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Effectiveness of a Parental Educational Intervention in Reducing Antibiotic Use in Children

A Randomized Controlled Trial

Taylor, James A. MD*; Kwan-Gett, Tao Sheng C. MD, MPH; McMahon, Edward M. Jr. MD

Author Information
The Pediatric Infectious Disease Journal: June 2005 - Volume 24 - Issue 6 - p 489-493
doi: 10.1097/01.inf.0000164706.91337.5d
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Abstract

The emergence of antibiotic resistant bacteria, particularly drug-resistant Streptococcus pneumoniae, is one of the most troubling public health problems in the United States.1–5 Although multiple factors may encourage the development of drug-resistant bacteria, evidence suggests that the injudicious use of antibiotics has been a major contributor.6–8 Fortunately there are also data to suggest that reducing the use of antibiotics lowers the prevalence of drug-resistant bacteria.9,10 Thus it is crucial that efforts be made to reduce the injudicious use of these medications.

Practice guidelines have been published on the judicious use of antibiotics for management of otitis media, sinusitis and upper respiratory tract infections (URIs) in children.11–14 It is encouraging that some data indicate a decrease in the frequency of antibiotic prescribing during the past decade.15,16 However, much of the ongoing unnecessary use of antibiotics may be driven by parental demands and physician perception of, and response to, these demands.17,18

We conducted a randomized controlled trial assessing the effect of a parental educational intervention on the judicious use of antibiotics in modifying both the attitudes of parents about these medications and the rate of antibiotic prescriptions for their children. Previously we reported that an educational pamphlet on antibiotics in children given to parents, augmented by a video from one of their child's pediatricians, resulted in changes in parental attitudes that were more supportive of the judicious use of these medications.19 The educational intervention was more effective in modifying parental attitudes about specific indications for antibiotics in young children (the lack of need for antibiotics for treatment of green nasal discharge, for example) than in changing more generic perceptions of the problem of overuse of these drugs. Before conducting the study, we postulated that a change in attitudes of parents would lead to fewer demands on pediatricians for antibiotics and fewer prescriptions for these medications. To test this hypothesis, we compared antibiotic use in children of parents who received the educational intervention and among children of parents in the control group.

METHODS

The study was conducted by the Puget Sound Pediatric Research Network, a regional practice-based research group comprised of Seattle, WA area pediatricians. Some of the details of the design of the study have been published previously.19 In brief, eligible patients were healthy children younger than 24 months old seen in the offices of participating pediatricians. Children and their parents were recruited for the study at the time of an office visit by a study coordinator who attended each practice on a regularly scheduled basis. After completing a enrollment questionnaire, parents of study children were randomized to receive either educational materials regarding the judicious use of antibiotics (antibiotic education, or intervention, group) or effective injury prevention (control group). Randomization was based on a computer-generated list of study numbers that were consecutively assigned to enrolled patients. In addition, randomization was stratified by practice and in blocks of 10.

Parents assigned to the intervention group received a copy of the educational pamphlet, “Your Child and Antibiotics,” developed by the American Academy of Pediatrics, Centers for Disease Control and Prevention and the American Society of Microbiology, and a video in which the main points discussed in the pamphlet were reinforced. The video, which was professionally produced and ran for ∼5 minutes, featured one of the physicians from the study child's pediatric practice. Parents assigned to the control group received copies of pamphlets developed by the American Academy of Pediatrics as part of the “Towards Injury Protection Program” or TIPP.20 Additional copies of either the “Your Child and Antibiotics,” or TIPP pamphlets, based on randomization, were mailed to parents of study children at 6 weeks and 6 months after enrollment. Parents in both groups were advised to discuss any issue raised in the pamphlets with their child's physician; however, participating Puget Sound Pediatric Research Network pediatricians were not informed of the participation or randomization status of any study patient.

Each study child was enrolled in the project for a 12-month observation period. After completion of this period, the child's medical record was reviewed by the study coordinator. For every visit occurring during the observation period, the study coordinator determined whether the primary reason for the visit was because of upper respiratory tract symptoms (defined as “URI symptoms”) or any other reason, based on the chief complaint. The study coordinator also determined whether a diagnosis of otitis media, sinusitis, or both, was made by the pediatrician and whether any antibiotics were prescribed. In addition to office visits, any written record of a visit to another facility that occurred during the observation period and was included in the practice medical record was reviewed. Finally the study coordinator reviewed the medical record to determine whether the study child transferred to another practice during the observation period. Data on inpatient hospital admissions were not reviewed.

Primary study outcomes included number of diagnoses of otitis media and sinusitis per study child, number of visits per child for which antibiotics (oral or intramuscular) were prescribed for a diagnosis of otitis media, number of visits per child for which antibiotics were prescribed for a diagnosis of otitis media and/or sinusitis and total number of antibiotics prescribed per child. Secondary outcomes were total number of visits per study patient and number of visits for URI symptoms per child. If a patient was switched from one antibiotic to another during treatment, each medication was counted separately. Intramuscular antibiotics given at a visit in which an oral antibiotic was also prescribed were only counted as one antibiotic.

For the analysis, we compared each outcome for children in the intervention group with those in the control group using Poisson regression. The effect of children clustering into different practices was controlled for in the regression models. In addition, the number of days contributed by the child to the observation period was included in the analyses to account for some children transferring to other practices. To evaluate whether the intervention was more effective if provided during the autumn or winter seasons, when URIs are most common,21 a Poisson regression analysis comparing the number of antibiotic prescriptions in intervention and control patients including a intervention-season of enrollment interaction term was also performed. Finally, because of the possibility that the effect of the intervention might be different among parents of children of differing ages, subgroup analyses were done including patients who were younger than 12 months old or 12 months of age or older at enrollment. To account for potential confounding despite randomization, parental education level, number of siblings, day-care attendance, cigarette smokers in the household, previous antibiotic use and age, among children in the intervention and control groups were compared according to χ2 tests for categoric data and t tests for continuous variables. Any variable that was not equally distributed between the 2 groups (P < 0.05) was included in the regression models.

Study patients were enrolled in the project from March 2000 through April 2001. All of the 12-month observation periods were completed by April 2002. The project was approved by the Children's Hospital and Regional Medical Center Institutional Review Board; written informed consent was obtained from the parents of children enrolled.

RESULTS

A total of 500 parent/child dyads were enrolled in the project. However, one child was subsequently diagnosed with complex congenital heart disease; data on this patient were not collected. Among the remaining 499 parent/child dyads, 252 were randomized to the intervention group and 247 to the control group. Data on all 499 patients were analyzed. The characteristics of children in the intervention and control groups are compared in Table 1. As can be seen in Table 1, the 2 groups were very similar. Parents of children in the control group had higher educational levels (P = 0.08) than those in the intervention group. Both unadjusted analyses and those adjusted for parental education were conducted. There were no significant changes in the results after adjusting for parental education level; thus only the results of the unadjusted analyses are presented. Overall 94.6% of study patients completed the entire 12-month observation period in the practice in which they had been enrolled. There was no difference in the number of study days per patient between children in the intervention and control groups (mean values, 357 ± 45 and 358 ± 41 days, respectively; P = 0.79).

T1-3
TABLE 1:
Comparison of Characteristics Among Children in the Intervention (Antibiotic Education) and Control Groups at Enrollment

Data were abstracted on 4924 outpatient visits by study patients; 91.2% of these visits occurred in the child's primary care pediatrician's office. URI symptoms were the chief complaint for 1418 visits (28.8% of all visits). One or more antibiotics were prescribed during 651 visits (45.9%) for which the chief complaint was URI symptoms; 92% of this use was for a diagnosis of otitis media or sinusitis. Conversely antibiotics were prescribed at only 10 visits at which the only diagnosis made was URI and at 7 visits for a diagnosis of bronchitis (2.6% of total antibiotic use for a chief complaint of URI symptoms). Overall the “average” study patient had 9.9 visits, 2.8 visits for URI symptoms, 2.1 diagnoses of otitis media, and received 2.4 prescriptions for antibiotics during the 12-month observation period; a total 1176 antibiotic prescriptions were written for enrolled children.

Comparisons of the main study outcomes among children in the intervention and control groups are presented in Table 2. As can be seen, there were no statistically significant differences for any outcome between children in the 2 groups for any of the measured outcomes. The effect of the intervention on total number of antibiotic prescriptions was similar among patients enrolled during the autumn or winter months and those enrolled during spring and summer (P = 0.72). There were also no significant differences between patients in the intervention and control groups for the number of antibiotics prescribed, number of antibiotics for a diagnosis of otitis media or number of antibiotics prescribed for otitis media and/or sinusitis, when the analyses were limited to the subgroups of children younger than 12 months old, or those 12 months of age or older at enrollment. Although the number of visits and antibiotic prescriptions per study patient varied significantly among the 8 participating practices, ranging from 6.9 to 12.6 for visits (P < 0.001, using analysis of variance) and 0.8 to 3.2 for antibiotic prescriptions (P < 0.001), there was no difference in the number of antibiotic prescriptions for children in the intervention and control groups within any practice.

T2-3
TABLE 2:
Comparison of Outcomes in Patients Whose Parents Received Antibiotic Education (Intervention Group) and Those Whose Parents Received Injury Prevention Education (Control Group)

DISCUSSION

Perhaps the most remarkable finding in this study was that antibiotics were prescribed during 45.9% of visits by young children presenting to their pediatrician for URI symptoms Virtually all of this use of antibiotics was for a diagnosis of otitis media and/or sinusitis. Certainly antibiotics were clearly indicated for a proportion of study patients with these diagnoses. However, it is equally certain that for a significant proportion of the diagnoses of otitis media or sinusitis there was uncertainty regarding the diagnosis and/or need for antibiotic therapy, or the diagnosis was made by the practitioner to justify the use of antibiotics. It is in this exact clinical setting that we believed that our parental educational intervention might be most effective in reducing antibiotic use. Mangione-Smith et al found that private practice pediatricians diagnosed otitis media at 49% of visits by children 2–10 years old presenting with URI symptoms when the physician reported that she or he perceived that the parent desired these medications versus 13% of visits at which the physician did not think the parent wanted these drugs for their child (P = 0.001); similar figures for a diagnosis of sinusitis were 38 and 5%, respectively (P = 0.001). When these diagnoses were made, prescription of antibiotics was nearly universal.18 For our study, we postulated that if parental expectations could be altered by an educational intervention, pediatricians would perceive less demand for antibiotics and prescribe fewer of these medications during visits for young children. Although our intervention resulted in changes in parental attitudes about antibiotics,19 at least in the short term, our results suggest that these changes in the attitudes of parents did not lead to fewer antibiotic prescriptions for their children. Perhaps combining the parental education materials with an intervention aimed at practitioners would be beneficial.

There are several possible explanations for the lack of effect of the educational intervention on antibiotic use. Perhaps the most likely is that, although attitudes about antibiotic use were modified, parents still desired these medications when their child was ill. It is also possible that pediatricians may have failed to detect a change in expectations for antibiotics by parents of children in the intervention group. Previous research indicates that physician perceptions of patient expectations are frequently inaccurate.18,22 We measured changes in parental attitudes about antibiotics 6 weeks after receiving the intervention; perhaps this effect was not sustained for the entire 12-month observation period. That the impact of the intervention was no greater among children enrolled during the fall and winter, when URIs are most common,21 suggests that the negative results of our study are not entirely explained by a diminution of the effect over time. Finally, although the impact on the results is uncertain, one of the more remarkable findings in this study was the high health care utilization by the participating children. The mean number of outpatient visits made by the patients in the study younger than 24 months old at enrollment was 9.9 during a 12-month period. This compares with national estimates of 8.2 visits per year in children younger than 1 year old and 3.6 visits per year in those 1–4 years old.23 It is possible that differences in antibiotic usage between patients in the intervention and control groups may have been more pronounced in a sample of children with lower levels of health care utilization.

Despite data suggesting that antibiotic use in children has declined in the last decade,15,16 we found that antibiotics were prescribed at almost one-half of visits for URI symptoms among children younger than 3 years old. Although the rate of antibiotic use of 2.4 prescriptions/child that we found is higher than the rate of 1.89 reported during a similar period among a nationally disparate sample of U.S. children,16 it is lower than that found in another assessment of office-based pediatricians in which antibiotics were prescribed during 65% of visits for URI symptoms.24

Because of limitations in study design, our results should be interpreted cautiously. Although pediatricians were not informed about which children were involved in the project, it is possible that, through discussion with parents, specific practice patients may have been identified as study participants. This may have resulted in fewer antibiotic prescriptions for children in both the intervention and control groups; this would bias the results of the study toward the null hypothesis. It is also possible that there was a small positive effect from the intervention that we were unable to detect because of our sample size. We had a power of ∼80% to detect a difference of ∼0.5 antibiotic prescriptions during the 12-month observation period between children in the 2 groups; the clinical importance of a smaller effect is questionable. Finally we measured the number of prescriptions given to patients rather than the number of antibiotics actually administered to study children. Anecdotally many of the practitioners in the study frequently advised parents to fill antibiotic prescriptions only if their child failed to improve within 2–3 days after an office visit. This practice of shared decision-making between practitioner and parent has been found to significantly reduce the number of antibiotics administered to children with otitis media.25,26

Reducing the prevalence of drug-resistant bacteria is a major public health goal. Central to efforts to accomplish this is an attempt to reduce the injudicious use of antibiotics; much of this use is in young children. In previously conducted studies, the use of extensive educational programs aimed at physicians, coupled with education provided to parents on an individual or community-wide basis, has been shown to result in a modest reduction in antibiotic usage in children.27,28 The applicability of these programs for routine clinical practice is unclear. Conversely the intervention used in our study was specifically designed to be low cost and require virtually no extra physician or office time, but it was unsuccessful in decreasing antibiotic use. Overall the use of the medications was high; pediatricians prescribed 1 or more antibiotics during 45.9% of visits for which the chief complaint was URI symptoms. Given the high rate of use that we found, it is clear that more research is needed to identify methods for reducing antibiotic use in children that are effective, inexpensive and easily implemented.

ACKNOWLEDGMENTS

Members of the Puget Sound Pediatric Research Network who participated in this study are: Matthew Allen, MD, Cynthia Brown, ARNP, Pakhi Chaudhuri, MD, T. Michael Claudson, MD, Ruth A. Conn, MD, Benjamin Danielson, MD, Steven Dassel, MD, Kathryn Del Beccaro, MD, Christianne Eldred, MD, JoEllen Estvold, Kenneth Feldman, MD, Robert T. Fukura, MD, Jenny Kleven, MD, Kathryn Koelemay, MD, Lenna Liu, MD, MPH, Ourania Malliris, MD, Jo Montgomery, ARNP, Sarah F. Munson, MD, Elizabeth K. Neuzil, MD, Catherine Nobis, MD, Tracie O'Neill, MD, Zaiga Phillips, MD, Rob Roskin, MD, Jeffrey R. Scott, MD, Don Shifrin, MD, James Stout, MD, MPH, Robert Telzrow, MD, Roberta L. Winch, MD, Agnes Wong, MD, Kyle E. Yasuda, MD, and Marina S. Zeiber, MD.

We thank Danika Claudson for her help in conducting the study.

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