Clinical trial NCT05608993: RELAX: Reducing Length of Antibiotics for Children With Ear Infections
Official title: RELAX: Reducing Length of Antibiotics for Children With Ear Infections
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Otitis Media
Pediatric Infectious Disease
Ear Infection
Keywords: Acute Otitis Media
Ear Infections
Pediatric Infectious Disease
Electronic Health Record
Antibiotic Stewardship
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Vanderbilt University Medical Center
name: Washington University School of Medicine
First posted: 2022-11-08
Enrollment: 500
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Proportion of children ≥ 2 years of age with AOM that are prescribed a short duration (5 days) of antibiotics.
timeFrame: 5 years
Secondary outcomes:
measure: Mean days of antibiotics prescribed
timeFrame: 5 years
measure: Adverse drug event
timeFrame: 5 years
measure: Treatment failure
timeFrame: 5 years
measure: Recurrence
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Denver Health and Hospital Authority
name: Holly M Frost, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Sophie E Katz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Jason Newland, MD
role: PRINCIPAL_INVESTIGATOR
References: