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Understanding Benzodiazepine and Non-benzodiazepine Sedative Use

Primary Purpose

Frailty, Deprescription, Aged

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
EMPOWER Educational Brochure
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Frailty focused on measuring benzodiazepines, Z-drugs

Eligibility Criteria

65 Years - 120 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McGill University Health Centre (Royal Victoria Hospital)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EMPOWER Educational Brochure

Arm Description

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.

Outcomes

Primary Outcome Measures

Stopped Use
Investigators will evaluate whether the patient has stopped use of benzodiazepines within 90 days of discharge from the hospital.

Secondary Outcome Measures

Sleep disturbance: sleep quality assessed by the PROMIS Sleep Disturbance 4a Short Form
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.
Change in patient self-reported falls
Investigators will evaluate whether there has been any change in patient self-reported falls.

Full Information

First Posted
July 12, 2016
Last Updated
February 14, 2017
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02833272
Brief Title
Understanding Benzodiazepine and Non-benzodiazepine Sedative Use
Official Title
Deprescribing Sedative Hypnotics on the Clinical Teaching Unit Using a Patient Empowerment Tool
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Deprescription, Aged
Keywords
benzodiazepines, Z-drugs

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EMPOWER Educational Brochure
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
EMPOWER Educational Brochure
Intervention Description
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 Information:
Title
Stopped Use
Description
Investigators will evaluate whether the patient has stopped use of benzodiazepines within 90 days of discharge from the hospital.
Time Frame
90 days post-discharge
Secondary Outcome Measure Information:
Title
Sleep disturbance: sleep quality assessed by the PROMIS Sleep Disturbance 4a Short Form
Description
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.
Time Frame
90 days post-discharge
Title
Change in patient self-reported falls
Description
Investigators will evaluate whether there has been any change in patient self-reported falls.
Time Frame
90 days post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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 No means of contacting patient or proxy after discharge
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily G McDonald, MD MSc
Phone
514-934-1934
Ext
32968
Email
emily.mcdonald@mcgill.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Todd C Lee, MD MPH
Phone
514-934-1934
Ext
34673
Email
todd.lee@mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily G McDonald, MD MSc
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Centre (Royal Victoria Hospital)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd C Lee, MD MPH
Phone
14-934-1934
Ext
53333
Email
todd.lee@mcgill.ca

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
24733354
Citation
Tannenbaum C, Martin P, Tamblyn R, Benedetti A, Ahmed S. Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial. JAMA Intern Med. 2014 Jun;174(6):890-8. doi: 10.1001/jamainternmed.2014.949.
Results Reference
background
PubMed Identifier
22129458
Citation
Guaraldo L, Cano FG, Damasceno GS, Rozenfeld S. Inappropriate medication use among the elderly: a systematic review of administrative databases. BMC Geriatr. 2011 Nov 30;11:79. doi: 10.1186/1471-2318-11-79.
Results Reference
background
PubMed Identifier
18570005
Citation
Brekke M, Rognstad S, Straand J, Furu K, Gjelstad S, Bjorner T, Dalen I. Pharmacologically inappropriate prescriptions for elderly patients in general practice: How common? Baseline data from The Prescription Peer Academic Detailing (Rx-PAD) study. Scand J Prim Health Care. 2008;26(2):80-5. doi: 10.1080/02813430802002875.
Results Reference
background
PubMed Identifier
16042666
Citation
van der Hooft CS, Jong GW, Dieleman JP, Verhamme KM, van der Cammen TJ, Stricker BH, Sturkenboom MC. Inappropriate drug prescribing in older adults: the updated 2002 Beers criteria--a population-based cohort study. Br J Clin Pharmacol. 2005 Aug;60(2):137-44. doi: 10.1111/j.1365-2125.2005.02391.x.
Results Reference
background
PubMed Identifier
22376048
Citation
American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2012 Apr;60(4):616-31. doi: 10.1111/j.1532-5415.2012.03923.x. Epub 2012 Feb 29.
Results Reference
background
Links:
URL
http://www.choosingwiselycanada.org/recommendations/geriatrics/
Description
Choosing Wisely Canada - Canadian Geriatrics Society Recommendations

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Understanding Benzodiazepine and Non-benzodiazepine Sedative Use

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