Abstract
BackgroundOpioid use has risen to epidemic proportions across Canada, with increasing evidence of harms including accidental overdose and death. Policy-makers have called for effective approaches to promote opioid reduction. One promising method from deprescribing randomized trials is to empower patients through direct-to-patient education. The current trial will evaluate the effectiveness of a government-led mail-out of educational information to adult community-dwelling, chronic opioid users on the reduction of opioids compared to usual care.MethodsThis is a pragmatic, prospective, cluster randomized, parallel-arm controlled trial, comparing mailed distribution of a direct-to-patient educational brochure for chronic opioid use (intervention arm) to usual care (control arm). Eligible participants from across Manitoba, Canada, will be identified by the Provincial Drug Programs Branch within the Manitoba Health, Seniors and Active Living Department of the Manitoba Government, allocated to primary care providers, and the latter will be randomized in clusters of family medicine practices to achieve a 1:1 ratio. The primary outcome is complete cessation of opioids after 6 months assessed using Drug Program Information Network data. Secondary outcomes include ≥ 25% dose reduction in the mean morphine milligram equivalent (MME) daily dose, reduction of daily dose to < 90 mg MME, or therapeutic switch to another opioid or non-opioid medication. Data will be analyzed using intent-to-treat generalized estimating equations.DiscussionThis trial will test the efficacy of a population-based, wide-scale, government-led direct-to-patient educational initiative to drive reductions in chronic opioid use by community-dwelling adults across Manitoba.Trial RegistrationClinicalTrials.gov, ID: NCT03400384. Registered on 18 January 2018.
Highlights
Opioid use has risen to epidemic proportions across Canada, with increasing evidence of harms including accidental overdose and death
In parallel to their increased use, opioid-induced harm and related deaths have tripled in Canada over the past decade, leading the government to declare the opioid crisis a federal priority [11,12,13]
The objective of the trial is to evaluate the effectiveness of a government-led mail-out of educational information directly to adult, community-dwelling, chronic opioid consumers on the reduction of opioid utilization, compared to usual care, as measured by the cessation or dose reduction of opioids after 6 months post intervention
Summary
Opioid use has risen to epidemic proportions across Canada, with increasing evidence of harms including accidental overdose and death. Opioids have been linked in a dose-response and duration of use fashion with fractures [4,5,6], myocardial infarction [7, 8], sexual dysfunction in men [9], and motor vehicle accidents [10]. In parallel to their increased use, opioid-induced harm and related deaths have tripled in Canada over the past decade, leading the government to declare the opioid crisis a federal priority [11,12,13]. One third of opioid-related deaths in the province of Ontario occurred in people with an active opioid prescription [18]
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