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

Phase 4

Terminated

• Conditions: Polypharmacy; Incontinence; Insomnia; Anxiety
• Interventions: Behavioral: knowledge transfer tool

• Registration Number: NCT01148186
• Lead Sponsor: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

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.

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 Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-21
• Study First Submitted QC: 2010-06-21
• Study First Posted: 2010-06-22
• Status Verified: 2013-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-14
• Last Update Posted: 2013-05-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational intervention	knowledge transfer tool	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.

Primary Outcome Measures

Name	Time	Method
Complete discontinuation of the targeted potentially inappropriate medication (e.g. benzodiazepines, oxybutynin)	6 months post-intervention

Secondary Outcome Measures

Name	Time	Method
Cognitive function	6-months post-intervention	Montreal cognitive assessment instrument Rey's auditory verbal learning test (immediate memory, learning, and delayed recall)
Sleep efficiency	6-months	Sleep efficiency as documented with a sleep diary
incontinence-related self-efficacy	6-months post-intervention	incontinence-related self-efficacy as measured with the geriatric self-efficacy index
frequency of urinary incontinence episodes	6-months post-intervention	frequency of urinary incontinence as measured with a 72-hour bladder diary

Trial Locations

Locations (1)

Le Groupe Jean Coutu Inc.; 🇨🇦 Longueuil, Quebec, Canada