NCT02833272|UnknownDMC
Understanding Benzodiazepine and Non-benzodiazepine Sedative Use
Deprescribing Sedative Hypnotics on the Clinical Teaching Unit Using a Patient Empowerment Tool
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Deprescribing Sedative Hypnotics on the Clinical Teaching Unit Using a Patient Empowerment Tool
Sponsor study identifier
interventional
50
1 country
1
Study Start
July 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2016
Date type not reportedThis date has not been verified as actual or estimated.
July 12, 2016
Actual (reported)July 14, 2016
Actual (reported)April 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Stopped Use
Investigators will evaluate whether the patient has stopped use of benzodiazepines within 90 days of discharge from the hospital.
90 days post-discharge
Sleep disturbance: sleep quality assessed by the PROMIS Sleep Disturbance 4a Short Form
90 days post-discharge
Change in patient self-reported falls
90 days post-discharge
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
McGill University Health Centre (Royal Victoria Hospital)
Montreal, Quebec, H4A3J1, Canada
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.
Emily G McDonald, MD MSc
McGill University Health Centre/Research Institute of the McGill University Health Centre
First Submitted
July 12, 2016
First Posted
July 14, 2016
Study Start
July 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2017
Contact the study team to confirm eligibility.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 15, 2017
Record last verified: 2017-02
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