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Benzodiazepines Deprescribing in the Community Setting: Intervention Feasibility (END-IT CS)

U

Université Catholique de Louvain

Status

Enrolling

Conditions

Benzodiazepine Deprescribing

Treatments

Other: END-IT intervention for the community setting

Study type

Interventional

Funder types

Other

Identifiers

NCT05929417
CLIP/2023/01

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

END-IT intervention for the community setting
Experimental group
Description:
The community pharmacist will distribute an educational brochure to the patient. He will also propose to the patient to communicate about a potential benzodiazepine deprescribing with his/her general practitioner through a document called pharmaceutical proposal.
Treatment:
Other: END-IT intervention for the community setting
Control
No Intervention group
Description:
The participants will receive the usual care. The community pharmacists allocated to the control group will have access to the intervention material at the end of the study.

Trial contacts and locations

1

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Central trial contact

Catherine Pétein, RN, MPH

Data sourced from clinicaltrials.gov

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