General practitioner-pharmacist collaboration to enhance deprescribing of psychotropics, sedatives, and anticholinergics among older polypharmacy patients in primary care: study protocol of a cluster-randomized controlled trial (PARTNER).

内容摘要

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. To evaluate the effectiveness and cost-effectiveness of the PARTNER intervention, and to understand the mechanisms of its effects. Multicenter, two-arm cluster-randomized controlled trial. 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. The PARTNER trial will provide evidence on the intervention's effectiveness, efficiency, and appropriateness, informing its potential for broader implementation. The trial has been registered with ClinicalTrials.gov (NCT05842928) on May 6, 2023; https://clinicaltrials.gov/search?term=NCT05842928. Improving medication safety: does collaboration between doctors and pharmacists help reduce psychotropic, sedative and anticholinergic drugs in older adults? Older adults often take multiple medications, including psychotropic (affecting the mind), sedative (sleep-inducing), and anticholinergic (e.g. certain drugs used in the treatment of incontinence) drugs. While these drugs can be beneficial, they may also cause harmful side effects. Especially if used for a long time, the risks can outweigh the benefits. When possible, deprescribing (stopping or reducing those medications) can lower the risk of adverse effects, but can be challenging. The PARTNER study was designed to address deprescribing challenges of these target drugs by enhanced collaboration between general practitioners (GPs) and pharmacists. The study will include at least 44 clusters, each consisting of one GP practice and one or more community pharmacies, across three German regions. The aim is to recruit at least 352 patients aged 65 years or older who are taking five or more medications, including at least one target drug for six months or longer. The clusters are randomly assigned to either the PARTNER intervention or a control group. The PARTNER intervention includes four components: (1) education for GPs and pharmacists on deprescribing, (2) joint workshop between GPs and pharmacists, (3) drug-specific empowerment brochures for patients, (4) patient-pharmacist consultation to enhance patient empowerment, and (5) GP-patient consultation focusing on shared decision-making. In the control group, patients consult with pharmacists for general medication safety checks, without a specific focus on deprescribing target drugs. The primary goal is to see if the PARTNER intervention can reduce patients’ exposure to target drugs after six months. Further goals include assessing intervention effects on falls, quality of life, healthcare utilization, and costs. If effective, the PARTNER intervention could provide a practical approach to safely reducing psychotropic, sedative and anticholinergic drugs in older adults through enhanced GP-pharmacist collaboration. This could improve patient safety and health outcomes.