International Network of Antibiotic Allergy Nations (iNAAN): Protocol for a type 2 hybrid effectiveness-implementation multicentre prospective cohort and target trial emulation study evaluating penicillin allergy delabeling via direct oral challenge

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BACKGROUND: Penicillin allergies are reported in 1 in 10 hospitalised patients globally and are associated with inferior patient and health service outcomes. However, more than 95% of low-risk penicillin allergies can be removed by direct oral challenge (DOC). OBJECTIVE: The International Network of Antibiotic Allergy Nations (iNAAN) aims to evaluate the utility of an audit and feedback (A&F) and education implementation strategy to increase the adoption of penicillin DOC in patients with a low-risk penicillin allergy, while concurrently assessing the impact of penicillin DOC on antibiotic prescribing and health service outcomes. METHODS: This is an international, multicentre type 2 hybrid effectiveness-implementation trial evaluating the widespread safety, clinical effectiveness and implementation of penicillin allergy delabeling via DOC, following penicillin allergy assessment using a purpose-built digital penicillin allergy toolkit within a smartphone application. The implementation strategy encompasses evaluation of co-designed digitally delivered bimonthly A&F reports to health services and clinicians, beginning a minimum of three months post site-activation, and optional education sessions that are delivered by the study team. The primary effectiveness outcome is the proportion of patients with a low-risk penicillin allergy that are delabeled following DOC. The primary implementation outcome is clinician adoption of the digital penicillin allergy toolkit within 6-months of site activation. Participants include adult patients who report a penicillin allergy and have undertaken a formalised penicillin allergy assessment, with or without DOC, at a participating health service. A target trial emulation approach will be used to analyse secondary effectiveness outcomes, including the impact of penicillin DOC on international antibiotic prescribing, infection-related and health service outcomes. DISCUSSION: This study protocol presents a type 2 hybrid effectiveness-implementation trial design that will provide high level evidence to aid widespread implementation of penicillin DOC. TRIAL REGISTRATION: ACTRN12623000484640 (https://www.anzctr.org.au/) (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385815&isReview=true).

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