CHU de Nantes
Nantes, 44093, France
Location status: Recruiting
NCT Number: NCT05765656
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Nantes, 44093, France
Location status: Recruiting
According to a 2017 report from the French National Agency for the Safety of Medicines and Health Products (ANSM), 13.4% 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 2/3. 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 physician's 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 to 6 months after the beginning of the enrollment period and 12 months after the end of the enrollment period
Four days of observations will be conducted with pharmacists who have just been trained in MI to study, in action, how they conduct their first interviews with the elderly. These same pharmacists will be observed a second time at the end of the study, to see how their approach to MI has evolved. A first wave of ten semi-structured interviews will be conducted with elderly patients who have already been seen by their pharmacist, to see what effects the pharmacist has had on their representations of BZDR and on their consumption. Finally, three focus groups will be carried out, one with CPs, one with GPs and one with pairs.
Time frame: 3 months after last inclusion
Number of clusters included / Number of clusters planned measured by logbooks
Time frame: within 6 months after refusal
Reason for pharmacists and general practitioners' refusal assesed by individual interviews
Time frame: 3 months after last inclusion
Number of patients included / Number of patients eligible measured by logbooks
Time frame: 12 months after the last inclusion
A Cost-Utility Analysis (CUA) expressed as a cost per Quality Adjusted Life Year (QALY) will be performed from a collective perspective and with a time horizon of 12 months
Time frame: 12 months after the last inclusion
Proportion of pairs completing the study measured through a logbook
Time frame: 12 months after the last inclusion
Proportion of patients who actually made appointments with the pharmacist measured through a logbook.
Time frame: 6 months after the last inclusion
Number of motivational interviews measured through a logbook.
Time frame: 6 months after the last inclusion
Number of reporting made by the pharmacist to the GP will be measured through a logbook.
Time frame: 10 to 12 months after enrollment in the study
Cessation or reduction of BZDR use at 12 months from inclusion measured using the National Health Data System.
Proportion of patients no longer being dispensed BZDR at 10 months after enrollment, with the last two months (10 to 12 months)
Time frame: 6 and 12 months after enrollment
Anxiety measured by General Anxiety Disorder (GAD-7)
Time frame: 6 and 12 months after enrollment
Quality of sleep measured by Insomnia Severity Index (ISI)
Time frame: 6 and 12 months after enrollment
Attachment to BZDR measured by Benzodiazepine Cognitive Attachment Scale (ECAB) scale at 6 and 12 months.
Score ranges from 0 to 10. A score ≥ 6 allows
Time frame: 6 and 12 months after enrollment
Quality of life measured by EQ-5D-5L questionnaire at 6 and 12 months. A total of 3125 possible health states is defined. Each state is referred to by a 5-digit code.
Time frame: 6 and 12 months after enrollment
Autonomy measured by Instrumental Activities of Daily Living (IADL) at 6 and 12 months.
The scale ranges from 0 to 8, with 0 indicating complete dysautonomia and 8 indicating complete autonomy.
Contact information is provided by the study sponsor or research team.
Nantes University Hospital
Other
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
Acronym: BESTOPH-MG
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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