Clinical trial NCT05765656: Effectiveness of a Joint General Practitioner-Pharmacist Intervention on Benzodiazepine Deprescribing in the Elderly
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Primary Care
Health Plan Implementation
Benzodiazepine Dependence
Elderly
Anxiety
Deprescribing
Keywords: Primary care
collaborative practice
health plan implementation
deprescribing
benzodiazepine
elderly
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Université de Nantes
First posted: 2023-03-13
Enrollment: 400
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic cluster-randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* outpatients aged 65 and over
* followed by the general practitioner and the pharmacist of the GP-PO pair
* having a prescription for an anxiolytic or hypnotic BZDR prescribed at least 4 times in the past year
* the last prescription being less than 3 months old
* having been dispensed monthly during the last 3 months
* affiliated to a social security scheme
* and having given consent to participate in the research.

Exclusion Criteria:

* patients living in an institution
* participating in a clinical trial
* with epilepsy
* active depression
* uncontrolled mental disorders
* unable to participate in an interview or answer a questionnaire (demented, non-French speaking, illiterate, deaf, ...)
* under guardianship
* with a dystonic syndrome
* and patients who are not sufficiently autonomous to carry out the steps inherent in the study

Primary outcomes:
measure: Appropriateness measured by sociological interviews of patients, general practicioners and pharmacists and pharmacists observations
timeFrame: 3 to 6 months after the beginning of the enrollment period and 12 months after the end of the enrollment period
Secondary outcomes:
measure: Acceptability 1
timeFrame: 3 months after last inclusion
measure: Acceptability 2
timeFrame: within 6 months after refusal
measure: Acceptability 3
timeFrame: 3 months after last inclusion
measure: Cost-Utility analysis assessed following the Haute Autorité de Santé 2020 recommendations
timeFrame: 12 months after the last inclusion
measure: Fidelity 1
timeFrame: 12 months after the last inclusion
measure: Fidelity 2
timeFrame: 12 months after the last inclusion
measure: Fidelity 3
timeFrame: 6 months after the last inclusion
measure: Fidelity 4
timeFrame: 6 months after the last inclusion
measure: BZDR consumption
timeFrame: 10 to 12 months after enrollment in the study
measure: Anxiety
timeFrame: 6 and 12 months after enrollment
measure: Insomnia
timeFrame: 6 and 12 months after enrollment
measure: Attachment to BZDR
timeFrame: 6 and 12 months after enrollment
measure: Reported Quality of life of patients
timeFrame: 6 and 12 months after enrollment
measure: Autonomy
timeFrame: 6 and 12 months after enrollment
Other outcomes:
Locations:
Study officials:
affiliation: Nantes University Hospital
name: Jean-François HUON, Pharm.D PhD
role: PRINCIPAL_INVESTIGATOR
References: