About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
patients living in an institution
participating in a clinical trial
with epilepsy
active depression
Trial design
Parallel
Treatments tested in this trial
GP - pharmacist collaboration and pharmacist motivational interviewing
Behavioral1. 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Acceptability 1
Number of clusters included / Number of clusters planned measured by logbooks
Acceptability 2
Reason for pharmacists and general practitioners' refusal assesed by individual interviews
Acceptability 3
Number of patients included / Number of patients eligible measured by logbooks
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nantes University Hospital
Lead sponsor
Université de Nantes
Collaborator