Benzodiazepines Deprescribing in the Community Setting: Intervention Feasibility

NCT ID: NCT05929417

Last Updated: 2023-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-23

Study Completion Date

2024-06-30

Brief Summary

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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

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Conditions

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Benzodiazepine Deprescribing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

END-IT intervention for the community setting

Intervention Type OTHER

The intervention was described in the arm/group descriptions.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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END-IT intervention for the community setting

The intervention was described in the arm/group descriptions.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EBPracticenet

UNKNOWN

Sponsor Role collaborator

Fonds National de la Recherche scientifique (FNRS)

UNKNOWN

Sponsor Role collaborator

Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Spinewine, PhD

Role: PRINCIPAL_INVESTIGATOR

UCLouvain, Louvain Drug Research Institute/Clinical pharmacy research group

Locations

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UCLouvain

Woluwe-Saint-Lambert, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Catherine Pétein, RN, MPH

Role: CONTACT

+3227647236

Facility Contacts

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Catherine Pétein, MPH

Role: primary

+3227647236

References

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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.

Reference Type DERIVED
PMID: 40037665 (View on PubMed)

Other Identifiers

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CLIP/2023/01

Identifier Type: -

Identifier Source: org_study_id

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