Improving Patient Safety by Supporting Older Adults in Managing Sleep Problems. (BE-SAFE)

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Problems; Benzodiazepines Deprescribing
• Intervention / Treatment: Other: Specific tapering plan for sleep medication, educational and cognitive behavioural therapy elements

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.

• Study Type: Interventional
• Enrollment (Estimated): 470
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carole E Aubert, MD, MSc; Phone Number: +41 31 664 24 34; Email: caroleelodie.aubert@insel.ch
• Study Contact Backup: Name: Nicolas Rodondi, MD, MAS; Phone Number: +41 31 632 00 69; Email: nicolas.rodondi@insel.ch

Study Locations

• Belgium
  • Yvoir, Belgium, 5530
    • Recruiting
    • Centre Hospitalier Universitaire CHU UCL Namur
• Greece
  • Athens, Greece, 10679
    • Recruiting
    • National and Kapodistrian University of Athens
• Norway
  • Nydalen, Norway, 4950
    • Recruiting
    • Oslo University Hospital
• Poland
  • Warsaw, Poland, 02-957
    • Recruiting
    • Institute of Psychiatry and Neurology
• Spain
  • Barcelona, Spain, 08041
    • Recruiting
    • Universitat Autonoma de Barcelona
• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Department of General Internal Medicine, University Hospital Bern (Inselspital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: Oslo University Hospital; National and Kapodistrian University of Athens; Université Catholique de Louvain; Universitat Autonoma de Barcelona; Institute of Psychiatry and Neurology, Warsaw; CHU UCL Namur
• Investigators: Study Chair: Nicolas Rodondi, MD, MAS, University Hospital Bern (Inselspital)

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: September 2, 2024
• First Submitted That Met QC Criteria: September 2, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: 2024-00702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No