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

NCT ID: NCT06584513

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 470 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-18
• Study Completion Date: 2026-02-01

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.

Conditions

Benzodiazepines Deprescribing; Sleep Problems

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Physician and patient intervention

Patients in the intervention group will be treated by physicians, who received informative and educative materials (including videos) and training, including guidelines and implementation recommendations on how to deprescribe, on shared-decision making with patients, on how to manage sleep problems using alternative methods other than BSH. Patients receive brochures and access to videos. Communication forms are implemented to ensure continuity of care.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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.

Control/Usual care

Participants in the control group receive treatment according to standard care of the prescribing physician, who did not receive any training or additional material.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Specific 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitat Autonoma de Barcelona

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: collaborator

National and Kapodistrian University of Athens

OTHER

Sponsor Role: collaborator

Institute of Psychiatry and Neurology, Warsaw

OTHER

Sponsor Role: collaborator

CHU UCL Namur

UNKNOWN

Sponsor Role: collaborator

Université Catholique de Louvain

OTHER

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas Rodondi, MD, MAS

Role: STUDY_CHAIR

University Hospital Bern (Inselspital)

Locations

Centre Hospitalier Universitaire CHU UCL Namur

Yvoir, , Belgium

Site Status: RECRUITING

National and Kapodistrian University of Athens

Athens, , Greece

Site Status: RECRUITING

Oslo University Hospital

Nydalen, , Norway

Site Status: RECRUITING

Institute of Psychiatry and Neurology

Warsaw, , Poland

Site Status: RECRUITING

Universitat Autònoma de Barcelona

Barcelona, , Spain

Site Status: RECRUITING

Department of General Internal Medicine, University Hospital Bern (Inselspital)

Bern, , Switzerland

Site Status: RECRUITING

Countries

Belgium; Greece; Norway; Poland; Spain; Switzerland

Central Contacts

Nicolas Rodondi, MD, MAS

Role: CONTACT

nicolas.rodondi@insel.ch

+41 31 632 00 69

Carole E Aubert, MD, MSc

Role: CONTACT

caroleelodie.aubert@insel.ch

+41 31 664 24 34

Other Identifiers

2024-00702

Identifier Type: -

Identifier Source: org_study_id