- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05765656
Effectiveness of a Joint General Practitioner-Pharmacist Intervention on Benzodiazepine Deprescribing in the Elderly (BESTOPH-MG)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jean-François HUON, Pharm.D PhD
- Phone Number: 332 0244768074
- Email: jeanfrancois.huon@chu-nantes.fr
Study Contact Backup
- Name: Jean-Pascal Fournier, Professor
- Email: jean-pascal.fournier@univ-nantes.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
|
No Intervention: Usual Care
The patient is handled by his GP and the pharmacist as usual (medical encounter plus medication dispensation)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appropriateness measured by sociological interviews of patients, general practicioners and pharmacists and pharmacists observations
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.
|
3 to 6 months after the beginning of the enrollment period and 12 months after the end of the enrollment period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability 1
Time Frame: 3 months after last inclusion
|
Number of clusters included / Number of clusters planned measured by logbooks
|
3 months after last inclusion
|
Acceptability 2
Time Frame: within 6 months after refusal
|
Reason for pharmacists and general practitioners' refusal assesed by individual interviews
|
within 6 months after refusal
|
Acceptability 3
Time Frame: 3 months after last inclusion
|
Number of patients included / Number of patients eligible measured by logbooks
|
3 months after last inclusion
|
Cost-Utility analysis assessed following the Haute Autorité de Santé 2020 recommendations
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
|
12 months after the last inclusion
|
Fidelity 1
Time Frame: 12 months after the last inclusion
|
Proportion of pairs completing the study measured through a logbook
|
12 months after the last inclusion
|
Fidelity 2
Time Frame: 12 months after the last inclusion
|
Proportion of patients who actually made appointments with the pharmacist measured through a logbook.
|
12 months after the last inclusion
|
Fidelity 3
Time Frame: 6 months after the last inclusion
|
Number of motivational interviews measured through a logbook.
|
6 months after the last inclusion
|
Fidelity 4
Time Frame: 6 months after the last inclusion
|
Number of reporting made by the pharmacist to the GP will be measured through a logbook.
|
6 months after the last inclusion
|
BZDR consumption
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) |
10 to 12 months after enrollment in the study
|
Anxiety
Time Frame: 6 and 12 months after enrollment
|
Anxiety measured by General Anxiety Disorder (GAD-7)
|
6 and 12 months after enrollment
|
Insomnia
Time Frame: 6 and 12 months after enrollment
|
Quality of sleep measured by Insomnia Severity Index (ISI)
|
6 and 12 months after enrollment
|
Attachment to BZDR
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 |
6 and 12 months after enrollment
|
Reported Quality of life of patients
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.
|
6 and 12 months after enrollment
|
Autonomy
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. |
6 and 12 months after enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jean-François HUON, Pharm.D PhD, CHU Nantes
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RC21_0357
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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