Benzodiazepines Deprescribing in the Community Setting: Intervention Feasibility (END-IT CS)

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

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 Overview

• Status: Recruiting
• Conditions: Benzodiazepine Deprescribing
• Intervention / Treatment: Other: END-IT intervention for the community setting

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

Contacts and Locations

• Study Contact: Name: Catherine Pétein, RN, MPH; Phone Number: +3227647236; Email: catherine.petein@uclouvain.be

Study Locations

• Belgium
  • Woluwe-Saint-Lambert, Belgium, 1200
    • Recruiting
    • UCLouvain
    • Contact: Catherine Pétein, MPH; Phone Number: +3227647236; Email: catherine.petein@uclouvain.be

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: END-IT intervention for the community setting; The intervention was described in the arm/group descriptions.
No Intervention: 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.

What is the study measuring?

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

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): May 23, 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; Community setting
• Other Study ID Numbers: CLIP/2023/01

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 2 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