Table 1 Outcome measures
Primary outcome measures | |
Feasibility outcome measures | |
Eligibility to screened ratio | Proportion of patients that are eligible for intervention |
Recruitment to eligibility ratio | Proportion of eligible patients consenting to the participation in the study (a ratio of ≥ 50% will be used as the primary determinant of feasibility) |
Intervention to recruitment ratio | Proportion of patients randomised to the intervention arm that had the intervention delivered as per protocol |
Protocol compliance | Proportion of randomised patients that complete all study activities as per protocol |
Safety outcome measures | |
Safety | Proportion of patients with a penicillin allergy who experience an antibiotic-associated immune-mediated adverse event OR serious adverse event (a proportion of < 5% will be used as the determinant of safety) |
Exploratory outcome measures | |
◦ Proportion of participants in the intervention arm successfully delabelled post oral challenge ◦ Proportion of participants in the intervention arm with positive repeat oral challenge (post-ICU discharge) ◦ Utilisation of any penicillin during hospital admission ◦ Utilisation of any narrow-spectrum beta-lactam during hospital admission ◦ Utilisation of vancomycin during hospital admission ◦ Utilisation of any restricted antibiotic during hospital admission ◦ In-Hhspital and 30-day mortality ◦ ICU length of stay and hospital length of stay | |