FrailtyNCT02833272
Understanding Benzodiazepine and Non-benzodiazepine Sedative Use
A study testing EMPOWER Educational Brochure in people with Frailty and Deprescription, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 120 years
- Conditions the study is for
- Frailty, Deprescription, Aged
- What is being tested?
- EMPOWER Educational Brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 120 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Centre (Royal Victoria Hospital)
Montreal, Quebec, H4A3J1
Todd C Lee, MD MPH, 14-934-1934 ext. 53333, todd.lee@mcgill.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Frailty, Deprescription, Aged
- Being tested
- EMPOWER Educational Brochure
- Keywords
- benzodiazepines, Z-drugs
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMPOWER Educational BrochureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| EMPOWER Educational Brochure | Experimental | 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. Receives: Behavioral: EMPOWER Educational Brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stopped Use
Investigators will evaluate whether the patient has stopped use of benzodiazepines within 90 days of discharge from the hospital.
Measured: 90 days post-discharge
Secondary outcomes (2)
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.
Measured: 90 days post-discharge
Change in patient self-reported falls
Investigators will evaluate whether there has been any change in patient self-reported falls.
Measured: 90 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionApr 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd Lee, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Emily G McDonald, MD MSc, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833272
- Sponsor's protocol ID
- 15-372
- Status last verified
- Feb 2017
- First submitted
- 12 Jul 2016
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 24733354Guaraldo 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.
PubMed 22129458Brekke 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.
PubMed 18570005van 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.
PubMed 16042666American 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.
PubMed 22376048
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deprescribing Sedative Hypnotics on the Clinical Teaching Unit Using a Patient Empowerment Tool
- ClinicalTrials.gov ID
- NCT02833272
- Acronym / sponsor ID
- 15-372
- Conditions
- Frailty, Deprescription, Aged
- Keywords
- benzodiazepines, Z-drugs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMPOWER Educational Brochure | Experimental | Behavioral: EMPOWER Educational BrochureThis 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. |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMPOWER 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. | Behavioural | EMPOWER Educational Brochure |
Primary outcome
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.
2 secondary outcomes
Sleep disturbance: sleep quality assessed by the PROMIS Sleep Disturbance 4a Short Form
Time frame: 90 days post-discharge
Change in patient self-reported falls
Time frame: 90 days post-discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Background: PubMed 24733354Tannenbaum 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.
- Background: PubMed 22129458Guaraldo 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.
- Background: PubMed 18570005Brekke 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.
- Background: PubMed 16042666van 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.
- Background: PubMed 22376048American 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.
- Choosing Wisely Canada - Canadian Geriatrics Society RecommendationsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily G McDonald, MD MSc principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMPOWER Educational Brochure in people with Frailty and Deprescription, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emily G McDonald, MD MSc (514-934-1934 ext. 32968, emily.mcdonald@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stopped Use (time frame: 90 days post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02833272, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.