Impact of a deprescribing tool on the use of sedative hypnotics among older patients: study protocol for a cluster randomised controlled trial in Swiss primary care (the HYPE trial)

Abstract

Introduction Benzodiazepines and other sedative hypnotics (BSH) are potentially inappropriate and harmful medications in older people due to their higher susceptibility for adverse drug events. BSH prescription rates are constantly high among elderly patients and even increase with higher age and comorbidity. Deprescribing BSH can be challenging both for healthcare providers and for patients for various reasons. Thus, physicians and patients may benefit from a supportive tool to facilitate BSH deprescribing in primary care consultations. This study intends to explore effectiveness, safety, acceptance and feasibility of such a tool.Methods and analysis In this prospective, cluster randomised, controlled, two-arm, double-blinded trial in the ambulatory primary care setting, we will include general practitioners (GPs) from German-speaking Switzerland and their BSH consuming patients aged 65 years or older, living at home or in nursing homes. GPs will be randomly assigned to either intervention or control group. In the intervention group, GPs will participate in a 1-hour online training on how to use a patient support tool (decision-making guidance plus tapering schedule and non-pharmaceutical alternative treatment suggestions for insomnia). The control group GPs will participate in a 1-hour online instruction about BSH epidemiology and sleep hygiene counselling. This minimal intervention aims to prevent unblinding of control group GPs without jeopardising their ‘usual care’.The primary outcome will be the percentage of patients who change their BSH use (ie, stop, reduce or switch to a non-BSH insomnia treatment) within 6 months from the initial consultation.Expected benefit Based on the results of the study, we will learn how GPs and their patients benefit from a supportive tool that facilitates BSH deprescribing in primary care consultations. The study will emphasise on exploring barriers and facilitators to BSH deprescribing among patients and providers. Positive results given, the study will improve medication safety and the quality of care for patients with sleeping disorders.Ethics and dissemination The study has been approved by the Ethics Committee of the Canton of Zurich (KEK-ZH Ref no. 2023-00054, 4 April 2023). Informed consent will be sought from all participating GPs and patients. The results of the study will be publicly disseminated.Trial registration number ISRCTN34363838