Clinical trial NCT01148186: An Intervention Study to Reduce the Use and Impact of Potentially Inappropriate Medications Among Older Adults
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Polypharmacy
Incontinence
Insomnia
Anxiety
Keywords: Polypharmacy
Benzodiazepine use
Oxybutynin use
cognition disorders/drug therapy
incontinence
Lead sponsor: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2010-06-22
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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

Primary outcomes:
measure: Complete discontinuation of the targeted potentially inappropriate medication (e.g. benzodiazepines, oxybutynin)
timeFrame: 6 months post-intervention
Secondary outcomes:
measure: Cognitive function
timeFrame: 6-months post-intervention
measure: Sleep efficiency
timeFrame: 6-months
measure: incontinence-related self-efficacy
timeFrame: 6-months post-intervention
measure: frequency of urinary incontinence episodes
timeFrame: 6-months post-intervention
Other outcomes:
Locations:
city: Longueuil
country: Canada
facility: Le Groupe Jean Coutu Inc.
state: Quebec
Study officials:
affiliation: Centre de recherche de l'Institut universitaire de gériatrie de Montréal
name: Cara Tannenbaum, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martin P, Tannenbaum C. A realist evaluation of patients' decisions to deprescribe in the EMPOWER trial. BMJ Open. 2017 May 4;7(4):e015959. doi: 10.1136/bmjopen-2017-015959.
citation: Martin P, Tannenbaum C. Use of the EMPOWER brochure to deprescribe sedative-hypnotic drugs in older adults with mild cognitive impairment. BMC Geriatr. 2017 Jan 31;17(1):37. doi: 10.1186/s12877-017-0432-5.
citation: Tannenbaum C, Martin P, Tamblyn R, Benedetti A, Ahmed S. Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial. JAMA Intern Med. 2014 Jun;174(6):890-8. doi: 10.1001/jamainternmed.2014.949.
citation: Martin P, Tamblyn R, Ahmed S, Tannenbaum C. An educational intervention to reduce the use of potentially inappropriate medications among older adults (EMPOWER study): protocol for a cluster randomized trial. Trials. 2013 Mar 20;14:80. doi: 10.1186/1745-6215-14-80.