Clinical trial NCT05929443: Benzodiazepines Deprescribing in Nursing Homes: Intervention Feasibility
Official title: Feasibility of a Theory-based Benzodiazepines Deprescribing Intervention in Belgian Nursing Homes: the END-IT Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benzodiazepines Deprescribing
Keywords: Benzodiazepines
Deprescribing
Long-term care
Older adults
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: EBPracticenet
name: Fonds National de la Recherche scientifique (FNRS)
First posted: 2023-07-03
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this feasibility study is to evaluate the feasibility of a complex intervention towards benzodiazepines and Z-drugs deprescribing in older adults living in the Belgian nursing home setting.

The main questions it aims to answer are:

* Is the intervention we developped feasible
* To what extent will the intervention be implemented in nursing homes
* To what extent is the design of the recruitment and data collection process feasible and acceptable for all participants

Participants will benefit from a complex intervention implemented at the level of the nursing home, encompassing process and goals setting, healthcare providers education, environmental adaptations, audit and feedback on benzodiazepines use, use of educational leaflet with residents and relatives, and multidisciplinary work.

Researchers will compare this intervention to usual care, to see if the intervention is feasible, and to gather first data on intervention effectiveness in benzodiazepines deprescriping.


Eligibility criteria: Inclusion Criteria:

* 65 years old and older
* Taking at least one benzodiazepine or Z-drug for 4 weeks or more

Exclusion Criteria:

* Unability to communicate in French
* Palliative care
* Ongoing benzodiazepine withdrawal
* Ongoing alcohol withdrawal
* Severe anxiety
* Severe depression

Primary outcomes:
measure: Nursing homes' adherence to the intervention
timeFrame: Assessed at 6 months
measure: Healthcare providers responsiveness to the intervention
timeFrame: Assessed at 6 months
measure: nursing home residents' responsiveness to the intervention
timeFrame: Assessed at 6 months
measure: Feasibility of the recruitment process
timeFrame: At 6 months
measure: Feasibility of the data collection process
timeFrame: At 6 months
Secondary outcomes:
measure: Contextual factors at the level of of the nursing home
timeFrame: Baseline
measure: Contextual factors at the level of the nursing home resident
timeFrame: Baseline
measure: Intervention mechanisms of impact
timeFrame: At baseline
measure: Intervention mechanisms of impact
timeFrame: At 3 months
measure: Intervention mechanisms of impact
timeFrame: At 6 months
measure: Exploratory benzodiazepine deprescribing rate analysis
timeFrame: At 3 months
measure: Exploratory benzodiazepine deprescribing rate analysis
timeFrame: At 6 months
Other outcomes:
Locations:
city: Woluwe-Saint-Lambert
country: Belgium
facility: UCLouvain
Study officials:
affiliation: UCLouvain / Louvain Drug Research Institute / Clinical pharmacy research group
name: Anne Spinewine, PhD
role: PRINCIPAL_INVESTIGATOR
References: