Barriers and Facilitators to Implementing Watchful Waiting for Pediatric Acute Otitis Media.
Deborah J Rinehart, Aiden Gilbert, Leisha M Andersen...
https://pubmed.ncbi.nlm.nih.gov/41241139Actively Recruiting
Led by Intermountain Health Care, Inc. · Updated on 2025-09-03
1566
Participants Needed
3
Research Sites
104 weeks
Total Duration
I
Intermountain Health Care, Inc.
Lead Sponsor
A
AllianceChicago
Collaborating Sponsor
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
Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for diagnosis and enrollment
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
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)
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
T
Theresa L Morin, MA
H
Holly M Frost, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Deborah J Rinehart, Aiden Gilbert, Leisha M Andersen...
https://pubmed.ncbi.nlm.nih.gov/41241139Timothy C Jenkins, Amy Keith, Amy B Stein...
https://pubmed.ncbi.nlm.nih.gov/38267837