Effectiveness of a Joint General Practitioner-Pharmacist Intervention on Benzodiazepine Deprescribing in the Elderly
- Conditions
- Health Plan ImplementationAnxietyPrimary CareElderlyDeprescribingBenzodiazepine Dependence
- Interventions
- Behavioral: GP - pharmacist collaboration and pharmacist motivational interviewing
- Registration Number
- NCT05765656
- Lead Sponsor
- Nantes University Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GP - pharmacist collaboration and pharmacist motivational interviewing GP - pharmacist collaboration and pharmacist motivational interviewing Once randomized, the patient will have three motivational interviews with their pharmacist. Each time, a report will be sent to the GP.
- Primary Outcome Measures
Name Time Method Appropriateness measured by sociological interviews of patients, general practicioners and pharmacists and pharmacists observations 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.
- Secondary Outcome Measures
Name Time Method Acceptability 2 within 6 months after refusal Reason for pharmacists and general practitioners' refusal assesed by individual interviews
Fidelity 2 12 months after the last inclusion Proportion of patients who actually made appointments with the pharmacist measured through a logbook.
BZDR consumption 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)Insomnia 6 and 12 months after enrollment Quality of sleep measured by Insomnia Severity Index (ISI)
Attachment to BZDR 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 allowsAcceptability 1 3 months after last inclusion Number of clusters included / Number of clusters planned measured by logbooks
Acceptability 3 3 months after last inclusion Number of patients included / Number of patients eligible measured by logbooks
Fidelity 1 12 months after the last inclusion Proportion of pairs completing the study measured through a logbook
Autonomy 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.Cost-Utility analysis assessed following the Haute Autorité de Santé 2020 recommendations 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
Fidelity 3 6 months after the last inclusion Number of motivational interviews measured through a logbook.
Fidelity 4 6 months after the last inclusion Number of reporting made by the pharmacist to the GP will be measured through a logbook.
Anxiety 6 and 12 months after enrollment Anxiety measured by General Anxiety Disorder (GAD-7)
Reported Quality of life of patients 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.