Clinical trial NCT05929417: Benzodiazepines Deprescribing in the Community Setting: Intervention Feasibility
Official title: Feasibility of a Benzodiazepine Deprescribing Intervention in Older Adults Living in the Belgian Community Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benzodiazepine Deprescribing
Keywords: Benzodiazepines
Deprescribing
Community setting
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 an intervention, led by the pharmacist, aiming at benzodiazepines and z-drugs deprescribing in older adults living in the Belgian community setting. The main questions it aims to answer are:

* To what extent will Belgian community pharmacists adhere to the intervention?
* To what extent will patients and general practitioners take up the intervention to deprescribe benzodiazepines and z-drugs?
* To what extent is the design of the recruitment and data collection process feasible and acceptable for all participants?

Participants will receive an educational brochure from their pharmacist. Their pharmacist will also propose to send a new standardized form to their general practitioner to enhance collaboration about a potential benzodiazepine deprescribing.

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


Eligibility criteria: Inclusion Criteria:

* being aged ≥65 years,
* taking a benzodiazepine receptor agonist for ≥4 weeks (Anatomical Therapeutic Chemical codes: N05BA, N05CD, N05CF and N03AE01)
* being a regular patient of the community pharmacy (defined as ≥ 4 visits/12 previous months).

Exclusion Criteria:

* Severe mental illness (assessed through having an active prescription of any antipsychotic medication).
* Dementia or significant cognitive impairment (assessed through an active prescription or any past prescription during the last 12 months of anticholinesterase inhibitors or memantine) and/or pharmacist's judgment).
* Patients unable to read or communicate in French.
* Ongoing benzodiazepine receptor agonist withdrawal at the time of recruitment.
* Known current alcohol withdrawal.

Primary outcomes:
measure: Pharmacists' adherence to the intervention
timeFrame: At 3 months
measure: Pharmacists' adherence to the intervention
timeFrame: At 6 months
measure: Participants' responsiveness
timeFrame: At 3 months
measure: Participants' responsiveness
timeFrame: 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 potentially influencing the intervention effects at the patient-level.
timeFrame: At baseline
measure: Contextual factors potentially influencing the intervention effects at the pharmacist-level.
timeFrame: At baseline
measure: Mechanisms of impact potentially influencing the intervention
timeFrame: At baseline
measure: Mechanisms of impact potentially influencing the intervention
timeFrame: At 3 months
measure: Mechanisms of impact potentially influencing the intervention
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: