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

Study Overview
=================
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

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

Conditions
-----------------
Polypharmacy, Incontinence, Insomnia, Anxiety

Intervention / Treatment
-----------------
* Behavioral: knowledge transfer tool


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational intervention<br>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<br>* knowledge transfer tool for empowering patients to engage in collaborative discontinuation of potentially inappropriate medication with their pharmacist and/or physician<br>|
| No Intervention: Wait-list group<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete discontinuation of the targeted potentially inappropriate medication (e.g. benzodiazepines, oxybutynin) |  | 6 months post-intervention | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polypharmacy, Benzodiazepine use, Oxybutynin use, cognition disorders/drug therapy, incontinence