Primary CareBESTOPH-MGNCT05765656
Effectiveness of a Joint General Practitioner-Pharmacist Intervention on Benzodiazepine Deprescribing in the Elderly
A study testing GP - pharmacist collaboration and pharmacist motivational interviewing in people with Primary Care and Health Plan Implementation, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Primary Care, Health Plan Implementation, Benzodiazepine Dependence
- What is being tested?
- GP - pharmacist collaboration and pharmacist motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2023to 16 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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, ...)
Show all 9Show fewer
- under guardianship
- with a dystonic syndrome
- and patients who are not sufficiently autonomous to carry out the steps inherent in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jean-Pascal Fournier, Professor contact
France1 site, 1 recruiting
- Recruiting
CHU de Nantes
Nantes, 44093
Jean-François HUON, 0244768074, jeanfrancois.huon@chu-nantes.fr
About this study
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
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.
Read the 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.
- Conditions
- Primary Care, Health Plan Implementation, Benzodiazepine Dependence, Elderly, Anxiety, Deprescribing
- Being tested
- GP - pharmacist collaboration and pharmacist motivational interviewing
- Keywords
- Primary care, collaborative practice, health plan implementation, deprescribing, benzodiazepine, elderly
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP - pharmacist collaboration and pharmacist motivational interviewingBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| GP - pharmacist collaboration and pharmacist motivational interviewing | Experimental | Once randomized, the patient will have three motivational interviews with their pharmacist. Each time, a report will be sent to the GP. Receives: Behavioral: GP - pharmacist collaboration and pharmacist motivational interviewing |
| Usual Care | No intervention | The patient is handled by his GP and the pharmacist as usual (medical encounter plus medication dispensation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriateness measured by sociological interviews of patients, general practicioners and pharmacists and pharmacists observations
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.
Measured: 3 to 6 months after the beginning of the enrollment period and 12 months after the end of the enrollment period
Secondary outcomes (14)
Acceptability 1
Number of clusters included / Number of clusters planned measured by logbooks
Measured: 3 months after last inclusion
Acceptability 2
Reason for pharmacists and general practitioners' refusal assesed by individual interviews
Measured: within 6 months after refusal
Acceptability 3
Number of patients included / Number of patients eligible measured by logbooks
Measured: 3 months after last inclusion
Cost-Utility analysis assessed following the Haute Autorité de Santé 2020 recommendations
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
Measured: 12 months after the last inclusion
Fidelity 1
Proportion of pairs completing the study measured through a logbook
Measured: 12 months after the last inclusion
Fidelity 2
Proportion of patients who actually made appointments with the pharmacist measured through a logbook.
Measured: 12 months after the last inclusion
Fidelity 3
Number of motivational interviews measured through a logbook.
Measured: 6 months after the last inclusion
Fidelity 4
Number of reporting made by the pharmacist to the GP will be measured through a logbook.
Measured: 6 months after the last inclusion
BZDR consumption
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)
Measured: 10 to 12 months after enrollment in the study
Anxiety
Anxiety measured by General Anxiety Disorder (GAD-7)
Measured: 6 and 12 months after enrollment
Insomnia
Quality of sleep measured by Insomnia Severity Index (ISI)
Measured: 6 and 12 months after enrollment
Attachment to BZDR
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
Measured: 6 and 12 months after enrollment
Reported Quality of life of patients
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.
Measured: 6 and 12 months after enrollment
Autonomy
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.
Measured: 6 and 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start16 Oct 2023
- Primary completion16 Feb 2027 (estimated)
- Study completion16 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic cluster-randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Nantes
- Responsible party
- Sponsor
- Investigators
- Jean-François HUON, Pharm.D PhD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765656
- Sponsor's protocol ID
- RC21_0357
- Acronym
- BESTOPH-MG
- Status last verified
- Jun 2026
- First submitted
- 10 Feb 2023
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huon JF, Nizet P, Caillet P, Lecompte H, Victorri-Vigneau C, Fournier JP; BESTOPH-MG consortium. Evaluation of the effectiveness of a joint general practitioner-pharmacist intervention on the implementation of benzodiazepine deprescribing in older adults (BESTOPH-MG trial): protocol for a cluster-randomized controlled trial. Front Med (Lausanne). 2023 Aug 25;10:1228883. doi: 10.3389/fmed.2023.1228883. eCollection 2023.
PubMed 37711743