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

Deprescription Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05859555
• Other study ID #: BZD001
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2022
• Est. completion date: May 21, 2024

Study information

• Verified date: November 2023
• Source: Réseau de soins Delta
• Contact: Minette-Joëlle Zeukeng, PharmD, PhD
• Phone: 079 892 19 81
• Email: minette.zeukeng[@]reseau-delta.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 21, 2024
• Est. primary completion date: May 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deprescription

Intervention

Other:
• Thematic quality circles - Deprescription
Thematic quality circles on benzodiazepines and analogues with a pharmacist (practical cases)

Locations

Country	Name	City	State
Switzerland	Réseau de soins Delta SA	Geneve	Petit Lancy

Sponsors (1)

Lead Sponsor	Collaborator
Réseau de soins Delta

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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