Benzodiazepines Deprescribing in Nursing Homes: Intervention Feasibility

NCT05929443 | Unknown

• 1 other identifier: CLIP/2023/02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Benzodiazepines Deprescribing

Keywords

Benzodiazepines; Deprescribing; Long-term care; Older adults

Outcome Measures

Primary Outcomes (5)

• Nursing homes' adherence to the intervention

  has the intervention been implemented as intended, e.g. global number of implemented intervention components

  Assessed at 6 months

• Healthcare providers responsiveness to the intervention

  has far did they respond to the intervention, and how far have them been engaged by the intervention, e.g level of attendance to education session for healthcare providers

  Assessed at 6 months

• nursing home residents' responsiveness to the intervention

  has far did they respond to the intervention, and how far have them been engaged by the intervention

  Assessed at 6 months

• Feasibility of the recruitment process

  The feasibility of the recruitment will be assessed through the ratio between included residents and residents contacted for participation.

  At 6 months

• Feasibility of the data collection process

  Data collection process will be assessed through the quality of collected data (rate of missing data)

  At 6 months

Secondary Outcomes (7)

• Contextual factors at the level of of the nursing home

  Baseline

• Contextual factors at the level of the nursing home resident

  Baseline

• Intervention mechanisms of impact

  At baseline

• Intervention mechanisms of impact

  At 3 months

• Intervention mechanisms of impact

  At 6 months

Study Arms (2)

END-IT intervention for nursing homes

EXPERIMENTAL

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.

Other: END-IT intervention for nursing homes

Control

NO INTERVENTION

Usual care. Nursing homes allocated to this study arm will access intervention material at the end of the study.

Interventions

END-IT intervention for nursing homes OTHER

Complex intervention, as described in the arm/group descriptions

END-IT intervention for nursing homes

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Unability to communicate in French
• Palliative care
• Ongoing benzodiazepine withdrawal
• Ongoing alcohol withdrawal
• Severe anxiety
• Severe depression

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)

• 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.

  PMID: 39438099 DERIVED

MeSH Terms

Interventions

Nursing Homes

Intervention Hierarchy (Ancestors)

Residential Facilities; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Anne Spinewine, PhD

  UCLouvain / Louvain Drug Research Institute / Clinical pharmacy research group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Perrine Evrard, MPharm

CONTACT

+3227647236; perrine.evrard@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• 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: June 22, 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)