Effectiveness of a Joint General Practitioner-Pharmacist Intervention on Benzodiazepine Deprescribing in the Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2025-09-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Primary Care Health Plan Implementation Benzodiazepine Dependence Elderly Anxiety Deprescribing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pragmatic cluster-randomized controlled trial

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Non applicable

Study Groups

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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.

Group Type EXPERIMENTAL

GP - pharmacist collaboration and pharmacist motivational interviewing

Intervention Type BEHAVIORAL

1. Patients in the GP-CP clusters randomized to the intervention arm will be offered a joint GP-CP deprescribing intervention by their GP.
2. After the encounter, the patients will go to the pharmacy to get their medication dispensed. They will be given education materials. The pharmacist will plan with the patients 3 Motivational Interviews which will address the risks of using BZDR, and the benefits and modalities of stopping them. The pharmacists will receive a 2-day training course in MI. They will be given guidelines on BZDR deprescribing. If required, the pharmacists will be supported in their first MI.
3. Following each interview, the pharmacist will inform the GP by means of a formalized report of the points discussed. The pharmacist will inform the GP of the patient's choice or not to get involved in a deprescribing process and of the protocol followed. The objective of this exchange is to formalize the joint GP-CP intervention and to secure the deprescribing of BZDR.

Usual Care

The patient is handled by his GP and the pharmacist as usual (medical encounter plus medication dispensation)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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GP - pharmacist collaboration and pharmacist motivational interviewing

1. Patients in the GP-CP clusters randomized to the intervention arm will be offered a joint GP-CP deprescribing intervention by their GP.
2. After the encounter, the patients will go to the pharmacy to get their medication dispensed. They will be given education materials. The pharmacist will plan with the patients 3 Motivational Interviews which will address the risks of using BZDR, and the benefits and modalities of stopping them. The pharmacists will receive a 2-day training course in MI. They will be given guidelines on BZDR deprescribing. If required, the pharmacists will be supported in their first MI.
3. Following each interview, the pharmacist will inform the GP by means of a formalized report of the points discussed. The pharmacist will inform the GP of the patient's choice or not to get involved in a deprescribing process and of the protocol followed. The objective of this exchange is to formalize the joint GP-CP intervention and to secure the deprescribing of BZDR.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No