Benzodiazepines Deprescribing in the Community Setting: Intervention Feasibility

NCT05929417 | Unknown

• 1 other identifier: CLIP/2023/01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Benzodiazepine Deprescribing

Keywords

Benzodiazepines; Deprescribing; Community setting; Older adults

Outcome Measures

Primary Outcomes (6)

• Pharmacists' adherence to the intervention

  Has the intervention been implemented as intended? (e.g: global number of implemented intervention components)

  At 3 months

• Pharmacists' adherence to the intervention

  Has the intervention been implemented as intended? (e.g: global number of implemented intervention components)

  At 6 months

• Participants' responsiveness

  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).

  At 3 months

• Participants' responsiveness

  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).

  At 6 months

• Feasibility of the recruitment process

  The feasibility of the recruitment will be assessed (e.g. the ratio between the number of included patients and patients contacted for participation).

  At 6 months

• Feasibility of the data collection process

  The feasibility of the data collection process will be assessed through the quality of the collected data (rate of missing data).

  At 6 months

Secondary Outcomes (7)

• Contextual factors potentially influencing the intervention effects at the patient-level.

  At baseline

• Contextual factors potentially influencing the intervention effects at the pharmacist-level.

  At baseline

• Mechanisms of impact potentially influencing the intervention

  At baseline

• Mechanisms of impact potentially influencing the intervention

  At 3 months

• Mechanisms of impact potentially influencing the intervention

  At 6 months

Study Arms (2)

END-IT intervention for the community setting

EXPERIMENTAL

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.

Other: END-IT intervention for the community setting

Control

NO INTERVENTION

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.

Interventions

END-IT intervention for the community setting OTHER

The intervention was described in the arm/group descriptions.

END-IT intervention for the community setting

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université Catholique de Louvain: lead
• EBPracticenet: collaborator
• Fonds National de la Recherche scientifique (FNRS): collaborator

Study Sites (1)

UCLouvain

Woluwe-Saint-Lambert, 1200, Belgium

RECRUITING

Related Publications (1)

• Petein C, Chevallereau T, Aikpitanyi J, Evrard P, Tubeuf S, Henrard S, Spinewine A. Protocol to evaluate the feasibility of the D-PRESCRIBE intervention adapted to the Belgian community setting (END-IT CS study). BMJ Open. 2025 Mar 4;15(3):e085434. doi: 10.1136/bmjopen-2024-085434.

  PMID: 40037665 DERIVED

Study Officials

• Anne Spinewine, PhD

  UCLouvain, Louvain Drug Research Institute/Clinical pharmacy research group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Pétein, RN, MPH

CONTACT

+3227647236; catherine.petein@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: July 3, 2023
• Study Start: May 23, 2023
• Primary Completion: January 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)