Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections
Recruiting now · Not applicable
Conditions studied: Acute Otitis Media, Ear Infection, Pediatric Infectious Disease
In brief
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.
Key facts
- Study ID
- NCT06034080
- Run by
- Intermountain Health Care, Inc.
- People needed
- 1566
- Starts
- 2025-02-03
- Expected to finish
- 2029-06-01
- Last updated by the study team
- 2025-09-03
Who can join
Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- A. Implementation of Interventions 1. Clinic at a participating organization 2. Provides care to children with AOM 3. Administrative or local approval for participation
- B. Secondary Electronic Health Record Data
- Aged 6 months-17-years-old (inclusive)
- Diagnosis of AOM by ICD10 code
- C. Video recordings or direct observation of the use of a shared decision aid
- Parent participation:
- Child aged 6 months-17 years (inclusive)
- Diagnosed with AOM by clinician
- Parent or legal guardian is present and is >=18 years or older
- Clinician Participation:
- Licensed clinician and not a medical trainee
- Age 18 >= years or older
- D. Pre-implementation interviews of clinicians and administrators
- Licensed clinician (physician or advanced practice clinician) that cares for children with AOM at a participating organization or an administrator/manager at a participating organization.
- Aged >=18 years-no maximum
- E. Pre-implementation focus groups of parents
- Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization.
- 18 years of age or older and able/willing to consent
- F. Parents enrolled for surveys
- Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization. 2. Willing to participate and able to complete electronic surveys at enrollment and 10 days after enrollment. 3. Working phone 4. Age >=18 years of age
- G. Post-intervention focus groups of parents
- Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization.
- 18 years of age or older and able/willing to consent
- H. Post-intervention surveys of clinicians and administrators
- Licensed clinician (physician or advanced practice clinician) that cares for children with AOM at a participating organization or an administrator/manager at a participating organization.
You may not qualify if…
- A. Implementation of Interventions
- Clinics that exclusively provide telehealth
- B. Secondary Electronic Health Record Data
- None
- C. Video recordings or direct observation of the use of a shared decision aid
- Parent participation:
- None
- Clinician Participation:
- None
- D. Pre-implementation interviews of clinicians and administrators 1. Medical trainee (student, resident, fellow, etc.)
- E. Pre-implementation focus groups of parents
- None
- F. Parents enrolled for surveys 1. Complicated or recurrent AOM as determined by the study team
- G. Post-intervention focus groups of parents 1. None
- H. Post-intervention surveys of clinicians and administrators
- Medical trainee (student, resident, fellow, etc.)
Where it is running
- Denver Health and Hospital Authority — Denver, Colorado, United States (enrolling)
- AllianceChicago — Chicago, Illinois, United States (enrolling)
- Intermountain Health — Murray, Utah, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.