Clinical Trial

Reduction of Low-value Prescribing Through Audit and Feedback

Study acronym: AFFAP
Not Yet Recruiting
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Summary
The objective is to estimate the effect attributable to a primary care pharmacist-led audit and feedback (AF) strategy compared to the currently used AF strategy as a management tool to evaluate healthcare performance focusing on processes and outcomes, for reducing the rate of patients over 65 years of age with potentially inappropriate prescribing (PIP) of benzodiazepines, proton pump inhibitors and opioids. A closed-cohort stepped-wedge cluster-randomised trial will be conducted in nine PC centres from Barakaldo-Sestao Integrated Health Organization, 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. Mixed-methods analysis will be performed, gathering quantitative data to assess the results of the implementations at health centre and clinician levels, and qualitative data to assess the feasibility and perceived impact of the de-implementation strategies from the clinicians' perspective, and explore the experience and satisfaction of patients regarding the healthcare received. This study will provide useful knowledge on the effect attributable to a more intensive AF strategy (facilitated AF) compared to standard procedures of AF reports, and of the characteristics of AF that are most effective.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2027-05 -> 2027-06 2026-05-14
minor Completion pushed: 2027-11 -> 2027-12 2026-05-14
Trial Details
NCT Number NCT07336550
Lead Sponsor Basque Health Service
Collaborators: Biobizkaia Health Research Institute, Basque Government Department of Public Health, European Union, Carlos III Health Institute (ISCIII), Spain
Conditions Inappropriate Prescribing, Implementation Science, Behavioral Sciences
Enrollment 540 participants
Start Date 2026-06
Primary Completion 2027-06 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-13