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Leveraging policy to reduce chronic opioid use by educating and empowering community dwelling adults: a study protocol for the TAPERING randomized controlled trial.

ABSTRACT: BACKGROUND:Opioid 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. METHODS:This 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

SUBMITTER: Turner JP

PROVIDER: S-EPMC6617933 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Leveraging policy to reduce chronic opioid use by educating and empowering community dwelling adults: a study protocol for the TAPERING randomized controlled trial.

Turner Justin P JP Caetano Patricia P Tannenbaum Cara C

Trials 20190709 1

<h4>Background</h4>Opioid 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 opioi ...[more]

PMID: 31288859

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Project description:With ageing comes increased vulnerability such that older adults' ability to recover from acute illnesses, fall-related injuries and other stresses related to the physical ageing processes declines. This increased vulnerability, also known as frailty, is common in older adults and associated with increased healthcare service use and adverse health outcomes. Currently, there is no overview of available interventions to prevent or reduce the level of frailty (as defined by study's authors) which will help healthcare providers in community settings caring for older adults. We will address this gap by reviewing interventions and international policies that are designed to prevent or reduce the level of frailty in community-dwelling older adults.We will conduct a scoping review using the updated guidelines of Arksey and O'Malley to systematically search the peer-reviewed journal articles to identify interventions that aimed to prevent or reduce the level of frailty. We will search grey literature for international policies. The 6-stage scoping review model involves: (1) identifying the research question; (2) identifying relevant studies; (3) selecting studies; (4) charting the data; (5) collating, summarising and reporting the results and (6) consulting with key stakeholders.Our scoping review will use robust methodology to search for available interventions focused on preventing or reducing the level of frailty in community-dwelling older adults. We will consult with stakeholders to find out whether they find the frailty interventions/policies useful and to identify the barriers and facilitators to their implementation in Canada. We will disseminate our findings to relevant stakeholders at local, national and international levels by presenting at relevant meetings and publishing the findings. Our review will identify gaps in research and provide healthcare providers and policymakers with an overview of interventions that can be implemented to prevent or postpone frailty.

Project description:IntroductionIncreases in pain and interference with quality of life is a common concern among people with chronic non-cancer pain (CNCP) who are tapering opioid medications. Research indicates that access to social and psychological support for pain self-management may help people to reduce their opioid dose without increasing pain and interference. This study evaluates the efficacy of a text messaging intervention designed to provide people with CNCP with social and psychological support for pain self-management while tapering long-term opioid therapy (LTOT) under the guidance of their prescriber.Methods and analysisA double-blind randomised controlled trial will be conducted. Patients with CNCP (n=74) who are tapering LTOT will be enrolled from across Australia. Participants will continue with their usual care while tapering LTOT under the supervision of their prescribing physician. They will randomly receive either a psychoeducational video and supportive text messaging (two Short Message Service (SMS) per day) for 12 weeks or the video only. The primary outcome is the pain intensity and interference assessed by the Pain, Enjoyment of Life and General Activity scale. Secondary outcomes include mood, self-efficacy, pain cognitions, opioid dose reduction, withdrawal symptoms, and acceptability, feasibility, and safety of the intervention. Participants will complete questionnaires at baseline and then every 4 weeks for 12 weeks and will be interviewed at week 12. This trial will provide evidence for the efficacy of a text messaging intervention to support patients with CNCP who are tapering LTOT. If proven to be efficacious and safe, this low-cost intervention can be implemented at scale.Ethics and disseminationThe study protocol was reviewed and approved by the Northern Sydney Local Health District (Australia). Study results will be published in peer-reviewed journals and presented at scientific and professional meetings.Trial registration numberACTRN12622001423707.

Project description:ImportanceFalls are the leading preventable cause of morbidity, mortality, and premature institutionalization for community-dwelling older adults.ObjectiveTo test the effectiveness of a behavioral intervention on fall risk among older adults receiving services from an Area Agency on Aging.Design, setting, and participantsThis randomized clinical trial examined a home hazard removal intervention in the community using a race- and sex-stratified randomization design. Older adults receiving services from the Area Agency on Aging in urban St Louis, Missouri, were assigned to a home hazard removal intervention delivered over 2 weeks with a 6-month booster or usual care control. Eligible participants were adults aged 65 years or older who did not have dementia, were at high risk for falling, and resided in the community. Enrollment occurred from January 2015 to September 2016; 12-month follow-up occurred from February 2016 to October 2017. Data were analyzed from February 2019 to July 2021.InterventionsThe intervention was a home hazard removal program delivered by an occupational therapist in the home that included a comprehensive clinical assessment and a tailored hazard removal plan. Usual care control consisted of annual assessments and community referral.Main outcomes and measuresThe primary outcome was the hazard of a fall over 12 months. Prespecified secondary outcomes included the rate of falls over 12 months, daily activity performance, falls self-efficacy, and self-reported quality of life.ResultsA total of 310 participants (mean [SD] age, 75 [7.4] years; 229 [74%] women; 161 Black participants [52%]) were randomized, with 155 participants assigned to the intervention and 155 participants assigned to usual care. Retention was 127 participants (82%) in the intervention group and 126 participants (81%) in the control group. There was no difference for our primary outcome of fall hazard (hazard ratio, 0.90; 95% CI, 0.66-1.27). There was a 38% reduction in the rate of falling in the intervention group compared with the control group (relative risk, 0.62; 95% CI, 0.40-0.95; P = .03). At 12 months, the rate of falls per person-year was 1.5 (95% CI, 1.32-1.75) in the intervention group and 2.3 (95% CI, 2.08-2.60) in the control group. There was no difference in daily activity performance (adjusted difference, -0.20; 95% CI, -0.95 to 0.55; P = .60), falls self-efficacy (adjusted difference, -0.12; 95% CI, -1.25 to 1.01; P = .84), or quality of life (adjusted difference, 0.84; 95% CI, -0.95 to 2.64; P = .35).Conclusions and relevanceThis randomized clinical trial found that a brief home hazard removal program did not reduce the hazard of falls among community-dwelling older adults at high risk for falling. The intervention was effective in achieving a reduced rate of falls, a prespecified secondary outcome. This effectiveness study has the potential for delivery through the national aging services network.Trial registrationClinicalTrials.gov Identifier: NCT02392013.

Project description:As a result of the ageing population, there is an urgent need for innovation in community health-care in order to achieve sustainability. Reablement is implemented in primary care in some Western countries to help meet these challenges. However, evidence to support the use of such home-based rehabilitation is limited. Reablement focuses on early, time-intensive, multidisciplinary, multi-component and individualised home-based rehabilitation for older adults with functional decline. The aim of this study is to investigate the effectiveness of reablement in home-dwelling adults compared with standard treatment in relation to daily activities, physical functioning, health-related quality of life, use of health-care services, and costs.The study will be a 1:1 parallel-group randomised controlled superiority trial conducted in a rural municipality in Norway. The experimental group will be offered reablement and the control group offered standard treatment. A computer-generated permuted block randomisation sequence, with randomly selected block sizes, will be used for allocation. Neither participants nor health-care providers will be blinded, however all research assistants and researchers will be blinded. The sample size will consist of 60 participants. People will be eligible if they are home-dwelling, over 18 years of age, understand Norwegian and have functional decline. The exclusion criteria will be people in need of institution-based rehabilitation or nursing home placement, and people who are terminally ill or cognitively reduced. The primary outcome will be self-perceived performance, and satisfaction with performance of daily activities, assessed with the Canadian Occupational Performance Measure. In addition, physical capacity, health-related quality of life, use of health-care services, and cost data will be collected at baseline, and after 3 and 9 months in both groups, and again after 15 months in the intervention group. Data will be analysed on an intention-to-treat basis using a linear mixed model for repeated measures.The findings will make an important contribution to evaluating cost-effective and evidence-based rehabilitation approaches for community-dwelling adults.The trial was registered in ClinicalTrials.gov November 20, 2012, identifier: NCT02043262.

Dataset Information

Leveraging policy to reduce chronic opioid use by educating and empowering community dwelling adults: a study protocol for the TAPERING randomized controlled trial.

Publications

Leveraging policy to reduce chronic opioid use by educating and empowering community dwelling adults: a study protocol for the TAPERING randomized controlled trial.

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