DeprescriptionNCT05859555
Multimodal Educative Data Feedback for Deprescribing BZD and Related Drugs in Outpatients: a Cluster RCT
A study testing Thematic quality circles - Deprescription in people with Deprescription and Benzodiazepine (BZD) and Related Drugs, run by Réseau de soins Delta at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deprescription, Benzodiazepine (BZD) and Related Drugs
- What is being tested?
- Thematic quality circles - Deprescription
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Dec 2022to 21 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Thematic quality circles - Deprescription
- Keywords
- Benzodiazepine (BZD) and related drugs, Deprescribing, Safety, Older patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thematic quality circles - DeprescriptionOther
Thematic quality circles on benzodiazepines and analogues with a pharmacist (practical cases)
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Thematic quality circles - Deprescription | Other | Not described Receives: Other: Thematic quality circles - Deprescription |
| No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 9 months
Secondary outcomes (1)
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).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start5 Dec 2022
- Primary completion21 May 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeprescriptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomised controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Réseau de soins Delta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minette-Joëlle Zeukeng, Réseau de soins Delta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859555
- Sponsor's protocol ID
- BZD001
- Status last verified
- Nov 2024
- First submitted
- 19 Mar 2023
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Educative Data Feedback for Deprescribing Benzodiazepine (BZD) and Related Drugs in Outpatients: a Cluster Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05859555
- Acronym / sponsor ID
- BZD001
- Keywords
- Benzodiazepine (BZD) and related drugs, Deprescribing, Safety, Older patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Réseau de soins DeltaUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cluster randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention: Thematic quality circles - Deprescription | Other | Other: Thematic quality circles - Deprescription |
| No intervention | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thematic quality circles - DeprescriptionThematic quality circles on benzodiazepines and analogues with a pharmacist (practical cases) | Other | Intervention: Thematic quality circles - Deprescription |
Primary outcome
Rate Benzodiazepine (BZD) and related drugs prescribed by primary care physicians
Time frame: 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).
1 secondary outcome
Rate of patients aged 65 years who took long-term BZD
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thematic quality circles - Deprescription in people with Deprescription and Benzodiazepine (BZD) and Related Drugs, run by Réseau de soins Delta at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate Benzodiazepine (BZD) and related drugs prescribed by primary care physicians (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024; AzTrials last refreshed its copy on 26 Oct 2026.