What is BE-SAFE?

BE-SAFE goals

Why BE-SAFE?

The general goal of BE-SAFE is to improve patient safety by addressing knowledge and practice gaps related to the reduction of benzodiazepine and sedative hypnotics (BSHs) used for sleep problems, paying particular attention to implementation aspects, to increase the chance of a large-scale impact at the European level. BSHs incur significant adverse effects and are a major threat to patient safety, especially in older adults. They are associated with an increased risk of falls, fractures, hospitalisations, impaired functioning, delirium, dementia and mortality.

Prescribing BSHs incurs significant costs for healthcare systems and societies. Hospital costs for fall injuries attributable to BSHs, extrapolated to the entire EU, reach € 1.8 billion yearly. BSH use is one of the three overuse practices that is measured by OECD.

BE-SAFE goals

The overall goal of BE-SAFE is to develop, test, implement and disseminate a harmonised and standardised patientcentred approach, accounting for European diversity, to improve patient safety by reducing use of Benzodiazepine and sedative hypnotics (BSHs) for sleep problems, one of the most frequently prescribed classes of harmful medication14 and of the three overuse practices measured by OECD,5 but challenging to reduce BSHs incur significant adverse effects and costs, especially in older adults.

Addressing BSH overuse in older adults is therefore an urgent priority to improve patient safety in Europe. However, previous attempts did not lead to large-scale reduction in use.
The goal of BE-SAFE is to improve patient safety by addressing knowledge and practice gaps related to the reduction of BSHs used for sleep difficulties in Europe.

BE-SAFE concept

BE-SAFE involves seven inter-related WPs to allow smooth coordination and project progression.

BE-SAFE will first identify barriers and enablers to reduce BSHs at patient, informal carer, HCP, healthcare system
and context levels and describe clinical pathways in six European countries (WP1).

BE-SAFE will then develop an intervention comprising trustworthy clinical guidelines, implementation recommendations and patient-centred
materials and procedures accounting for the identified barriers and enablers (WP2-3).

The effectiveness of the intervention in terms of BSH discontinuation, clinical outcomes and PROMs will be evaluated in a cluster RCT
in hospital and outpatient settings of the six participating countries (WP4).

BE-SAFE will model the long-term impact on patient safety at population level. Case studies will assess PREMs and help understand contextual aspects (WP5) to optimise the intervention and adapt the clinical pathways.

Finally, BE-SAFE will produce a toolkit to broadly implement and disseminate the programme.