Actively Recruiting

Phase Not Applicable
Age: 6Months - 17Years
All Genders
ID06034080

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

Led by Intermountain Health Care, Inc. · Updated on 2025-09-03

1566

Participants Needed

3

Research Sites

104 weeks

Total Duration

On this page

Sponsors

I

Intermountain Health Care, Inc.

Lead Sponsor

A

AllianceChicago

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating two approaches to reduce unnecessary antibiotic prescribing for children with ear infections, also known as acute otitis media (AOM). This common condition affects millions of children yearly and often leads to overuse of antibiotics despite guidelines recommending watchful waiting. The study compares a standard Health System Level Intervention with a Hybrid Intervention that adds a Shared Decision-Making component to involve parents more in their child's care. The goal is to increase parent satisfaction and align treatment with national guidelines while reducing antibiotic use and adverse effects. The study involves 33 clinics across the United States, where clinics are randomly assigned to one of two groups. The Health System Level Intervention includes changes to electronic health records (EHR) to support guideline-based prescribing, audit and feedback reports for clinicians, and virtual education sessions offering continuing medical education credits. The Hybrid Intervention includes all these elements plus use of a validated Shared Decision-Making aid and additional clinician education on how to use it effectively during visits. Participants include children aged 6 months to 17 years diagnosed with AOM, their parents or legal guardians, clinicians, and administrators. Data collection includes surveys, focus groups, interviews, and observation of shared decision-making use. Outcomes measured include parent satisfaction and antibiotic use at 10 days post-visit, as well as quality of life, symptom duration, adverse drug events, and treatment failure. The study also assesses implementation challenges and preferences to support future wider use of these interventions.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 6Months - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinic is part of a participating organization providing care to children with acute otitis media (AOM)
  • Administrative or local approval for clinic participation
  • Children aged 6 months to 17 years inclusive diagnosed with AOM by ICD10 code or clinician
  • Parent or legal guardian aged 18 years or older present for the child
  • Licensed clinicians aged 18 years or older who are not medical trainees
  • Parents or legal guardians willing and able to complete electronic surveys and participate in focus groups or interviews
  • Administrators or managers at participating organizations aged 18 years or older
Not Eligible

You will not qualify if you...

  • Clinics that exclusively provide telehealth services
  • Medical trainees such as students, residents, or fellows
  • Children with complicated or recurrent AOM as determined by the study team

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for diagnosis and enrollment

Intervention Period

Duration - Up to 10 days after clinic visit for ear infection

Participants receive care under one of two interventions to improve antibiotic prescribing practices for ear infections, including changes to electronic health records, clinician audit and feedback, education sessions, and use of shared decision-making tools depending on the assigned group.

1 clinic visit for ear infection treatment

Follow-up

Duration - 10 days after clinic visit for ear infection

Participants and their parents or guardians complete surveys and assessments focused on patient outcomes such as parent satisfaction, antibiotic use, symptom severity, quality of life, and adverse events after the initial clinic visit.

1 follow-up survey (remote)

Trial Site Locations

Total: 3 locations

1

Denver Health and Hospital Authority

Denver, Colorado, United States, 80204

Actively Recruiting

2

AllianceChicago

Chicago, Illinois, United States, 60654

Actively Recruiting

3

Intermountain Health

Murray, Utah, United States, 84107

Actively Recruiting

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Research Team

T

Theresa L Morin, MA

H

Holly M Frost, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Interventions to de-implement unnecessary antibiotic prescribing for ear infections (DISAPEAR Trial): protocol for a cluster-randomized trial.

Timothy C Jenkins, Amy Keith, Amy B Stein...

https://pubmed.ncbi.nlm.nih.gov/38267837