Allergy, antibiotics and microbial resistance

INTERVENTION: During their call with the research team, participants will be asked if they have taken any antibiotics in the previous two weeks, if they have, the randomisation/baseline call will be postponed until the participant has been free of antibiotic use for two weeks. The research team will arrange another call for when the participant is free of antibiotics use for two weeks. During the call, the participants will be asked to complete the baseline assessment and the member of the research team will perform randomisation. Randomisation will be performed using Sortition (PC‐CTU’s in‐house online randomisation system) according to the current version of the SOP PC‐CTU_SOP_IT104. Allocation will be minimised by general practice, age, number of antibiotic prescriptions/year, and number of QOF registered diseases, to ensure balance of allocation of these baseline covariates. Patients will be randomised to either usual care (with monitoring of any symptoms following an antibiotic prescription) or the PAAP intervention arm using an allocation ratio of 1:1. Both the participants and the recruiter will know which arm they have been randomised into. The trial statistician will remain blinded to treatment allocation when performing the final analysis. Unblinding of the allocation will take place in accordance of the SOP PC‐CTU_SOP_ST106. Patients who are randomised to the PAAP arm will be asked to undergo penicillin allergy testing, involving: penicillin allergy history; skin testing and/or oral challenge test. Patients will receive their allergy test result by a letter and/or email. Practices will be informed of the results and will be asked to ensure that the patient's electronic health records are updated. Antibiotic prescriptions will be monitored as well as other health outcomes. Patients will be followed up for 4 months for the feasibility study and, following a stop go, 12 months in the main trial. When patients are presc CONDITION: Penicillin allergy ; Injury, Occupational Diseases, Poisoning PRIMARY OUTCOME: Treatment “response failureâ€? defined as: re‐presentation with worsening or non‐resolving symptoms following treatment with an antibiotic up to 28 days after initial antibiotic prescription (including re‐prescription of antibiotic within 28 days of an index prescription) for predefined conditions (TPP/notes review), over the year subsequent to randomisation INCLUSION CRITERIA: 1. Participant is willing and able to give informed consent for participation in the study 2. Male or female, aged 18 years or above 3. Penicillin allergy (or sensitivity) record of any kind in their electronic health record 4. Receipt of either: penicillin, cephalosporin, tetracycline, quinolone or macrolide class antimicrobial or fosfomycin, nitrofurantoin, trimethoprim, clindamycin in the previous 12 months NB Patients with a penicillin allergy record and a recent penicillin prescription would still be eligible because their allergy status will need assessment and records correcting if necessary. SECONDARY OUTCOME: ; 1. Duration of symptoms rated ‘moderately bad’ or worse by patients after antibiotic treatment, measured on Day 1 – 28 diary after each antibiotic prescription and at day 28‐30 by phone call; 2. Total antibiotic use (number and ADQ – average daily quantity) and total number of penicillin and non‐penicillin antibiotic prescriptions (number and ADQ) measured at 12 month post‐randomisation notes review (continues annually until end of study)/secondary care notes review; 3. Number of hospital admissions and length of hospital stays, measured using Hospital Episode Statistics (HES)/secondary care notes review 12 month post‐randomisation (continues annually until end of study); 4. Mortality rates measured using ONS/12 monthly notes review post‐randomisation (continues annually until end of study); 5. Number of patients with MRSA infection/colonisation, measured at 12 month post‐randomisation notes review (continues annually until end of study); 6. Number of patients with Clostridium difficile infection, measured at 12 month post‐randomisation notes review (continues annually until end of study); 7. Patient and clinician views and experiences of penicillin allergy testing, test results and future antibiotic use, assessed using qualitative interviews with GPs once their practice has recruited a proportion of patients to the trial and participants once they have received their PAAP result; 8. Patient and clinician experiences of trial procedures, assessed using qualitative interviews with GPs once their practice has recruited a proportion of patients to the trial and participants once they have received their PAAP result; 9. Change in self‐reported behaviour and influences on behaviour by clinicians and patients, measured using GP questionnaire (throughout trial) and participant allergy belief questionnaires (baseline, days 28 – 30 post‐PAAP, days 2 ‐4 post‐antibiotic episode); 10. Cost effectiveness for the PAAP intervention compared to usual care, measured using self‐reported health/QoL outcome and NHS health resource use. EQ‐5D‐5Lâ„¢ will be used as a standardised instrument for measuring health outcome at baseline and 12 months post randomisation and on day 2 – 4 post antibiotic episode (endpoint is 12 months post randomisation);