Optimising pain management in children with acute otitis media through a primary care-based multifaceted educational intervention: study protocol for a cluster randomised controlled trial

• Published in: Current controlled trials in cardiovascular medicine 2018-09, Vol.19 (1), p.501-501, Article 501
• Main Authors: van Uum, Rick T, Venekamp, Roderick P, Sjoukes, Alies, van de Pol, Alma C, de Wit, G Ardine, Schilder, Anne G M, Damoiseaux, Roger A M J
• Format: Article
• Language: English
• Subjects: Acetaminophen - therapeutic use; Acute otitis media; Acute Pain - diagnosis; Acute Pain - economics; Acute Pain - etiology; Acute Pain - therapy; Age Factors; Analgesics; Analgesics, Non-Narcotic - therapeutic use; Antibiotics; Attitudes; Care and treatment; Child; Child, Preschool; Communication; Complications and side effects; Cost-Benefit Analysis; Cyclooxygenase Inhibitors - therapeutic use; Drug therapy; Ear diseases; Earache - diagnosis; Earache - economics; Earache - etiology; Earache - therapy; Feedback; Female; Health Care Costs; Health Knowledge, Attitudes, Practice; Humans; Ibuprofen - therapeutic use; Infant; Intervention; Knowledge; Male; Methods; Multicenter Studies as Topic; Multifaceted intervention; Netherlands; Nonsteroidal anti-inflammatory drugs; Online instruction; Otitis Media - complications; Otitis Media - diagnosis; Otitis Media - economics; Otitis Media - therapy; Pain management; Pain Management - economics; Pain Management - methods; Pain Measurement; Parents & parenting; Parents - education; Parents - psychology; Pediatric pain; Pediatricians; Practice; Primary care; Primary health care; Primary Health Care - economics; Primary Health Care - methods; Randomized Controlled Trials as Topic; RCT; Risk factors; Self evaluation; Study Protocol; Time Factors; Training; Treatment Outcome
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-018-2880-4

Whilst current guidelines highlight the importance of pain management for children with acute otitis media (AOM), there is evidence to suggest that this is not implemented in everyday practice. We have developed a primary care-based multifaceted educational intervention to optimise pain management in children with AOM, and we trial its clinical and cost effectiveness. This cluster randomised controlled trial aims to recruit 250 children aged 6 months to 10 years presenting with AOM to general practitioners (GPs) in 30 primary care centres (PCCs) across the Netherlands. GPs in the PCCs allocated to the intervention group receive a blended GP educational programme (online and face-to-face training). The intervention asks GPs to proactively discuss pain management with parents using an information leaflet, and to prescribe paracetamol and ibuprofen according to current guidelines. GPs in both groups complete an online module illustrating various otoscopic images to standardise AOM diagnosis. GPs in the PCCs allocated to the control group do not receive any further training and provide 'care as usual'. During the 4-week follow-up, parents complete a symptom diary. The primary outcome is the difference in parent-reported mean earache scores over the first 3 days. Secondary outcomes include both number of days with earache and fever, GP re-consultations for AOM, antibiotic prescriptions, and costs. Analysis will be by intention-to-treat. The optimal use of analgesics through the multifaceted intervention may provide symptom relief and thereby reduce re-consultations and antibiotic prescriptions in children with AOM. Netherlands Trial Register, NTR4920 . Registered on 19 December 2014.