Recruiting

Sedative Use

Sponsor:

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

Code:

NCT02833272

Conditions

Frailty

Deprescription

Aged

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Interventions

EMPOWER Educational Brochure

Study Details

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.

Conditions

Frailty

Deprescription

Aged

Study ID

NCT02833272

Start date

Jul, 2016

Status verified date

Feb, 2017

Completion date

Jun, 2017

Anticipated

Primary completion date

Apr, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

  • Stopped Use [ Time Frame: 90 days post-discharge ]

Central Contacts and Locations

Central contacts

Emily G McDonald, MD MSc

514-934-1934emily.mcdonald@mcgill.ca

Todd C Lee, MD MPH

514-934-1934todd.lee@mcgill.ca

Locations

McGill University Health Centre (Royal Victoria Hospital)

Recruiting

Montreal, Quebec, Canada, H4A3J1

Contacts

Todd C Lee, MD MPH

14-934-1934todd.lee@mcgill.ca

More Information

Sponsor

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

Last update posted

Feb 15, 2017

Last verified

Feb, 2017

Keywords

  • benzodiazepines
  • Z-drugs

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2017-02-15.