Clinical Trials Directory

Trials / Unknown

UnknownNCT02833272

Understanding Benzodiazepine and Non-benzodiazepine Sedative Use

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
Sex
All
Age
65 Years – 120 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALEMPOWER Educational BrochureThe 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.

Timeline

Start date
2016-07-01
Primary completion
2017-04-01
Completion
2017-06-01
First posted
2016-07-14
Last updated
2017-02-15

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT02833272. Inclusion in this directory is not an endorsement.