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Clinical Trials in France / NCT05765656
Recruiting Not applicable

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

NCT05765656 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-10-16
Last updated
2026-06-24

Condition(s) studied

Primary CareHealth Plan ImplementationBenzodiazepine DependenceElderlyAnxietyDeprescribing

Investigational drug(s) / intervention(s)

GP - pharmacist collaboration and pharmacist motivational interviewing

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.

Study 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. 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

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
CHU de Nantes Nantes France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05765656 on ClinicalTrials.gov ↗ ← All trials in France