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    2000;106;1006Pediatrics

    Kevin B. Johnson, Carol J. Blaisdell, Allen Walker and Peyton EgglestonEffectiveness of a Clinical Pathway for Inpatient Asthma Management

    http://pediatrics.aappublications.org/content/106/5/1006.full.htmllocated on the World Wide Web at:

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    of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.Boulevard, Elk Grove Village, Illinois, 60007. Copyright 2000 by the American Academypublished, and trademarked by the American Academy of Pediatrics, 141 Northwest Point

    publication, it has been published continuously since 1948. PEDIATRICS is owned,PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly

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    2000;106;1006PediatricsKevin B. Johnson, Carol J. Blaisdell, Allen Walker and Peyton Eggleston

    Effectiveness of a Clinical Pathway for Inpatient Asthma Management

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    concern was that residents in training simulta-neously assume the role of primary inpatient careprovider, teacher, administrator, and student. Wean-ing the nebulized -agonists of a patient with asthmais one of many responsibilities in this setting and hasa particularly low priority in the evening and earlymorning hours, when fewer staff are available. Sim-ilarly, respiratory therapists are not adequatelystaffed to assess each patient and administer eachnebulized-agonist. Attending staff and senior res-idents are less available than are interns and wouldnot be likely to provide assistance in a timely man-

    ner. We hypothesized that an approach using ourregistered nursing staff to evaluate and modify neb-ulized-agonist therapy might improve the rate andconsistency of weaning. However, this change inpractice could either improve or worsen other out-comes, including length of stay and readmissionrates. For example, the pathway could increase thenumber of subsequent urgent care, ED, or inpatientencounters for patients who were discharged tooquickly. Therefore, we initiated a study to determinethe impact of a clinical pathway for inpatient asthmamanagement on the patients duration of hospitaliza-tion, amount of bronchodilator therapy, and fre-

    quency of readmissions within 2 weeks of discharge.METHODS

    Study Design

    This was a randomized, controlled study conducted from thesummer of 1995 through the summer of 1997 at Johns HopkinsHospital, an urban academic medical center. There are 500 pe-diatric admissions for asthma annually, accounting for just over7% of all admissions to the pediatric service. The clinical pathwaywas constructed over a 4-month period before beginning thestudy. A pediatric multidisciplinary team, consisting of generalhospital-based physicians, pulmonologists, emergency medicinephysicians, outpatient physicians, clinical nurses, a respiratorytherapists, social workers, and other members of our asthma careteam participated actively in the design of the pathway. In addi-tion to the pathway, a weaning protocol was constructed, based on

    the NHLBI guidelines (Fig 1). Four months before starting thestudy, all nursing staff on our clinical research (intervention) unitwere taught how to assess patients with asthma using a train-the-trainer approach, with 1 attending physician and 4 senior resi-dents as the educators. This group used a standard teaching planthat had been constructed by a nurse educator in our departmentto train the senior nurses on the intervention unit. These seniornurses then conducted one training session on the unit duringeach nursing shift, and conducted additional one-on-one sessionsas new nurses were hired during the study. The senior residentswho helped with training completed their residency before thestart of the study and, therefore, were not included in the study.Nurses and physicians at this site were familiar with the designand operation of clinical pathways.

    The clinical pathway was designed for patients between 2 and18 years of age, who were being admitted to the hospital with aprimary diagnosis of an asthma exacerbation, and who were notcared for by an asthma specialist. Patients meeting these criteriaand whose families had a phone or pager were eligible for thestudy. Patients admitted to the intensive care unit and patientswho had previously been enrolled in the study were excluded.Study enrollment also required that inpatient beds be available in

    both our intervention and control sites at the time of admission, sothat randomization could take place.

    After written, informed consent was obtained, each patientsfamily completed an enrollment questionnaire, after which thepatient was randomized to a bed on either the intervention unit ora control unit. The control and intervention units were located ondifferent floors within the hospital. Although housestaff coveragewas the same on both units, there was no exchange of nursing staff

    between the control and intervention units. Nurse-to-patient ratioswere identical on both units, with more acutely ill patients receiv-ing a more nursing time (1:23) and more stable patients receivinga bit less time (1:45). Staff demographics and experience innursing were similar. Patients admitted to the intervention unitreceived care according to the clinical pathway. Nursing staff onthe intervention unit assessed patients before each nebulized -ag-onist, using the guidelines in Fig 1. If the patient met criteria forchanging the frequency of therapy, then the nurse notified thehouse officer on call, who assessed the patient and determinedwhether the patients therapy could be weaned. If the patient didnot meet criteria for weaning, the nurse administered the treat-ment and reassessed the patient to ensure that the patients symp-toms were not worsening. Nursing staff on the control unit fol-lowed our usual standard of care, including obtaining vital signs

    before administering each nebulized -agonist. They did not de-termine whether patients were ready to be weaned from theirmedications. However, they would notify the house officer ifasked to before administering a nebulized -agonist (as was oftenthe case when house officers were ready to assess a patient forweaning). Control patients received education about the use of aninhaler and spacer, as well as some coordination of postdischargecare from our case management team.

    After patients were discharged, one of the investigators (K.B.J.)reviewed the chart and the medication administration documen-tation to record the time the discharge order was written, theactual time of discharge, and details about when and what med-ications were administered during the hospital stay. Dischargemedications were written on a follow-up form, which was given toa research assistant. This person was blinded to the patientsgroup assignment. The research assistant conducted phone fol-

    Fig 1. Weaning guidelines for asthmainpatient clinical pathway.*

    TABLE 1. Key Features of the Clinical Pathway

    Nurse-driven protocol for weaning bronchodilatorsPeak flow measurement (for children over age 5 y) every 4 h,

    before and after nebulizationAsthma teaching essentials, including spacer and peak flow

    meter training, beginning the day of admissionPrescriptions for home therapies given to family before

    dischargeEarly contact between attending physician and private medical

    doctor to establish plan for asthma management and improvecoordination of care

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    low-up of each patient at 1 day, 1 week, and 2 weeks afterdischarge, to determine whether there had been any unscheduledhealth care encounters related to asthma. For patients who couldnot be reached by phone at the end of 2 weeks, we reviewed themedical records and computer scheduling system data at our site,as well as those of our affiliated health management organization,for evidence of unplanned encounters related to asthma.

    Analysis

    The study was designed to evaluate 4 main variables. The firstof these, the duration of hospitalization, was defined as the num-

    ber hours that elapsed from the first every 2-hour bronchodilatoruntil the time the discharge order was written. We chose to use thefirst every 2-hour nebulized -agonist as a standard starting point,which also is a point at which we typically admit patients to a bedoutside of intensive care. The study also evaluated the number ofnebulization therapies, defined as the number of nebulized -ago-nists given during the hospitalization (within the time periodabove); and the number of unplanned health care interventions,defined as the number of urgent care, emergency department, orinpatient encounters related to worsening symptoms of asthmawithin 2 weeks of discharge. Finally, the study examined thehospital charges for each patient.

    Data for the first 2 dependent variables were obtained byreviewing the clinical pathway, and the medical record after thepatient was discharged. A research assistant obtained data aboutunplanned health care interventions. Each family completed asurvey at the time of enrollment to provide data about the pa-tients disease severity, medical history, home environment, andsocioeconomic status. Hospital charge data were obtained fromour inpatient charge database.

    Initial sample size was calculated at 120 patients per group tohave 80% power to detect a 10% decrease in the number ofunplanned health care interventions, using a 2-tailed of .05. Asample size of 50 patients per group was required to detect a 20%difference in the duration of hospitalization using similar param-eters. Randomization was blocked to allow the study to be safelydiscontinued at 100 patients. Because of a need to make changes inour practice pattern as described in the clinical pathway, and

    because study enrollment was slowing down attributable to lim-ited bed availability, we elected to terminate the study after justover 100 patients had been enrolled.

    Data were analyzed using the SPSS statistical package.18 2 andFishers exact tests were used to characterize any differences be-

    tween our control and intervention groups as measured by nom-inal variables, and the Students t test was used for interval andratio data. Analyses of covariance and multivariate regressiontechniques were used to determine the effect, if any, that con-founders had on our outcomes of interest. Institutional review

    board approval was obtained for this study.

    RESULTS

    Enrollment

    During the study, 432 patients met criteria to beenrolled into the study. Of these, 314 patients wereadmitted on days when a bed was not available oneither our intervention or our control units. There-

    fore, 118 patients were approached to participate inthe study. Six of these patients did not wish to par-ticipate. In addition, 2 patients who were admittedsubsequently asked to be disenrolled from the studyand were excluded from analyses, leaving a total of110 patients, or 26% of the potential enrollees, whoparticipated in the study. One of the patients whodisenrolled did so because of conflicting willingnesson the part of the parents to be involved in the study.This child had been enrolled in the control group.The other childs parent disenrolled after finding thather child, who also was to be assigned to the controlgroup, would have to wait for an inpatient bed. Bothchildren had uncomplicated inpatient stays.

    Control Versus Intervention Characteristics

    Table 2 summarizes the demographic and asthmaseverity characteristics of the control and interven-tion groups. More intervention patients had receivedsteroids before arrival to the ED (22 vs 10; P .02).The control patients were younger on average (8.2 vs6.6 years; P .04). There was no significant differ-ence between the number of preschool or adolescentpatients in either group. Otherwise, the 2 groupswere similar. As is shown in Table 2, there was no

    difference between the 2 groups with respect to com-mon surrogates for disease severity (including schooldays missed and parents perception of asthma se-verity), home pharmacotherapy, reported triggers, ortheir management in the ED. Both groups had simi-lar pulse oximetry values on arrival to the ED, sim-ilar needs for supplemental oxygen at admission,and similar average respiratory rates on admission.

    Length of Stay and Therapy Differences

    The duration of hospitalization was 13 hoursshorter for the patients managed according to theclinical pathway (53.7 vs 40.3 hours; P .01). This

    difference was not affected when controlling for theadministration of steroids before arrival (F .06),and was independent of patient age (F 3.2; P .05). The clinical pathway group had a larger per-centage of patients discharged within the first 24hours of admission (38% vs 14.5%;P .01), as shownin Fig 2. In addition, there was a significantly shorterduration of every 2-hour nebulized -agonist ther-apy in the clinical pathway group, as shown in Table3, with a trend toward a smaller mean number ofnebulized -agonists at every frequency at whichthey were administered. Table 4 shows the effect ofthe clinical pathway on other variables of interest.

    There was a significant difference between the rou-tine (room) charges and medication administrationcharges between the 2 groups. In addition, there wasa trend toward lower mean medication and labora-tory tests charges between the groups. There was nosignificant difference in the use of other resources

    between groups. There was an expected significantdifference between the 2 groups with respect to ther-apy charges, attributable to the fact that both nursesand respiratory therapists administered nebulized-agonists on the control unit, while only nursesadministered this therapy to patients on the clinicalpathway.

    Adverse Events

    Phone follow-up at 2 weeks was completed for 77patients. The other patients either were lost to fol-low-up after discharge (n 21) or had phone fol-low-up at 1 week, but not at 2 weeks after discharge(n 12). Charts and electronic schedule records werereviewed for all patients, regardless of whetherphone follow-up was completed. One patient in eachgroup made a phone call to their care provider be-cause of worsening asthma symptoms in the 2 weeksafter discharge. Two patients in the control grouphad unscheduled clinic visits for asthma symptoms.No patients were admitted to the hospital in the 2

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    weeks after discharge. One control patient had a visitto the emergency department within the 2-week pe-riod with a chief complaint of wheezing but was freeof symptoms and subsequently discharged after 3nebulization therapies. There were no deaths in ei-ther group.

    DISCUSSION

    This study demonstrates that a clinical pathwayfor children with asthma, using a nurse-driven

    weaning protocol adopted from nationally acceptedguidelines, significantly decreased the length of hos-pitalization, the charges associated with the admis-sion, and the overall nebulized -agonist use. Whatmay seem to be a modest decrease in the length ofstay (13 hours) has significant implications for aninpatient unit, in addition to the modest decrease incharges incurred by each patient. Consider, for ex-ample, the impact that 13 additional hours in thehospital will have on bed availability. If we assumethat we admit 600 patients each year, with an aver-age length of stay of 53.7 hours, then these patientswill occupy 600 beds for 31 800 hours. If we decreasethe length of stay to an average of 40 hours, we will

    create 7800 hours of bed availability, which willmake room for 195 additional patients. From theperspective of an insurer, this pathway will reducethe per-patient charges for an inpatient stay, includ-ing inpatient physician professional fees, and medi-cations. These families also would welcome otherimprovements that relate to a shorter length of stay,including reducing costs associated with transporta-tion to and from the hospital, lost work hours, andpotentially less nosocomial spread of disease.

    Our weaning protocol is based on clinical param-eters suggested by the NHLBI asthma guidelines.4

    We asked primary nurses to wean patients fromnebulized -agonist therapy in our institution be-cause our registered nurses are primarily responsiblefor obtaining vital signs and administering thesemedications, and because we do not have 24-hourrespiratory therapy on a consistent basis. Neverthe-less, we believe that either nurses or respiratory ther-apists could function in this role, if they have beensuitably educated and tested.

    This is, to our knowledge, the first study demon-strating an impact of an asthma clinical pathway onthe length of stay. Two points should be noted about

    TABLE 2. Comparison of Clinical Path and Control Group Demographics and Disease Severity*

    Variable Clinical Path Control PValue

    Total subjects 55 55 NSAverage age 8.2 6.6 .04Gender (# male) 38 32 NSRace (# black) 50 54 NSMedical assistance (%) 81 80 NSArrived from home (%) 76 81 NSCaregiver a high school graduate (%) 34 38 NSNumber children (14 y) in home 2.0 2.5 NSED visits/y 4.2 3.4 NSAdmissions/y 1.7 2.1 NSSchool days missed/y 11 9.9 NSPerception of severity (% without

    symptoms between episodes)68 58 NS

    ComorbiditiesAtopy 14 8 NSHeart disease 2 0 NSHistory of sinusitis 8 4 NSHistory of pneumonia 17 13 NSChronic lung disease of prematurity 5 3 NSHuman immunodeficiency virus 1 0 NSCystic fibrosis 0 0 NS

    Exposure to tobacco smoke 22 18 NSExposure to pets in the home 33 35 NSExpremie 11 4 NSHome medications

    Metered-dose inhaler -agonist 16 21 NS

    Nebulized-agonist 30 25 NSChronic steroids 1 2 NSCromolyn sodium 22 17 NSInhaled steroids 8 11 NS

    ED managementPrednisone before arrival 22 10 .02Albuterol nebulizer/metered-dose

    inhaler before arrival25 17 NS

    Albuterol doses in ED 6.1 6.2 NSIpatropium bromide doses in ED 1 1.1 NS

    Severity on admissionSpo2 on arrival 94 93 NSOn supplemental oxygen at admission 20 21 NSRespiratory rate on admission 40 38 NS

    NS indicates not significant.

    * Data obtained from parent report. Values do not differ from those of general hospital admissions for asthma.

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    this conclusion. The first point is that we reported alength of stay in hours rather than in days, which isthe more common practice. Although many hospitals

    bill patients based on whether they were present ona midnight census, this crude measure of length ofstay does not account for overall hospital census,which is a more accurate depiction of activity. Usinga length of stay measured in hours allows us torecognize the potential for a higher overall numberof admissions. More admissions benefit both the hos-pital and any urgent care facilities that might beholding patients in anticipation of a bed becomingavailable. The second point is that at least one otherstudy by Kwan-Gett and colleagues17 reported an

    average length of stay of 2 days, which is extremelyshort3 days shorter than the national medianlength of stay. The study by Kwan-Gett might havesuffered from a ceiling effect, making it less likely toshow an advantage to using clinical pathways even ifone existed.

    One of the interesting outcomes of the clinicalpathway was a more rapid weaning of bronchodila-tors in the intervention versus the control group. Bydiminishing the duration of more frequent therapies,this approach will decrease the time that the healthcare team spends administering medications and

    checking vital signstime that can be spent assess-ing the patient and educating the patient and family.In fact, the rapid weaning of bronchodilators couldpotentially relieve nurse and respiratory staffing, be-cause these patients can be managed with a slightlylower nurse-to-patient ratio. Because more frequentadministration of albuterol is occasionally associatedwith insomnia, tremor, agitation, hyperglycemia, hy-pokalemia, and cardiac complications,19 more rapidweaning of bronchodilators also will decrease therisk of iatrogenic complications.

    The intervention in this study was clearly morecomplex than simply allowing nursing staff to have

    autonomy over the weaning of-agonist therapy. Asshown in Table 1, the clinical pathway described anapproach to asthma education and discharge plan-ning. Although this study had insufficient power todetermine whether the clinical pathway reducedacute care encounters in the period after discharge,we are reassured that our approach to education anddischarge planning is likely to decrease postdis-charge symptoms. However, a larger study will beneeded to better estimate the effect of improved dis-charge planning and asthma education.

    One of the unanswered questions arising from thisproject is the effect of clinical pathways on overallnursing workload. This pathway makes nurses ac-

    Fig 2. Comparative length of stay distribu-tions for clinical path and control groups.

    TABLE 3. Comparative Frequency of-Agonist Administra-tion

    Nebulized-AgonistFrequency

    Number of Doses

    Control Clinical Path P Value

    Every 2 h 6.5 4.5 .02Every 3 h 5.9 3.7 .002Every 4 h 4.7 3.5 .044Every 6 h 2.2 1.4 .01Every 8 h 0 .1 .32

    TABLE 4. Comparative Outcomes in Clinical Path and Con-trol Groups

    ClinicalPath

    (n 55)

    Control(n 55)

    PValue

    Routine charges (room charge) $2407 $3116 .001Medication charges $ 129 $ 153 .24Laboratory test charges $ 21 $ 42 .10Therapy charges

    (respiratory therapy)$ 42 $ 250 .001

    Follow-up appointmentscheduled

    66% 77% .20

    Prednisone at discharge 98% 98% 1.00Days to follow-up appointment 5 5.4 .81

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    countable for weaning the frequency of patientsmedication and educating patients and families.Rather than increasing the amount of time a nursespends with each patient, nurses who use this path-way believe it optimizes their time. Nurses believethat it takes 5 minutes to set up a nebulized bron-chodilator therapy. Because we are able to weanpatients from more frequent therapy, we decreasethe time nurses are engaged in this activity. Nursesroutinely have assessed patients in our institution

    the pathway allows them some autonomy in deci-sion-making based on their assessment. The educa-tion aspects of the pathway should not increasenursing time, because our nurses have been educat-ing patients and families before we standardized theprocess. The less organized educational efforts thatnurses used before the pathway resulted in timespent finding all the necessary handouts and deter-mining what the patient had already been taught.Therefore, their assessment of the pathway is that itsaves time, rather than having the opposite effect ontheir day.

    Clinical pathways may affect patient care in otherways. For example, this pathway would be expectedto increase the caseload of asthmatics in our hospital

    by making more beds available for admissions. Therapid admission and discharge of these patients willincrease the intensity of care delivered by our nurs-ing and resident staff. From the nursing perspective,more intense care demands higher staffing, which isunlikely to happen without a significant increase inpatient acuity. From the standpoint of resident edu-cation, increased asthma admissions resulting fromthe pathway may or may not improve resident edu-cation. Taking on a more reactive stance towardmedication weaning could detract from the educa-tional goals of a residency, but admitting more pa-

    tients with asthma could enhance the educationabout asthma. In the managed care era, this question

    becomes extremely important and should be the sub-ject of additional study.

    Study Limitations

    This study was limited primarily by an inability toenroll some eligible patients because of bed short-ages. Before patients could be approached about thisstudy, a bed had to be available on both our inter-vention and control units. As the study proceeded, ahigh-inpatient census made beds largely unavailable.Therefore, in the interests of the patients, we chose to

    assign these patients to the first available bed ratherthan to enroll them in the study. There was no dif-ference between the length of stay for these patientsand for our control group. However, we had ade-quate power with our existing sample to detect aclinically significant difference in length of stay butnot to detect a 20% or smaller difference in un-planned health care interventions. Therefore, the lim-ited enrollment could disguise a negative effect thatthe clinical pathway might have had on unplannedhealth care interventions relative to our usual prac-tice pattern.

    Our intervention group had a higher percentage ofpatients who received steroids before their arrival to

    the ED. Although studies have shown that early useof steroids in an asthma exacerbation may reduce theneed for hospitalization,2023 few studies have eval-uated whether such therapy affects the outcome ofpatients who are admitted.22 In our study, control-ling for the administration of steroids before arrival

    by analysis of covariance was not associated with ashorter length of stay. There also was a statisticallysignificant difference in the mean age of our 2groups. However, there was no significant difference

    between the number of preschool children or adoles-cents in either group. In addition, analyzing our datawith and without appropriate controls for steroiduse and age did not significantly affect the outcomevariables of interest.

    Resident education about asthma has become animportant topic at most academic medical centers.One possible confounder of this study is that resi-dents could have become more knowledgeable abouthow best to manage patients with asthma during thestudy. Because any such improvement in asthmamanagement should have been evident in both ourcontrol and intervention groups, it would haveserved to decrease rather than increase the differ-ences in outcomes between these groups. A similarresult should have been seen from any Hawthorneeffect24 related to the fact that residents were awarethat they and their patients were being studied.

    Because the intervention unit had a smaller possi-ble census than did the control units, the nursingratio could have been more favorable for aggressivemanagement of asthma at times (and less favorableat other times). This might have contributed to alower length of stay and a more rapid weaning ofpatients. However, we are reassured by the lack ofED or inpatient encounters after these discharges,which suggest that patients did not experience a

    worsening of their symptoms after discharge.

    Implications

    This study provides further evidence of the valueof guidelines such as those developed by the NHLBI.Such guidelines, when carefully evaluated and cus-tomized for a particular setting, can have a signifi-cant effect on the management of patients and on theoutcomes of interest to patients, staff, and adminis-trators. As in all cases, clinical pathways for diag-noses such as asthma can form a framework forperformance improvement in a variety of areas. Clin-

    ical pathways also enable an institution to clearlyidentify processes that vary from an establishedguideline and to investigate whether these practicesare associated with improved outcomes, worsenedoutcomes, or no change in outcomes. These investi-gations lead to adoption of new processes or recom-mendations to discontinue existing processes. In ourinstitution, this study provided evidence to allow usto implement a new approach to asthma manage-ment throughout the institution. It confirmed ourhypothesis that our nursing staff could safely andreliably assess patients and improve our ability towean the frequency of their medications in a timelymanner. Hopefully, additional studies based on the

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    NHLBI guidelines will further improve our ability tomanage this disease.

    ACKNOWLEDGMENTS

    This study was partially supported by the Johns Hopkins Mir-acle Telethon Funds (the Johns Hopkins Childrens Center).

    We thank Jeanne Butta, RN, for her assistance in data collectionand analysis.

    We thank Gerald Loughlin, MD, and Edward B. Chambers fortheir review of this manuscript.

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    JAPANS EMPLOYERS ARE GIVING BONUSES FOR HAVING BABIES

    In the hallways, bathrooms, and lunchroom of the Bandai Corporation, a majorJapanese toy maker, the talk these days revolves around one topican announce-ment that the company will pay employees 1 million yen, or $10,000, for every babythey have after their second child.

    Although many other companies give congratulatory bonuses to workers whobecome parents, Bandai is offering the largest baby bounty in Japan, which is

    struggling to reverse record low birthrates that pose many long-term problems.

    Sims C.New York Times. May 30, 2000

    Noted by JFL, MD

    1012 EFFECTIVENESS OF AN ASTHMA CLINICAL PATHWAY