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
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 - 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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