RELAX: Reducing Length of Antibiotics for Children With Ear Infections

NCT05608993 | Active Not Recruiting

• 2 other identifiers: 22-15281R01HS029153-01
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching goal of this study is to evaluate the effectiveness and implementation outcomes of two low-cost interventions of different intensities to increase prescribing of recommended short antibiotic durations for acute otitis media (AOM) for children 2 years of age and older. A multi-center cluster randomized controlled trial using a hybrid type 2 implementation effectiveness design will be used to evaluate interventions. The High-Intensity intervention will include clinician education, individualized clinician audit and feedback with peer comparison, and electronic health record (EHR) changes of prescription fields, whereas the Low-Intensity intervention will include clinician education and EHR changes. In total, 46 community-based clinics and/or urgent care centers across two distinct geographic regions in the United States will be randomized to one of the two interventions. The Practical Robust Implementation and Sustainability Model (PRISM) will be used to guide implementation and the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework will be used to evaluate outcomes. A mixed-methods approach will be used in the pre-implementation and evaluation phases and will utilize quantitative analyses, semi-structured interviews, focus groups, surveys, and cost analyses. National stakeholders at the American Academy of Pediatrics and the Centers for Disease Control and Prevention will assist with dissemination of findings and scaling of interventions.

Conditions

Acute Otitis Media; Pediatric Infectious Disease; Ear Infection

Keywords

Acute Otitis Media; Ear Infections; Pediatric Infectious Disease; Electronic Health Record; Antibiotic Stewardship

Outcome Measures

Primary Outcomes (1)

• Proportion of children ≥ 2 years of age with AOM that are prescribed a short duration (5 days) of antibiotics.

  Determine the effectiveness of a High and Low intensity intervention to increase prescribing of recommended antibiotic durations (short, 5 days) for AOM in children ≥ 2 years of age.

  5 years

Secondary Outcomes (4)

• Mean days of antibiotics prescribed

  5 years

• Adverse drug event

  5 years

• Treatment failure

  5 years

• Recurrence

  5 years

Study Arms (2)

High Intensity

EXPERIMENTAL

Community-based clinics and/or urgent care centers that are assigned to the high intensity arm will receive the high intensity intervention.

Other: High Intensity Intervention

Low Intensity

EXPERIMENTAL

Community-based clinics and/or urgent care centers that are assigned to the low intensity arm will receive the low intensity intervention.

Other: Low Intensity Intervention

Interventions

High Intensity Intervention OTHER

The High Intensity intervention will include clinician education, individualized clinician audit and feedback with peer comparison, and electronic health record (EHR) changes of prescription fields.

High Intensity

Low Intensity Intervention OTHER

The Low Intensity intervention will include clinician education and EHR changes only.

Low Intensity

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A. Secondary use data of encounters for children with AOM
• Aged 2-17-years-old (inclusive)
• Diagnosis of AOM by ICD10 code
• AOM is uncomplicated
• Prescribed an oral antibiotic
• B. Clinician and administrator interviews
• Licensed clinician (physician or advanced practice clinician) that cares for children with AOM
• Practices in an intervention study site
• Is not a medical trainee (student, resident, fellow, etc.)
• Aged \>=18 years-no maximum
• C. Parent focus groups
• Parent or legal guardian of a child aged 2-17 years that has had AOM diagnosed at Vanderbilt University Medical Center or Washington University
• years of age or older and able/willing to consent
• D. Clinician and administrator surveys
• Licensed clinician (physician or advanced practice clinician) that cares for children with AOM

You may not qualify if:

• A. Secondary use data of encounters for children with AOM
• \. Complicated infection (determined a priori)
• B. Clinician and administrator interviews 1. Medical trainee
• C. Parent focus groups
• Not parent or legal guardian
• Does not speak English or Spanish (focus groups can only be conducted in these languages).
• D. Clinician and administrator surveys
• \. Medical trainee

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• Vanderbilt University Medical Center: collaborator
• Washington University School of Medicine: collaborator

Study Sites (1)

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

Related Publications (2)

• Rinehart DJ, Gilbert A, O'Leary S, Katz SE, Frost HM. Reducing antibiotic duration for acute otitis media: clinician, administrator, and parental insights to inform implementation of system-level interventions. Antimicrob Steward Healthc Epidemiol. 2025 Jan 6;5(1):e3. doi: 10.1017/ash.2024.469. eCollection 2025.

  PMID: 39781291 DERIVED

• Keith A, Jenkins TC, O'Leary S, Stein AB, Katz SE, Newland J, Rinehart DJ, Gilbert A, Dodd S, Terrill CM, Frost HM. Reducing length of antibiotics for children with ear infections: protocol for a cluster-randomized trial in the USA. J Comp Eff Res. 2023 Nov;12(11):e230088. doi: 10.57264/cer-2023-0088. Epub 2023 Oct 19.

  PMID: 37855227 DERIVED

MeSH Terms

Conditions

Otitis Media; Otitis

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Holly M Frost, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

• Sophie E Katz, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Jason Newland, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Timothy C Jenkins, MD

  Denver Health and Hospital Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 8, 2022
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)