RecruitingNot ApplicableNCT06584513

Improving Patient Safety by Supporting Older Adults in Managing Sleep Problems.

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)

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

470 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

Sleep Problems Benzodiazepines Deprescribing

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.

Eligibility

Min Age: 65 Years

Inclusion Criteria3

≥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 Criteria14

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

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Interventions

OTHERSpecific tapering plan for sleep medication, educational and cognitive behavioural therapy elements

The intervention consists of a patient-centred intervention to help patients in deprescribing BSHs and better managing their sleep problems. The material used consists of training modules, brochures, and self-monitoring tools. There are materials for physicians and for patients.