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

ConditionsBenzodiazepines Deprescribing Sleep Problems

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age65+

SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

≥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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

470 Participants

are divided into 2 treatment groups

Group A: Physician and patient interventionExperimental treatment 1 intervention

Group B: Control/Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

12 months after enrollment

Secondary outcomes

Use of a substitute medication for sleep

Use of a substitute medication for sleep, according to self-/informal carer disclosure

Time frame

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

Time frame

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.

Time frame

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

Time frame

12 months after enrollment