Clinical trial NCT02053194: A Trial to De-prescribe Inappropriate Medications in the Community Dwelling Elderly
Official title: Developing Pharmacist-led Research to Educate and Sensitive Community Residents to the Inappropriate Prescription Burden in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inappropriate Dose of Drug Administered
Health Behavior
Keywords: Inappropriate prescribing
Health Education
Community Pharmacy Services
Medication Therapy Management
Preventive Health Services
Polypharmacy
Inappropriate prescriptions
Aged
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: 2014-02-03
Enrollment: 600
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: The objective of this trial is to test the beneficial effect of a pharmacist-initiated knowledge transfer intervention to both patients and prescribers on the discontinuation of inappropriate prescriptions, compared to usual care. The investigators hypothesize that the pharmacist-led intervention will reduce inappropriate prescriptions by at least 20% over 6-months compared to usual care. The intervention consists of simultaneously educating consumers and providing physicians with an evidence-based pharmaceutical opinion on inappropriate prescriptions.


Eligibility criteria: Inclusion Criteria:

* Men and women 65 years of age and older (no upper age limit)
* Individuals for whom prescription claims derive from only one pharmacy identifier
* Chronic consumption (\> 3 month claims) of one of the target inappropriate prescriptions. (benzodiazepine/non benzodiazepine hypnotic, long-acting sulfonylurea oral hypoglycemic agents, anticholinergic agents (in the form of first-generation antihistamines) or Nonsteroidal anti-inflammatory drugs \[NSAIDs\] )
* Patients who are willing to participate in the study.

Exclusion Criteria:

* A probable diagnosis of dementia (persons without the capacity to provide informed consent), as determined by a) a prescription for memantine or a cholinesterase inhibitor; b) report from a caregiver or family-member; or c) a baseline screening score on the Folstein Mini-Mental State Exam \< 24
* Inability to understand and or communicate in English and/or French
* Patients living in a long-term care facility
* Concomitant use of any antipsychotic medication

Primary outcomes:
measure: Complete discontinuation of inappropriate prescriptions.
timeFrame: 6 months
Secondary outcomes:
measure: The frequency, timing and type of pharmaceutical opinions sent by the pharmacist to the patient's primary care physician.
timeFrame: 6 months
measure: Effect of the pharmaceutical opinion on the prescriber's behaviour.
timeFrame: 6 months
measure: Patient-physician encounters to discuss inappropriate prescriptions.
timeFrame: 6 months
Other outcomes:
measure: Change in risk perception around inappropriate prescriptions
timeFrame: Baseline, 6 months
Locations:
Study officials:
affiliation: Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal
name: Cara Tannenbaum, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turner JP, Martin P, Zhang YZ, Tannenbaum C. Patients beliefs and attitudes towards deprescribing: Can deprescribing success be predicted? Res Social Adm Pharm. 2020 Apr;16(4):599-604. doi: 10.1016/j.sapharm.2019.07.007. Epub 2019 Jul 10.
citation: Martin P, Tamblyn R, Benedetti A, Ahmed S, Tannenbaum C. Effect of a Pharmacist-Led Educational Intervention on Inappropriate Medication Prescriptions in Older Adults: The D-PRESCRIBE Randomized Clinical Trial. JAMA. 2018 Nov 13;320(18):1889-1898. doi: 10.1001/jama.2018.16131.
citation: Martin P, Tamblyn R, Ahmed S, Benedetti A, Tannenbaum C. A consumer-targeted, pharmacist-led, educational intervention to reduce inappropriate medication use in community older adults (D-PRESCRIBE trial): study protocol for a cluster randomized controlled trial. Trials. 2015 Jun 10;16:266. doi: 10.1186/s13063-015-0791-1.