Understanding Benzodiazepine and Non-benzodiazepine Sedative Use (NCT02833272) | Clinical Trial Compass
UnknownNot Applicable
Understanding Benzodiazepine and Non-benzodiazepine Sedative Use
Canada50 participantsStarted 2016-07
Plain-language summary
Inappropriate medication use among the elderly ranges from 11% to 62% and is a major concern for patient safety. Benzodiazepines account for approximately 20 to 25% of inappropriate medications prescribed to the elderly, thus reducing their inappropriate use could have a substantial impact on patient safety and overall well-being among elderly patients. The Choosing Wisely Canada- Geriatrics guidelines for high value health care recommend against the prescription of benzodiazepines or other sedative-hypnotics (Z drugs) in older adults as first choice for insomnia, agitation or delirium. Despite evidence of potential harms, benzodiazepines and non-benzodiazepine sedatives (including the "Z-drugs": eszopiclone, zopiclone, zolpidem and zaleplon, henceforth referred to as "sedatives") continue to be prescribed inappropriately to patients in hospital and community settings.
Our primary objective is to facilitate the deprescription of benzodiazepine and non-benzodiazepine sedative hypnotics (sedatives) using a combination of physician education sessions and an updated patient educational pamphlet based on Tannenbaum's EMPOWER study conducted in a community-based setting.
Who can participate
Age range
65 Years – 120 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:
* Inpatients 65 years or older admitted to study units
* Have a benzodiazepine or sedative prescription used at least 3 times in the week prior to enrolment
Exclusion Criteria:
* Less than 65 years of age
* Admitted for the treatment of alcohol or benzodiazepine withdrawal
* Not having a prescription for benzodiazepines or Z-drugs
* Not reporting use of either medication at least 3 times in the week prior to admission
* Not being enrolled in the provincial drug plan
* Opting out of the provincial drug database (DSQ)
* Previous enrolment in the study
* Patients expected to die before primary endpoint can be realized (e.g., patients admitted for end of life care or prognosis of 3 months or less)
* Patient lives in nursing home and has dementia without an identifiable proxy
* Inability for patient or proxy to speak English or French
* No means of contacting patient or proxy after discharge
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
Stopped Use
Timeframe: 90 days post-discharge
Trial details
NCT IDNCT02833272
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre