NCT05859555

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2024

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

1.5 years

First QC Date

March 19, 2023

Last Update Submit

November 26, 2024

Conditions

Keywords

Benzodiazepine (BZD) and related drugsDeprescribingSafetyOlder patients

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Rate of patients aged 65 years who took long-term BZD

    18 months

Study Arms (2)

Intervention: Thematic quality circles - Deprescription

OTHER
Other: Thematic quality circles - Deprescription

No intervention

NO INTERVENTION

Interventions

Thematic quality circles on benzodiazepines and analogues with a pharmacist (practical cases)

Intervention: Thematic quality circles - Deprescription

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Réseau de soins Delta SA

Geneva, Petit Lancy, Switzerland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Cluster randomised controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Manager

Study Record Dates

First Submitted

March 19, 2023

First Posted

May 16, 2023

Study Start

December 5, 2022

Primary Completion

May 21, 2024

Study Completion

June 21, 2024

Last Updated

November 29, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations