Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05765656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-13
First Post:
2023-02-10
Brief Title:
Effectiveness of a Joint General Practitioner-Pharmacist Intervention on Benzodiazepine Deprescribing in the Elderly
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Evaluation of the Effectiveness of a Joint General Practitioner-Pharmacist Intervention on the Implementation of Benzodiazepine Deprescribing in the Elderly BESTOPH-MG Trial Protocol for a Cluster-randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
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:
BESTOPH-MG
Brief Summary:
Benzodiazepines or related drug BZDR are consumed for hypnotic or anxiolytic purposes in most cases The consequences of BZDR are multiple with an increased risk of daytime sedation balance disorders leading to falls and fractures cognitive disorders road accidents and dementia Given their comorbidities physiological changes and multiple medications the elderly are more at risk of suffering from BZDR adverse events
Interprofessional collaboration has shown efficacy in improving prescribing appropriateness and may affect patients outcomes positively Morever motivational interviews MI may reduce the extent of substance abuse compared to no intervention
Interprofessional collaboration has shown efficacy in improving prescribing appropriateness and may affect patients outcomes positively Morever motivational interviews MI may reduce the extent of substance abuse compared to no intervention
Detailed Description:
According to a 2017 report from the French National Agency for the Safety of Medicines and Health Products ANSM 134 of the French population used a benzodiazepine or related drug BZDR at least once in 2015 These drugs are consumed for hypnotic or anxiolytic purposes in most cases As per the recommendations BZDR should not be prescribed for more than 28 days when for hypnotic use and for 8 to 12 weeks including withdrawal when for anxiolytic purpose Indeed these drugs have shown a real but mediocre short-term efficacy on anxiety and sleep disorders Moreover their long-term effectiveness is almost nil However the literature shows that nearly one patient out of six taking a BZDR is a long-term user and that the proportion of patients for whom the indication is questionable can reach 23 The consequences of BZDR are multiple with an increased risk of daytime sedation balance disorders leading to falls and fractures cognitive disorders road accidents and dementia Also given their comorbidities physiological changes and multiple medications the elderly are more at risk of suffering from BZDR adverse events like falls driving accidents dementia or even death The majority of patients are unaware of these potential risks and continue to use these medications over the long term They overestimate the benefits of BZDR and underestimate their harmful effects The consequences are substantial both from a health and financial perspective
At the national level numerous actions have been taken by the health authorities to reduce the use of BZDR information for health professionals pictograms on drug boxes recommendations by health authorities incentive measures by the Health Insurance services or else health surveillance and regulatory measures to control prescribing However despite these numerous initiatives the consumption of BZDR remains too high even emphasized by the pandemic and their deprescribing is struggling to be implemented in real life Literature showed that many levers can facilitate the implementation of actions for the proper use of drugs Interprofessional collaboration has shown efficacy in improving prescribing appropriateness and may affect patients outcomes positively as shown by many recent systematic reviews and meta-analysis General practitioners GPs who do not feel fully capable of implementing actions to deprescribe BZDR if they have to rely solely on guidelines and because of the lack of time to re-evaluate these treatments Yet current international deprescribing studies remain based on actions only directed at the prescriber Collaboration between two primary care professionals therefore appears to be a solution for implementing a medical decision to stop treatment In addition GPs are faced with a population which is very often reluctant to stop for fear of a return of anxiety or insomnia In this context another lever usable to achieve the implementation of deprescribing is the use of techniques that allow the patient to accept the physicians intervention As such motivational interviews MI may reduce the extent of substance abuse compared to no intervention Developing and promoting training for healthcare professionals in MI may be a simple and pragmatic implementation strategy to reduce BZDR use
At the national level numerous actions have been taken by the health authorities to reduce the use of BZDR information for health professionals pictograms on drug boxes recommendations by health authorities incentive measures by the Health Insurance services or else health surveillance and regulatory measures to control prescribing However despite these numerous initiatives the consumption of BZDR remains too high even emphasized by the pandemic and their deprescribing is struggling to be implemented in real life Literature showed that many levers can facilitate the implementation of actions for the proper use of drugs Interprofessional collaboration has shown efficacy in improving prescribing appropriateness and may affect patients outcomes positively as shown by many recent systematic reviews and meta-analysis General practitioners GPs who do not feel fully capable of implementing actions to deprescribe BZDR if they have to rely solely on guidelines and because of the lack of time to re-evaluate these treatments Yet current international deprescribing studies remain based on actions only directed at the prescriber Collaboration between two primary care professionals therefore appears to be a solution for implementing a medical decision to stop treatment In addition GPs are faced with a population which is very often reluctant to stop for fear of a return of anxiety or insomnia In this context another lever usable to achieve the implementation of deprescribing is the use of techniques that allow the patient to accept the physicians intervention As such motivational interviews MI may reduce the extent of substance abuse compared to no intervention Developing and promoting training for healthcare professionals in MI may be a simple and pragmatic implementation strategy to reduce BZDR use
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