Abstract
BACKGROUND: Appropriate deprescribing of psychotropic, sedative, and anticholinergic potentially inappropriate medication (PSA-PIM) in older adults with polypharmacy can reduce the risk of adverse drug reactions, but is inconsistently implemented in primary care. The PARTNER intervention was designed to address challenges in PSA-PIM deprescribing at both provider and patient levels. OBJECTIVES: To evaluate the effectiveness and cost-effectiveness of the PARTNER intervention, and to understand the mechanisms of its effects. DESIGN: Multicenter, two-arm cluster-randomized controlled trial. METHODS AND ANALYSIS: The study aims to recruit at least 44 clusters and 352 patients (⩾65 years old with polypharmacy (⩾5 drugs) and use of ⩾1 PSA-PIM for ⩾6 months) across three study sites in Germany. Clusters consist of one general practice and one or more community pharmacies, randomly allocated to either the PARTNER intervention or control group. The PARTNER intervention includes: (A) education for general practitioners (GPs) and pharmacists on PSA-PIM deprescribing, (B) an interprofessional workshop, (C) drug-specific empowerment brochures for patients, (D) a patient-pharmacist consultation to enhance patient empowerment, and (E) a GP-patient consultation focusing on shared decision-making. The control group receives enhanced usual care, comprising a one-off patient-pharmacist consultation for medication safety checks without a specific focus on PSA-PIM deprescribing. The intervention's focus on PSA-PIM deprescribing is blinded to control group clusters throughout the study. The primary endpoint is a reduction in PSA-PIM exposure at 6 months (⩾0.15-point decrease in the Drug Burden Index). Secondary endpoints include falls, quality of life, healthcare utilization, and costs. The primary analysis will use a generalized linear mixed model to estimate the odds ratio for achieving the primary endpoint, adjusting for study center, age, sex, and pre-randomization PSA-PIM type and count. The process evaluation will explore the understanding of how and why the intervention succeeded or failed. DISCUSSION: The PARTNER trial will provide evidence on the intervention's effectiveness, efficiency, and appropriateness, informing its potential for broader implementation. TRIAL REGISTRATION: The trial has been registered with ClinicalTrials.gov (NCT05842928) on May 6, 2023; https://clinicaltrials.gov/search?term=NCT05842928.