- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01148186
An Intervention Study to Reduce the Use and Impact of Potentially Inappropriate Medications Among Older Adults
May 14, 2013 updated by: Cara Tannenbaum, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
The Patient as a Driver of Change: an Intervention Study to Reduce the Use and Impact of Potentially Inappropriate Medications Among Older Adults
An educational intervention targeting community-dwelling older adults will lead to a reduction in potentially inappropriate prescriptions (e.g. benzodiazepines, oxybutynin).
Cessation of potentially inappropriate medications (e.g. benzodiazepines, oxybutynin)will lead to improved cognitive outcomes in older adults.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
This study tests the effectiveness of a knowledge transfer tool for empowering patients to engage in collaborative discontinuation of potentially inappropriate medication with their pharmacist and/or physician
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Phase 4
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
-
-
Quebec
-
Longueuil, Quebec, Canada, J4G 1S8
- Le Groupe Jean Coutu Inc.
-
-
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 and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 65 year old human adults
- who fill a prescription for at least 5 medications
- community dwelling
- chronic use (3 months or longer) of at least one potentially inappropriate medication (e.g. benzodiazepine, oxybutynin)
Exclusion Criteria:
- patients with severe mental illness, dementia and epilepsy
- concomitant consumption of any other antipsychotic medication (including lithium, olanzapine, clozapine, quetiapine, risperidone, haloperidol etc.)
- concomitant consumption of any antiepileptic (including carbamazepine, valproate, gabapentin, lamotrigine, topiramate, oxcarbazepine etc.)
- concomitant consumption of a cholinesterase inhibitor or memantine
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Educational intervention
Administration of an educational intervention to inform patients of the risks and safe alternatives to their current potentially inappropriate medication.
The textual content of this knowledge transfer tool will be divided into three parts: a) presentation of the evidence-based risks associated with the targeted potentially inappropriate medication (e.g.
benzodiazepines); b) presentation of evidence-based equally or more effective therapeutic substitutes for the medical condition (e.g.
insomnia and anxiety); and c) presentation of evidence based tapering recommendations where applicable.
|
knowledge transfer tool for empowering patients to engage in collaborative discontinuation of potentially inappropriate medication with their pharmacist and/or physician
|
No Intervention: Wait-list group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complete discontinuation of the targeted potentially inappropriate medication (e.g. benzodiazepines, oxybutynin)
Time Frame: 6 months post-intervention
|
6 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive function
Time Frame: 6-months post-intervention
|
Montreal cognitive assessment instrument Rey's auditory verbal learning test (immediate memory, learning, and delayed recall)
|
6-months post-intervention
|
Sleep efficiency
Time Frame: 6-months
|
Sleep efficiency as documented with a sleep diary
|
6-months
|
incontinence-related self-efficacy
Time Frame: 6-months post-intervention
|
incontinence-related self-efficacy as measured with the geriatric self-efficacy index
|
6-months post-intervention
|
frequency of urinary incontinence episodes
Time Frame: 6-months post-intervention
|
frequency of urinary incontinence as measured with a 72-hour bladder diary
|
6-months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
- Martin P, Tannenbaum C. A realist evaluation of patients' decisions to deprescribe in the EMPOWER trial. BMJ Open. 2017 May 4;7(4):e015959. doi: 10.1136/bmjopen-2017-015959.
- Martin P, Tannenbaum C. Use of the EMPOWER brochure to deprescribe sedative-hypnotic drugs in older adults with mild cognitive impairment. BMC Geriatr. 2017 Jan 31;17(1):37. doi: 10.1186/s12877-017-0432-5.
- 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.
- Martin P, Tamblyn R, Ahmed S, Tannenbaum C. An educational intervention to reduce the use of potentially inappropriate medications among older adults (EMPOWER study): protocol for a cluster randomized trial. Trials. 2013 Mar 20;14:80. doi: 10.1186/1745-6215-14-80.
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
June 1, 2010
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
June 21, 2010
First Submitted That Met QC Criteria
June 21, 2010
First Posted (Estimate)
June 22, 2010
Study Record Updates
Last Update Posted (Estimate)
May 15, 2013
Last Update Submitted That Met QC Criteria
May 14, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CIHR-2009MOP-201314-KTE
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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