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* From the National Jewish Medical and Research Center (Dr. Walders), Denver, CO; the Rainbow Babies and Children’s Hospital (Dr. Drotar), Cleveland, OH; Case School of Medicine (Drs. Kercsmar, Schluchter, Redline, Kirchner), Cleveland, OH.
Correspondence to: Natalie Walders, PhD, Division of Psychosocial Medicine A109, National Jewish Medical and Research Center, 1400 Jackson St, Denver, CO 80206; e-mail:waldersn{at}njc.org
Abstract
Study objectives: To examine the effectiveness of an interdisciplinary intervention for pediatric asthma.
Design: Randomized, controlled study.
Setting: Urban tertiary-referral pediatric hospital.
Participants: One hundred seventy-five patients with asthma lacking written treatment plans and presenting with asthma-related emergency department visits (two or more) and/or hospitalizations (one or more) in the past year were randomized to a comparison group receiving medical care alone (n = 86) or to an interdisciplinary intervention group receiving medical care, asthma education, and problem-solving therapy (n = 89)
Intervention: All participants received written asthma management plans, peak flow meters, and spacer devices. The intervention group also received asthma education, an asthma risk profile assessment, brief problem-solving therapy, and access to a 24-h nurse advice line. The primary outcome measure was change in asthma symptoms, and secondary outcomes included health-care utilization and asthma-related quality of life.
Results: Both groups demonstrated significant reductions in asthma symptoms and improvements in quality of life without any between-group differences identified over the course of follow-up. In contrast, the intervention group demonstrated less frequent health-care utilization than the comparison group, with 28% of the intervention group requiring emergency department or inpatient services for asthma compared to 41% of the comparison group (adjusted odds ratio, 1.92; 95% confidence interval, 1.00 to 3.69) over the 12-month follow-up period.
Conclusions: This study examined the effectiveness of an interdisciplinary intervention for undertreated asthma. The intervention did not result in improvements in asthma symptoms, but accomplished modest reductions in the utilization of acute medical care.
Key Words: interdisciplinary intervention • pediatric asthma • problem-solving • randomized controlled trial
Pediatric asthma is a leading cause of health-care utilization, school absences, and activity restriction for children and adolescents.123 Despite considerable advances in the medical management of asthma, coupled with the standardization of treatment guidelines,4 asthma prevalence and morbidity remain high.56 Furthermore, asthma disproportionately impacts ethnic minorities, inner-city communities, and low-income families.789 These factors underscore the importance of implementing and evaluating innovative asthma interventions for groups at high risk for asthma complications.10
Research111213 has suggested that nonadherence, substandard medical care, exposure to asthma triggers, and psychosocial concerns are predictors of asthma risk and are important priorities for intervention protocols. Numerous interventions for improving asthma knowledge and management skills have been evaluated with mixed results. Two recent metaanalyses assessing the impact of pediatric asthma education programs reached somewhat different conclusions, with one study14 noting minimal positive effects, and the other15 reporting significant improvements across multiple domains for asthma education programs.
The existing literature has been limited by the scarcity of interdisciplinary family-based interventions that merge medical, behavioral, and educational components. Moreover, randomized controlled study designs are underrepresented among the published outcome studies. The National Cooperative Inner-City Asthma Study16 (NCICAS) addressed these gaps by assessing the effectiveness of a multifaceted intervention with a high-risk pediatric population using a randomized controlled study design. Children in urban communities aged 5 to 11 years with moderate-to-severe asthma were randomized to either a control group (no intervention) or to an intervention program consisting of a series of group and individual sessions (focused on adherence, behavioral, and environmental issues), which was led by an asthma counselor (medical social worker). At the 12-month follow-up, the intervention group reported fewer symptom days and less frequent hospitalizations than the comparison group, and improvements were sustained over a second year of monitoring.17 Using a randomized controlled design, we examined whether an interdisciplinary intervention that combined medical, educational, and psychosocial techniques would improve asthma management. We hypothesized that an interdisciplinary intervention consisting of a written asthma treatment plan, asthma education, an asthma risk assessment,18 problem-solving, and access to a 24-h nurse advice line would reduce asthma symptoms and health-care utilization and improve quality of life.
Materials and Methods
Participants
English-speaking children between the ages of 4 and 12 years with physician-diagnosed asthma of at least 3 months duration and their families were eligible. The inclusion criteria for identifying patients with undertreated asthma included the following: (1) two or more emergency department visits for asthma in the past year and/or (2) one or more asthma hospitalizations in the past year; and (3) the lack of an asthma treatment plan. Patients under the active care of an asthma specialist, with a history of near-fatal asthma, or a serious comorbid chronic health condition were excluded. The study was conducted in an urban academic tertiary-care medical center. The University Hospitals of Cleveland institutional review board approved all study protocols, measures, and procedures. The study was initiated on March 22, 1999, and the final follow-up visit was completed on October 29, 2001.
Study Design
The study included two visits to the medical center prerandomization, and an additional visit for families randomized to the intervention group, along with six follow-up contacts, as depicted in Figure 1 . Participants were recruited from outpatient clinics, inpatient units, and emergency departments. All eligible patients and their families made a baseline visit to the medical center, and completed a biopsychosocial assessment. The baseline visit was followed by a 2-week "run-in" period that was intended to limit patient attrition.1920 The only run-in requirement was that patients return for a second visit to the medical center. During the second visit, all participants received a written asthma treatment plan prepared by a pediatric pulmonologist (C.K.) that was based on their asthma severity ratings per National Institutes of Health guidelines.4 The treatment plans contained instructions for general asthma management, responding to worsening asthma symptoms, and managing of acute asthma exacerbations. The individualized plans described symptoms and peak flow readings at each zone of asthma management and recommended modifications in medication use (eg, increase the dosage of inhaled corticosteroids and initiate inhaled bronchodilator therapy) and/or contact with a health-care provider in response to exacerbations. All participants were given a valved holding chamber for use with a metered-dose inhaler (MDI), a peak flowmeter, and a prescription for a 1-month supply of medications to be refilled subsequently by their primary care provider. After receipt of the treatment plan, participants were randomized into either the interdisciplinary intervention group or the standard treatment (comparison) group using a permuted block randomization scheme with random block sizes stratified by the age of the child (4 to 9 vs 10 to 12 years of age). Participants randomized into the comparison group completed their second visit after receiving their treatment plan, whereas the intervention group received an additional session of asthma education with a nurse or an asthma social worker. This additional asthma education session, lasting about 1 h, provided families with information on the pathophysiology, triggers, and treatment of asthma. During the interval between the second and third study visits, an asthma risk profile (ARP) was compiled by psychologists (N.W. and D.D.) for each family that had been randomized to the intervention group. The ARP involved a systematic review of baseline data to identify families’ biopsychosocial barriers to effective asthma management. The identification of ARP barriers allowed for a tailored problem-solving session targeting each intervention family’s particular challenges.21 Intervention families returned for a third study visit to participate in a cognitive-behavioral problem-solving session based on their ARP results.2223 At the conclusion of the third study visit, intervention families also received access to a 24-h nurse advice line. The purpose of the nurse advice line was to assist families in the implementation of asthma treatment plans during symptom exacerbations and to provide unrestricted access to medical advice, a recommended intervention component.24 Accessing the advice line was voluntary, and participants in the intervention group were instructed to contact the hotline as many times as they deemed necessary. The nurses providing telephone advice were unaffiliated with the research center or protocol. Families in the intervention group were contacted by telephone 4 weeks following their third study visit to reinforce problem-solving strategies.
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Measures
ARP:
Baseline data for the intervention group were reviewed in a structured manner by a psychologist to identify primary asthma management barriers using the ARP system. The identification of ARP risk barriers organized the problem-solving intervention. Up to four primary barriers were identified for each intervention family and were selected based on the following categories established as risk factors in the asthma literature182526: adherence behavior; distribution of management tasks among family members; economic resources; emotional factors; family stress; health beliefs; health-care utilization patterns; intervention skills; knowledge limitations; prevention skills; and school management concerns.
Medical Outcomes: Two asthma symptom scores were measured, including the number of days with wheeze or an asthma attack during the previous month (ie, 0 to 30 days) and a symptom score. The symptom score rated the frequency of symptoms (eg, shortness of breath, chest tightness, wheezing, cough, and nocturnal symptoms) on a 5-point Likert scale (ie, 0 [none of the time] to 4 [all the time]). Emergency department visits and hospitalizations during the follow-up period were tracked by parent report and were verified via medical chart review to confirm the date and reason for utilization.
Asthma-Related Quality of Life: The Children’s Health Survey for Asthma (CHSA) was used to assess asthma-related quality of life.2728 The following four CHSA quality-of-life scales were included in the present study: child physical health; child emotional health; child activities; and family activities. The CHSA has demonstrated good internal consistency reliability, test-retest reliability, and content validity.27
Statistical Analysis
A target sample size of 86 subjects randomized per group was chosen to provide an 80% power to detect a mean difference of 2.8 symptom days in the outcome of mean symptom days per month, averaged across 1 year of follow-up, using a two-sided t test with significance level of 0.05. This sample size assumed a SD of 6.0 symptom days and allowed for a 15% dropout. Group differences at baseline were examined across demographic and illness variables to ensure group comparability. Baseline between-group comparisons of nominal and ordinal variables were made using the Pearson’s 
2 test or the Fisher exact test, and Cochran-Armitage trend tests, respectively. For continuous data, we used the two-sample t test or the Wilcoxon rank-sum test. Analyses of symptom days, symptom score, and asthma-related quality of life were conducted using mixed repeated measures modeling, adjusting for baseline asthma severity, age stratum (ie, < 10 and > 10 years of age), and the season of the year during which the visit occurred. In these models, baseline levels of outcomes were adjusted for either by examining the mean changes from baseline, or by including the baseline level as a covariate. Health-care utilization was examined as a dichotomous variable comparing patients with either an emergency department visit and/or a hospital admission over the course of follow-up to those patients without any health-care utilization. A logistic regression model was used to compare groups adjusting for baseline asthma severity and age stratum.
Results
A total of 327 eligible families were asked to participate in the study, and 216 families (66%) completed a baseline visit. Of those families, 175 (81%) returned for their second visit and were randomized to either the intervention group (n = 89) or the comparison group (n = 86). Six families who were randomized to the intervention group did not return for their third visit, but the available follow-up data were included in the analyses. A detailed description of attrition has been published elsewhere.29
No significant demographic differences were found between the intervention and comparison groups at baseline on child age, child sex, ethnicity, caregiver marital status, caregiver education level, caregiver occupational status, or family insurance status. The intervention and comparison groups were comparable in asthma severity, the number of asthma hospitalizations in the previous year, and the number of emergency department visits in the previous year (Table 1 ).
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Utilization of Asthma Advice Line
Over the course of the study period, the asthma nurse advice line was utilized 31 times. Only 26% of families with access to the advice line used it. Of the 31 calls made to the advice line, 7 (23%) were followed by a same-day emergency department visit or hospital admission.
Discussion
The results of our interdisciplinary intervention were mixed. The intervention group did not show evidence of reduced asthma symptoms or improved measures of quality of life beyond the changes demonstrated by the comparison group. However, the interdisciplinary intervention group had less frequent health-care utilization for asthma over the course of the 1-year follow-up period. The comparison group was approximately twice as likely to experience an emergency department visit or hospital admission than the intervention group. In light of research30 questioning the utility of written treatment plans for asthma, our finding suggests that additional support and behavioral tools may be additions that are necessary to maximize the effectiveness of written asthma treatment plans.
It appears that the intervention used in our study provided families with tools to respond more effectively and independently to acute exacerbations, thus resulting in less need for emergency or inpatient health care. These improvements did not translate to reductions in chronic asthma symptoms or improvements in quality of life above and beyond those noted for the comparison group. This may be due to the fact that both groups received an enhanced level of asthma care. We provided all participants with written asthma treatment plans, MDI training, and access to spacers and peak flow meters prior to randomization. In this regard, we lacked a true "no treatment control group," and our comparison group may have demonstrated an "intervention effect." Additionally, the lack of between-group differences in symptoms and quality of life may reflect a process of "regression to the mean," due to the fact that study recruitment occurred after an asthma exacerbation. Statistically, when baseline symptoms are high, one would expect to observe subsequent reductions in symptoms.31 An additional consideration is the fact that attrition may have suppressed the strength of the group differences in health-care utilization. Despite our efforts to maximize subject retention, 28% of health-care visits (7 of 25 visits) among those patients randomized to the intervention group were for patients who had not attended their third study visit (ie, those patients lacking access to problem-solving therapy and the asthma nurse advice line). While it is impossible to speculate whether attending the third study visit and receiving the complete intervention package would have influenced health-care utilization, it is noteworthy.
While our intervention was able to reduce health-care utilization, the more expansive NCICAS was able to significantly lessen the symptom burden in addition to reduced utilization.16 Our study differed from the NCICAS in several ways. The NCICAS included a true control group, whereas our study design incorporated a comparison group that received enhanced asthma care. Our study also differed from NCICAS by featuring an interdisciplinary intervention team of physicians, nurses, psychologists, and social workers, rather than asthma counselors, the use of individual family intervention sessions, rather than group sessions, and a briefer intervention protocol with fewer face-to-face contacts. Additionally, we provided all families with a written asthma treatment plan, while the NCICAS study17 instructed caregivers in the intervention group to obtain plans from their pediatricians, and only 54% were able to do so. Last, our study was unique in the use of cognitive-behavioral problem-solving techniques and access to a 24-h nurse advice line to support families when responding to acute asthma exacerbations.
Our study had several limitations. First, the intervention may have been too brief in duration and too limited in scope to impact the full spectrum of outcomes. It is also possible that the measures used to assess symptom reduction were not sufficiently sensitive to detect intervention effects and to differentiate between the groups. The results of the ARP demonstrated the complexity of the barriers to asthma management that were encountered within the intervention group, and, despite the use of a tailored intervention approach, the barriers faced by some families may have been too burdensome to surmount. Most families presented with a constellation of long-standing barriers reflecting entrenched patterns of treatment nonadherence, emotional distress related to asthma, and inadequate prevention skills. The potential mismatch between the complex needs of families and the brief nature of the present intervention study has been highlighted by other studies in the literature3032 that were unable to document comprehensive treatment effects using more extensive protocols. The demonstration of consistent and pervasive improvements in asthma outcome among high-risk patient populations may require much more intensive intervention efforts. For instance, substantial improvements in adherence and quality of life, along with reductions in asthma morbidity and health-care expenditures, have been reported among patients receiving long-term day treatment for asthma in a hospital setting with the length of treatment ranging from 2 to 51 days (mean duration, 15.6 days).33
In conclusion, we found that our interdisciplinary intervention did not decrease asthma symptoms or improve quality of life but was successful in decreasing health-care utilization. This suggests that families in the intervention group were able to gain and maintain some level of enhanced family-based asthma management skills. The effectiveness of the interdisciplinary model examined in the present study, along with others, underscores the potential utility of blending medical and behavioral strategies in the management of pediatric asthma.173435
Acknowledgements
We gratefully acknowledge the assistance of Terri Casey, RN, Jill Goodman, LISW, and Pamela Scott, RN, in the successful completion of this project.
Footnotes
Abbreviations: ARP = asthma risk profile; CHSA = Children’s Health Survey for Asthma; CI = confidence interval; MDI = metered-dose inhaler; NCICAS = National Cooperative Inner-City Asthma Study
This research was supported by the American Lung Association (LH-002), the National Institute of Mental Health (18830), The Cleveland Foundation, the American Psychological Association, and the Association for the Advancement of Behavior Therapy.
Received for publication June 24, 2004. Accepted for publication July 8, 2005.
References
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