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RELAX: Reducing Length of Antibiotics for Children With Ear Infections

Launched by DENVER HEALTH AND HOSPITAL AUTHORITY · Nov 4, 2022

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

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

ClinConnect Summary

The RELAX trial is studying how to reduce the length of antibiotic treatment for children with ear infections, specifically those aged 2 to 17 years. The main goal is to find the best ways to encourage doctors to prescribe shorter courses of antibiotics for these infections, which can help reduce side effects and antibiotic resistance. The study will take place in 46 clinics across the United States, where clinics will be divided into two groups: one group will receive more extensive training and feedback, while the other will get basic training.

To be eligible for participation, children must be diagnosed with a simple ear infection and prescribed oral antibiotics. Additionally, parents or guardians of these children, as well as healthcare providers who treat them, may be invited to participate in interviews and focus groups. Throughout the study, participants will be asked about their experiences, and researchers will evaluate the effectiveness of the interventions through surveys and discussions. This research aims to improve how ear infections are treated and ensure that children receive the best care possible.

Gender

ALL

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

About Denver Health And Hospital Authority

Denver Health and Hospital Authority is a leading integrated healthcare system dedicated to providing high-quality medical care and advancing public health through innovative research and clinical trials. As a prominent academic medical center, Denver Health combines comprehensive patient services with a commitment to medical education and community outreach. The organization plays a vital role in advancing healthcare solutions by conducting rigorous clinical trials that aim to improve patient outcomes and address pressing health challenges. With a focus on collaboration and ethical standards, Denver Health is dedicated to enhancing the understanding of disease and treatment efficacy through its robust research initiatives.

Locations

Patients applied

0 patients applied

Trial Officials

Holly M Frost, MD

Principal Investigator

Denver Health and Hospital Authority

Sophie E Katz, MD

Principal Investigator

Vanderbilt University Medical Center

Jason Newland, MD

Principal Investigator

Washington University School of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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