Feasibility of a Benzodiazepine Deprescribing Intervention in Older Adults Living in the Belgian Community Setting
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Pharmacists' adherence to the intervention
Study Overview
Brief Summary
The goal of this feasibility study is to evaluate the feasibility of an intervention, led by the pharmacist, aiming at benzodiazepines and z-drugs deprescribing in older adults living in the Belgian community setting. The main questions it aims to answer are:
- To what extent will Belgian community pharmacists adhere to the intervention?
- To what extent will patients and general practitioners take up the intervention to deprescribe benzodiazepines and z-drugs?
- To what extent is the design of the recruitment and data collection process feasible and acceptable for all participants?
Participants will receive an educational brochure from their pharmacist. Their pharmacist will also propose to send a new standardized form to their general practitioner to enhance collaboration about a potential benzodiazepine deprescribing.
Researchers will compare this intervention to usual care to see if the intervention is feasible and to gather first data on intervention effectiveness in benzodiazepine deprescribing.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •being aged ≥65 years,
- •taking a benzodiazepine receptor agonist for ≥4 weeks (Anatomical Therapeutic Chemical codes: N05BA, N05CD, N05CF and N03AE01)
- •being a regular patient of the community pharmacy (defined as ≥ 4 visits/12 previous months).
Exclusion Criteria
- •Severe mental illness (assessed through having an active prescription of any antipsychotic medication).
- •Dementia or significant cognitive impairment (assessed through an active prescription or any past prescription during the last 12 months of anticholinesterase inhibitors or memantine) and/or pharmacist's judgment).
- •Patients unable to read or communicate in French.
- •Ongoing benzodiazepine receptor agonist withdrawal at the time of recruitment.
- •Known current alcohol withdrawal.
Arms & Interventions
END-IT intervention for the community setting
The community pharmacist will distribute an educational brochure to the patient. He will also propose to the patient to communicate about a potential benzodiazepine deprescribing with his/her general practitioner through a document called pharmaceutical proposal.
Intervention: END-IT intervention for the community setting (Other)
Control
The participants will receive the usual care. The community pharmacists allocated to the control group will have access to the intervention material at the end of the study.
Outcomes
Primary Outcomes
Pharmacists' adherence to the intervention
Time Frame: At 6 months
Has the intervention been implemented as intended? (e.g: global number of implemented intervention components)
Feasibility of the data collection process
Time Frame: At 6 months
The feasibility of the data collection process will be assessed through the quality of the collected data (rate of missing data).
Participants' responsiveness
Time Frame: At 6 months
How far participants (pharmacists, patients, and general practitioners) have responded to the intervention and have been engaged by the intervention: e.g. number of altered prescriptions).
Feasibility of the recruitment process
Time Frame: At 6 months
The feasibility of the recruitment will be assessed (e.g. the ratio between the number of included patients and patients contacted for participation).
Pharmacists' adherence to the intervention
Time Frame: At 3 months
Has the intervention been implemented as intended? (e.g: global number of implemented intervention components)
Participants' responsiveness
Time Frame: At 3 months
How far participants (pharmacists, patients, and general practitioners) have responded to the intervention and have been engaged by the intervention: e.g. number of altered prescriptions).
Secondary Outcomes
- Mechanisms of impact potentially influencing the intervention(At 6 months)
- Contextual factors potentially influencing the intervention effects at the patient-level.(At baseline)
- Contextual factors potentially influencing the intervention effects at the pharmacist-level.(At baseline)
- Exploratory benzodiazepine deprescribing rate analysis(At 6 months)
- Mechanisms of impact potentially influencing the intervention(At baseline)
- Mechanisms of impact potentially influencing the intervention(At 3 months)
- Exploratory benzodiazepine deprescribing rate analysis(At 3 months)