Understanding Benzodiazepine and Non-benzodiazepine Sedative Use

February 14, 2017 updated by: Todd Lee, McGill University Health Centre/Research Institute of the McGill University Health Centre

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A3J1
        • Recruiting
        • McGill University Health Centre (Royal Victoria Hospital)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 120 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days post-discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days post-discharge
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.
90 days post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Emily G McDonald, MD MSc, McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (Estimate)

July 14, 2016

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 14, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-372

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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