Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446349
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-05-31
Brief Title:
Brief Motivational Intervention BMI on the Deprescription of Benzodiazepines and Related Substances in Adult Chronic Drug Users
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Impact of Identification and Brief Motivational Intervention in Dispensing Pharmacies BMI on the Deprescription of Benzodiazepines and Related Substances in Adult Chronic Drug Users
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BENZ_HALTE
Brief Summary:
We hypothesise that a short-term intervention by dispensing pharmacists is feasible and relatively easy to implement and that it could have an impact on the deprescribing of BZDZ in adult patients
Two primary objectives will be evaluated in a sequential hierarchical manner with two primary endpoints analysed one after the other without alpha risk adjustment but the second can only be analysed if the null hypothesis is rejected for the first
1 Evaluate the impact of brief motivational intervention BMI on reducing the daily dose of BZDZ prescribed at 6 months superiority hypothesis compared with the usual practice of dispensing BZDZ in pharmacies
2 Evaluate the impact of BMI on clinical worsening at 6 months non-inferiority hypothesis in comparison with the usual practice of dispensing BZDZ in pharmacies
Two primary objectives will be evaluated in a sequential hierarchical manner with two primary endpoints analysed one after the other without alpha risk adjustment but the second can only be analysed if the null hypothesis is rejected for the first
1 Evaluate the impact of brief motivational intervention BMI on reducing the daily dose of BZDZ prescribed at 6 months superiority hypothesis compared with the usual practice of dispensing BZDZ in pharmacies
2 Evaluate the impact of BMI on clinical worsening at 6 months non-inferiority hypothesis in comparison with the usual practice of dispensing BZDZ in pharmacies
Detailed Description:
In France the prevalence of use of benzodiazepines BZDs and related drugs Z-drugs zolpidem zopiclone BZDZ was estimated at 134 in 2015 and 15 of new users had a first prescription exceeding the legal duration The increase in prescriptions has continued to grow in the first 4 months of 2021 an increase of 13 million anxiolytic treatments and 580000 hypnotic treatments was observed with new prescriptions for these treatments increasing by 15 for anxiolytics and 26 for hypnotics over the same year The prevalence of long-term 6 months BZD prescriptions varies from country to country between 6 and 15 in the general population and is estimated to reach 22 to 55 in people aged 65 years In France recommendations and good practice guidelines recommend prescriptions limited to 4 weeks for hypnotic BZDZ and 12 weeks for anxiolytic BZD However a recent study focusing solely on anxiolytic BZDs carried out in patients covered by the general social security system excluding special schemes such as self-employed workers farmers etc showed that 122 of women and 93 of men aged over 50 were prescribed for longer than the legal duration
All countries agree on the need to limit the length of time these drugs are prescribed because of the rapid inversion of the benefitrisk ratio in the case of prolonged and continuous prescribing rapid loss of efficacy due to the tolerance effect associated with the occurrence of adverse effects
A number of public health initiatives have been taken in France to reduce the initiation or continued use of long-term BZDZ prescriptions including information for healthcare professionals about the risks pictograms on drug packaging directives from the health authorities incentives offered by the Assurance Maladie and regulatory measures to control prescribing Alongside these measures various types of psychosocial intervention are specifically aimed at deprescribing defined as a clinically supervised process of stopping or reducing the dose of drugs when they cause harm or when the potential risks outweigh the benefits These strategies have been evaluated for several years ranging from brief interventions in the form of letters self-support manuals and targeted consultations to more complex psychotherapeutic interventions such as cognitive behavioural therapy CBT or pharmacological interventions
Although complex interventions such as structured educational programmes or 3rd wave CBT have been shown to be effective in reducing long-term BZDZ use particularly in the elderly they are often too long and complex to be implemented on a large scale particularly in primary care and all the more so in a context of increasing shortage of specialists Brief interventions which are both more realistic and functional have been shown to be effective in reducing and stopping long-term use of BZDZ at 6 and 12 months post-intervention At the same time very few studies have involved the active participation of pharmacy professionals Yet the involvement of pharmacists would optimise prescribing and a simple psychoeducation action carried out in pharmacies would have an economic impact With a view to the shift to ambulatory care centred on the structuring of care pathways increasing the skills of local pharmacists as part of a multiprofessional coordination strategy is a response to the requirements of the law modernising the French healthcare system while offering a simple and pragmatic intervention model for patients whose prescriptions need to be optimised
In this study the investigators propose to evaluate the impact of identification combined with a brief motivational intervention in pharmacies BMI targeting the deprescription of BZDZ in adult patients with long-term prescriptions 6 months
All countries agree on the need to limit the length of time these drugs are prescribed because of the rapid inversion of the benefitrisk ratio in the case of prolonged and continuous prescribing rapid loss of efficacy due to the tolerance effect associated with the occurrence of adverse effects
A number of public health initiatives have been taken in France to reduce the initiation or continued use of long-term BZDZ prescriptions including information for healthcare professionals about the risks pictograms on drug packaging directives from the health authorities incentives offered by the Assurance Maladie and regulatory measures to control prescribing Alongside these measures various types of psychosocial intervention are specifically aimed at deprescribing defined as a clinically supervised process of stopping or reducing the dose of drugs when they cause harm or when the potential risks outweigh the benefits These strategies have been evaluated for several years ranging from brief interventions in the form of letters self-support manuals and targeted consultations to more complex psychotherapeutic interventions such as cognitive behavioural therapy CBT or pharmacological interventions
Although complex interventions such as structured educational programmes or 3rd wave CBT have been shown to be effective in reducing long-term BZDZ use particularly in the elderly they are often too long and complex to be implemented on a large scale particularly in primary care and all the more so in a context of increasing shortage of specialists Brief interventions which are both more realistic and functional have been shown to be effective in reducing and stopping long-term use of BZDZ at 6 and 12 months post-intervention At the same time very few studies have involved the active participation of pharmacy professionals Yet the involvement of pharmacists would optimise prescribing and a simple psychoeducation action carried out in pharmacies would have an economic impact With a view to the shift to ambulatory care centred on the structuring of care pathways increasing the skills of local pharmacists as part of a multiprofessional coordination strategy is a response to the requirements of the law modernising the French healthcare system while offering a simple and pragmatic intervention model for patients whose prescriptions need to be optimised
In this study the investigators propose to evaluate the impact of identification combined with a brief motivational intervention in pharmacies BMI targeting the deprescription of BZDZ in adult patients with long-term prescriptions 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A01747-38 | OTHER | ID RCB | None |