Phased In: delivering antimicrobial stewardship in primary care

Approved 24/05/2024, Cambridge Central REC (2 Redman Place, London, E20 1JQ, United Kingdom; +44 (0)2071048285; cambridgecentral.rec@hra.nhs.uk), ref: 24/EE/0050

The primary feasibility outcome measures include:
1. To establish recruitment methods for a future definitive trial by evaluating recruitment and retention of pharmacies and GP practices in a range of UK geographical and sociodemographic regions. Data collected will include numbers invited, responded, initiated, completed/withdrawn, and reasons for not taking part at each stage, at the end of the study.
2. To establish the feasibility of cluster randomisation by evaluating recruitment of pharmacies/GP practices clusters and acceptability of randomisation to intervention and control arms through qualitative interviews with pharmacy and practice staff after randomisation, during and at the end of the study
3. To determine the feasibility of the triage/referral pathway from GP practices to their linked cluster pharmacy, by establishing: i) time taken, staff requirements, and resources used to triage and manage infections in both the general practices and pharmacies; ii) staffing requirements including time and resource required for training, monitoring and supporting pharmacy staff iii) referral rates to and from pharmacies, referrals to pharmacies not made, and referrals from pharmacies to hospitals. Data will be recorded directly by GP practice and pharmacy staff, qualitative interviews, and through the digital intervention, during and at the end of the study.
4. To establish patient recruitment and consent to i) the main study period and ii) the more intensive audit period, through numbers approached, referred, and consented to the trial collected by GP practice staff and pharmacists, by the digital intervention, and through qualitative interviews during and at the end of the study
5. To finalise data collection methods for primary and secondary outcomes by evaluating i) rates of completion of CRFs by pharmacists and GP practices through data from the digital intervention ii) rates of routine practice level antibiotic prescribing data through data from the RCGP Research and Surveillance Centre (RSC) iii) rates of patient-level data (baseline and audit patients) through medical notes review at the end of the study

The following outcomes will be collected in preparation for a future definitive trial:
1. Experience of the intervention (decision-making tools and point-of-care tests), acceptability of the intervention, and trial materials, through qualitative process interviews conducted during and at the end of the study
2. Engagement with key behaviours – the use of online training; the use of decision support; and engagement with the in-practice audit through qualitative interviews and digital intervention usage data during and at the end of the study
3. Effects on antibiotic prescribing: i) Antibiotic prescribing rates at practice level for the key bundle of antibiotics; ii) Overall antibiotic prescribing at individual level, controlling for illness spectrum, iii) Antibiotic prescribing at individual level for each condition (e.g. LRTI, sore throat), iv) Appropriateness of antibiotic prescribing. Data will be collected through practice level and individual patient data (audit patients) at the end of the study.
4. Consultation rates and complication rates at practice level, through collection of practice level and individual patient data (audit patients) at the end of the study
5. Clinical safety (complications recorded; adverse events) of the triage/referral pathway, and use of the intervention/POCTs through collecting individual patient data (medical notes review and GP/pharmacy report) during and at the end of the study
6. Characteristics of participants in intervention and control practices through the collection of individual patient data at baseline and audit periods recorded by the digital intervention and through medical notes review at the end of the study