Study protocol for a single-centre, prospective, non-blinded, randomised, 12-month, parallel-group superiority study to compare the efficacy of pharmacist intervention versus usual care for elderly patients hospitalised in orthopaedic wards

INTRODUCTION: Given that polypharmacy and potentially inappropriate prescribing are common in elderly orthopaedic patients, pharmacist interventions to improve medication practices among this population are important. However, past studies have reported mixed results regarding the effectiveness of pharmacist-led interventions in inpatient elderly care. Furthermore, few randomised controlled trials have evaluated patient-relevant outcomes as a primary endpoint. Therefore, we will evaluate whether a pharmacist-led intervention could reduce readmission of hospitalised elderly orthopaedic patients with polypharmacy or potentially inappropriate prescribing. METHODS AND ANALYSIS: This is an ongoing single-centre, prospective, non-blinded, randomised controlled trial designed to evaluate the superiority of a pharmacist-led intervention for hospitalised elderly patients compared with usual care. The trial will include newly admitted orthopaedic patients 70 years of age and older with polypharmacy or at least one potentially inappropriate prescription, as identified by the screening tool of older people’s prescriptions (STOPP) criteria. Usual care includes medication reconciliation, patient education and monitoring, as well as providing information about discharge medications. Pharmacist interventions, in addition to usual care, include advising the patient’s physician to stop unnecessary or inappropriate medications and start necessary medications. The primary outcome is the 1-year readmission rate. Secondary outcomes are the proportion of patients who undergo emergency department visits and the occurrences of all-cause death, a new fracture, myocardial infarction and ischaemic stroke. The study started in November 2017, and up to approximately 220 patients will be enrolled. ETHICS AND DISSEMINATION: The protocol was approved by the Medical Ethics Committee of the National Hospital Organization Tochigi Medical Center (No. 29–22). The trial was registered at the University Hospital Medical Information Network (UMIN) clinical registry. The results of this trial will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: UMIN000029404.