None listed
Conditions
Brief summary
Patient-reported antibiotic allergy labels are a major public health concern with an estimated 18% of all hospitalised Australians reporting an antibiotic allergy. In one study, the prevalence of paediatric antibiotic allergy labels was 5.3%, with an increasing incidence of reported antibiotic allergy labels with age. Paediatric inpatients with an antibiotic allergy are more likely to receive inferior antibiotics and those reporting a beta-lactam allergy are more likely to have a prolonged hospital length of stay. In the paediatric population, penicillin direct oral challenge has been demonstrated to be a safe delabelling strategy in the outpatient setting, however the safety and effectiveness of paediatric inpatient direct oral challenge and its subsequent impact on antibiotic prescribing and antimicrobial resistance is ill-defined. Furthermore, a national implementation strategy for an effective paediatric antibiotic allergy toolkit has not been previously published. We seek to prospectively audit implementation of paediatric clinical antibiotic allergy delabelling programs, via the International Network of Antibiotic Allergy Nations (iNAAN) platform, to assess safety and the subsequent effects of antibiotic allergy delabelling on antibiotic prescribing and patient outcomes.
Interventions
Paediatric (age < 18 years) patients who have a documented antibiotic allergy label will be identified by site investigators in the inpatient, outpatient and day unit setting at participating hospitals. Antibiotic allergy labels include those from the following antibiotic classes: penicillins, cephalosporins, sulfonamide antibiotics or 'sulfonamide/sulfa unspecified'. Identified patients with an antibiotic allergy label will undergo a formal antibiotic allergy assessment using a digital antibiotic allergy assessment tool and/or according to the local health service antibiotic allergy assessment protocol. EFFECTIVENESS INTERVENTION: Patients identified as having a low-risk penicillin, cephalosporin or sulfonamide allergy will be offered a direct challenge ("effectiveness intervention"), as part of standard clinical practice, in accordance with the local health service protocol for allergy evaluation. The direct challenge is offered to low-risk patients, regardless of participation in the study. Patients who have a negative challenge outcome will be delabelled of their antibiotic allergy. Patient demographic data (age, sex, ethnicity), medical co-morbidities, antibiotic allergy phenotype and challenge data (if performed) will be collected by the National Antibiotic Allergy Network (NAAN) smartphone app with secure upload to a iNAAN REDCap database, hosted by BioGrid. The NAAN app is accessible only by participating health service study teams. Data is entered into the NAAN app by multi-disciplinary clinicians (Medical, Nursing, Pharmacy) who are part of the site project team. Additional data, including hospital admission data, antibiotic usage pre- and post- antibiotic allergy evaluation and antibiotic adverse events may also be entered into the REDCap database for up to 12 months post-antibiotic allergy evaluation. IMPLEMENTATION INTERVENTION: Clinicians at participating health services will receive digital audit and feedback (A&F) ("implementation strategy"), known as the iNAAN-Kids Health Service Report (HSR). The iNAAN-Kids HSR will contain aggregate, deidentified data detailing the local clinical effectiveness and implementation outcomes of antibiotic allergy evaluation, with hospital level benchmarking. The iNAAN-Kids HSR will be delivered digitally every 8 weeks, beginning 12-weeks post site-activation. The effect of digital A&F on ongoing adoption of the digital antibiotic allergy toolkit to perform assessment, and the sustainability of direct challenge in paediatric health services will be audited. This includes an audit of the number of antibiotic allergy assessments and direct challenges performed throughout the study period, both without A&F (baseline 12 weeks) and with A&F (every 8 weeks, from 12 weeks post-activation). Note: The digital antibiotic allergy toolkit and implementation strategy will remain the same throughout the study period.
Sponsors
Eligibility
Inclusion criteria
Patients < 18 years of age reporting a penicillin, cephalosporin and/or sulfonamide antibiotic allergy.
Exclusion criteria
Nil