PRP079: Efficacy of a multi-faceted intervention to deprescribe PPIs in primary care: protocol for a population-based pragmatic trial
Jean-Pascal Fournier, MD, PhD; Jerome Nguyen, MD, MSc
Context: Inappropriate use of proton pump inhibitors (PPIs) is associated with severe adverse drug reactions and has a major economic impact. Deprescribing (the process of withdrawal of an inappropriate medication, supervised by a health care professional with the goal of managing polypharmacy and improving outcomes) should be considered when inappropriate prescription of PPIs is identified. Deprescribing interventions directed solely on prescribers have limited efficacy. Deprescribing interventions should be also targeted to patients. Objective: To assess the efficacy and effectiveness of a multi-faceted intervention on patients and general practitioners (GPs) to deprescribe PPIs. Study Design: Pragmatic, cluster-randomized controlled trial. Setting: Population-based study conducted in two departments of Western France. Population studied: GPs with more than 100 patients in the year before baseline will be included. Their patients aged over 18 years and dispensed with >300 Defined daily dose (DDD) of PPI in the year before baseline will be included. A total of 1300 GPs and 30000 patients will be cluster-randomized according to GPs practices. Intervention/Instrument (for interventional studies): Three arms will be compared: i) multi-faceted intervention associating a) patient education material (PEM) on PPI deprescribing sent directly to patients (the PEM was designed after a focused review and tested with patients), and b) a "dear doctor" letter with the Bruyere Research Institute's PPI deprescribing algorithm sent to their respective GPs , ii) single intervention of sending the letter and algorithm to GPs only, iii) no intervention. Outcome Measures: The primary outcome will be PPI deprescribing defined as the proportion of patients achieving at least a 50% decrease in their PPI dispensing (DDD/year) at 12 months compared to baseline. Secondary outcomes will include incremental cost-utility ratio (using EQ5D-5L scale and Health Insurance’s reimbursement database), acid rebound (using the Gerd Impact Scale), and the patients’ attitudes towards deprescribing (using the French rPATD). Results: Based on previous trials, we anticipate more than 10% “successful PPI deprescribing” in the multi-faceted intervention compared to the single intervention on GPs and the control arm. The study has been funded through a national grant and will be launched in 2020 fall, for early results by the end of 2021.