RELAX: Reducing Length of Antibiotics for Children With Ear Infections

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

Interventions

OTHER

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.

OTHER

Low Intensity Intervention

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

Sponsors & Collaborators

• Agency for Healthcare Research and Quality (AHRQ)

  collaborator FED

• Vanderbilt University Medical Center

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Intermountain Health Care, Inc.

  lead OTHER

Principal Investigators

• Holly M Frost, MD · Intermountain Health Care, Inc.

• Sophie E Katz, MD · Vanderbilt University Medical Center

• Jason Newland, MD · Washington University School of Medicine

• Timothy C Jenkins, MD · Denver Health and Hospital Authority

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-01

Primary Completion

2027-04-30

Completion

2027-10-31

Countries

• United States

Study Locations