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

NCT06034080 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1566

Last updated 2025-09-03

No results posted yet for this study

Summary

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.

Conditions

  • Acute Otitis Media
  • Ear Infection
  • Pediatric Infectious Disease

Interventions

OTHER

Changes to the electronic health record (EHR)

EHR changes will include minor changes to prescription fields to make it easier for clinicians to order "wait and see" antibiotics to be filled only if the child worsens or does not improve rather than antibiotics to take immediately.

OTHER

Individualized audit and feedback reporting for clinicians

Automated audit and feedback reports detailing participating clinicians' antibiotic prescribing habits for AOM both individually and in comparison to their peers will be shared with clinicians on a quarterly basis throughout the intervention period.

OTHER

Clinician education sessions

Virtual education sessions will be held for clinicians to learn more about national guidelines for antibiotic prescribing for AOM, etc. The sessions will be recorded and distributed to clinicians who were unable to attend. Attendance of these sessions will apply toward continuing medical education credits for participants.

OTHER

Use of a shared decision-making (SDM) aide

A previously validated SDM aide for AOM will be used by clinicians during visits with children with AOM. The aide will be available online and in paper form.

OTHER

Shared decision-making (SDM) education

Clinicians will receive education on SDM and how to use the aid via virtual, recorded sessions.

Sponsors & Collaborators

  • AllianceChicago

    collaborator OTHER
  • Mayo Clinic

    collaborator OTHER
  • Patient-Centered Outcomes Research Institute

    collaborator OTHER
  • Denver Health and Hospital Authority

    collaborator OTHER
  • Intermountain Health Care, Inc.

    lead OTHER

Principal Investigators

  • Holly Frost, MD · Intermountain Health

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-03
Primary Completion
2027-06-01
Completion
2029-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06034080 on ClinicalTrials.gov