[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ear-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ear-infection":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100518710","interventions-to-de-implement-unnecessary-antibiotic-prescribing-for-children-with-ear-infections-100518710",false,"NCT06034080","Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections","DISAPEAR Trial: Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections","DISAPEAR","Inclusion Criteria:\n\nA. Implementation of Interventions 1. Clinic at a participating organization 2. Provides care to children with AOM 3. Administrative or local approval for participation\n\nB. Secondary Electronic Health Record Data\n\n1. Aged 6 months-17-years-old (inclusive)\n2. Diagnosis of AOM by ICD10 code\n\nC. Video recordings or direct observation of the use of a shared decision aid\n\nParent participation:\n\n1. Child aged 6 months-17 years (inclusive)\n2. Diagnosed with AOM by clinician\n3. Parent or legal guardian is present and is \\>=18 years or older\n\nClinician Participation:\n\n1. Licensed clinician and not a medical trainee\n2. Age 18 \\>= years or older\n\nD. Pre-implementation interviews of clinicians and administrators\n\n1. Licensed clinician (physician or advanced practice clinician) that cares for children with AOM at a participating organization or an administrator\u002Fmanager at a participating organization.\n2. Aged \\>=18 years-no maximum\n\nE. Pre-implementation focus groups of parents\n\n1. Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization.\n2. 18 years of age or older and able\u002Fwilling to consent\n\nF. Parents enrolled for surveys\n\n1\\. Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization. 2. Willing to participate and able to complete electronic surveys at enrollment and 10 days after enrollment. 3. Working phone 4. Age \\>=18 years of age\n\nG. Post-intervention focus groups of parents\n\n1. Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization.\n2. 18 years of age or older and able\u002Fwilling to consent\n\nH. Post-intervention surveys of clinicians and administrators\n\n1. Licensed clinician (physician or advanced practice clinician) that cares for children with AOM at a participating organization or an administrator\u002Fmanager at a participating organization.\n2. Aged \\>=18 years-no maximum\n\nExclusion Criteria:\n\nA. Implementation of Interventions\n\n1\\. Clinics that exclusively provide telehealth\n\nB. Secondary Electronic Health Record Data\n\n1\\. None\n\nC. Video recordings or direct observation of the use of a shared decision aid\n\nParent participation:\n\n1\\. None\n\nClinician Participation:\n\n1\\. None\n\nD. Pre-implementation interviews of clinicians and administrators 1. Medical trainee (student, resident, fellow, etc.)\n\nE. Pre-implementation focus groups of parents\n\n1\\. None\n\nF. Parents enrolled for surveys 1. Complicated or recurrent AOM as determined by the study team\n\nG. Post-intervention focus groups of parents 1. None\n\nH. Post-intervention surveys of clinicians and administrators\n\n1\\. Medical trainee (student, resident, fellow, etc.)","ALL","6 Months","17 Years",{"count":21,"type":22},1566,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.\n\nThis 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.",[28,29,30],"Acute Otitis Media","Ear Infection","Pediatric Infectious Disease",[32,33],"Shared Decision-Making","Health-System Level Intervention","RECRUITING","2025-08-26",{"date":37,"type":38},"2025-09-03","ACTUAL",{"date":40,"type":38},"2025-02-03",{"date":42,"type":22},"2029-06",{"name":44,"class":45},"Intermountain Health Care, Inc.","OTHER",3,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":19,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100594901","application-of-the-belleai-comparative-image-reference-system-for-describing-chronic-ear-infections-in-pediatric-patients-from-low-resource-communities-100594901","NCT07025473","Application of the Belle.AI Comparative Image Reference System for Describing Chronic Ear Infections in Pediatric Patients From Low-Resource Communities","Application of the Belle.AI Comparative Image Reference System for Describing Chronic Ear Infections in Pediatric Patients From Low-Resource Communities in Remote, At-Home Settings","Otoscopy AI","Inclusion Criteria:\n\n* Patient must be aged 1 to 17 years old.\n* Patient must present with a primary middle ear complaint.\n* Parent of the pediatric patient must have the ability and willingness to provide informed consent and comply with study procedures and visits.\n* Participants must have access to the required technology (e.g., smartphone with internet access) and be capable of using the provided off-the-shelf otoscope for the required image capture.\n\nExclusion Criteria:\n\n• Patients who are unable to comply with study procedures due to physical or mental health limitations (as assessed by study coordinator).","1 Year",{"count":57,"type":22},20,[25],"The purpose of this research is to examine the clinical effectiveness of an investigational AI-powered smartphone app that describes the physical characteristics of an otoscopy image. It is not intended to make any diagnosis. Only healthcare professionals will make the diagnosis. The investigators will compare the diagnosis made by physicians or physician extenders (healthcare professionals) against the description provided by the support AI app tool to determine the clinical relevance of the system and examine its use within a clinical setting.",[29],[62,63,64,65,66,67,68],"AI","Artificial Intelligence","Digital Health","Ear Disorders","Otoscopy","Digital Videoscope","Ear Health","NOT_YET_RECRUITING","2025-06-13",{"date":72,"type":38},"2025-06-17",{"date":74,"type":22},"2025-06-30",{"date":76,"type":22},"2025-09-30",{"name":78,"class":79},"BelleTorus Corporation","INDUSTRY",1]