Acute Otitis MediaRELAXNCT05608993
RELAX: Reducing Length of Antibiotics for Children With Ear Infections
A study testing High Intensity Intervention and Low Intensity Intervention in people with Acute Otitis Media and Pediatric Infectious Disease, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Acute Otitis Media, Pediatric Infectious Disease, Ear Infection
- What is being tested?
- High Intensity Intervention and Low Intensity Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Secondary use data of encounters for children with AOM
- Aged 2-17-years-old (inclusive)
- Diagnosis of AOM by ICD10 code
- AOM is uncomplicated
- Prescribed an oral antibiotic
- Clinician and administrator interviews
Show all 18Show fewer
- Licensed clinician (physician or advanced practice clinician) that cares for children with AOM
- Practices in an intervention study site
- Is not a medical trainee (student, resident, fellow, etc.)
- Aged >=18 years-no maximum
- Parent focus groups
- Parent or legal guardian of a child aged 2-17 years that has had AOM diagnosed at Vanderbilt University Medical Center or Washington University
- 18 years of age or older and able/willing to consent
- Clinician and administrator surveys
- Licensed clinician (physician or advanced practice clinician) that cares for children with AOM
- Practices in an intervention study site
- Is not a medical trainee (student, resident, fellow, etc.)
- Aged >=18 years-no maximum
Who cannot join
- Secondary use data of encounters for children with AOM
- 1. Complicated infection (determined a priori)
- Clinician and administrator interviews 1. Medical trainee
- Parent focus groups
- Not parent or legal guardian
- Does not speak English or Spanish (focus groups can only be conducted in these languages).
- Clinician and administrator surveys
- 1. Medical trainee
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health and Hospital Authority
Denver, Colorado, 80204
About this study
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.
Read the 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.
- Being tested
- High Intensity Intervention, Low Intensity Intervention
- Keywords
- Acute Otitis Media, Ear Infections, Pediatric Infectious Disease, Electronic Health Record, Antibiotic Stewardship
- Medical subject headings
- Otitis Media, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity InterventionOther
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 InterventionOther
The Low Intensity intervention will include clinician education and EHR changes only.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity | Experimental | Community-based clinics and/or urgent care centers that are assigned to the high intensity arm will receive the high intensity intervention. Receives: Other: High Intensity Intervention |
| Low Intensity | Experimental | Community-based clinics and/or urgent care centers that are assigned to the low intensity arm will receive the low intensity intervention. Receives: Other: Low Intensity Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (4)
Mean days of antibiotics prescribed
Mean number of days of antibiotics prescribed for children ≥ 2 years of age with AOM
Measured: 5 years
Adverse drug event
Number of adverse drug events among children ≥ 2 years of age prescribed antibiotics for AOM
Measured: 5 years
Treatment failure
Treatment failure defined as a new antibiotic associated with an AOM encounter within 3-14 days of the initial encounter.
Measured: 5 years
Recurrence
Recurrence defined as a new antibiotic associated with an AOM encounter within 15-30 days of initial encounter.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Apr 2024
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Vanderbilt University Medical Center, Washington University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Holly M Frost, MD, Principal investigator, Intermountain Health Care, Inc.Sophie E Katz, MD, Principal investigator, Vanderbilt University Medical CenterJason Newland, MD, Principal investigator, Washington University School of MedicineTimothy C Jenkins, MD, Principal investigator, Denver Health and Hospital Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608993
- Sponsor's protocol ID
- 22-1528
- Other IDs
- 1R01HS029153-01
- Acronym
- RELAX
- Status last verified
- Aug 2025
- First submitted
- 24 Oct 2022
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Publications
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.
PubMed 39781291Keith 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.
PubMed 37855227
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELAX: Reducing Length of Antibiotics for Children With Ear Infections
- ClinicalTrials.gov ID
- NCT05608993
- Acronym / sponsor ID
- RELAX / 22-1528
- Keywords
- Acute Otitis Media, Ear Infections, Pediatric Infectious Disease, Electronic Health Record, Antibiotic Stewardship
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Vanderbilt University Medical Center, Washington University School of Medicine
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity | Experimental | Other: High Intensity InterventionCommunity-based clinics and/or urgent care centers that are assigned to the high intensity arm will receive the high intensity intervention. |
| Low Intensity | Experimental | Other: Low Intensity InterventionCommunity-based clinics and/or urgent care centers that are assigned to the low intensity arm will receive the low intensity intervention. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (18 listed)
- Secondary use data of encounters for children with AOM
- Aged 2-17-years-old (inclusive)
- Diagnosis of AOM by ICD10 code
- AOM is uncomplicated
- Prescribed an oral antibiotic
Key exclusion criteria (8 listed)
- Secondary use data of encounters for children with AOM
- 1. Complicated infection (determined a priori)
- Clinician and administrator interviews 1. Medical trainee
- Parent focus groups
- Not parent or legal guardian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity InterventionThe 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 | High Intensity |
| Low Intensity InterventionThe Low Intensity intervention will include clinician education and EHR changes only. | Other | Low Intensity |
Primary outcome
Proportion of children ≥ 2 years of age with AOM that are prescribed a short duration (5 days) of antibiotics.
Time frame: 5 years
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.
4 secondary outcomes
Mean days of antibiotics prescribed
Time frame: 5 years
Adverse drug event
Time frame: 5 years
Treatment failure
Time frame: 5 years
Recurrence
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Derived from this study: PubMed 39781291Rinehart 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.
- Derived from this study: PubMed 37855227Keith 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.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly M Frost, MD principal investigator
Intermountain Health Care, Inc.
Sophie E Katz, MD principal investigator
Vanderbilt University Medical Center
Jason Newland, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Intervention and Low Intensity Intervention in people with Acute Otitis Media and Pediatric Infectious Disease, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children ≥ 2 years of age with AOM that are prescribed a short duration (5 days) of antibiotics. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05608993, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.