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Ear Infection clinical trials

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NCT ID: NCT06034080 Not yet recruiting - Acute Otitis Media Clinical Trials

Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections

DISAPEAR
Start date: December 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05741333 Recruiting - Otitis Media Clinical Trials

In-Office Clinical Study of the Solo+ TTD

VENTY
Start date: March 30, 2023
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure.

NCT ID: NCT05641285 Active, not recruiting - Otitis Media Clinical Trials

Diagnostic Utility of Otosight Middle Ear Scope

Start date: February 21, 2023
Phase:
Study type: Observational

Evaluate clinic workflow impact of OtoSight use for patients seen in the pediatric otolaryngology clinic.

NCT ID: NCT05608993 Not yet recruiting - Acute Otitis Media Clinical Trials

RELAX: Reducing Length of Antibiotics for Children With Ear Infections

RELAX
Start date: April 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04296448 Completed - Acute Otitis Media Clinical Trials

Evaluation of Cellphone Based Otoscopy in Pediatric Patients

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

The Cellscope is an iPhone-based otoscope that uses the iPhone camera and light source to capture HIPAA compliant images and video recordings of the external and middle ear structure. This technology allows multiple providers, at different levels of training, the ability to simultaneously exam a child's external and middle ear structures. The investigators hypothesize this device will result in improved concordance in trainee/supervisor exam findings, increase trainee confidence in exam findings, decreased antibiotic prescriptions, and fewer repeat exams by multiple providers. Thus, this study has the potential to improve physician training and examination confidence, decrease the unnecessary use of antibiotics, and improve the patient/caregiver experience in healthcare interactions.

NCT ID: NCT04148417 Active, not recruiting - Otitis Media Clinical Trials

Clinical Study of the Solo+ Tympanostomy Tube Device

Start date: February 9, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the safety and performance of the Solo+ Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure

NCT ID: NCT03722160 Recruiting - Otitis Media Clinical Trials

Clinical Study of the Solo Tympanostomy Tube Device

Start date: September 13, 2018
Phase: N/A
Study type: Interventional

The objective of this study is post-approval evaluation of the safety and performance of the Solo Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure

NCT ID: NCT03544138 Completed - Otitis Media Clinical Trials

In-Office Study of the Hummingbird® in Children 6 Months-21 Years Old

Start date: July 24, 2018
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the safety and performance of the Hummingbird® for the placement of ear tubes in children undergoing tympanostomy tube placement in an otolaryngology clinic using local anesthetic.

NCT ID: NCT03101605 Completed - Ear Infection Clinical Trials

E-learning on the Trainees' Ability to Diagnose and Treat Acute Otitis Media Among Children

Start date: June 15, 2017
Phase: N/A
Study type: Interventional

An e-learning module to teach how to evaluate ears in children was recently designed. The aim of this study is to measure the impact of this e-learning module on the trainees' ability to appropriately diagnose ear infection in clinical setting.

NCT ID: NCT02723890 Completed - Pharyngitis Clinical Trials

The Efficacy and Safety of Using the Novel Tyto Device

Start date: July 2016
Phase: N/A
Study type: Interventional

To investigate the efficacy and safety of using the novel Tyto device for remote physical examination by co-investigators as compared to a standard medical physical examination by physicians.