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

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01148186
• Other study ID #: CIHR-2009MOP-201314-KTE
• Status: Terminated
• Phase: Phase 4
• First received: June 21, 2010
• Last updated: May 14, 2013
• Start date: June 2010
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Anxiety
• Incontinence
• Insomnia
• Polypharmacy

Intervention

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

Locations

Country	Name	City	State
Canada	Le Groupe Jean Coutu Inc.	Longueuil	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete discontinuation of the targeted potentially inappropriate medication (e.g. benzodiazepines, oxybutynin)		6 months post-intervention	No
Secondary	Cognitive function	Montreal cognitive assessment instrument Rey`s auditory verbal learning test (immediate memory, learning, and delayed recall)	6-months post-intervention	Yes
Secondary	Sleep efficiency	Sleep efficiency as documented with a sleep diary	6-months	No
Secondary	incontinence-related self-efficacy	incontinence-related self-efficacy as measured with the geriatric self-efficacy index	6-months post-intervention	No
Secondary	frequency of urinary incontinence episodes	frequency of urinary incontinence as measured with a 72-hour bladder diary	6-months post-intervention	No