An Intervention Study to Reduce the Use and Impact of Potentially Inappropriate Medications Among Older Adults
|ClinicalTrials.gov Identifier: NCT01148186|
Recruitment Status : Terminated (Study funding period reached conclusion. Sample size sufficient to complete the analysis on benzodiazepines.)
First Posted : June 22, 2010
Last Update Posted : May 15, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Polypharmacy Incontinence Insomnia Anxiety||Behavioral: knowledge transfer tool||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||The Patient as a Driver of Change: an Intervention Study to Reduce the Use and Impact of Potentially Inappropriate Medications Among Older Adults|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
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.
Behavioral: knowledge transfer tool
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|
- Complete discontinuation of the targeted potentially inappropriate medication (e.g. benzodiazepines, oxybutynin) [ Time Frame: 6 months post-intervention ]
- Cognitive function [ Time Frame: 6-months post-intervention ]Montreal cognitive assessment instrument Rey`s auditory verbal learning test (immediate memory, learning, and delayed recall)
- Sleep efficiency [ Time Frame: 6-months ]Sleep efficiency as documented with a sleep diary
- incontinence-related self-efficacy [ Time Frame: 6-months post-intervention ]incontinence-related self-efficacy as measured with the geriatric self-efficacy index
- frequency of urinary incontinence episodes [ Time Frame: 6-months post-intervention ]frequency of urinary incontinence as measured with a 72-hour bladder diary
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148186
|Le Groupe Jean Coutu Inc.|
|Longueuil, Quebec, Canada, J4G 1S8|
|Principal Investigator:||Cara Tannenbaum, MD||Centre de recherche de l'Institut universitaire de gériatrie de Montréal|