AFFAP Trial: The Comparative Evaluation of Audit and Feedback-based De-implementation Strategies to Reduce Low-value Prescribing in Primary Care in Patients Over 65 Years of Age.

NCT07336550 NA NOT_YET_RECRUITING

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.

Details

Lead sponsor	Basque Health Service
Phase	NA
Status	NOT_YET_RECRUITING
Enrolment	540
Start date	2026-06
Completion	2027-12

Conditions

• Inappropriate Prescribing
• Implementation Science
• Behavioral Sciences

Interventions

• Usual AF
• Facilitated AF

Primary outcomes

• Primary effectiveness: Proportion of patients with deprescribing or tapering of any of the PIP — From baseline to 13 months
  proportion of patients for whom appropriateness is achieved, either through deprescribing or tapering (for example, dose reduction) of any of the drugs potentially inappropriately prescribed in the patients included in the clusters.

Countries

Spain