Benzodiazepines Deprescribing in Nursing Homes: Intervention Feasibility

Study Overview
=================
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.

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

Conditions
-----------------
Benzodiazepines Deprescribing

Intervention / Treatment
-----------------
* Other: END-IT intervention for nursing homes


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: END-IT intervention for nursing homes<br>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<br>* Complex intervention, as described in the arm/group descriptions<br>|
| No Intervention: Control<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Benzodiazepines, Deprescribing, Long-term care, Older adults