Clinical trial NCT06584513: Improving Patient Safety by Supporting Older Adults in Managing Sleep Problems.
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benzodiazepines Deprescribing
Sleep Problems
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Universitat Autonoma de Barcelona
name: Oslo University Hospital
name: National and Kapodistrian University of Athens
name: Institute of Psychiatry and Neurology, Warsaw
name: CHU UCL Namur
name: Université Catholique de Louvain
First posted: 2024-09-04
Enrollment: 470
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participating physicians will be randomly assigned in a 1:1 ratio in clusters to either the intervention group or the control group. Patients of participating physicians will be assigned to the physician randomisation group.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Background:

Use of Benzodiazepine and Sedative Hypnotics (BSHs) is one of the three overuse practices measured by the OECD. BSH use has been reported to be as high as 15-30% in older adults with 87% taking BSHs for sleep problems. Use of BSHs is associated with significant adverse effects such as falls, fractures, hospitalisations, impaired functioning, delirium, dementia and mortality and therefore threatens patient safety. This applies especially to older adults as they are more susceptible to adverse effects due to changes in pharmacokinetics and pharmacodynamics associated with age and to the frequent presence of polypharmacy and comorbidities.

Design:

Multicenter, superiority (first co-primary endpoint) and non-inferiority (second co-primary endpoint) cluster randomised controlled trial (RCT) conducted in six countries across Europe (Belgium, Greece Norway, Poland, Spain, and Switzerland). Participating physicians will be randomly assigned in a 1:1 ratio in clusters to either the intervention group (with training and additional material to overcome sleeping problems and to help participants discontinue BSH) or the control group (treatment according to standard of care without training or additional material). Eligible patients will be enrolled with their treating physician defined as the cluster. Outcome assessment will be blinded.

Eligibility criteria: Inclusion Criteria:

* ≥65 years old
* BSH (ATC codes N05BA, N05CF, N05CD, and N03AE01) use on average ≥3 times a week during the last 3 months prior to providing informed consent, as self-reported by the patient or by the informal carer
* Taking BSH for sleep problems, as self-reported by the patient or by the informal carer

Exclusion Criteria:

* Indication for BSH appropriate or withdrawal dangerous, based on available documents (diagnosis list) or General Practitioner (GP) information:

  * Current use of BSH for alcohol withdrawal
  * BSH use in the context of addiction
  * Rapid Eye Movement (REM) sleep Behaviour Disorders
  * Active diagnosis of severe non-REM-related parasomnias with risk of self-damage or giving harm to others or with high frequency or social embarrassment
  * Epilepsy (all forms, because of risk of seizures by sleep deprivation)
  * Current active diagnosis of severe general or specific anxiety disorder (including obsessive compulsive disorder, social phobia, post-traumatic stress disorder, panic disorder with or without agoraphobia)
  * Current active diagnosis of psychotic disorder with or without antipsychotic medication
  * Current active diagnosis of severe depression with or without major anxiety symptoms
  * Current active diagnosis of bipolar disorder with or without major anxiety symptoms
  * Acute suicidal ideation
* Current formal active tapering process of BSHs supported by a physician
* Planned admission to palliative care within 24 hours of inclusion or estimated life-expectancy of less than 12 months i.e., patient is in a state or has a diagnosis where the cluster physician would not be surprised if patient dies within the next months (this criterion is relatively vague and subjective but because there is no validated prognostic score, it is justified)
* Inability to provide informed consent (e.g., because of cognitive impairment), except if a proxy can provide consent, be actively involved in the study, and patient shows no sign of disagreement

Primary outcomes:
measure: BSH discontinuation
timeFrame: 12 months after enrollment
measure: Quality of sleep
timeFrame: 12 months after enrollment
Secondary outcomes:
measure: Use of a substitute medication for sleep
timeFrame: 2 months, 6 months, and 12 months after enrollment
measure: BSH discontinuation discussion with HCP
timeFrame: 1 month, 2 months, and 6 months after enrollment
measure: Benzodiazepines (BSH) discontinuation or dose reduction
timeFrame: 2 months and 6 months after enrollment
measure: BSH adverse events
timeFrame: 12 months after enrollment
measure: Quality of sleep
timeFrame: 2 months and 6 months after enrollment
measure: BSH standardized daily dose intake
timeFrame: 2 months, 6 months, and 12 months after enrollment
measure: Health-related quality of life
timeFrame: 2 months, 6 months, and 12 months after enrollment
measure: Withdrawal symptoms from BSH discontinuation
timeFrame: 2 months and 6 months after enrollment
Other outcomes:
Locations:
city: Yvoir
country: Belgium
facility: Centre Hospitalier Universitaire CHU UCL Namur
city: Athens
country: Greece
facility: National and Kapodistrian University of Athens
city: Nydalen
country: Norway
facility: Oslo University Hospital
city: Warsaw
country: Poland
facility: Institute of Psychiatry and Neurology
city: Barcelona
country: Spain
facility: Universitat Autònoma de Barcelona
city: Bern
country: Switzerland
facility: Department of General Internal Medicine, University Hospital Bern (Inselspital)
Study officials:
affiliation: University Hospital Bern (Inselspital)
name: Nicolas Rodondi, MD, MAS
role: STUDY_CHAIR
References: