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Trial record 4 of 121 for:    ZOLPIDEM AND Central Nervous System Depressants

Understanding Benzodiazepine and Non-benzodiazepine Sedative Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02833272
Recruitment Status : Unknown
Verified February 2017 by Todd Lee, McGill University Health Center.
Recruitment status was:  Recruiting
First Posted : July 14, 2016
Last Update Posted : February 15, 2017
Information provided by (Responsible Party):
Todd Lee, McGill University Health Center

Brief 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.

Condition or disease Intervention/treatment Phase
Frailty Deprescription Aged Behavioral: EMPOWER Educational Brochure Not Applicable

Detailed Description:

This study will be a pragmatic before-after intervention trial at the McGill University Health Centre (MUHC) Royal Victoria Hospital (Glen Site) using historical controls from 2014-2016 at our hospital.The intervention will begin July 2016 and conclude January 2016.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Deprescribing Sedative Hypnotics on the Clinical Teaching Unit Using a Patient Empowerment Tool
Study Start Date : July 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

Primary Outcome Measures :
  1. Stopped Use [ Time Frame: 90 days post-discharge ]
    Investigators will evaluate whether the patient has stopped use of benzodiazepines within 90 days of discharge from the hospital.

Secondary Outcome Measures :
  1. Sleep disturbance: sleep quality assessed by the PROMIS Sleep Disturbance 4a Short Form [ Time Frame: 90 days post-discharge ]
    Investigators will evaluate whether the patient's sleep quality has changed since they left the hospital. The PROMIS Sleep Disturbance 4a Short Form will be used to assess sleep.

  2. Change in patient self-reported falls [ Time Frame: 90 days post-discharge ]
    Investigators will evaluate whether there has been any change in patient self-reported falls.

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 120 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02833272

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Contact: Emily G McDonald, MD MSc 514-934-1934 ext 32968
Contact: Todd C Lee, MD MPH 514-934-1934 ext 34673

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Canada, Quebec
McGill University Health Centre (Royal Victoria Hospital) Recruiting
Montreal, Quebec, Canada, H4A3J1
Contact: Todd C Lee, MD MPH    14-934-1934 ext 53333   
Sponsors and Collaborators
McGill University Health Center
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Principal Investigator: Emily G McDonald, MD MSc McGill University Health Center

Additional Information:
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Responsible Party: Todd Lee, Associate Professor of Medicine, McGill University Health Center Identifier: NCT02833272     History of Changes
Other Study ID Numbers: 15-372
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Todd Lee, McGill University Health Center:

Additional relevant MeSH terms:
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Pathologic Processes
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs