RELAX: Reducing Length of Antibiotics for Children With Ear Infections

NCT ID: NCT05608993

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2027-10-31

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.

Detailed Description

Acute otitis media (AOM) is the most commonly cited indication for antibiotics in children, accounting for 24% of all pediatric antibiotic prescriptions and affecting 60% of children by 3 years of age. For most children ≥ 2 years of age with AOM, 5-7 days, rather than 10 days, of antibiotics have been shown to be sufficient and result in fewer adverse drug events with similar failure and recurrence rates. Thus, national guidelines recommend short durations of antibiotics for non-severe AOM in this age group. Despite these recommendations, >94% of children ≥2 years of age are prescribed longer than recommended antibiotic durations and over 41% of antibiotic exposure days for AOM in this age group are likely unnecessary. In a recent pilot study that compared a low-cost High-intensity intervention with clinician education, individualized clinician audit and feedback with peer comparison and electronic health record (EHR) changes of prescription fields to a Low-intensity intervention with only EHR changes prescribing of recommended short antibiotic durations increased significantly (76% and 50%, absolute percentage). A definite study is needed to make appropriate recommendations on which intervention to implement, while minimizing resource utilization.

The overarching goal of this study is to evaluate the effectiveness and implementation outcomes of two low-cost pragmatic interventions of different intensities to increase prescribing of recommended short antibiotic durations for 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 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 will be used to guide implementation and the Reach Effectiveness Adoption Implementation Maintenance 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.

Conditions

Acute Otitis Media; Pediatric Infectious Disease; Ear Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

High Intensity

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

Group Type: EXPERIMENTAL

High Intensity Intervention

Intervention Type: 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.

Low Intensity

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

Group Type: EXPERIMENTAL

Low Intensity Intervention

Intervention Type: OTHER

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

Interventions

High Intensity Intervention

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.

Intervention Type: OTHER

Low Intensity Intervention

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

A. Secondary use data of encounters for children with AOM

1. Aged 2-17-years-old (inclusive)

2. Diagnosis of AOM by ICD10 code

3. AOM is uncomplicated

4. Prescribed an oral antibiotic

B. Clinician and administrator interviews

1. Licensed clinician (physician or advanced practice clinician) that cares for children with AOM

2. Practices in an intervention study site

3. Is not a medical trainee (student, resident, fellow, etc.)

4. Aged >=18 years-no maximum

C. Parent focus groups

1. Parent or legal guardian of a child aged 2-17 years that has had AOM diagnosed at Vanderbilt University Medical Center or Washington University

2. 18 years of age or older and able/willing to consent

D. Clinician and administrator surveys

1. Licensed clinician (physician or advanced practice clinician) that cares for children with AOM

2. Practices in an intervention study site

3. Is not a medical trainee (student, resident, fellow, etc.)

4. Aged >=18 years-no maximum

Exclusion Criteria

A. Secondary use data of encounters for children with AOM

1. Complicated infection (determined a priori)

B. Clinician and administrator interviews 1. Medical trainee

C. Parent focus groups

1. Not parent or legal guardian

2. Does not speak English or Spanish (focus groups can only be conducted in these languages).

D. Clinician and administrator surveys

1. Medical trainee

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

Intermountain Health Care, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Holly M Frost, MD

Role: PRINCIPAL_INVESTIGATOR

Intermountain Health Care, Inc.

Sophie E Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Jason Newland, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Timothy C Jenkins, MD

Role: PRINCIPAL_INVESTIGATOR

Denver Health and Hospital Authority

Locations

Denver Health and Hospital Authority

Denver, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39781291 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37855227 (View on PubMed)

Other Identifiers

1R01HS029153-01

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

22-1528

Identifier Type: -

Identifier Source: org_study_id