Reducing unnecessary antibiotic use for children with ear infections

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

This study is testing two different ways to help doctors give fewer unnecessary antibiotics to kids with ear infections to see which one makes parents happier and follows health guidelines better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1566 (estimated)
• Ages: 6 Months to 17 Years
• Sex: All
• Sponsor: Intermountain Health Care, Inc. (Academic / other)
• Locations: 3 sites (Denver, Colorado and 2 other locations)
• Trial ID: NCT06034080 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 6 months to 17 years diagnosed with acute otitis media, along with their parents or legal guardians.

Not a fit: Patients who do not have a diagnosis of acute otitis media or are outside the age range of 6 months to 17 years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a significant reduction in unnecessary antibiotic prescriptions for children, improving their overall health and quality of life.

How similar studies have performed: Previous studies have shown success with similar interventions, particularly in reducing antibiotic use through watchful waiting strategies.

Eligibility criteria

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 this trial is running

Denver, Colorado and 2 other locations

• 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

Conditions Acute Otitis Media; Ear Infection; Pediatric Infectious Disease; Shared Decision-Making; Health-System Level Intervention