Understanding Benzodiazepine and Non-benzodiazepine Sedative Use
NCT ID: NCT02833272
Last Updated: 2017-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2016-07-31
2017-06-30
Brief Summary
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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.
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Detailed Description
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The intervention will include the following components:
1. Educational campaign toward physicians about benzodiazepine and Z-drug prescriptions:
An educational campaign about the purpose of the study and risks of benzodiazepine and sedative prescriptions will be delivered to physicians in each intervention cluster. The educational campaign will include a presentation by the chief of the medical service at teaching rounds at the beginning of the intervention, an electronic message sent to all physicians on the medical service, and posting of the Choosing Wisely Canada- Geriatrics guidelines.
2. In-hospital patient education campaign:
Patients will be identified from the pharmacy database and validated by a research associate in collaboration with the unit pharmacists based on the patient's best possible medication history taken at time of admission. Eligibility will be confirmed by the patient's treating physician with support from the principal investigator and site coordinators. Patients will receive a previously validated (in the outpatient setting) educational brochure about the risks of chronic sedative use and how to stop using them through a tapering regimen. The booklet currently includes information about benzodiazepines but will be adapted to also include information about sedatives. The preparation of the brochure has been validated in both English and French for comprehension and readability.
Clusters will be defined by clinical teaching unit (CTU) at the Royal Victoria Hospital, - the C9 CTU and D9 CTU. Follow up of discharged patients will be until 30 and 90 days post-discharge.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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EMPOWER Educational Brochure
This is the only arm of the study. All participants will undergo the intervention, which is an educational brochure (EMPOWER educational brochure) to explain the possible harms of benzodiazepine and non-benzodiazepine sedative drugs.
EMPOWER Educational Brochure
The EMPOWER educational brochure explains the risk of benzodiazepine and non-benzodiazepine sedative use to patients with a current prescription. The brochure also provides a tapering schedule if the patient chooses to discontinue taking the drug.
Interventions
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EMPOWER Educational Brochure
The EMPOWER educational brochure explains the risk of benzodiazepine and non-benzodiazepine sedative use to patients with a current prescription. The brochure also provides a tapering schedule if the patient chooses to discontinue taking the drug.
Eligibility Criteria
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Inclusion Criteria
* Have a benzodiazepine or sedative prescription used at least 3 times in the week prior to enrolment
Exclusion Criteria
* 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
65 Years
120 Years
ALL
No
Sponsors
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McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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Todd Lee
Associate Professor of Medicine
Principal Investigators
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Emily G McDonald, MD MSc
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Locations
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McGill University Health Centre (Royal Victoria Hospital)
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Tannenbaum C, Martin P, Tamblyn R, Benedetti A, Ahmed S. Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial. JAMA Intern Med. 2014 Jun;174(6):890-8. doi: 10.1001/jamainternmed.2014.949.
Guaraldo L, Cano FG, Damasceno GS, Rozenfeld S. Inappropriate medication use among the elderly: a systematic review of administrative databases. BMC Geriatr. 2011 Nov 30;11:79. doi: 10.1186/1471-2318-11-79.
Brekke M, Rognstad S, Straand J, Furu K, Gjelstad S, Bjorner T, Dalen I. Pharmacologically inappropriate prescriptions for elderly patients in general practice: How common? Baseline data from The Prescription Peer Academic Detailing (Rx-PAD) study. Scand J Prim Health Care. 2008;26(2):80-5. doi: 10.1080/02813430802002875.
van der Hooft CS, Jong GW, Dieleman JP, Verhamme KM, van der Cammen TJ, Stricker BH, Sturkenboom MC. Inappropriate drug prescribing in older adults: the updated 2002 Beers criteria--a population-based cohort study. Br J Clin Pharmacol. 2005 Aug;60(2):137-44. doi: 10.1111/j.1365-2125.2005.02391.x.
American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2012 Apr;60(4):616-31. doi: 10.1111/j.1532-5415.2012.03923.x. Epub 2012 Feb 29.
Related Links
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Choosing Wisely Canada - Canadian Geriatrics Society Recommendations
Other Identifiers
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15-372
Identifier Type: -
Identifier Source: org_study_id
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