Gamified Training and AI Support for Improving Ear Infection Diagnosis in Primary Care

NCT07246551 | Not Yet Recruiting

• 1 other identifier: 2025-03523-01
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 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. 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.

Conditions

Otitis Media Acute; Otitis Media Effusion

Keywords

Otitis Media; Primary Health Care; Artificial Intelligence; Antimicrobial Stewardship; Clinical Decision Support Systems

Outcome Measures

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.

  During the 8-week inclusion period at each participating centre (per patient consultation).

Secondary Outcomes (2)

• Adherence to national AOM treatment guidelines

  During the 8-week inclusion period at each participating centre (per patient consultation).

• Diagnostic performance across groups

  Retrospective analysis after completion of data collection (expected within 12 months of final patient inclusion).

Study Arms (2)

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.

Other: No Intervention - Standard Care

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.

Behavioral: AOM Dx Trainer (gamified educational program)

Interventions

AOM Dx Trainer (gamified educational program) BEHAVIORAL

Educational digital training program for physicians, not psychotherapy or counseling. Designed to improve diagnostic accuracy in acute otitis media through gamified learning with feedback.

Behavioral: AOM Dx Trainer - Intervention Group

No Intervention - Standard Care OTHER

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.

No Intervention: Standard Care - Control Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• At intervention centres, the managing physician must have completed the AOM Diagnosis (Dx) Trainer and reached the required score threshold ("diploma") before including patients.
• General practitioners (GP specialists), GP residents, or junior physicians (interns or basic training physicians) working clinically at participating primary care centres.
• Have provided written informed consent to participate in the study as physician participants.
• At control centres, receive no access to the AOM Dx Trainer during the study period.

You may not qualify if:

• Withdrawal of consent by the participant (physician or patient).

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Umeå University: collaborator
• Lund University: collaborator
• Linkoeping University: collaborator
• Göteborg University: collaborator

MeSH Terms

Conditions

Otitis Media; Otitis Media with Effusion

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Pär-Daniel Sundvall, Professor, MD, PhD

CONTACT

+46(0)72 250 61 96; par-daniel.sundvall@gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-10