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An Intervention Study to Reduce the Use and Impact of Potentially Inappropriate Medications Among Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Cara Tannenbaum, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Study Description
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Brief Summary:

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Complete discontinuation of the targeted potentially inappropriate medication (e.g. benzodiazepines, oxybutynin) [ Time Frame: 6 months post-intervention ]

Secondary Outcome Measures :
  1. Cognitive function [ Time Frame: 6-months post-intervention ]
    Montreal cognitive assessment instrument Rey's auditory verbal learning test (immediate memory, learning, and delayed recall)

  2. Sleep efficiency [ Time Frame: 6-months ]
    Sleep efficiency as documented with a sleep diary

  3. incontinence-related self-efficacy [ Time Frame: 6-months post-intervention ]
    incontinence-related self-efficacy as measured with the geriatric self-efficacy index

  4. frequency of urinary incontinence episodes [ Time Frame: 6-months post-intervention ]
    frequency of urinary incontinence as measured with a 72-hour bladder diary


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Canada, Quebec
Le Groupe Jean Coutu Inc.
Longueuil, Quebec, Canada, J4G 1S8
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Cara Tannenbaum, MD Centre de recherche de l'Institut universitaire de gériatrie de Montréal
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cara Tannenbaum, Dr., Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
ClinicalTrials.gov Identifier: NCT01148186    
Other Study ID Numbers: CIHR-2009MOP-201314-KTE
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: May 2013
Keywords provided by Cara Tannenbaum, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal:
Polypharmacy
Benzodiazepine use
Oxybutynin use
cognition disorders/drug therapy
incontinence