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Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections

Study acronym: DISAPEAR
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Collaborators revised (4)v7
  2. Notable Lead sponsor: Denver Health and Hospital Authority to Intermountain Health Care, Inc.
    • Collaborators revised (4)
    v6
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Dec 2024 to Feb 3, 2025
    • Collaborators reordered
    v5
  4. Minor Re-verified, no change to tracked fieldsv4
  5. Minor Enrollment target: 1450 to 1566
    • Primary completion date: Apr 2027 to Jun 1, 2027
    v3
  6. Minor Study description revisedv2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study aims to improve care and reduce unnecessary antibiotic prescribing for children with ear infections. The study will compare the effectiveness of a "gold standard" to a hybrid intervention combined with this gold standard, in order to identify steps to increase parent satisfaction for child ear infection care. The "gold standard" approach is a Health System Level Intervention. On its own, it involves clinician education, tools in electronic medical records, and audit and feedback reports for clinician prescribing habits. The hybrid intervention includes the elements of the health systems level intervention in addition to a Shared Decision-Making component, which allows for both an increase in the role parents play in their child's care, as well as clinician education for how to use this method. The goals of this work are to increase parent satisfaction, reduce antibiotics taken for childhood ear infections, align medical care with the current national guidelines, and evaluate differences in the two intervention groups. Both groups will be evaluated for implementation outcomes to improve dissemination and scalability for future use of these models in antibiotic prescribing for children with ear infections. This study will recruit a diverse group of patients and clinicians to complete surveys, parents to participate in focus groups, and clinicians and administrators to be interviewed in order to meet study aims and receive sufficient feedback on the interventions performed. There are two hypotheses for this research: 1. The Hybrid Intervention will have higher parent satisfaction and reduced antibiotic use compared to the Health-System Level Intervention and 2. The Hybrid Intervention will be more challenging to implement than the Health-System Level Intervention, but will be preferred by parents, clinicians, and administrators.
Trial Details
NCT Number NCT06034080
Lead Sponsor Intermountain Health Care, Inc.
Collaborators: AllianceChicago, Mayo Clinic, Patient-Centered Outcomes Research Institute, Denver Health and Hospital Authority
Conditions
(from sponsor)
Acute Otitis Media, Ear Infection, Pediatric Infectious Disease
Related terms Otitis, Otitis Media
Enrollment 1,566 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov