Periodic Reporting for period 2 - 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)
Reporting period: 2024-03-01 to 2025-08-31
Benzodiazepine and sedative hypnotics (BSH) commonly called “tranquilizers,” “sleeping pills,” or “sedatives” are medications mainly used for sleep disorders and anxiety. They can cause undesired side effects and costs, especially in older people. It is a priority to improve patient safety by limiting the overuse of BSH in older people in Europe. Despite previous efforts, there has been no large-scale reduction in use of these drugs.
Deprescription aims to tackle medication overuse. It is a systematic process of identifying and discontinuing or reducing the dosage of medications in persons who may experience more harms than benefits. In this process, it is always important to consider the individual patient’s care goals, current level of functioning, life expectancy, and values and preferences. This process is supervised by a healthcare professional (HCP).
BE-SAFE aims to improve patient safety by addressing knowledge and practice gaps related to the deprescription of BSH used for sleeping disorders in Europe. It gathers experts in guidelines, implementation, dissemination, case studies, geriatrics, and sleep medicine.
The consortium includes researchers from six European countries (Belgium, Greece, Norway, Poland, Spain and Switzerland) and Canada. BE-SAFE emphasizes patient involvement through a Patient Partnership Advisory Council with patients, informal carers, and patient organisations, which provides patients perscpective throughout the project.
Deprescription aims to tackle medication overuse. It is a systematic process of identifying and discontinuing or reducing the dosage of medications in persons who may experience more harms than benefits. In this process, it is always important to consider the individual patient’s care goals, current level of functioning, life expectancy, and values and preferences. This process is supervised by a healthcare professional (HCP).
BE-SAFE aims to improve patient safety by addressing knowledge and practice gaps related to the deprescription of BSH used for sleeping disorders in Europe. It gathers experts in guidelines, implementation, dissemination, case studies, geriatrics, and sleep medicine.
The consortium includes researchers from six European countries (Belgium, Greece, Norway, Poland, Spain and Switzerland) and Canada. BE-SAFE emphasizes patient involvement through a Patient Partnership Advisory Council with patients, informal carers, and patient organisations, which provides patients perscpective throughout the project.
The BE-SAFE project is firmly established, with strong collaboration among all consortium partners and active progress across all work packages (WPs).
At project initiation, a comprehensive governance structure (WP7) was created to ensure effective implementation and management. This structure includes several governance boards and committees, each with defined responsibilities and representation from all partner organisations. It ensures compliance with ethical and legal standards across participating countries. The consortium has also developed key policies and plans guiding data management, scientific publication, and gender equity throughout the project.
Under WP1, two major studies were conducted in the first project phase. The first examined care trajectories and healthcare systems related to benzodiazepine and sedative-hypnotic (BSH) deprescription in adults aged 65 and older across six participating countries. The second was a cross-sectional, multicentre survey identifying barriers and enablers of BSH deprescription from the perspectives of physicians, healthcare professionals, and patients. Findings from these studies informed the development of the BE-SAFE intervention (WP3). In parallel, a Patient Reported Experience Measure (PREM) was designed to capture what occurs during BSH deprescription and how it is experienced by patients. The PREM is currently being tested in the ongoing BE-SAFE trial.
Within WP2, a systematic review (SR) and network meta-analysis (NMA) were conducted to assess the comparative effectiveness of interventions facilitating BSH deprescription. These findings informed the development of an international clinical guideline for BSH deprescription in insomnia disorder, now published in the MAGICapp platform. To ensure local relevance, the guideline is being adapted in each BE-SAFE country. In addition, a second SR and NMA on non-pharmacological management of chronic insomnia is in progress, with a clinical guideline to follow. Together, these outputs, alongside WP1 results, underpin the BE-SAFE intervention and its implementation recommendations.
WP3 focused on developing patient-centred resources to support BSH deprescription, using a theory-informed approach. These include brochures and videos for patients and caregivers, a deprescription algorithm, and three online training modules for physicians to strengthen skills in deprescription and shared decision-making. Written communication tools were also created to promote continuity of care. All materials were translated from English into six additional project languages: French, German, Greek, Norwegian, Polish, and Spanish.
WP4 developed the protocol and documentation for the BE-SAFE randomised controlled trial (RCT), designed to evaluate whether the BE-SAFE intervention improves BSH discontinuation compared to standard care while maintaining sleep quality. Ethical approvals were obtained in all six participating countries in 2024. Recruitment began in December 2024 and is ongoing, with close monitoring and data management coordinated by the consortium.
In parallel, WP5 is conducting case studies to assess the effectiveness of the BE-SAFE intervention—exploring how, why, for whom, and in what contexts it works. This involves evaluating implementation, mechanisms of behaviour change, and contextual factors influencing trial outcomes, using a combination of qualitative and quantitative data.
WP6 established Patient Partnership Advisory Councils (PACs) to ensure meaningful patient and public involvement (PPI) across BE-SAFE. Each participating country has a national PAC, and an International PAC brings together representatives from all national groups. WP6 also leads the project’s dissemination, exploitation, and communication plan, guiding outreach through the public website, newsletters, and social media. Furthermore, WP6 developed the Open Science infrastructure, enabling data sharing via an EU-trusted repository (OSF) and supporting knowledge transfer for broad dissemination and impact.
Finally, WP7 ensures effective coordination, management, and governance of the project, overseeing scientific and technical progress, facilitating collaboration across partners and work packages, and maximising the project’s overall relevance and impact.
At project initiation, a comprehensive governance structure (WP7) was created to ensure effective implementation and management. This structure includes several governance boards and committees, each with defined responsibilities and representation from all partner organisations. It ensures compliance with ethical and legal standards across participating countries. The consortium has also developed key policies and plans guiding data management, scientific publication, and gender equity throughout the project.
Under WP1, two major studies were conducted in the first project phase. The first examined care trajectories and healthcare systems related to benzodiazepine and sedative-hypnotic (BSH) deprescription in adults aged 65 and older across six participating countries. The second was a cross-sectional, multicentre survey identifying barriers and enablers of BSH deprescription from the perspectives of physicians, healthcare professionals, and patients. Findings from these studies informed the development of the BE-SAFE intervention (WP3). In parallel, a Patient Reported Experience Measure (PREM) was designed to capture what occurs during BSH deprescription and how it is experienced by patients. The PREM is currently being tested in the ongoing BE-SAFE trial.
Within WP2, a systematic review (SR) and network meta-analysis (NMA) were conducted to assess the comparative effectiveness of interventions facilitating BSH deprescription. These findings informed the development of an international clinical guideline for BSH deprescription in insomnia disorder, now published in the MAGICapp platform. To ensure local relevance, the guideline is being adapted in each BE-SAFE country. In addition, a second SR and NMA on non-pharmacological management of chronic insomnia is in progress, with a clinical guideline to follow. Together, these outputs, alongside WP1 results, underpin the BE-SAFE intervention and its implementation recommendations.
WP3 focused on developing patient-centred resources to support BSH deprescription, using a theory-informed approach. These include brochures and videos for patients and caregivers, a deprescription algorithm, and three online training modules for physicians to strengthen skills in deprescription and shared decision-making. Written communication tools were also created to promote continuity of care. All materials were translated from English into six additional project languages: French, German, Greek, Norwegian, Polish, and Spanish.
WP4 developed the protocol and documentation for the BE-SAFE randomised controlled trial (RCT), designed to evaluate whether the BE-SAFE intervention improves BSH discontinuation compared to standard care while maintaining sleep quality. Ethical approvals were obtained in all six participating countries in 2024. Recruitment began in December 2024 and is ongoing, with close monitoring and data management coordinated by the consortium.
In parallel, WP5 is conducting case studies to assess the effectiveness of the BE-SAFE intervention—exploring how, why, for whom, and in what contexts it works. This involves evaluating implementation, mechanisms of behaviour change, and contextual factors influencing trial outcomes, using a combination of qualitative and quantitative data.
WP6 established Patient Partnership Advisory Councils (PACs) to ensure meaningful patient and public involvement (PPI) across BE-SAFE. Each participating country has a national PAC, and an International PAC brings together representatives from all national groups. WP6 also leads the project’s dissemination, exploitation, and communication plan, guiding outreach through the public website, newsletters, and social media. Furthermore, WP6 developed the Open Science infrastructure, enabling data sharing via an EU-trusted repository (OSF) and supporting knowledge transfer for broad dissemination and impact.
Finally, WP7 ensures effective coordination, management, and governance of the project, overseeing scientific and technical progress, facilitating collaboration across partners and work packages, and maximising the project’s overall relevance and impact.
• BE-SAFE generated the first European data on barriers and enablers to BSH deprescription from the perspective of multiple stakeholders.
• BE-SAFE published an international trustworthy guideline on BSH deprescription.
• The project developed a multicomponent intervention aiming at supporting physicians, older adults, and their caregivers in reducing BSHs use. The intervention is currently being tested in the BE-SAFE RCT.
• BE-SAFE published an international trustworthy guideline on BSH deprescription.
• The project developed a multicomponent intervention aiming at supporting physicians, older adults, and their caregivers in reducing BSHs use. The intervention is currently being tested in the BE-SAFE RCT.