AFFAP stepped-wedge cluster-randomised trial: study protocol for the comparative evaluation of audit and feedback-based de-implementation strategies to reduce low-value prescribing in primary care in patients aged 65 years or more

The study objective is to estimate the effect attributable to a primary care pharmacist-led audit and feedback (AF) strategy compared to that of the AF strategy currently used (as a management tool to evaluate healthcare performance focusing on processes and outcomes) for reducing the proportion of patients aged 65 years or more with potentially inappropriate prescriptions of benzodiazepines, proton pump inhibitors and opioids for non-cancer pain. A closed-cohort stepped-wedge cluster-randomised trial will be conducted in nine PC centres in the Barakaldo-Sestao Integrated Health Organisation, Basque Health Service (Osakidetza). All health centre clusters will start under the control condition, and after an initial study period of 4 months in the control phase, one centre per step at 1-month intervals will be randomly assigned to crossover to the intervention, under which they will be exposed to an additional component of AF, namely, primary care pharmacist-led facilitation. The study will include at least 540 patients (60 per centre), randomly selected from among all ≥65-year-olds who meet the criteria for potentially inappropriate prescribing on the lists of GPs at the participating centres. Data will be collected monthly. We will perform between-group comparisons of the proportion of patients in whom appropriateness of prescribing is achieved, using generalised linear mixed models, taking into the clustering and repeated measurements effects of a closed-cohort stepped-wedge design. Implementation outcomes of fidelity, professionals’ adoption and perceived feasibility, and user-reported satisfaction will also be assessed. This study will provide useful knowledge on the characteristics of AF that are most effective and specifically on the effect attributable to a more intensive AF strategy (facilitated AF) compared to standard procedures involving AF reports. ClinicalTrials.gov: NCT07336550 (Registered 30 December 2025; last update 11 May 2026)