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Status:

RECRUITING

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

Lead Sponsor:

Intermountain Health Care, Inc.

Collaborating Sponsors:

AllianceChicago

Mayo Clinic

Conditions:

Acute Otitis Media

Ear Infection

Eligibility:

All Genders

6-17 years

Phase:

NA

Brief 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 c...

Detailed Description

Acute otitis media (AOM), commonly referred to as an ear infection, is the most common reason children are prescribed antibiotics, affecting 5 million children and resulting in 10 million antibiotic p...

Eligibility Criteria

Inclusion

  • 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
  • 1\. 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.
  • Aged \>=18 years-no maximum

Exclusion

  • A. Implementation of Interventions
  • 1\. Clinics that exclusively provide telehealth
  • B. Secondary Electronic Health Record Data
  • 1\. None
  • C. Video recordings or direct observation of the use of a shared decision aid
  • Parent participation:
  • 1\. None
  • Clinician Participation:
  • 1\. None
  • D. Pre-implementation interviews of clinicians and administrators 1. Medical trainee (student, resident, fellow, etc.)
  • E. Pre-implementation focus groups of parents
  • 1\. 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
  • 1\. Medical trainee (student, resident, fellow, etc.)

Key Trial Info

Start Date :

February 3 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2029

Estimated Enrollment :

1566 Patients enrolled

Trial Details

Trial ID

NCT06034080

Start Date

February 3 2025

End Date

June 1 2029

Last Update

September 3 2025

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Denver Health and Hospital Authority

Denver, Colorado, United States, 80204

2

AllianceChicago

Chicago, Illinois, United States, 60654

3

Intermountain Health

Murray, Utah, United States, 84107