[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518710":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":45,"centralContacts":50,"locations":60,"responsibleParty":121,"collaborators":123,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":132,"sex":138,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":28,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":152,"overallStatus":63,"whyStopped":28,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"Intermountain Health Care, Inc.","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Health System Level (HSL) Intervention","ACTIVE_COMPARATOR","The HSL Intervention is based on the CDC Core Elements of Stewardship and the HSL intervention is recommended by national guidelines. Sites randomized to this arm will require:\n\n1. A change in their Electronic Health Record to their prescription fields to align with national guidelines\n2. Individualized feedback report to their clinicians and clinic overall\n3. And virtual learning sessions and continuing medical education credits for clinicians.",[13,14,15],"Other: Changes to the electronic health record (EHR)","Other: Individualized audit and feedback reporting for clinicians","Other: Clinician education sessions",{"label":17,"type":18,"description":19,"interventionNames":20},"Hybrid Intervention","EXPERIMENTAL","The Hybrid Intervention will be comprised of Shared Decision-Making (SDM) and the HSL Intervention. A previously validated SDM aid for ear infection care will be implemented. The aid was developed using the International Patient Decision Aid Standards and is freely available. Sites randomized to this arm will require all of the HSL components as well as:\n\n1. Use of the Shared-Decision Aide\n2. Clinician Education on SDM",[13,14,15,21,22],"Other: Use of a shared decision-making (SDM) aide","Other: Shared decision-making (SDM) education",[24,29,33,37,41],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Changes to the electronic health record (EHR)","EHR changes will include minor changes to prescription fields to make it easier for clinicians to order \"wait and see\" antibiotics to be filled only if the child worsens or does not improve rather than antibiotics to take immediately.",[9,17],null,{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Individualized audit and feedback reporting for clinicians","Automated audit and feedback reports detailing participating clinicians' antibiotic prescribing habits for AOM both individually and in comparison to their peers will be shared with clinicians on a quarterly basis throughout the intervention period.",[9,17],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Clinician education sessions","Virtual education sessions will be held for clinicians to learn more about national guidelines for antibiotic prescribing for AOM, etc. The sessions will be recorded and distributed to clinicians who were unable to attend. Attendance of these sessions will apply toward continuing medical education credits for participants.",[9,17],{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Use of a shared decision-making (SDM) aide","A previously validated SDM aide for AOM will be used by clinicians during visits with children with AOM. The aide will be available online and in paper form.",[17],{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":28},"Shared decision-making (SDM) education","Clinicians will receive education on SDM and how to use the aid via virtual, recorded sessions.",[17],[46],{"name":47,"affiliation":48,"role":49},"Holly Frost, MD","Intermountain Health","PRINCIPAL_INVESTIGATOR",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":28,"email":55},"Theresa L Morin, MA","CONTACT","802-881-9534","theresa.morin@imail.org",{"name":57,"role":53,"phone":58,"phoneExt":28,"email":59},"Holly M Frost, MD","715-437-0270","holly.frost@imail.org",[61,86,103],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Denver Health and Hospital Authority","RECRUITING","Denver","Colorado","80204","United States","US",{"type":70,"coordinates":71},"Point",[72,73],-104.9847,39.73915,{"lat":73,"lon":72},[76,80,84],{"name":77,"role":53,"phone":78,"phoneExt":28,"email":79},"Aiden Gilbert, MPA","303-602-2709","aiden.gilbert@dhha.org",{"name":81,"role":53,"phone":82,"phoneExt":28,"email":83},"Timothy Jenkins, MD","303-602-5041","timothy.jenkins@dhha.org",{"name":85,"role":49,"phone":28,"phoneExt":28,"email":28},"Timothy C Jenkins, MD",{"facility":87,"status":63,"city":88,"state":89,"zip":90,"country":67,"countryCode":68,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"AllianceChicago","Chicago","Illinois","60654",{"type":70,"coordinates":92},[93,94],-87.65005,41.85003,{"lat":94,"lon":93},[97,101],{"name":98,"role":53,"phone":99,"phoneExt":28,"email":100},"Mirta Milanes, MPH","872-227-6673","mmilanes@alliancechicago.org",{"name":102,"role":49,"phone":28,"phoneExt":28,"email":28},"Rasmi Narayan, MD",{"facility":48,"status":63,"city":104,"state":105,"zip":106,"country":67,"countryCode":68,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Murray","Utah","84107",{"type":70,"coordinates":108},[109,110],-111.88799,40.66689,{"lat":110,"lon":109},[113,115,119],{"name":114,"role":53,"phone":54,"phoneExt":28,"email":55},"Theresa Morin, MA",{"name":116,"role":53,"phone":117,"phoneExt":28,"email":118},"Hannah Jensen","801-507-4910","hannah.curtis@imail.org",{"name":120,"role":49,"phone":28,"phoneExt":28,"email":28},"Payal Patel, MD",{"type":122,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[124,125,127,129],{"name":87,"class":6},{"name":126,"class":6},"Mayo Clinic",{"name":128,"class":6},"Patient-Centered Outcomes Research Institute",{"name":62,"class":6},"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":142,"type":143},1566,"ESTIMATED","INTERVENTIONAL",[146],"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.",[149,150,151],"Acute Otitis Media","Ear Infection","Pediatric Infectious Disease",[153,154],"Shared Decision-Making","Health-System Level Intervention","2025-08-26",{"date":157,"type":158},"2025-09-03","ACTUAL",{"date":160,"type":158},"2025-02-03",{"date":162,"type":143},"2029-06",{"name":5,"class":6},3]