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

Sponsor
Réseau de soins Delta (Other)
Overall Status
Recruiting
CT.gov ID
NCT05859555
Collaborator
(none)
300
1
2
15.5
19.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Thematic quality circles - Deprescription
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Cluster randomised controlled trialCluster randomised controlled trial
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Multimodal Educative Data Feedback for Deprescribing Benzodiazepine (BZD) and Related Drugs in Outpatients: a Cluster Randomized Controlled Study
Actual Study Start Date :
Dec 5, 2022
Anticipated Primary Completion Date :
May 21, 2023
Anticipated Study Completion Date :
Mar 21, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Intervention: Thematic quality circles - Deprescription

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

No Intervention: No intervention

Outcome Measures

Primary Outcome Measures

  1. Rate Benzodiazepine (BZD) and related drugs prescribed by primary care physicians [9 months]

    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).

Secondary Outcome Measures

  1. Rate of patients aged 65 years who took long-term BZD [18 months]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Réseau de soins Delta SA Geneve Petit Lancy Switzerland

Sponsors and Collaborators

  • Réseau de soins Delta

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Minette-Joëlle Zeukeng, Project Manager, Réseau de soins Delta
ClinicalTrials.gov Identifier:
NCT05859555
Other Study ID Numbers:
  • BZD001
First Posted:
May 16, 2023
Last Update Posted:
May 16, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Minette-Joëlle Zeukeng, Project Manager, Réseau de soins Delta

Study Results

No Results Posted as of May 16, 2023