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

This study has been terminated.
(Study funding period reached conclusion. Sample size sufficient to complete the analysis on benzodiazepines.)
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
ClinicalTrials.gov Identifier:
NCT01148186
First received: June 21, 2010
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Polypharmacy
Incontinence
Insomnia
Anxiety
Behavioral: knowledge transfer tool
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal:

Primary Outcome Measures:
  • Complete discontinuation of the targeted potentially inappropriate medication (e.g. benzodiazepines, oxybutynin) [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive function [ Time Frame: 6-months post-intervention ] [ Designated as safety issue: Yes ]
    Montreal cognitive assessment instrument Rey`s auditory verbal learning test (immediate memory, learning, and delayed recall)

  • Sleep efficiency [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    Sleep efficiency as documented with a sleep diary

  • incontinence-related self-efficacy [ Time Frame: 6-months post-intervention ] [ Designated as safety issue: No ]
    incontinence-related self-efficacy as measured with the geriatric self-efficacy index

  • frequency of urinary incontinence episodes [ Time Frame: 6-months post-intervention ] [ Designated as safety issue: No ]
    frequency of urinary incontinence as measured with a 72-hour bladder diary


Enrollment: 300
Study Start Date: June 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01148186

Locations
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
Principal Investigator: Cara Tannenbaum, MD Centre de recherche de l'Institut universitaire de gériatrie de Montréal
  More Information

No publications provided by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cara Tannenbaum, Dr., Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
ClinicalTrials.gov Identifier: NCT01148186     History of Changes
Other Study ID Numbers: CIHR-2009MOP-201314-KTE
Study First Received: June 21, 2010
Last Updated: May 14, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal:
Polypharmacy
Benzodiazepine use
Oxybutynin use
cognition disorders/drug therapy
incontinence

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014