An interventional study of END-IT intervention for nursing homes in Benzodiazepines Deprescribing, sponsored by Université Catholique de Louvain. Recruiting at 1 site in Belgium. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-07-03.
Sponsored by Université Catholique de Louvain · Not applicable, Interventional, and Other
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:
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.
Université Catholique de Louvain is the lead sponsor of 144 studies on the registry; 57 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Usual care. Nursing homes allocated to this study arm will access intervention material at the end of the study.
Complex intervention, as described in the arm/group descriptions
Nursing homes' adherence to the intervention
has the intervention been implemented as intended, e.g. global number of implemented intervention components
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: At 6 months
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: At 6 months
Exploratory benzodiazepine deprescribing rate analysis
Defined as either a complete benzodiazepine/Z-drug cessation, or a dose reduction
Time frame: At 3 months
Exploratory benzodiazepine deprescribing rate analysis
Defined as either a complete benzodiazepine/Z-drug cessation, or a dose reduction
Time frame: At 6 months
Plan to share: No — 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.
No publications or documents are linked to this record.
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Université Catholique de Louvain