Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HS029153-01 | U.S. AHRQ Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
| Vanderbilt University Medical Center | OTHER |
| Washington University School of Medicine | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Intensity Intervention | Other | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
A. Secondary use data of encounters for children with AOM
B. Clinician and administrator interviews
C. Parent focus groups
D. Clinician and administrator surveys
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
D. Clinician and administrator surveys
1. Medical trainee
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Holly M Frost, MD | Intermountain Health Care, Inc. | Principal Investigator |
| Sophie E Katz, MD | Vanderbilt University Medical Center | Principal Investigator |
| Jason Newland, MD | Washington University School of Medicine | Principal Investigator |
| Timothy C Jenkins, MD | Denver Health and Hospital Authority | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Health and Hospital Authority | Denver | Colorado | 80204 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39781291 | Derived | 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. | |
| 37855227 | Derived | Keith 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. |
Not provided
Not provided
IPD will not be shared with other researchers.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010033 | Otitis Media |
| D010031 | Otitis |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Low Intensity Intervention | Other | The Low Intensity intervention will include clinician education and EHR changes only. |
|
| 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 |