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NCT Number: NCT05765656

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

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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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nantes

Nantes, 44093, France

Location status: Recruiting

Location contact

Jean-François HUON

CONTACT

[email protected]

0244768074

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GP - pharmacist collaboration and pharmacist motivational interviewing

Behavioral
  • Patients in the GP-CP clusters randomized to the intervention arm will be offered a joint GP-CP deprescribing intervention by their GP.
  • 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.
  • 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Acceptability 1

    Time frame: 3 months after last inclusion

    Number of clusters included / Number of clusters planned measured by logbooks

  2. Acceptability 2

    Time frame: within 6 months after refusal

    Reason for pharmacists and general practitioners' refusal assesed by individual interviews

  3. Acceptability 3

    Time frame: 3 months after last inclusion

    Number of patients included / Number of patients eligible measured by logbooks

  4. 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

  5. Fidelity 1

    Time frame: 12 months after the last inclusion

    Proportion of pairs completing the study measured through a logbook

  6. Fidelity 2

    Time frame: 12 months after the last inclusion

    Proportion of patients who actually made appointments with the pharmacist measured through a logbook.

  7. Fidelity 3

    Time frame: 6 months after the last inclusion

    Number of motivational interviews measured through a logbook.

  8. 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.

  9. 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. Anxiety

    Time frame: 6 and 12 months after enrollment

    Anxiety measured by General Anxiety Disorder (GAD-7)

  11. Insomnia

    Time frame: 6 and 12 months after enrollment

    Quality of sleep measured by Insomnia Severity Index (ISI)

  12. 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

  13. 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.

  14. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-François HUON, Pharm.D PhD

CONTACT

[email protected]

0244768074 ext. 332

Jean-Pascal Fournier, Professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Université de Nantes

Registry information

Official study 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

Acronym: BESTOPH-MG

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 13, 2023
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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