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Implementing a patient-centred and evidence-based intervention to reduce BEnzodiazepine and sedative-hypnotic use to improve patient SAFEty and quality of care (BE-SAFE): study protocol of a cluster randomised controlled trial

Year: 2026

Type: article

Abstract: Introduction The use of benzodiazepine receptor agonists (BZRA) is associated with increased risks of falls, fractures, hospitalisations and mortality, particularly in older adults, causing substantial patient harm and healthcare costs across Europe. Despite well-established safety concerns and limited effectiveness for sleep problems, BZRA remain widely prescribed. Although previous interventions, including those initiated in hospital settings, reduced BZRA use under study conditions, evidence on patient-relevant outcomes is limited and implementation in real-world European healthcare settings remains scarce. The BE-SAFE (Implementing a patient-centred and evidence-based intervention to reduce BEnzodiazepine and sedative-hypnotic use to improve patient SAFEty and quality of care) trial evaluates whether a theory-based, hospital-initiated, deprescribing intervention increases BZRA discontinuation without compromising sleep quality in older adults treated for sleep problems, compared with usual care. Methods and analysis BE-SAFE is a multicentre, parallel group, cluster-randomised controlled trial conducted in inpatient and outpatient hospital settings across six European countries (Belgium, Greece, Norway, Poland, Spain and Switzerland). The trial assesses superiority for BZRA discontinuation and non-inferiority for sleep quality. Recruitment started in December 2024. Patients aged ≥65 years who have used BZRA for sleep problems on average ≥3 times per week for the preceding 3 months are eligible. Clusters are defined at the hospital physician level and are randomised 1:1 to usual care or the multicomponent, theory-based deprescribing intervention. The intervention includes senior-physician endorsement; BZRA deprescribing training (including shared decision-making); a structured deprescribing algorithm; self-monitoring; patient and caregiver educational materials (including cognitive behavioural therapy for insomnia); and structured communication with community healthcare professionals. The co-primary outcomes are BZRA discontinuation and sleep quality at 12 months. Secondary outcomes include BZRA discontinuation or dose reduction, withdrawal symptoms and sleep quality, health-related quality of life, standardised daily BZRA dose and use of substitute sleep medication; adverse effects (falls, fractures, delirium, hospitalisations and mortality). The target sample size is 470 participants across 62 clusters. Ethics and dissemination Ethics approval was obtained from all participating centres: CHU UCL Namur, site Godinne (approval number: NUB0392024000049 – 111/2024, Belgium); CHU UCL Namur, site St. Elisabeth (approval number: NUB0392024000049 – 19/2024, Belgium); CHU UCL Namur, site Dinant (approval number: NUB0392024000049 – 5/2025, Belgium); Bioethics Committee of the Institute of Psychiatry and Neurology (approval number: 10/2024, Poland); Regional Committee for Medical and Health Research Ethics (approval number: REK sør-øst C - 722845, Norway); Ethics Committee of Eginition Hospital, Laikon Hospital, Sotiria Hospital and Ippokratio Hospital (approval numbers respectively: 1217/02-08-2024, 606/03-09-2024, 3532/10-02-2026 and 65/16-07-2024, Greece); the Commission on Ethics in Animal and Human Experimentation (CEEAH) of the Universitat Autònoma de Barcelona (approval number: 6221, Spain); Ethics Committee of Germans Trias i Pujol Hospital of Badalona (approval number PI-24-206, Spain); the Ethical Committee of the Canton of Bern (approval number: BASEC2024-00702, Switzerland). Results will be disseminated through peer-reviewed journals and presentations at scientific conferences. Trial registration number ClinicalTrials.gov (NCT06584513); Swiss National Clinical Trials Portal (HumRes65897 | SNCTP000006133 | BASEC2024-00702).

Source: BMJ Open

DOI: 10.1136/bmjopen-2026-123804