Multimodal Educative Data Feedback for Deprescribing BZD and Related Drugs in Outpatients: a Cluster RCT

Multimodal Educative Data Feedback for Deprescribing Benzodiazepine (BZD) and Related Drugs in Outpatients: a Cluster Randomized Controlled Study

Benzodiazepine (BZD) and related drugs are sedative anxiolytics and hypnotics that should be avoided especially in people aged 65 years and older, given the high risk of falling, fracture, dependence, respiratory depression and cognitive disorders. Despite these contraindications, their consumption continues to increase in Switzerland.

Although it can be assumed that deprescribing a drug has a direct benefit, it is nevertheless necessary to determine how to implement this process effectively and safely. To change healthcare professionals' prescribing behaviours for BZD, the most common deprescribing interventions include identification of appropriate patients, education and training of GPs and patients, and gradual and appropriate reduction of the dose of BZD. Thus, the DELTA CARE NETWORK and the DELTA VAUD CARE NETWORK have set themselves the task of evaluating the effectiveness of a multimodal deprescribing intervention for Delta primary care physicians and their patients aged 65 and over, in the cantons of Geneva and Vaud. The goal is to reduce the total BZD prescription rate among this population.

This quality development project is fully in line with the Quality Federal Commission's objectives of efficiency, safety, patient-centred and in the interests of the patient.

Study Overview

• Status: Recruiting
• Conditions: Deprescription; Benzodiazepine (BZD) and Related Drugs
• Intervention / Treatment: Other: Thematic quality circles - Deprescription

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Minette-Joëlle Zeukeng, PharmD, PhD; Phone Number: 079 892 19 81; Email: minette.zeukeng@reseau-delta.ch

Study Locations

• Switzerland
  • Petit Lancy
    • Geneve, Petit Lancy, Switzerland
      • Recruiting
      • Réseau de soins Delta SA
      • Contact: Philippe Schaller, MD,MPH; Email: philippe.schaller@reseau-delta.ch

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Physician who attended a quality cercle in the cantons of Geneva and Vaud
• Prescribed at least one prescription of Benzodiazepines during the year of analysis to patient aged 65 years and older

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
No Intervention: No intervention
Other: Intervention: Thematic quality circles - Deprescription	Other: Thematic quality circles - Deprescription; Thematic quality circles on benzodiazepines and analogues with a pharmacist (practical cases)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate Benzodiazepine (BZD) and related drugs prescribed by primary care physicians	Reduce the total BZD prescribing frequency by 20% 9 months after the interventioncompared to the control group (DDD/1000 patients over 9 months). The drug measure will be the DDD daily dose defined by the World Health Organization Collaborating Centre for Drug Statistics Methodology (or number of tablets or number of packages).	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients aged 65 years who took long-term BZD	Reduce by 20% the prevalence of 65-year-old patients with long-term use (more than 3 months) of BZD as well as the prevalence of long-term users 18 months after intervention (number of BDZ patients per physician/QC per year).	18 months

Collaborators and Investigators

• Sponsor: Réseau de soins Delta

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Estimated): May 21, 2024
• Study Completion (Estimated): May 21, 2024

Study Registration Dates

• First Submitted: March 19, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Older patients; Deprescribing; Benzodiazepine (BZD) and related drugs
• Other Study ID Numbers: BZD001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No