The Value of Care Algorithms

The Value of Care Algorithms

Timothy Myers, B.S., R.R.T.-N.P.S.

The use of protocols or care algorithms in medical facilities has increased inthe managed care environment. The definition and application of carealgorithms, with a particular focus on the treatment of acute bronchospasm,are explored in this review. The benefits and goals of using protocols,especially in the treatment of asthma, to standardize patient care based onclinical guidelines and evidence-based medicine are explained. Ideally,evidence-based protocols should translate research findings into best medicalpractices that would serve to better educate patients and their medicalproviders who are administering these protocols. Protocols should includeevaluation components that can monitor, through some mechanism of qualityassurance, the success and failure of the instrument so that modifications canbe made as necessary. The development and design of an asthma carealgorithm can be accomplished by using a four-phase approach: phase 1,identifying demographics, outcomes, and measurement tools; phase 2,reviewing, negotiating, and standardizing best practice; phase 3, testing andimplementing the instrument and collecting data; and phase 4, analyzing thedata and identifying areas of improvement and future research. Theexperiences of one medical institution that implemented an asthma carealgorithm in the treatment of pediatric asthma are described. Their carealgorithms served as tools for decision makers to provide optimal asthmatreatment in children. In addition, the studies that used the asthma carealgorithm to determine the efficacy and safety of ipratropium bromide andlevalbuterol in children with asthma are described.Key Words: asthma, algorithms, chronic obstructive pulmonary disease,COPD, bronchial spasm, albuterol, ipratropium, albuterol-ipratropium.(Pharmacotherapy 2006;26(9 Pt 2):181S–192S)

The use of care algorithms—frequently referredto as protocols, care paths, and clinical or criticalpathways—has grown out of necessity in theprofession of respiratory care as a result of manyinstitutional and economic factors. The managedcare environment has favored the optimization oftreatment plans such that the ideal treatmentregimen (e.g., aerosol therapy or oxygen therapy)is matched with the appropriate patient popu-

lation. Optimizing patient care with feweravailable respiratory care resources, including thenumber of respiratory therapists, has necessitatedthe institution of care algorithms, particularly inthe setting of acute bronchospasm in theemergency department or hospital setting.

For a working definition, a care algorithm maybe described as a structured set of standingorders based on both patient-specific conditions,such as asthma and chronic obstructive pulmonarydisease (COPD), and objective assessments.1

These standing orders should preferentially allowancillary practitioners (e.g., respiratory therapists,nurse practitioners, physician assistants, andpharmacists) to have some flexibility to begin,alter, and discontinue therapy without the need

From the Department of Pediatric Pulmonology, RainbowBabies and Children’s Hospital, Case Western ReserveUniversity, Cleveland, Ohio.

Address reprint requests to Timothy Myers, B.S., RRT-NPS, Rainbow Babies and Children’s Hospital, Departmentof Pediatric Pulmonology, Case Western Reserve University,11100 Euclid Avenue, Cleveland, OH 44106; e-mail:[email protected].

Supplement PHARMACOTHERAPY Volume 26, Number 9, 2006

for additional physician orders. A care algorithmthat offers built-in flexibility to ancillarypractitioners facilitates the process of care in asmooth continuum.

The benefits of care algorithms have been citedby various researchers.2–5 Incorporating carealgorithms into the health care process minimizeserrors in clinical management, improves theeffectiveness of available treatments, andincreases accountability of medical providers.Care algorithms can also be used as a referencetool for standardizing medical practices,particularly those practices that may deviate froman acceptable standard. The focus of this articleis on the use of care algorithms in the manage-ment of acute bronchospasm in asthma and, to alesser degree, in COPD. Care algorithms orprotocols will help address certain questionsassociated with the management of these diseasessuch as when to begin and discontinue b2-agonists, corticosteroids, and oxygen therapy, andwhat type of diagnostic and laboratory tests toorder.

Protocols and Evidence-Based Medicine

The main objective of protocols is to stan-dardize care based on established or publishedclinical guidelines, which are optimallydeveloped with use of evidence-based medicine.Deviations from protocols tend to drive up costsand tend not to produce beneficial patientoutcomes. Reliance on protocols may thereforeincrease accountability of medical providers andimprove the overall effectiveness of the availabletreatments or care provided to patients.

Protocols are operational versions of clinicalpractice guidelines aimed at the management ofcommon procedures, common tasks, or certaindisease states. Protocols work best for procedures,tasks, or diseases for which there is scientificallydocumented evidence and established carepractices within the literature, the communityitself, or the institution.

Evidence-based medicine may be defined asthe exclusive use of current best evidence inmaking decisions about the care of an individualpatient.6 Clinicians may be slow to adoptevidence-based medicine principles and practicesbecause of concerns over institution- or patient-specific variables that may influence choice oftreatment. However, evidence-based medicine isbased on clinically relevant efficacy and safetydata from research and from diagnostic tests;although, it still requires individual clinical

expertise. When scientific evidence is lacking,protocols should include components that allowfor data collection, protocol refinement, andoutcomes research.

Development of Protocols: A Team Approach

Development of protocols inevitably leads tofurther definition of related policies, identifi-cation of team member roles, determination ofcompetencies and required training, and qualityassurance or monitoring programs. Treatment ofrespiratory diseases involves many disciplines inmedical institutions. Drawing on the clinicalexpertise of all these medical practitioners,including primary care physicians, pediatricians,specialists, respiratory therapists, nurses,pharmacists, and social workers, is crucial in thedevelopment of a protocol to ensure that alldisease management aspects are considered.Before implementation of a protocol, manyrelated policies, such as discontinuation andadmission criteria, may need to be developed tostandardize the care process. Identifying roles ofvarious team health care providers and trainingstaff members to develop their competencies inthis disease management process are essential.

During the development phases of an asthmacare protocol, diagnostic practices may also bequestioned. For example, basic laboratory testsand bilateral chest radiographs are often orderedout of habit and may produce useful informationfor a few patients; however, in most patients,these tests do not provide relevant clinicalevidence or information for the medicalpractitioner and only increase the cost of patientcare.

Using Protocols for Continuous Assessment ofQuality of Care

Initiating a protocol and collecting data allowan institution to establish a baseline practicethat can be used as a reference such thatmodifications can be made at some point in timeas part of a quality assurance and monitoringprogram. Once collected from care algorithms,these data can be evaluated retrospectively toestablish best practice compared with otherinstitutions or within an institution’s ownhistorical database. Data derived from theprotocol can also be used for benchmarkinginternally from year to year or every 2 years toprovide continuous quality improvements inpatient care.

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VALUE OF CARE ALGORITHMS Myers

Asthma and Chronic Obstructive PulmonaryDisease as Ideal Illnesses for ProtocolManagement

The six characteristics of the ideal illness forprotocol management are as follows: largepatient population, high rates of emergencydepartment visits and hospital admissions, highlyvisible costs, improper drug prescribing, abilityto lower costs through education, and ability tomeasure outcomes.7 Some diseases and popula-tions are better suited than others for manage-ment by protocols. Asthma and COPD representlarge patient populations that have frequentemergency department visits and hospitali-zations. These frequent visits are accompaniedby exorbitant costs to patients and to the entirehealth care system. However, expenses incurredas a result of these illnesses are easy to identifyand track.

Although expert panel reports identify drugtherapies for successful management ofexacerbations of asthma and COPD, managementstrategies differ markedly among institutions andamong physicians at the same institution.Monitoring exacerbations, choice of drugs,dosages, timing of administration, duration oftreatment, and assessment measures are often leftto individual physician discretion. Treatmentplans often are not formulated on the basis ofefficacy data, but on local availability and physi-cian experience and preference. Physicians maybe hesitant to relinquish control of managingpatients, particularly if there is no evidence tosupport a care algorithm. Merging these differ-ences into prescribing habits for exacerbations ofasthma and COPD and basing treatment decisionson evidence-based medicine are quite feasible.

In asthma and COPD, costs can be lowered byeducating patients about measures to preventexacerbations. Patient education programs thatemphasize the development of treatment plansand early intervention in asthma and COPD givepatients the tools to help them manage theirdisease and can lower costs of treatment. Finally,working with diseases in which outcomes can bemeasured, either in the emergency department orinpatient setting, facilitates monitoring of theprotocol’s impact.

Clinical Practice Guidelines and Protocols forAsthma and Chronic Obstructive PulmonaryDisease

Clinical practice guidelines for the treatment ofasthma and COPD have been available since

1991 and 2001, respectively.8–10 Since publicationof the National Asthma Education and PreventionProgram (NAEPP) guidelines for the diagnosisand treatment of asthma, several investigatorshave evaluated the extent of adoption of theguidelines into clinical practice.11–14 In 1992, asurvey of 376 hospitals was conducted toevaluate conformity of treatment practices tonational guideline recommendations with regardto treatment of pediatric asthma.14 In this surveythat had a high response rate of 61%, the authorsreported that approximately 17% of all visits tothe emergency department were due to pediatricasthma. At that time, written protocols wereavailable in only 2% of hospitals. Most hospitalsused pulse oximetry (67%) as an objectivemeasure of an exacerbation. Although mosthospitals used inhaled b2-agonists for initialtherapy (80%), corticosteroids were underutilized.Less than half (45%) of the medical institutionsused corticosteroids as recommended by theNAEPP guidelines. It is also concerning that asubstantial number (20%) of children who cameto the emergency department with acute broncho-spasm were not being treated with an inhaled b2-agonist. Fewer than half (46%) of surveyrespondents were aware of NAEPP guidelines,and only 24% had actually read them, indicatingthe existence of individual and potentiallyinstitutional barriers in implementing evidence-based or expert panel recommendations.

Four years after the development of theNAEPP guidelines, the first report describing theeffectiveness of an asthma care algorithm waspublished.15 Since that time, only 15–20 reportsin the literature describe protocols for asthma inthe emergency department or inpatient setting. Acurrent search found no reports in the literatureregarding care algorithms for COPD. Thedevelopment of the Global Initiative for ChronicObstructive Lung Disease (GOLD) clinicalguidelines from evidence-based medicine in 2001established an infrastructure upon which carealgorithms can be created.10 The functionalityand cost benefits of COPD care algorithms willhopefully be the topic of future reports in thepublished medical literature.

Clinical Protocol Design at Rainbow Babies andChildren’s Hospital: Four-Phase Process

Phase 1: Identify Demographics, Outcomes, andMeasurement Tools

Protocol development at Rainbow Babies andChildren’s Hospital in 1995 occurred in a four-

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phase process (Figure 1),16 similar to the JointCommission on Accreditation of HealthcareOrganization process improvement model at thattime: “Plan, Do, Check, and Act.” The first stepin phase 1 of the process was to identify thepatient population: pediatric asthma. Then,short- and long-term outcomes needed to beidentified. The primary or short-term outcomesincluded average length of stay, protocolvariances or deviations, cost/discharge, and timespent on treatment frequencies or regimens.Deviations from the protocol were important tocapture because some deviations may represent amore efficient process to be adopted later;however, other deviations may be due to barriersin the process that need to be addressed. At thisinstitution, no standardized documentedassessments to evaluate progress of recovery werebeing conducted with aerosol treatments. Long-term outcomes included assessments offunctional morbidity after discharge, readmissionrates, and effect of parent and patient education.Within 72 hours of discharge, the care teamcalled patients or parents to ask them questionsabout the patient’s recovery, the ability of thechild to return to school, and follow-up drug use.

The next step in this phase was to identifymeasurement tools. Entry criteria limitedpatients to those with asthma and excludedrespiratory conditions such as cystic fibrosis,bronchopulmonary dysplasia, chronic lungdisease, or congenital lung defects. Checklistsand monitoring forms were created and data werecollected to identify variations from the protocol,which identified unexpected actions or deviationsfrom the protocol by the health care team. Inaddition to tracking charges and expenses, thehospital information system was used to providecost analyses; also, it could track where resourcedollars were spent on any given patient admission.

Phase 2: Review Traditional Practice andLiterature, and Negotiate and Standardize BestPractices

Benchmarking occurred as part of phase 2 ofthe protocol design process. In 1995, a stan-dardized practice could not be easily or clearlyidentified at Rainbow Babies and Children’sHospital; therefore, practice guidelines needed tobe established from an external source, aconsortium of children’s hospitals that sharedoutcomes data. A literature search was conductedto determine standardized practice for thetreatment of asthma in the medical community atlarge, and at that time there was no scientificevidence to establish the benefits of carealgorithms. Since then, a search of the literaturewas conducted for emergency department andinpatient asthma protocols, the results of whichare shown in Table 115, 17–22 and Table 2,17, 23–31

respectively. Three of the seven studies in theemergency department showed a reduction inlength of stay with the implementation ofprotocols,15, 21 whereas four studies showed areduction in hospital or intensive care unitadmission rates.15, 19, 21 Two studies demonstrateda reduction in overall cost when asthma protocolswere used.15 Two prospective randomized trialshad very similar protocols with almost duplicateresults,15 suggesting that “real-world” studies canbe conducted and replicated in an evidence-basedapproach.

Six of the nine studies that evaluated inpatientprotocols for asthma showed a reduction inlength of stay.24, 25, 27–30 Three of the nine studiesshowed a reduction in b-agonist treatment,24–26

and six studies showed a reduction in overallcost.23–25, 27, 28, 31 Three studies were able todemonstrate a reduction in recidivism.26, 28, 29

The results from this literature search suggestedthat the use of protocols can be highly effectiveand can provide good quality care, with an addedbenefit of cost reduction to the patient and themedical institution.

Negotiating practice standards was the nextstep in this phase and required a meeting withstakeholders who interacted with patients on aroutine basis. The protocol treatments orinterventions could be generalized or left up tothe discretion of the individual orderingphysician, or they could be directly specified ormandated. The stakeholders needed to hear thatthe draft protocol should be considered as astarting place rather than as a reference standardfor the future. They needed to understand that

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Figure 1. The four-phase process for developing a clinicalprotocol (From reference 16 with permission.) CQI =continuous quality improvement.

Phase 1: Identify demographics Identify long-term and intermediate outcomes Identify measurement tools

Phase 2: Review traditional practice Review literature Negotiate practice standards Standardize practice

Phase 4: Analyze interdisciplinary data Identify improvement areas Generate CQI questions

Phase 3: Role model new practice Implement practice standards Collect data and check reliability


data would be collected and tracked over timeand that modifications, if needed, would be made

based on data, not anecdotal experiences oropinions. Safeguards were built into the protocol

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Table 1. Documented Improvements with Emergency Department Asthma Protocols

Study Design Improvements After Protocol Implementation Guideline AdherenceSequential Decreased ED length of stay,a rates of admission Not reported(pre- and to hospitalb and intensive care unit,b overallpostprotocol)15 cost,c and recidivismd

Sequential Decreased ED length of stay,c hospital Not reported(protocol vs admission rate,d and overall costc

postprotocol)15

Retrospective18 Increased documentationa Increased for adherence,c compliance,a andpeak flowsa

Retrospective19 Decreased hospital admission rated and Not reportedrecidivisma

Retrospective20 None Increased for oral steroidd and MDIa therapiesDecreased for oxygen use,a nebulizer treatments,a

intravenous lines,d and intravenous steroidtherapyd

Retrospective21 Decreased ED length of stayd and hospital Increased for peak flowsa

admission rated Decreased for time to b2-agonist therapya and time to steroidd therapies

Retrospective22 None Decreased for time to b2-agonist therapyc, steroiddosec, and diagnostic testd

ED = emergency department; MDI = metered-dose inhaler.ap≤0.001.bp≤0.005.cp≤0.01.dp≤0.05.All p values are for comparisons of data after implementation of the protocol with data before implementation.Adapted with permission from reference 17.

Table 2. Documented Improvements with Inpatient Asthma Protocols

Study Design Improvements After Protocol Implementation Guideline AdherenceRetrospective23 Decreased radiologya and laboratoryb costs Not reported

Prospective, Decreased length of stay,a b-agonist treatment,a and costa Not reportedrandomized24

Prospective, Decreased length of stay,c b-agonist treatment,b and Not reportedrandomized25 routinea and respiratory carea costs

Prospective26 Decreased b-agonist treatmentd and recidivisme Not reported

Retrospective27 Decreased length of staya and costa Increased for discharge drugsc, peak flowIncreased asthma educationa metersb, and spacersa

Retrospective28 Decreased length of stayf; decreased total,d laboratory,b Decreased for laboratory testsg

and nursinge costs; and decreased recidivisme

Retrospective29 Decreased length of staye and recidivismb Increased for patient satisfactionc

Retrospective30 Decreased length of staya Increased for inhaled steroidsa, peak flowIncreased asthma education for patientsa and residentsa metersa, and spacersa

Decreased for intravenous steroidsa andmethylxanthinesa

Retrospective31 Decreased aerosol coste Increased for metered-dose inhaler used

ap≤0.001.bp≤0.05.cp≤0.01.dp≤0.005.eNot significant.fp<0.0001.gp<0.0006.All p values are for comparisons of data after implementation of the protocol with data before implementation.Adapted with permission from reference 17.


for obtaining physician input for those patientswho were unable to tolerate these standardizedprocesses. For example, in an asthmatic patientwho was not tolerating the prescribed therapy,the resident or the attending physician wascontacted to reassess the patient. Only afterreassessment could the patient’s therapy beintensified.

The final step before testing the pilot protocolwas to standardize practice and create astandardized document that could be used forassessment and treatment. The preprintedprotocol algorithm outlined standardizedassessments and treatment decisions and servedas a document for charting these decisions. Theprotocol document also standardized drugtherapies and administration procedures, timingof assessments and observations, identification ofevaluators, and discharge criteria.

An example of this process that took place atUniversity Hospitals in Cleveland, Ohio, servedas a model for Rainbow Babies and Children’sHospital and was published as a sequentiallydesigned study in 1995.15 Investigators in thisstudy evaluated a protocol for the treatment ofacute asthma in patients aged 16 years or older.The effect of an asthma care path and preprintedstanding orders on hospital admission, length ofstay in the emergency department, and returnvisits was evaluated after 1 year. These data werecompared with retrospective data from 8 monthsbefore the protocol and with data from the 12-month period after protocol use, in which strictadherence to the protocol declined due to hiringof new emergency department staff. The asthmacare path in this study significantly reducedlength of stay by 50 minutes compared withpreprotocol data, with resolution of symptomswithin 2 hours in 77% of patients (p<0.005). Byestablishing criteria determining whether apatient should go to a medical intensive care unitversus a general division, the protocol reducedthe number of medical intensive care unitadmissions by 41% (p<0.005). Recidivism rateswithin 24 hours and within 7 days were signifi-cantly reduced (p<0.05) and costs were reducedby $395,000 (p<0.01). These outcomes worsenedto baseline levels during the 12-month periodwhen adherence to the protocol greatly declined.

Phases 3 and 4: Conduct Pilot Study, CollectData, Analyze Results, and Identify Areas ofImprovement

After phases 1 and 2 were completed at Rainbow

Babies and Children’s Hospital (approximately 10mo), the protocol was tested in a pilot study(phase 3) in the fall during a high asthmaadmission season, on a ward with a large numberof asthmatic patients and a vested group ofcaregivers. A prospective cohort of patients whowere admitted simultaneously to other wardsserved as a control group. Care providers receivedongoing education and training on use of theprotocol. Support and assistance for care providersregarding protocol issues were provided aroundthe clock, as needed. Data could be collectedprospectively in real-time or retrospectively andwere compared with data from the previous 8months of preprotocol use.

In phase 4, interdisciplinary data analyses wereconducted, areas of potential improvement wereidentified, and questions for future research weregenerated.

Treatment of Asthma at Rainbow Babies andChildren’s Hospital

Similar to other children’s hospitals, asthma isthe single most common discharge diagnosis atRainbow Babies and Children’s Hospital, and itaccounts for 10–15% of all admissions to thehospital and more than 2500 emergency depart-ment visits each year. Before implementing anasthma care algorithm in 1995, this hospitalranked last (out of 27 children’s hospitals) inaverage length of stay (3.2 days, InternationalClassification of Diseases, Ninth Revision code)with an average cost/case of $2800.

Asthma Care Algorithms

Some of the initial questions asked by theasthma care algorithm team were as follows:How do you organize the treatment plan? Howdo you assess improvement? How do you measuresuccess? Who do you involve in the process?The asthma care algorithm team decided to adopta standardized assessment-driven step care plan.The emergency department and inpatient asthmacare algorithms at Rainbow Babies and Children’sHospital serve as a continuum of acute asthmacare and treatment.

Emergency Department Algorithm

A schematic of the emergency departmentasthma care algorithm used at Rainbow Babiesand Children’s Hospital is shown in Figure 2.24

In the emergency room, b-agonists wereadministered as nebulized treatments every 20

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minutes up to a maximum of six treatments.Patients who met the discharge criteria wereobserved for 60 minutes and then released if thedischarge criteria were still met. If patients failedto respond after administration of the first b-agonist, systemic corticosteroids were prescribed.All patients preferentially receive oral rather thanintravenous corticosteroids, based on results ofstudies that showed equal efficacy between thesetwo routes of administration.32 Supplementaloxygen was also given to patients who met thenecessary criteria.

Inpatient Algorithm

Care providers followed the inpatient asthmacare algorithm once the patient was admitted(Figure 3).24 Chest assessment scores provided auniform tool for describing clinical examinationfindings and included measurement of heart andrespiratory rates, pulse oximetry, and rating ofaccessory muscle use, wheezing severity, and airentry according to predefined criteria. Thesecriteria were easy to address because caregivershad to answer only three yes or no questions.Chest assessment scores were rated as good, fair,or poor (Table 3).33 Treatments were given by

nebulizer at predetermined intervals in fourphases such that the frequency of b-agonistadministration increased in a stepwise fashion(every 2 hrs, every 3 hrs, every 4 hrs, and every 6hrs). There was a 12-hour limit for each phase(e.g., patients who received nebulization every 2hrs could only receive six treatments). After 12hours, patients had to move to the next phase orreceive more aggressive therapy. As patientsimproved, the interval between aerosol treatmentsincreased.

Intensification Protocol

An intensification protocol (immediatetreatments) was established for patients whowere not responding to treatment; this protocolcould be used on arrival to the emergency depart-ment if the patient was in severe respiratorydistress or if clinical worsening occurred aftertreatment. The intensification protocol was alsoincluded in the inpatient asthma care algorithmand could be used in patients who failed toprogress from phase to phase after the 12-hourtime limit and if clinical worsening occurredwithin a given phase. The intensification regimenincluded a one-time administration of subcu-taneous epinephrine 0.01 mg/kg (maximum 0.5

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Figure 2. Emergency department asthma care algorithm.ACU = asthma care unit; PICU = pediatric intensive careunit.

Intensify therapy(for treatment failure at any time)

Corticosteroids given for failure to improve after one aerosol inhalation

Admission to ACU or PICU

Assess Every 20 minutes(maximum of 6)

Observe for 60 min Home

Table 3. Asthma Care Algorithm Chest Assessment Scores for Symptom Classification

Chest Assessment ScoreChest Assessment Good Fair PoorWheeze None or end-expiratory Inspiratory and/or expiratory Breath sounds becoming

inaudible

Air exchange Equal, all lobes Decreased, some lobes Decreased, all lobes

Accessory muscle use None Intercostal and/or Same as fair with use oftracheosternal retractions sternocleidomastoid muscles

Oxygen saturation bypulse oximetry ≥ 94% 91–93% < 90%

Adapted with permission from reference 33.

Figure 3. Inpatient asthma care algorithm. ED =emergency department.

Intensify therapy(for treatment failure at any time)

Education and discharge planning begins

Assessment phase

Admit Every 2 hours Every 3 hours Every 4 hours Every 6 hours Home(maximum of 6) (maximum of 4) (maximum of 3) (maximum of 2)

ED


mg) followed by aerosolized high-dose albuterol5 mg combined with ipratropium bromide 500µg 15–20 minutes later. The corticosteroid dosewas optimized at 2 mg/kg and given intra-venously if the patient was unable to tolerate oraldoses. Supplemental oxygen was administered, ifneeded. Care providers could then go back tothe beginning of the inpatient protocol andconduct assessments and treatments every 2hours if necessary.

Experience with the Asthma Care Algorithm inPediatric Asthma

The Asthma Care Path Assessment andTreatment Record shown in Figure 4 is notsimply a standardized treatment protocol. Thedata collected from this document will determinemeasures of success, which are defined as areduction in length of stay and reduced admis-sion rates. The results of using the asthma carealgorithm in the treatment of status asthmaticusin children admitted to a single ward (104patients) at Rainbow Babies and Children’sHospital between September 1, 1995, andFebruary 28, 1996, have been published (Table4).24 Children with asthma who were admittedto other wards served as the control group (97patients). The asthma care algorithm signifi-cantly reduced mean length of stay by almost afull day (2.1 vs 3.0 days, p<0.001) and reduced30-day readmissions (6% vs 8%), mean cost/case($1880 vs $2305), and mean number of aerosoltreatments (10 vs 16 treatments). Medicaidreimbursements increased with the asthma carealgorithm ($844 vs $419). These data validatethe concept of achieving evidence-based goals byconstructing protocols that translate researchfindings into best medical practice and thateducate patients and medical care providers inthe process.

When there are gaps in the scientific evidence,data can be extrapolated from the institution byincluding components in these documents thatallow for data collection to refine the protocoland to conduct outcomes research. On evalu-ation of the data, several areas of improvementwere identified. Only 70–80% of patients werebeing enrolled in the asthma care algorithm.Patient education outcomes were below anacceptable threshold level, monthly in-serviceswere inadequate, and a variance rate of ninedeviations for each case indicated room forimprovement in the number of protocoldeviations.

Improvements in Care Based on the AsthmaCare Algorithm: A Follow-Up Study

A follow-up study (262 patients) with use ofthe asthma care algorithm compared the effectsof an Asthma Care Unit staffed primarily byrespiratory therapists and patient care assistants(with supplemental coverage by registerednurses) with that of a historical control groupfrom multiple patient units staffed primarily byregistered nurses.33 The team of asthmaspecialists in the Asthma Care Unit consisted of amedical director (pediatric pulmonologist), adisease manager (respiratory therapist), anasthma counselor (social worker), and bedsidecaregivers. Mean length of stay was significantlyreduced even further in this study compared withthe control group (1.8 vs 2.0 days, p=0.003,Table 4). Reductions were also noted in 30-dayreadmissions because of better patient education(3.5% vs 6%). A further cost reduction wasobserved in costs for each case ($1850 vs $1880)along with increases in Medicaid reimbursements($1450 vs $844).

Use of the Asthma Care Algorithm as aResearch Tool

Determination of Efficacy of Add-on IpratropiumBromide

The addition of anticholinergic therapy to b2-agonist treatment for the management of acutebronchospasm in the emergency departmentsetting offers modest clinical improvement insome patients.34, 35 However, the clinical benefitsof the routine addition of inhaled ipratropiumbromide to b2-agonists in hospitalized patientshad not been fully established. With use of theasthma care algorithm, a randomized, double-blind, placebo-controlled study was conducted atRainbow Babies and Children’s Hospital todetermine if the addition of nebulized ipratropium

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Table 4. Results from Studies Using the Asthma CareAlgorithm

AsthmaCare Path24 Care Unit33

Variable (n=104) (n=262)30-day readmission rate (%) 6 3.5

MeanLength of stay (days) 2.1 1.8Cost/case ($) 1880 1850Medicaid reimbursement ($) 844 1450No. of aerosol treatments 10 11


bromide 250 µg to a regimen of nebulizedalbuterol 2.5 mg improved clinical outcomes inchildren aged 1–18 years (210 patients) withstatus asthmaticus.36 No significant differences

were noted between treatment groups in lengthof stay, asthma care path progression, need foradditional drugs, or occurrence of adverse events.The authors concluded that routine addition of

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Figure 4. Assessment and treatment record used as part of the asthma care algorithm.

Date

Time

Wheeze

Air Exch.

Acc. Musc.

Puls. P-dox.Sp02

Pulse Rate

Resp. Rate

Peak Flow

FEV1

FEF 25–75

Initials

Initials

Assessment(Phase I) 1 2 3 4 5 6

Time

InitialsOxygen

Albuterol in 2 cc salineCromolyn/2.5 mg Alb.

Prednisone (mg)

Treatment(Phase I) 1 2 3 4 5 6

Observe until 2 hsince lasttreatment

• Intensify therapy • sc Epinephrine x 1 • Atrovent in 5 mg Alb. • iv Solumedrol q6h• Pulmonary consult• Start new record

Dischargecriteria

met

Patientcondition

worse

Six q2haerosols

given

Observe until 3 h sincelast treatment

Start

A

yes

yes

yes

no

no

no

Date

Time

Wheeze

Air Exch.

Acc. Musc.

Puls. P-dox.Sp02

Pulse Rate

Resp. Rate

Peak Flow

FEV1

FEF 25–75

Initials

Initials

Assessment(Phase II) 1 2 3 4

Time

InitialsOxygen

Albuterol in 2 cc salineCromolyn/2.5 mg Alb.

Prednisone (mg)

Treatment(Phase II) 1 2 3 4

Dischargecriteria

met

Patientcondition

worse

Four q3haerosols

given

Ayes

yes

yes

no

no

no

to page 2

Page 1

B

University Hospitals of ClevelandAsthma Care PathAssessment & Treatment Record(pediatric inpatients)

Height __________ cm Weight __________ kgo Intensification Record

sc Epineph. (mg)Atrovent/5 mg Alb.iv Solumedrol (mg)

sc Epineph. (mg)Atrovent/5 mg Alb.iv Solumedrol (mg)


ipratropium bromide to b2-agonist therapy didnot improve clinical outcomes in hospitalizedchildren with acute bronchospasm. The asthmacare algorithm, used as a research and decision-making tool, provided valuable evidence to theasthma care team regarding efficacy of drugs usedin patient care.

Comparison of Efficacy of Levalbuterol versusRacemic Albuterol

The same asthma care algorithm was used in arandomized, double-blind study to compare theefficacy of levalbuterol 1.25 mg (278 patients) orracemic albuterol 2.5 mg (269 patients) inreducing hospital admissions in children aged 1-18 years.37 Most patients were African-Americanboys with moderate-to-severe chronic asthma.Levalbuterol significantly reduced the rate ofhospital admissions compared with racemicalbuterol (36% vs 45%, p=0.02, Figure 5), whichrepresented a 9% absolute reduction and a 20%relative reduction in hospital admission rates. A9% reduction in admission translates into anannual cost savings of approximately $180,000 atthis institution. After controlling for the studydrug group, children who used racemic albuterolfrequently before the emergency department visitwere approximately 35% more likely to beadmitted. After controlling for age, number ofaerosol treatments, and corticosteroid use, therelative risk of admission for children whocontinued to receive racemic albuterol in theemergency department was 1.25 (95% confidence

interval 1.01–1.57). No significant differenceswere noted between treatment groups inreduction of length of stay, number of aerosoltreatments required, or adverse effects.

Factors that may have played a role in the lackof difference between the two treatments in theirability to reduce length of stay include thefollowing: more severely ill patients in thelevalbuterol group hospital cohort (as a result ofhigher emergency department discharge rate),unmeasured pulmonary function or atopic status,or short hospital length of stay before the study.The asthma care algorithm proved to be aneffective tool that provided data to support theefficacy, safety, and potential cost savings oflevalbuterol compared with racemic albuterol inthe treatment of acute bronchospasm in children.

Conclusion

A care algorithm is a highly effective instrumentfor providing quality care in children withasthma. The clinical protocol design process canbe described as a four-phase process. There aresome standards that are necessary within amedical institution for the successful developmentand implementation of clinical protocols. Amultidisciplinary, committed collaboration with aphysician “champion” who can serve as theprotocol development team manager will drivethe process forward in an efficient manner.Asthma care team members must be committedto patient-focused care, as well as to the need touse resources wisely and effectively. Finally, theentire health care team must recognize the impor-tance of identifying and measuring objectivehealth outcomes that will aid in the pursuit ofbest practices and quality of care through thecontinuous reassessment of care standards.

The four main goals of protocols are to imple-ment state-of-the-art medical care, to improvequality of care as measured by defined outcomes,to reduce unnecessary variation in patient carethat contributes to cost and lower quality care,and to provide patient and physician satisfactionwith the care process. These goals were accom-plished by the asthma care algorithm that wasdesigned and implemented at Rainbow Babiesand Children’s Hospital. Use of an asthma carealgorithm reduced the length of stay and costsassociated with prolonged treatment andhospitalization. Data collected from the asthmacare algorithm were used as evidence for makingdecisions regarding effective and safe treatmentof acute bronchospasm in children.

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Figure 5. Use of the asthma care algorithm as a researchtool. Primary end point (rate of hospital admissions) in astudy comparing the efficacy of levalbuterol and racemicalbuterol in children with asthma.37

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Acknowledgment

The author would like to acknowledge thecontributions of Kim Poinsett-Holmes, Pharm.D.,Poinsett Publications, Inc., for her editorial assistancein the preparation of the manuscript.

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Question and Answer Discussion

Question: How do you collect the outcomes datafrom using the asthma care protocol? Are thevariables actually identified in the protocol?

Mr. Myers: Most of the outcomes data that wewant or that we track on a regular basis arecollected in that protocol, so the protocol canbe considered a type of charting mechanism.In the protocol, there is a predefined form on

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which the residents will record results fromthe complete history and physical examination.All the data that we track are outcomes withthe exception of financial data. We take thedata from our protocol and enter them into adatabase. The hospital can then providepatient-by-patient financial data based on thisinformation.

Question: How did you manage to have anincrease in Medicaid reimbursements usingthis protocol?

Mr. Myers: From year to year, Medicare andMedicaid reassess the amount that they will

reimburse for a particular diagnosis-relatedgroup based on regional and historical dataand general annual health care costs. Sincewe were holding costs of asthma care downrelatively successfully over a period of time,costs were staying flat and reimbursementwas inching up over a period of time. In thebenchmark data that I showed you, the 3.2-day length of stay was a $2800 cost/case inthe Medicaid population, which was 65% oftotal inpatient asthma admission volume. Wewere losing, on average, $641/patient. So, wewent from losing $641 to a gain of $1400–$2000/year.

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The Value of Care Algorithms

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