Gamified Training and AI Support for Improving Ear Infection Diagnosis in Primary Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorVastra Gotaland Region
About this trial
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.
This study evaluates two digital tools designed to support more accurate diagnosis and treatment decisions in primary care:
1. 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. 2. 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.
The 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.
Physicians 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.
The 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.
By 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Age: Children and adults of all ages are eligible to participate.
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.
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.
Disqualifiers
Withdrawal of consent by the participant (physician or patient).
Trial design
Design model
Parallel
Treatments tested in this trial
AOM Dx Trainer (gamified educational program)
BehavioralEducational digital training program for physicians, not psychotherapy or counseling. Designed to improve diagnostic accuracy in acute otitis media through gamified learning with feedback.
No Intervention - Standard Care
Other interventionParticipants 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: No Intervention: Standard Care - Control GroupActive comparator 1 intervention
Group B: Behavioral: AOM Dx Trainer - Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic accuracy of tympanic membrane assessment by primary care physicians
Diagnostic accuracy of tympanic membrane classification (normal, acute otitis media, erythematous membrane without effusion, or otitis media with effusion) by primary care physicians trained with the AOM Dx Trainer compared with untrained physicians (control group). Accuracy is defined as correct versus incorrect diagnosis relative to the expert panel consensus. Analysed using mixed-effects logistic regression adjusted for physician sex, age, and training level (GP specialist, resident, or junior physician), with physician ID included as a random effect to account for clustering at the physician level.
Time frame
During the 8-week inclusion period at each participating centre (per patient consultation).Secondary outcomes
1
Adherence to national AOM treatment guidelines
Proportion of correct vs. incorrect treatment decisions (antibiotic vs. watchful waiting, drug choice, duration) according to national guidelines, comparing trained vs. untrained physicians. Analysed using mixed-effects logistic regression with the same covariates and random effect as for the primary outcome.
Time frame
During the 8-week inclusion period at each participating centre (per patient consultation).2
Diagnostic performance across groups
Sensitivity, specificity, predictive values, and ROC analyses (with 95% confidence intervals) will be calculated for classification of the four tympanic membrane categories. Performance will be compared against the expert panel, separately for: 1. physicians without training, 2. physicians with AOM Dx Trainer training, 3. the AI diagnostic tool, evaluated with (i) image only, (ii) image + symptoms, (iii) image + tympanometry, and (iv) all modalities combined. In this project, the AI will be evaluated retrospectively in a laboratory setting and will not influence clinical consultations; all patient care remains the responsibility of the treating physician.
Time frame
Retrospective analysis after completion of data collection (expected within 12 months of final patient inclusion).Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Vastra Gotaland Region
Lead sponsor
Umeå University
Collaborator
Lund University
Collaborator
Linkoeping University
Collaborator
Göteborg University
Collaborator
Source ClinicalTrials.gov
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