[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611897":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":26,"responsibleParty":38,"collaborators":40,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":26,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":26,"maxAge":26,"enrollmentInfo":57,"targetDuration":26,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":73,"whyStopped":26,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":26},{"fullName":5,"class":6},"Vastra Gotaland Region","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"No Intervention: Standard Care - Control Group","ACTIVE_COMPARATOR","Physicians at control centres will provide standard care without access to the AOM Dx Trainer. Consultations will proceed as usual for patients with ear symptoms. Research nurses will collect tympanic membrane images and tympanometry data for expert panel and AI evaluation.",[13],"Other: No Intervention - Standard Care",{"label":15,"type":16,"description":17,"interventionNames":18},"Behavioral: AOM Dx Trainer - Intervention Group","EXPERIMENTAL","Primary care physicians at centres randomized to the intervention arm will complete training with the AOM Diagnosis (Dx) Trainer, a gamified educational program designed to improve diagnostic accuracy in acute otitis media. After completing the training, these physicians will manage patients as usual. Research nurses will collect tympanic membrane images and tympanometry data for expert panel and AI evaluation.",[19],"Behavioral: AOM Dx Trainer (gamified educational program)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","AOM Dx Trainer (gamified educational program)","Educational digital training program for physicians, not psychotherapy or counseling. Designed to improve diagnostic accuracy in acute otitis media through gamified learning with feedback.",[15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"OTHER","No Intervention - Standard Care","Participants in this arm will receive standard care according to clinical routines, without access to the AOM Diagnosis (Dx) Trainer. No experimental or additional interventions will be applied.",[9],[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Pär-Daniel Sundvall, Professor, MD, PhD","CONTACT","+46(0)72 250 61 96","par-daniel.sundvall@gu.se",{"type":39,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[41,43,45,47],{"name":42,"class":28},"Umeå University",{"name":44,"class":28},"Lund University",{"name":46,"class":6},"Linkoeping University",{"name":48,"class":28},"Göteborg University","100611897","gamified-training-and-ai-support-for-improving-ear-infection-diagnosis-in-primary-care-100611897",false,"NCT07246551","Gamified Training and AI Support for Improving Ear Infection Diagnosis in Primary Care","Enhancing Diagnosis of Otitis Media in Primary Care: Gamified Training and AI-Driven Tools","Inclusion Criteria Patients:\n\n* Newly developed ear discomfort or symptoms within the past month. The patient seeks care at a participating primary care centre and is assessed by a physician because of these ear-related symptoms. Alternatively, for young children: respiratory tract infection with concurrent signs or symptoms suggesting possible ear involvement, even if the child cannot clearly express ear pain.\n* Age: Children and adults of all ages are eligible to participate.\n* Informed consent: The patient (or guardian for minors) agrees to participate and provides written informed consent. For children under 15 years, consent is obtained from both guardians before any data storage.\n* The patient must have been managed by a physician who has consented to participate in the study (as a physician participant) and who is a GP specialist, GP resident, or junior physician (intern or basic training physician) working at the primary care centre.\n* At intervention centres, the managing physician must have completed the AOM Diagnosis (Dx) Trainer and reached the required score threshold (\"diploma\") before including patients.\n\nInclusion Criteria Physicians:\n\n* General practitioners (GP specialists), GP residents, or junior physicians (interns or basic training physicians) working clinically at participating primary care centres.\n* Have provided written informed consent to participate in the study as physician participants.\n* At intervention centres, must have completed the AOM Dx Trainer and achieved the required diploma level before patient inclusion.\n* At control centres, receive no access to the AOM Dx Trainer during the study period.\n\nExclusion Criteria:\n\n* Withdrawal of consent by the participant (physician or patient).","ALL",{"count":58,"type":59},200,"ESTIMATED","INTERVENTIONAL",[62],"NA","Acute otitis media (AOM), or middle ear infection, is one of the most common childhood infections and a leading cause of antibiotic prescribing in primary care. Diagnosing AOM can be challenging, as ear symptoms and eardrum appearances often overlap with mild or transient conditions. This uncertainty may lead to both unnecessary antibiotic use and missed cases requiring treatment, affecting patient safety and contributing to antibiotic resistance.\n\nThis study evaluates two digital tools designed to support more accurate diagnosis and treatment decisions in primary care:\n\n1. AOM Dx \\[diagnosis\\] Trainer (Otitspelet) - a gamified digital training program for physicians that provides interactive exercises using eardrum images and patient cases, with direct feedback to improve diagnostic accuracy and adherence to guidelines.\n2. AI-based diagnostic support - a system that analyses tympanic membrane images, with and without symptom and tympanometry data, to evaluate its potential for future diagnostic use.\n\nThe trial is coordinated by the Västra Götaland Region (VGR) in collaboration with Umeå University and conducted across four Swedish regions: Västra Götaland, Västerbotten, Östergötland, and Skåne. VGR leads the evaluation of the AOM Dx Trainer intervention, while Umeå University leads the AI development and retrospective diagnostic analyses. The study is carried out as a multicentre, cluster-randomised controlled trial in primary care, where participating primary care centres are randomised to either the training intervention or standard care.\n\nPhysicians are the research participants under evaluation. At intervention centres, physicians complete training with the AOM Diagnosis (Dx) Trainer before study start; at control centres, no training is provided. Each participating centre then conducts an 8-week observation period, during which physicians diagnose and manage patients with new-onset ear symptoms. Patients are included only to allow evaluation of physicians' diagnostic and treatment decisions and to provide data for AI analysis. Estimated patient enrollment is \\~200. Depending on centre size and recruitment success, up to 20 primary care centres across four Swedish regions - Västra Götaland, Västerbotten, Östergötland, and Skåne - will participate. After each consultation, research nurses collect tympanic membrane images and tympanometry data from patients who have given informed consent. These data are used for expert panel reference diagnoses and retrospective AI analysis; no information is shared with treating physicians.\n\nThe primary outcome is diagnostic accuracy of tympanic membrane assessment by physicians trained with the AOM Dx Trainer compared with untrained physicians, using expert consensus as the reference standard. Secondary outcomes include adherence to treatment guidelines and antibiotic prescribing rates. The AI system's diagnostic performance will also be benchmarked against the expert panel and physician groups.\n\nBy combining educational and technological innovation, this study aims to enhance diagnostic precision, improve guideline adherence, and reduce unnecessary antibiotic use in primary care-strengthening antimicrobial stewardship and providing a scalable model for future infection management.",[65,66],"Otitis Media Acute","Otitis Media Effusion",[68,69,70,71,72],"Otitis Media","Primary Health Care","Artificial Intelligence","Antimicrobial Stewardship","Clinical Decision Support Systems","NOT_YET_RECRUITING","2025-11-17",{"date":76,"type":77},"2025-11-24","ACTUAL",{"date":79,"type":59},"2025-12-01",{"date":81,"type":59},"2027-12-31",{"name":5,"class":6}]