Benzodiazepines Deprescribing in the Community Setting: Intervention Feasibility

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility of a Benzodiazepine Deprescribing Intervention in Older Adults Living in the Belgian Community Setting

Conditions
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Benzodiazepine Deprescribing

Intervention / Treatment
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* Other: END-IT intervention for the community setting


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: END-IT intervention for the community setting<br>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. | Other: END-IT intervention for the community setting<br>* The intervention was described in the arm/group descriptions.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacists' adherence to the intervention | Has the intervention been implemented as intended? (e.g: global number of implemented intervention components) | At 3 months | 
| Pharmacists' adherence to the intervention | Has the intervention been implemented as intended? (e.g: global number of implemented intervention components) | At 6 months | 
| Participants' responsiveness | 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). | At 3 months | 
| Participants' responsiveness | 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). | At 6 months | 
| Feasibility of the recruitment process | The feasibility of the recruitment will be assessed (e.g. the ratio between the number of included patients and patients contacted for participation). | At 6 months | 
| Feasibility of the data collection process | The feasibility of the data collection process will be assessed through the quality of the collected data (rate of missing data). | At 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contextual factors potentially influencing the intervention effects at the patient-level. | Use of a questionnaire to assess factors that could explain potential differences in intervention implementation between patients. | At baseline | 
| Contextual factors potentially influencing the intervention effects at the pharmacist-level. | Use of a questionnaire to assess factors that could explain potential differences in intervention implementation between pharmacies. | At baseline | 
| Mechanisms of impact potentially influencing the intervention | Use a questionnaire to assess mechanisms of impact in relation with how the intervention is supposed to have its effects. | At baseline | 
| Mechanisms of impact potentially influencing the intervention | Use of a questionnaire to assess mechanisms of impact in relation with how the intervention is supposed to have its effects. | At 3 months | 
| Mechanisms of impact potentially influencing the intervention | Use of a questionnaire to assess mechanisms of impact in relation with how the intervention is supposed to have its effects. | At 6 months | 
| Exploratory benzodiazepine deprescribing rate analysis | Defined as benzodiazepine reduction or cessation at 6 months | At 3 months | 
| Exploratory benzodiazepine deprescribing rate analysis | Defined as benzodiazepine reduction or cessation at 6 months | At 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benzodiazepines, Deprescribing, Community setting, Older adults