Benzodiazepines Deprescribing in Nursing Homes: Intervention Feasibility (END-IT NH)

Feasibility of a Theory-based Benzodiazepines Deprescribing Intervention in Belgian Nursing Homes: the END-IT Study

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.

Study Overview

• Status: Recruiting
• Conditions: Benzodiazepines Deprescribing
• Intervention / Treatment: Other: END-IT intervention for nursing homes

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Perrine Evrard, MPharm; Phone Number: +3227647236; Email: perrine.evrard@uclouvain.be

Study Locations

• Belgium
  • Woluwe-Saint-Lambert, Belgium, 1200
    • Recruiting
    • UCLouvain
    • Contact: Perrine Evrard, MPharm; Phone Number: +3227647236; Email: perrine.evrard@uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: END-IT intervention for nursing homes; Complex intervention, as described in the arm/group descriptions
No Intervention: Control; Usual care. Nursing homes allocated to this study arm will access intervention material at the end of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contextual factors at the level of of the nursing home	Use of a questionnaire to assess factors that could explain potential differences in intervention implementation between nursing homes	Baseline
Contextual factors at the level of the nursing home resident	Use of a questionnaire to assess factors that could explain potential differences in intervention implementation between nursing home residents	Baseline
Intervention mechanisms of impact	Use of a questionnaire to assess intervention mechanisms of impact, in relation with how the intervention is supposed to have its impact	At baseline
Intervention mechanisms of impact	Use of a questionnaire to assess intervention mechanisms of impact, in relation with how the intervention is supposed to have its impact.	At 3 months
Intervention mechanisms of impact	Use of a questionnaire to assess intervention mechanisms of impact, in relation with how the intervention is supposed to have its impact.	At 6 months
Exploratory benzodiazepine deprescribing rate analysis	Defined as either a complete benzodiazepine/Z-drug cessation, or a dose reduction	At 3 months
Exploratory benzodiazepine deprescribing rate analysis	Defined as either a complete benzodiazepine/Z-drug cessation, or a dose reduction	At 6 months

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Collaborators: EBPracticenet; Fonds National de la Recherche scientifique (FNRS)
• Investigators: Principal Investigator: Anne Spinewine, PhD, UCLouvain / Louvain Drug Research Institute / Clinical pharmacy research group

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Benzodiazepines; Older adults; Deprescribing; Long-term care
• Other Study ID Numbers: CLIP/2023/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only publishable project data relating to the main analysis and research output will be shared on a data repository after an embargo period of two years after June 2024. All relevant documentation necessary to facilitate data re-use will be shared along with the datasets.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No