Periodic Reporting for period 1 - 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: 2022-09-01 to 2024-02-29
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).
The goal of BE-SAFE is 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 will emphasize patient involvement by establishing a Patient Partnership Advisory Council with patients, informal carers, and patient organisations, which will advise on various aspects all along the project.
BE-SAFE follows a structured approach, which includes 7 work packages (WPs), and is inspired by the Choosing Wisely De-Implementation Framework to reduce low-value care. BE-SAFE will first conduct a survey among patients, informal carers, and HCPs to describe current care trajectories and identify barriers and enablers to BSH deprescription (WP1). The results will inform the development of guidelines, implementation recommendations and patient-centred materials to support physicians and patients in BSH deprescription (WP2 and WP3). This approach will be tested in a randomised controlled trial (RCT) in the six European countries involved. In parallel, researchers will conduct case studies to develop general models to be applied in each country, but also to help in the scale up and spread of the BE-SAFE intervention (WP5). Finally, BE-SAFE will create a toolkit to share the new best practices across Europe, enabling healthcare systems to implement this process in a standardised way, while accounting for country and context differences (WP6).
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).
The goal of BE-SAFE is 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 will emphasize patient involvement by establishing a Patient Partnership Advisory Council with patients, informal carers, and patient organisations, which will advise on various aspects all along the project.
BE-SAFE follows a structured approach, which includes 7 work packages (WPs), and is inspired by the Choosing Wisely De-Implementation Framework to reduce low-value care. BE-SAFE will first conduct a survey among patients, informal carers, and HCPs to describe current care trajectories and identify barriers and enablers to BSH deprescription (WP1). The results will inform the development of guidelines, implementation recommendations and patient-centred materials to support physicians and patients in BSH deprescription (WP2 and WP3). This approach will be tested in a randomised controlled trial (RCT) in the six European countries involved. In parallel, researchers will conduct case studies to develop general models to be applied in each country, but also to help in the scale up and spread of the BE-SAFE intervention (WP5). Finally, BE-SAFE will create a toolkit to share the new best practices across Europe, enabling healthcare systems to implement this process in a standardised way, while accounting for country and context differences (WP6).
During the first 18 months, all 7 WPs of the project started their work. Partners collaborated closely across WPs to optimise impact.
At the beginning of the project, a governance structure was set up to ensure the effective implementation and management of the project (WP7). Different governance boards and committees, each with specific responsibilities and including representatives from each partner organization were established. This structure ensures compliance with ethical and legal standards across all participating countries. Additionally, the consortium developed several policies and plans to articulate guidelines for data management, scientific publications, and gender equity throughout the project duration.
Then, the consortium focused on laying the groundwork for the implementation of the BE-SAFE RCT. In WP1, two studies were conducted. The first study described the care trajectories and healthcare systems in relation to BSH deprescription in adults aged 65 and over in the six participating countries. The second study was a cross-sectional, multicentre survey. It aimed to identify the barriers to and enablers of BSH deprescription, from the perspective of physicians, other HCPs, and patients. The project team also started developing a Patient Reported Experience Measure (PREM) to capture “what” happens in relation to BSH deprescription during an episode of care, and “how” it happens from the perspective of patients.
In WP2, the project conducted a systematic review and developed an international guideline on BSH deprescription in insomnia disorder. To account for local context and country specificity, the guideline is currently being adapted in Belgium and Norway, and will later be adapted in the other BE-SAFE countries. These recommendations, and findings from WP1 guided the development of implementation recommendations. In addition, a systematic review on non-pharmacological management of chronic insomnia is ongoing.
In WP3, the project developed patient-centred materials to support BSH deprescription. Three brochures and videos were developed for patients and their caregivers. The consortium also developed a deprescription algorithm, and three online training modules for physicians to enhance their skills in BSH deprescription and in shared decision making. Written communication forms were also developed to facilitate seamless care throughout the process.
The WP4 developed the materials and documents needed for the BE-SAFE RCT (protocol and appendixes, informed consent forms, monitoring plan, etc.). This RCT aims to assess whether the intervention developed in WP3 enhances BSH discontinuation compared to standard care, while maintaining sleep quality. In parallel, WP5 case studies will explore why, how, for whom and where the BE-SAFE intervention is, or is not, effective. The full protocol for both WP4 and WP5 is now being evaluated by the local ethics committees in each country. The trial is expected to start mid-2024.
In WP6, Patient Partnership Advisory Councils (PAC) aiming at ensuring patients and public involvement in BE-SAFE were established, with a local PAC in each country and an International PAC gathering one representative of each local PAC. Furthermore, WP6 enabled to elaborate the Plan for dissemination, exploitation and communication. This plan describes how the work conducted in BE-SAFE will be broadcasted, the target audiences and the means and tools to be used (public website (https://besafe-horizon.eu/(opens in new window) newsletters, social media etc.). Finally, the consortium set up the structure necessary to align with Open science requirements (storage of BE-SAFE sharable data on an EU trusted repository (OSF), Knowledge transfer approach for wide dissemination…).
At the beginning of the project, a governance structure was set up to ensure the effective implementation and management of the project (WP7). Different governance boards and committees, each with specific responsibilities and including representatives from each partner organization were established. This structure ensures compliance with ethical and legal standards across all participating countries. Additionally, the consortium developed several policies and plans to articulate guidelines for data management, scientific publications, and gender equity throughout the project duration.
Then, the consortium focused on laying the groundwork for the implementation of the BE-SAFE RCT. In WP1, two studies were conducted. The first study described the care trajectories and healthcare systems in relation to BSH deprescription in adults aged 65 and over in the six participating countries. The second study was a cross-sectional, multicentre survey. It aimed to identify the barriers to and enablers of BSH deprescription, from the perspective of physicians, other HCPs, and patients. The project team also started developing a Patient Reported Experience Measure (PREM) to capture “what” happens in relation to BSH deprescription during an episode of care, and “how” it happens from the perspective of patients.
In WP2, the project conducted a systematic review and developed an international guideline on BSH deprescription in insomnia disorder. To account for local context and country specificity, the guideline is currently being adapted in Belgium and Norway, and will later be adapted in the other BE-SAFE countries. These recommendations, and findings from WP1 guided the development of implementation recommendations. In addition, a systematic review on non-pharmacological management of chronic insomnia is ongoing.
In WP3, the project developed patient-centred materials to support BSH deprescription. Three brochures and videos were developed for patients and their caregivers. The consortium also developed a deprescription algorithm, and three online training modules for physicians to enhance their skills in BSH deprescription and in shared decision making. Written communication forms were also developed to facilitate seamless care throughout the process.
The WP4 developed the materials and documents needed for the BE-SAFE RCT (protocol and appendixes, informed consent forms, monitoring plan, etc.). This RCT aims to assess whether the intervention developed in WP3 enhances BSH discontinuation compared to standard care, while maintaining sleep quality. In parallel, WP5 case studies will explore why, how, for whom and where the BE-SAFE intervention is, or is not, effective. The full protocol for both WP4 and WP5 is now being evaluated by the local ethics committees in each country. The trial is expected to start mid-2024.
In WP6, Patient Partnership Advisory Councils (PAC) aiming at ensuring patients and public involvement in BE-SAFE were established, with a local PAC in each country and an International PAC gathering one representative of each local PAC. Furthermore, WP6 enabled to elaborate the Plan for dissemination, exploitation and communication. This plan describes how the work conducted in BE-SAFE will be broadcasted, the target audiences and the means and tools to be used (public website (https://besafe-horizon.eu/(opens in new window) newsletters, social media etc.). Finally, the consortium set up the structure necessary to align with Open science requirements (storage of BE-SAFE sharable data on an EU trusted repository (OSF), Knowledge transfer approach for wide dissemination…).
During this first implementation period:
• 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 will be tested in the BE-SAFE RCT.
• 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 will be tested in the BE-SAFE RCT.