RELAX: Reducing Length of Antibiotics for Children With Ear Infections (RELAX)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric Infectious Disease; Acute Otitis Media; Ear Infection
• Intervention / Treatment: Other: High Intensity Intervention; Other: Low Intensity Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amy Keith, MPH; Phone Number: 303-602-7198; Email: amy.keith@dhha.org
• Study Contact Backup: Name: Holly M Frost, MD; Phone Number: 303-602-6461; Email: holly.frost@dhha.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Intensity; 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; 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.
Experimental: Low Intensity; 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; The Low Intensity intervention will include clinician education and EHR changes only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean days of antibiotics prescribed	Mean number of days of antibiotics prescribed for children ≥ 2 years of age with AOM	5 years
Adverse drug event	Number of adverse drug events among children ≥ 2 years of age prescribed antibiotics for AOM	5 years
Treatment failure	Treatment failure defined as a new antibiotic associated with an AOM encounter within 3-14 days of the initial encounter.	5 years
Recurrence	Recurrence defined as a new antibiotic associated with an AOM encounter within 15-30 days of initial encounter.	5 years

Collaborators and Investigators

• Sponsor: Denver Health and Hospital Authority
• Collaborators: Washington University School of Medicine; Vanderbilt University Medical Center; Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Holly M Frost, MD, Denver Health and Hospital Authority; Principal Investigator: Sophie E Katz, MD, Vanderbilt University Medical Center; Principal Investigator: Jason Newland, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: November 4, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Antibiotic Stewardship; Electronic Health Record; Acute Otitis Media; Ear Infections; Pediatric Infectious Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Otorhinolaryngologic Diseases; Ear Diseases; Infections; Communicable Diseases; Otitis; Otitis Media
• Other Study ID Numbers: 22-1528; 1R01HS029153-01 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No