Reducing unnecessary antibiotic use for children with ear infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to improve care for children with acute otitis media (ear infections) by comparing two interventions designed to reduce unnecessary antibiotic prescriptions. One intervention is a 'gold standard' health system approach that includes clinician education and electronic medical record tools, while the other adds a shared decision-making component to enhance parent involvement in care decisions. The study will evaluate the effectiveness of these interventions in increasing parent satisfaction and aligning care with national guidelines. By addressing the over-prescription of antibiotics, the study seeks to improve pediatric health outcomes and reduce the risk of antibiotic resistance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

1. Aged 6 months-17-years-old (inclusive)
2. Diagnosis of AOM by ICD10 code

C. Video recordings or direct observation of the use of a shared decision aid

Parent participation:

1. Child aged 6 months-17 years (inclusive)
2. Diagnosed with AOM by clinician
3. Parent or legal guardian is present and is \>=18 years or older

Clinician Participation:

1. Licensed clinician and not a medical trainee
2. Age 18 \>= years or older

D. Pre-implementation interviews of clinicians and administrators

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

E. Pre-implementation focus groups of parents

1. Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization.
2. 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

1. Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization.
2. 18 years of age or older and able/willing to consent

H. Post-intervention surveys of clinicians and administrators

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

Exclusion Criteria:

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.)

Where it's running

• Denver Health and Hospital Authority
  Denver, Colorado, United States Recruiting
• AllianceChicago
  Chicago, Illinois, United States Recruiting
• Intermountain Health
  Murray, Utah, United States Recruiting

Study contacts

• Principal investigator: Holly Frost, MD — Intermountain Health
• Study coordinator: Theresa L Morin, MA
• Email: theresa.morin@imail.org
• Phone: 802-881-9534

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.