown variation locally and/or among peer institutionsHigh risk condition or known safety issuesPatient satisfaction issuesPresence of clinical champion, stakeholder supportLeadership directive, topic aligned with operating plan

Leadership team Physician actively practicing who is a content expertNurse actively practicing who is a content expertOther physicians with specific content expertiseSenior improvement advisorResource for quality improvement methodsAssists in defining scope, driving agendas, workFacilitates discussion and improvement efforts

Other team members Other content experts necessary for the disease/clinical processPharmacistLaboratory physician/technicianRadiologistSocial workChild life specialistNutritionFacility expertsOther subspecialist content expert

Review evidence collect information Team leaders, content experts, improvement advisor gather existingevidence, available guidelines, query improvement network

Systematic literature review around specific questions if need from theCenter for Evidence-Based Medicine, University of Pennsylvania

Review safety eventsClinician interviewPatient satisfaction

Define goals Scope Team develops general goals for the pathwaySpecific patient populationArea of care (inpatient, outpatient, etc.)

Develop algorithm BWhite-board session^ Team leaders and content experts describe clinical reasoning, presentsummary of literature review

White-board session with pathway team nodesPatient population: inclusion and exclusion criteriaSpecific categories of patients (risk stratification)Develop decision nodesIdentify main processes that need standardization

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Refine algorithm Experienced clinician drafts initial conceptual algorithm draftAlgorithm discussed and edited by the team iterativelyInitial review with pertinent stakeholders for feedback

Supplemental information, attentionto work flow changes

Supplemental information added in hyperlinksPertinent policies, procedures added as linksHospital drug formulary updated as neededProcesses and work flow changes made as neededPatient discharge instructions reviewed, developed as neededPatient video instructions added as neededDraft to web developer to create link

Clinical decision support EMR template for clinician documentation developed as neededElectronic order set developed to guide clinician choicesRN electronic documentation changes as neededDischarge order sets developed as neededDischarge instructions added as neededPatient follow-up/best practice alerts added as needed

Education PowerPoint RN Learning Module developed focusing onRN-specific processes

Electronic Pathway draft reviewed at multidisciplinary meetingfor final discussion

Web draft is presented at all stakeholder meetingsFinal edits are made; pathway is pushed to production

Communication Pathway posted to website, order set live in EMR with link tothe pathway

Information incorporated in MD/CRNP/RN updatesPosted in quality updatesComputer screensaversUnit bulletin boards, electronic displays

Measurement 2–5 metrics are chosen to measure improvementBalancing measures (aim for at least 2), some examples:Hospital readmission rates at 7 and 30 daysED revisits within 72 h, revisit requiring hospitalization at second visitSpecific to given clinical pathway (examples)E. coli resistance rate to cephalothinBlood culture results/sensitivities for low-risk neutropenic oncology patients

Continuous improvement Pathway team meetsNote opportunities for improvementReview, refine metricsDevelop specific aimsProcess management and education as neededDesigns PDSA cyclesWeekly huddles to discuss data, review chartsData feed to larger community of clinicians using the pathwayIndividual feedback as needed

Table 1. (continued)

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other institutions and query quality sites. This informa-tion is summarized for presentation at the first pathwaymeeting. The pathway team meets to review this infor-mation along with current process, patient data, safetyevents, patient satisfaction issues, and information fromclinician interview. They work together to generate ex-pert consensus and then define overall goals for theproject. Using a white-board, the team then developskey decision-making nodes for patient care. They mustexplicitly define the population of patients and the areaof care to which the pathway is to be applied.

An experienced clinician then drafts the initial algo-rithm. At subsequent team meetings, this is iterativelyedited to reflect the optimal process of care. The pathwaymust reflect the flow of work with attention to staffing,training and education, supplies, and physical layout. Adetailed draft is then shared with key stakeholders torecruit support and to incorporate important feedback.As much of this work is based on expert consensus dueto lack of evidence, it is imperative to have stakeholderagreement. The pathway, including the algorithm,supporting evidence, important policies/proceduresand links to related websites are then published on theInternet for easy access by all clinicians. See Fig. 1. Clin-ical decision support tools such as documentation tem-plates, electronic order sets, and best practice alerts aredeveloped for each pathway. These powerful tools de-crease error and assure that all steps of the complexprocess are completed, making it easy for the clinician

to provide the care recommended in the pathway. How-ever, they also do not prevent the provider frommakingdifferent choices if necessitated by the patient’s uniquepresentation. Examples of Pathways from The Chil-dren’s Hospital can be viewed at http://www.chop.edu/pathways#.Vb0VNniLJUQ.

Pathway implementation and improvement(see Table 1)The pathway facilitates the ability to meaningfully mea-sure care delivery processes and patient outcomes usingcontinuous quality improvement by reducing variationcoming from providers but maintaining variation re-quired by individual patients. The team focuses on afew key measures to follow during implementation.Aims, which detail how much improvement is to bemade by a targeted date, are documented. Rapid cycleimprovement methodology using iterative Plan-Do-Study-Act (PDSA) cycles is used to test needed changesin the care delivery process. At weekly huddles, the teamreviews the most recent data and designs the next test ofchange sharing information with all clinicians. This pro-cess continues until the aim is achieved. Monitoring ofthe process continues to ensure that the change hastaken hold. Statistical Process Control Charts (SPC) arean ideal way to track the process, separating deviationarising from differences in patient presentation (appro-priate, common, or random variation) and those arisingfrom external practice patterns (inappropriate, special,

Measurement shared with local team oftenE-mail updates, meetings, computer screensaversData displayed on large screen in treatment area available to patientsQuality office updatesMeasurement shared with community, patients/families, insurerspromoting transparency

Maintenance Pathway, order set, patient instructions reviewed every 2 years at aminimum by pathway team

Changes incorporated as needed if new evidence, technology orprocesses become available sooner

Continued review of metrics to assure sustained improvementusing SPC Charts

Review for new opportunities to improve further

Estimated timeline Pathway development 4–6 monthsImplementation/improvement 4–6 months

Table 1. (continued)

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or assignable cause) The goal is to eliminate unnecessaryvariation across clinicians over time and to retain varia-tion that arises from important individual patient differ-ences [12•, 19•, 22•].

Infrastructure

Considerable infrastructure is required to support apathway program. Senior Improvement Advisors withknowledge of improvement science and experience inclinical medicine are an invaluable resource. They orga-nize busy clinicians, spread knowledge about improve-ment science, and drive work to completion. A signifi-cant investment in data management is also required.Data integration specialists are needed to move datafrom the clinical information systems to a data ware-house. Data analyst must be available to turn the data inthe data warehouse into meaningful information. De-velopers of data visualization tools help to display per-formance metrics in a format that is easy for teammem-bers and clinicians to follow.

To help hard wire recommendations into practice, itis extremely helpful to have clinical informatics expertsto design order sets, best practice alerts, and patientregistries. Pathways must be reviewed and updated at aminimum of every 2 years; this includes evidence re-view, improvements made to date; next areas of im-provement focus, updated education and continued dis-cussion with all stakeholders.

Examples of pathways and improvement projects EDproject for timely pain management for children withfractures (see Fig. 1)A multidisciplinary ED team including ED MD, CRNP,RN, orthopedic surgeon, radiology technician, child lifespecialist, family advocate, senior improvement advisor,and data analyst met to improve fracture care in our EDand developed a pathway that was posted in December2013 (see Fig. 1). The team wanted to improve timelypain management and the coordination of care for chil-dren with acute fractures. In the spring of 2014, the teambegan to meet weekly and decided to focus on painmanagement first. The initial aims were to increase ibu-profen use (instead of acetaminophen), decrease time toopioid administration, and increase use of intranasalfentanyl. Initial data revealed opportunities for improve-ment; median time to opioid administration was960 min, and only 18 % of these children received intra-nasal fentanyl. It was noted that MD time to order repre-sented the largest portion of time between evaluation and

opioid. Interventions included presentation of initial datafor discussion at multidisciplinary ED meetings, includ-ing a quality tip about pain management emphasizingintranasal fentanyl to be used during ED patient rounds,and posting data on an ED computer screensaver. Thefracture electronic order set was modified to facilitatemedication orders by moving these choices to the top ofthe order set list. Data was shared with ED team at 2–4-week intervals. Opioid order delays were reviewed andfeedback was given back to the individual clinicians. Theclinicians responded to these interventions and increasedthe percent of patients with an opioid order within20 min of MD evaluation from 21 to 50 %. The team isnow beginning to focus on processes around fracturereduction. The initial aim is to reduce unnecessary post-reduction films. See Fig. 2a, b, c.

Outpatient pneumonia and antibiotic project (see Fig. 3)

The use of the narrowest spectrum antibiotic for a giveninfection is an important quality initiative to reduce anti-microbial resistance, side effects, and cost. A pathway forthe treatment of community-acquired pneumonia waspublished based on the IDSA Guidelines in September2012 focusing on the appropriate use of high-dose amox-icillin for patient with typical community-acquired pneu-monia [23]. The aim of Ambulatory Pneumonia QI teamwas to increase the use of amoxicillin as first-line treat-ment for outpatient community-acquired pneumonia inhealthy children at three care sites in the network. Toensure uptake of the pathway, three outpatient practiceswere identified based on high practice volume and lowamoxicillin prescribing rates. Provider leads in each prac-tice completed 1 year of baseline chart review of patientswith community-acquired pneumonia and interviewedtheir colleagues to identify common reasons that amox-icillin was not prescribed. Targeted education developedby an Infectious Disease Specialist and Director of theAntibiotic Stewardship Program was used to create anelectronic learning module that was required of all phy-sicians in the practices. The physician project leaders werethen provided weekly prescribing data and provided in-dividual feedback to the providers. Over an 8-month timeframe, amoxicillin prescribing increased to approximately80 % (see Fig. 2). An automated data visualization toolwas introduced which included practice, provider, andpatient-level prescribing information. Balancing mea-sures included 7-day revisit rate of patients treated withamoxicillin that had the same diagnosis at the secondvisit but were prescribed a different antibiotic. The per-centage was low in the baseline period and did not

Standardizing Care Processes and Improving Quality Using Pathways Lavelle et al. 353

Fig. 1. Example of Web-base Pathway: Evaluation/Treatment for child with suspected extremity fracture. Translating evidence intopoint of care for the clinician team.

354 Quality Improvement (E Alessandrini, Section Editor)

Fig. 2. ED fracture project. a Increased ibuprofen and intranasal fentanyl use and decreased time to MD order. b Median time fromMD evaluation to opioid administration. The fracture team looked at critical steps of the process to time of pain medication todesign next interventions. They noted that time to physician order represented the largest proportion of time, interventionsincluded moving pain medications to the top of the order set, including time to pain management as tip on rounds, and data waspresented on the ED screensavers. c Percent of fentanyl use: % patients receiving opioid who received fentanyl.

Standardizing Care Processes and Improving Quality Using Pathways Lavelle et al. 355

increase during the intervention. Next steps planned in-clude education across all practices in the network,

followed by continued audit/feedback email to individu-al physicians around prescribing data (Fig. 3).

Conclusion

Pathways, when successfully implemented bring benefits to patients and toproviders. Unnecessary testing, decreased admission rates, and shorter hospitallength of stay can be attained when care is standardized. Efforts to improvepatient care quality are natural goals for clinicians, and thus, programs tostandardize care should focus mainly on improving quality; cost reduction isa secondary benefit. This work brings clinicians together, appealing to thegreater good, reinforcing the passion for clinical medicine which is much morepowerful than financial rewards. Physician leadership is critical to the process;they must be supported by an infrastructure that minimizes extra time added totheir schedule. Success should be celebrated and attributed to the work of thepathway owners and their team. Administrative support is also critical tofinance the necessary infrastructure. Data must be accurate; metric must becarefully chosen and thoughtfully displayed in order to drive change. Avoidfulfilling endless data requests as this approach is not only unsustainable butoften causes confusion that slows or even stops work. Attention to balancingmeasures and untoward/unrecognized consequences of process change is alsoimportant [12•, 13, 14].

Clinicians at our institution recognized the need for standardization almosta decade ago and have seen the advantages of using a shared mental model inimproving the collaboration that is demanded by complex patients within acomplex care environment. Processes have been improved as part of this work;the electronic medical record has provided endless ways to provide immediateclinical decision support to the frontline clinician. In the last 3 years, robust dataextracted by analysts and under the guidance of improvement advisors, real-time data is now available to inform the teams of successes as well as newopportunities to improve care. Overall, it is an exciting time to practice medi-cine and to participate in creating the dynamic learning health care system of

Fig. 3. Ampicllin use as first-line treatment for community-acquired pneumonia in pediatric ambulatory practices after educationalintervention and audit/feedback. SPC chart displaying proportion of patients 956 days to 18 years who received amoxicillin amongall patients with the ICD-9 diagnosis of pneumonia. The pathway QI team set a goal of 80 %. The project started in the fall of 2013.December 2013 Clinician Education. January–April 2104 Data review, clinician feedback.

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the future that promises the health of our children, move toward mutualdecision-making and focus on the patient experience while continuing tosupport innovation.

Compliance with Ethics GuidelinesConflict of InterestJane Lavelle, Aileen Schast, and Ron Keren declare that they do not have any conflicts of interest.

Human and Animal Rights and Informed ConsentThis article does not contain any studies with human or animal subjects performed by any of the authors.

References and Recommended ReadingPapers of particular interest, published recently, have beenhighlighted as:• Of importance•• Of major importance

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