Improving Patient Safety by Supporting Older Adults in Managing Sleep Problems.
NCT Number: NCT06584513
Acronym: BE-SAFE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Benzodiazepines Deprescribing|Sleep Problems
Interventions: OTHER: Specific tapering plan for sleep medication, educational and cognitive behavioural therapy elements
Sponsor: Insel Gruppe AG, University Hospital Bern
Collaborators: Universitat Autonoma de Barcelona|Oslo University Hospital|National and Kapodistrian University of Athens|Institute of Psychiatry and Neurology, Warsaw|CHU UCL Namur|Université Catholique de Louvain
Sex: ALL
Age: OLDER_ADULT
Enrollment: 470
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-15
Completion Date: 2026-02-01
Locations: Centre Hospitalier Universitaire CHU UCL Namur, Yvoir, 5530, Belgium|National and Kapodistrian University of Athens, Athens, 10679, Greece|Oslo University Hospital, Nydalen, 4950, Norway|Institute of Psychiatry and Neurology, Warsaw, 02-957, Poland|Universitat Autònoma de Barcelona, Barcelona, 08041, Spain|Department of General Internal Medicine, University Hospital Bern (Inselspital), Bern, 3010, Switzerland

Summary:
Among older adults (≥65 years), use of sleeping pills, such as benzodiazepines and other sedative-hypnotics, to treat sleep problems is common. While sleeping pills are effective in the first few weeks of use, their effect diminishes significantly after that. Especially older adults are susceptible to significant adverse effects of sleep pills, yet stopping sleeping pills remains challenging. BE-SAFE aims to conduct a randomised study testing a patient-centred intervention to reduce sleeping pill use and to improve patient safety and quality of care focusing on implementation aspects. The intervention addresses knowledge and practice gaps related to discontinuation of sleeping pills in older adults with sleep problems.

Primary Outcome Measures: BSH discontinuation, Number of patients with BSH discontinuation according to self-/informal carer-disclosure. Discontinuation is defined as the intake of a maximum of one tablet within the previous 14 days., 12 months after enrollment|Quality of sleep, Quality of sleep measured by the Insomnia Severity Index (ISI). The questionnaire consists of 7 questions, answers range from 0-4 points, which are added up to get a total score. The higher the total score, the more severe level of insomnia., 12 months after enrollment
Secondary Outcome Measures: Use of a substitute medication for sleep, Use of a substitute medication for sleep, according to self-/informal carer disclosure, 2 months, 6 months, and 12 months after enrollment|BSH discontinuation discussion with HCP, Number of patients who discussed BSH discontinuation with a HCP during the last month at M01 and M02, and during the last 4 months at M06, 1 month, 2 months, and 6 months after enrollment|Benzodiazepines (BSH) discontinuation or dose reduction, Number of patients with BSH discontinuation or dose reduction, according to self-/informal carer disclosure. Defined as the intake of a maximum of one tablet within the previous 14 days., 2 months and 6 months after enrollment|BSH adverse events, Number of patients with adverse effects of BSHs within 12 months of follow-up, according to self/informal carer disclosure, that is:

* Falls leading to emergency room visit or hospitalisation
* Fall-related fractures leading to emergency room visit or hospitalisation. As a sensitivity analysis, facial, fingers/toes, and ankle fractures that are less likely to be osteoporotic fractures will be excluded.
* Delirium leading to emergency room visit or hospitalisation
* Hospitalisations
* Death from any cause, 12 months after enrollment|Quality of sleep, Quality of sleep measured by the Insomnia Severity Index (ISI). The questionnaire consists of 7 questions, answers range from 0-4 points, which are added up to get a total score. The higher the total score, the more severe level of insomnia., 2 months and 6 months after enrollment|BSH standardized daily dose intake, Standardized daily dose intake based on equivalent doses for BSH (lorazepam-equivalent)., 2 months, 6 months, and 12 months after enrollment|Health-related quality of life, Health-related quality of life measured by the European Quality of Life-5 Dimensions questionnaire (EQ-5D-5L). Consists of a visual analogue scale and short descriptive system questionnaire, corresponding to 5 severity levels of health state, higher level indicating more severe problems., 2 months, 6 months, and 12 months after enrollment|Withdrawal symptoms from BSH discontinuation, Number of patients with withdrawal symptoms from BSH discontinuation measured by the Clinical Institute Withdrawal Assessment Scale (CIWA-B). Questionnaires composed of 20 questions, with scale that range from 0-4, which are added up to give a total score. Higher scores indicate more severe levels of withdrawal symptoms., 2 months and 6 months after enrollment|Level of shared decision making (SDM), Level of SDM, using CollaboRATE scale. It ranges from 0-9, higher scores corresponding to higher level of efforts of SDM made during consultations., 1 month after enrollment