Benzodiazepines Deprescribing in the Community Setting: Intervention Feasibility

Not Applicable

Recruiting

• Conditions: Benzodiazepine Deprescribing
• Interventions: Other: END-IT intervention for the community setting

• Registration Number: NCT05929417
• Lead Sponsor: Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-23
• Study First Submitted: 2023-05-23
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-26
• Last Update Submitted: 2023-06-26
• Study First Posted: 2023-07-03
• Last Update Posted: 2023-07-03
• Primary Completion: 2024-01
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
END-IT intervention for the community setting	END-IT intervention for the community setting	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.

Primary Outcome Measures

Name	Time	Method
Pharmacists' adherence to the intervention	At 6 months	Has the intervention been implemented as intended? (e.g: global number of implemented intervention components)
Feasibility of the data collection process	At 6 months	The feasibility of the data collection process will be assessed through the quality of the collected data (rate of missing data).
Participants' responsiveness	At 6 months	How far participants (pharmacists, patients, and general practitioners) have responded to the intervention and have been engaged by the intervention: e.g. number of altered prescriptions).
Feasibility of the recruitment process	At 6 months	The feasibility of the recruitment will be assessed (e.g. the ratio between the number of included patients and patients contacted for participation).

Secondary Outcome Measures

Name	Time	Method
Mechanisms of impact potentially influencing the intervention	At 6 months	Use of a questionnaire to assess mechanisms of impact in relation with how the intervention is supposed to have its effects.
Contextual factors potentially influencing the intervention effects at the patient-level.	At baseline	Use of a questionnaire to assess factors that could explain potential differences in intervention implementation between patients.
Contextual factors potentially influencing the intervention effects at the pharmacist-level.	At baseline	Use of a questionnaire to assess factors that could explain potential differences in intervention implementation between pharmacies.
Exploratory benzodiazepine deprescribing rate analysis	At 6 months	Defined as benzodiazepine reduction or cessation at 6 months

Trial Locations

Locations (1)

UCLouvain; 🇧🇪 Woluwe-Saint-Lambert, Belgium