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Clinical Trials/NCT02833272
NCT02833272
Unknown
Not Applicable

Deprescribing Sedative Hypnotics on the Clinical Teaching Unit Using a Patient Empowerment Tool

McGill University Health Centre/Research Institute of the McGill University Health Centre1 site in 1 country50 target enrollmentJuly 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frailty
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Enrollment
50
Locations
1
Primary Endpoint
Stopped Use
Last Updated
9 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
June 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible Party
Principal Investigator
Principal Investigator

Todd Lee

Associate Professor of Medicine

McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • 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)

Study Sites (1)

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