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. 2023 Nov;12(11):e230088.
doi: 10.57264/cer-2023-0088. Epub 2023 Oct 19.

Reducing length of antibiotics for children with ear infections: protocol for a cluster-randomized trial in the USA

Amy Keith  1 , Timothy C Jenkins  2   3 , Sonja O'Leary  4   5 , Amy B Stein  1 , Sophie E Katz  6 , Jason Newland  7 , Deborah J Rinehart  1   8 , Aiden Gilbert  1 , Sherry Dodd  7 , Cindy M Terrill  7 , Holly M Frost  1   4   5
Affiliations

Reducing length of antibiotics for children with ear infections: protocol for a cluster-randomized trial in the USA

Amy Keith et al. J Comp Eff Res. 2023 Nov.

Abstract

Aim: Preventing unnecessarily long durations of antibiotic therapy is a key opportunity to reduce antibiotic overuse in children 2 years of age and older with acute otitis media (AOM). Pragmatic interventions to reduce durations of therapy that can be effectively scaled and sustained are urgently needed. This study aims to fill this gap by evaluating the effectiveness and implementation outcomes of two low-cost interventions of differing intensities to increase guideline-concordant antibiotic durations in children with AOM. Methods: The higher intensity intervention will consist of clinician education regarding guideline-recommended short durations of antibiotic therapy; electronic health record (EHR) prescription field changes to promote prescribing of recommended short durations; and individualized clinician audit and feedback on adherence to recommended short durations of therapy in comparison to peers, while the lower intensity intervention will consist only of clinician education and EHR changes. We will explore the differences in implementation effectiveness by patient population served, clinician type, clinical setting and organization as well as intervention type. The fidelity, feasibility, acceptability and perceived appropriateness of the interventions among different clinician types, patient populations, clinical settings and intervention type will be compared. We will also conduct formative qualitative interviews with clinicians and administrators and focus groups with parents of patients to further inform the interventions and study. The formative evaluation will take place over 1.5 years, the interventions will be implemented over 2 years and evaluation of the interventions will take place over 1.5 years. Discussion: The results of this study will provide a framework for other healthcare systems to address the widespread problem of excessive durations of therapy for AOM and inform national antibiotic stewardship policy development. Clinical Trial Registration: NCT05608993 (ClinicalTrials.gov).

Keywords: acute otitis media; antibiotic stewardship; interventions; outcomes.

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Conflict of interest statement

Competing interests disclosure

The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Figures

Figure 1.
Figure 1.. Interventions comparator.
EHR: Electronic health record.
Figure 2.
Figure 2.. Example Outpatient Antibiotic Stewardship Information System report.
AMOX: Amoxicillin; AOM: Acute otitis media.
See this image and copyright information in PMC

References

    1. Kaur R, Morris M, Pichichero ME. Epidemiology of acute otitis media in the postpneumococcal conjugate vaccine era. Pediatrics 140(3), 1–9 (2017). - PMC - PubMed
    1. Fleming-Dutra KE, Hersh AL, Shapiro DJ et al. Prevalence of inappropriate antibiotic prescriptions among US ambulatory care visits, 2010–2011. JAMA 315(17), 1864–1873 (2016). - PubMed

    2. • Highlights the scope of the problem of over-prescribing antibiotics.

    1. Hersh AL, Shapiro DJ, Pavia AT, Shah SS. Antibiotic prescribing in ambulatory pediatrics in the United States. Pediatrics 128(6), 1053–1061 (2011). - PubMed
    1. Kozyrskyj A, Klassen TP, Moffatt M, Harvey K. Short-course antibiotics for acute otitis media. The Cochrane database of systematic reviews. 9(Cd001095),1–16 (2010). - PMC - PubMed

    2. • This is a large meta-analysis that demonstrates the safety and efficacy of short versus long durations of antibiotics for uncomplicated acute otitis media.

    1. Lieberthal AS, Carroll AE, Chonmaitree T et al. The diagnosis and management of acute otitis media. Pediatrics 131(3), e964–999 (2013). - PubMed

    2. • This reference is for the American Academy of Pediatrics guidelines for the diagnosis and management of acute otitis media (AOM).

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