Effectiveness of a Joint General Practitioner-Pharmacist Intervention on Benzodiazepine Deprescri… (NCT05765656) | Clinical Trial Compass
RecruitingNot Applicable
Effectiveness of a Joint General Practitioner-Pharmacist Intervention on Benzodiazepine Deprescribing in the Elderly
France400 participantsStarted 2023-10-16
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Appropriateness measured by sociological interviews of patients, general practicioners and pharmacists and pharmacists observations
Timeframe: 3 to 6 months after the beginning of the enrollment period and 12 months after the end of the enrollment period