Acute Otitis Media Clinical Trial
Official title:
DISAPEAR Trial: Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections
This study aims to improve care and reduce unnecessary antibiotic prescribing for children with ear infections. The study will compare the effectiveness of a "gold standard" to a hybrid intervention combined with this gold standard, in order to identify steps to increase parent satisfaction for child ear infection care. The "gold standard" approach is a Health System Level Intervention. On its own, it involves clinician education, tools in electronic medical records, and audit and feedback reports for clinician prescribing habits. The hybrid intervention includes the elements of the health systems level intervention in addition to a Shared Decision-Making component, which allows for both an increase in the role parents play in their child's care, as well as clinician education for how to use this method. The goals of this work are to increase parent satisfaction, reduce antibiotics taken for childhood ear infections, align medical care with the current national guidelines, and evaluate differences in the two intervention groups. Both groups will be evaluated for implementation outcomes to improve dissemination and scalability for future use of these models in antibiotic prescribing for children with ear infections. This study will recruit a diverse group of patients and clinicians to complete surveys, parents to participate in focus groups, and clinicians and administrators to be interviewed in order to meet study aims and receive sufficient feedback on the interventions performed. There are two hypotheses for this research: 1. The Hybrid Intervention will have higher parent satisfaction and reduced antibiotic use compared to the Health-System Level Intervention and 2. The Hybrid Intervention will be more challenging to implement than the Health-System Level Intervention, but will be preferred by parents, clinicians, and administrators.
Acute otitis media (AOM), commonly referred to as an ear infection, is the most common reason children are prescribed antibiotics, affecting 5 million children and resulting in 10 million antibiotic prescriptions annually. By 3 years of age over 60% of children will have had AOM. Though 84% of AOM episodes resolve without antibiotics, antibiotics are prescribed to >95% of children. The American Academy of Pediatrics (AAP) recommends that most children with AOM do not receive an immediate antibiotic (an antibiotic to take right away) and instead be managed with watchful waiting, where an antibiotic is used only if the child worsens or does not improve. In clinical trials watchful waiting reduced antibiotic use by over 62% and did not result in increased complications, reduced parent satisfaction, or increased symptoms. Unfortunately, despite these trials <5% of children with AOM are managed with watchful waiting. The use of antibiotics when not needed contributes to the development of antibiotic resistant organisms, which makes future infections more difficult to treat. Additionally, unnecessary antibiotics reduce pediatric quality of life and over 26% of children who take an antibiotic experience an adverse drug event (ADE). Thus, for every 100 children with AOM who take an antibiotic at least 26 children experience harm; whereas only 5 children have symptomatic benefit. This study aims to compare the effectiveness of two pragmatic interventions to improve patient-centered outcomes and reduce unnecessary antibiotics taken for AOM. Interventions will be conducted at 33 community-based clinics and/or urgent care centers across three distinct geographic regions in the United States. Randomization will occur at the clinic center level to either the gold standard approach or the hybrid intervention. 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, and surveys. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02092454 -
Study to Assess the Safety and Efficacy of Benzocaine for Pain Relief in Children Presenting With Acute Otitis Media
|
Phase 2 | |
Completed |
NCT01202578 -
Evaluation of the Tympanostomy Tube Delivery System
|
Phase 2/Phase 3 | |
Withdrawn |
NCT00502450 -
Is There Hearing Loss After Acute Mastoiditis
|
N/A | |
Completed |
NCT04296448 -
Evaluation of Cellphone Based Otoscopy in Pediatric Patients
|
N/A | |
Terminated |
NCT05651633 -
Analgesic Ear Drops for Children With Acute Otitis Media
|
Phase 3 | |
Completed |
NCT02345447 -
Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence
|
Phase 3 | |
Completed |
NCT01941381 -
Does Tympanometry Predict Antibiotic Usage in Acute Otitis Media?
|
||
Recruiting |
NCT01214538 -
Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children
|
N/A | |
Completed |
NCT03614117 -
Effect of a New Probiotic Strain on Recurrent Acute Otitis Media in Children (PROMAR)
|
N/A | |
Recruiting |
NCT06027593 -
Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions
|
N/A | |
Completed |
NCT02918773 -
Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)
|
N/A | |
Completed |
NCT02567747 -
Vaccination Impact Against Pneumococcal Disease on Acute Otitis Media Morbidity in Colombian Children < 5 Years of Age
|
||
Completed |
NCT02935374 -
Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children
|
Phase 4 | |
Completed |
NCT02567825 -
Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media
|
N/A | |
Completed |
NCT02037893 -
Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media
|
Phase 2 | |
Completed |
NCT00578773 -
A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea
|
Phase 2 | |
Completed |
NCT00377260 -
Acute Otitis Media (AOM) Therapy Trial in Young Children
|
Phase 4 | |
Completed |
NCT00645112 -
A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media
|
Phase 4 | |
Completed |
NCT00368823 -
A Trial of Point of Care Information in Ambulatory Pediatrics
|
Phase 3 | |
Completed |
NCT01272999 -
Impact of Prevnar 13 on Ear Infections in Children
|