Benzodiazepines Deprescribing in Nursing Homes: Intervention Feasibility

NCT ID: NCT05929443

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

2023-06-22

Study Completion Date

2024-06-30

Brief Summary

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The goal of this feasibility study is to evaluate the feasibility of a complex intervention towards benzodiazepines and Z-drugs deprescribing in older adults living in the Belgian nursing home setting.

The main questions it aims to answer are:

* Is the intervention we developped feasible
* To what extent will the intervention be implemented in nursing homes
* To what extent is the design of the recruitment and data collection process feasible and acceptable for all participants

Participants will benefit from a complex intervention implemented at the level of the nursing home, encompassing process and goals setting, healthcare providers education, environmental adaptations, audit and feedback on benzodiazepines use, use of educational leaflet with residents and relatives, and multidisciplinary work.

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

Detailed Description

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Conditions

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Benzodiazepines Deprescribing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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END-IT intervention for nursing homes

This complex intervention, implemented at the level of the nursing home, encompasses process and goals setting, education for healthcare providers, environmental adaptations, audit and feedback on benzodiazepine use, use of an educational leaflet for residents and relatives, and multidisciplinary work.

Group Type EXPERIMENTAL

END-IT intervention for nursing homes

Intervention Type OTHER

Complex intervention, as described in the arm/group descriptions

Control

Usual care. Nursing homes allocated to this study arm will access 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 nursing homes

Complex intervention, as described in the arm/group descriptions

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 65 years old and older
* Taking at least one benzodiazepine or Z-drug for 4 weeks or more

Exclusion Criteria

* Unability to communicate in French
* Palliative care
* Ongoing benzodiazepine withdrawal
* Ongoing alcohol withdrawal
* Severe anxiety
* Severe depression
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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Perrine Evrard, MPharm

Role: CONTACT

+3227647236

Facility Contacts

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Perrine Evrard, MPharm

Role: primary

+3227647236

References

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Evrard P, Chevallereau T, Aikpitanyi J, Petein C, Tubeuf S, Henrard S, Spinewine A. Feasibility of a theory-based intervention towards benzodiazepine deprescribing in Belgian nursing homes: protocol of the END-IT NH cluster-randomised controlled trial. BMJ Open. 2024 Oct 22;14(10):e085435. doi: 10.1136/bmjopen-2024-085435.

Reference Type DERIVED
PMID: 39438099 (View on PubMed)

Other Identifiers

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CLIP/2023/02

Identifier Type: -

Identifier Source: org_study_id

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