Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584513
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
Improving Patient Safety by Supporting Older Adults in Managing Sleep Problems
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BE-SAFE
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 11 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
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None