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

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

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.

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

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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