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Feasibility of a tapering opioids prescription program for trauma patients at high risk of chronic consumption (TOPP-trauma): protocol for a pilot randomized controlled trial.

ABSTRACT: Background:Opioid use disorder (OUD) and deaths related to the chronic use of opioids have increased significantly over the last two decades. Chronic consumption of opioids has been documented in many patients with traumatic injuries. Preliminary research findings have shown that interventions using cognitive-behavioral strategies were a promising adjunct in decreasing the burden associated with opioid consumption. Accordingly, the Tapering Opioids Prescription Program in Trauma (TOPP-Trauma) was developed. Purpose:To assess the feasibility of the TOPP-Trauma intervention and its research methods; and explore the potential efficacy of TOPP-Trauma in reducing opioid consumption. Methods:A 2-arm pilot randomized controlled trial (RCT) will be conducted in patients presenting a high risk for chronic opioid consumption. Fifty participants at high risk for chronic consumption of opioid will receive either TOPP-Trauma or an educational pamphlet. The feasibility assessment of TOPP-Trauma will be based on the ability to provide its components as initially planned. Several parameters will be evaluated to determine the feasibility of the research methods, including the adequacy of the sampling pool, the dropout rate, and the ease of data collection. The morphine equivalent dose (MED) per day between both groups will be measured at 6 and 12?weeks. Pain intensity and pain interference with activities will also be evaluated at the same time points. Discussion:This study will provide evidence on the feasibility of a preventive program aimed at reducing chronic opioid use in high risk trauma patients. Information will also be gathered on the methods that should be used to test the efficacy of such programs. Trial registration:International Standard Randomized Controlled Trial Number (ISRCTN): 40263056. Registered 26 May 2018.

SUBMITTER: Berube M

PROVIDER: S-EPMC6511175 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Feasibility of a tapering opioids prescription program for trauma patients at high risk of chronic consumption (TOPP-trauma): protocol for a pilot randomized controlled trial.

Bérubé M M Deslauriers V V Leduc S S Turcotte V V Dupuis S S Roy I I Clairoux S S Panic S S Nolet M M

Pilot and feasibility studies 20190510

<h4>Background</h4>Opioid use disorder (OUD) and deaths related to the chronic use of opioids have increased significantly over the last two decades. Chronic consumption of opioids has been documented in many patients with traumatic injuries. Preliminary research findings have shown that interventions using cognitive-behavioral strategies were a promising adjunct in decreasing the burden associated with opioid consumption. Accordingly, the Tapering Opioids Prescription Program in Trauma (TOPP-Tr ...[more]

PMID: 31110776

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Project description:IntroductionOpioid medications are no longer recommended as long-term therapy for chronic non-cancer pain, and many patients are advised to reduce or discontinue opioid medications. Many patients report difficulties in tapering opioid medications, necessitating supporting interventions. This protocol describes a pilot randomised controlled trial (RCT) to investigate the acceptability, feasibility and potential efficacy of a mobile health intervention to improve the opioid tapering self-efficacy of patients with chronic non-cancer pain.Methods and analysisThe trial will be a single-blind (clinician, data collector and statistician-blinded) pilot RCT with two parallel arms. Forty adult patients with chronic non-cancer pain who are voluntarily reducing their prescribed opioid medications under medical guidance will be recruited from two tertiary pain clinics (Start date 25 August 2021). Participants will be randomly assigned to an intervention or control group. Both groups will receive usual care, including multidisciplinary pain management. In addition to usual care, the intervention group will receive a short informational and testimonial video about opioid tapering and will receive two specifically text messages per day for 28 days. The intervention is codesigned with patients and clinicians to provide evidence-based informational, motivational and emotional support to patients with chronic pain to taper opioid medications. Feasibility of the intervention and a future definitive RCT will be evaluated by measuring patient acceptability, delivery of the intervention, rates and reasons of exclusions and drop-outs, completion rates and missing data in the study questionnaires, and obtaining estimates for sample size determination. Potential efficacy will be evaluated by comparing changes in opioid tapering self-efficacy between the two groups.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 numberACTRN12621000795897.

Project description:ObjectiveOpioid consumption in China has been very less and has varied widely since 1995. The representatively high level of consumption in Mainland China has never been reported. Our aim was to describe the consumption trends and prescription patterns of opioids in Nanjing, a highly developed city of Mainland China, and compare the results with selected worldwide regions.MethodsApplication data of opioids in 2011-2016 were extracted from the Jiangsu Medicine Information Institute. Six opioids were included. Consumption was expressed in terms of defined daily doses (DDDs), morphine equivalents (MEs) and expenditure. The correlation between consumption of opioids and gross domestic product (GDP), Human Development Index (HDI) and cancer incidence was analysed by Pearson's correlation test.ResultsDDDs, expenditure and MEs of opioids were, respectively, 256.04, $599.24 and 13.07 g in 2011, and increased to 361.27, $1041.79 and 18.09 g in 2016. DDDs in Nanjing were 2.80-fold that in Mainland China, 1.42-fold that in East and South-East Asia, but only equivalent to 8.89% of the worldwide average level. From 2011 to 2016, the consumption had a linear correlation with GDP, HDI and cancer incidence (p<0.05). However, DDDs varied greatly in countries with similar GDP or HDI. Within 45 Asian countries, the GDP only contributed to 10.47% of change in DDDs, while the HDI contributed to 20.32%. Consumption of non-intravenous opioids or strong opioids always comprised majority of the total consumption. The opioids prescribed predominantly were fentanyl, oxycodone and morphine. Fentanyl and oxycodone account for most of the increase in consumption.ConclusionOpioid consumption has increased >40% from 2011 to 2016, with consumption of fentanyl and oxycodone accounting for most of that increase. The consumption in Nanjing was higher than the average Chinese level, but lower than the global average. An increase in pain control services might be needed, but this need should be highly regulated.

Project description:BackgroundSurgical site infections (SSI) represent a significant public health problem as the most common nosocomial infection and a leading cause of unplanned hospital readmissions among surgical patients. Many develop following hospital discharge and often go unrecognized by patients. Telemedicine offers the opportunity to leverage the mobile technology to remotely monitor wound recovery in the transitional period between hospital discharge and routine clinic follow-up. However, many existing telemedicine platforms are episodic, replacing routine follow-up, rather than equipped for continued monitoring; they include only low-risk patient populations and those who already have access to and comfort with the necessary technology; and transmit no visual information.ObjectiveDrawing upon the Coleman model for care transitions and the Proctor model for implementation, we propose a protocol of postoperative wound monitoring using smartphone digital images. In this study, we will establish the feasibility of such a program, both for patients and for the clinical care team.MethodsWe will recruit 40 patients or patient/caregiver pairs from our inpatient vascular surgery service. Eligible patients will be English-speaking, 18 years of age or older, and have an incision at least 3 cm in length. Participants will receive a training session, during which they will learn to use the device and the wound monitoring smartphone app. Following hospital discharge, they will submit digital images of their wound and responses to a survey about their recovery for 14 days. Experienced health care providers on the vascular surgery inpatient service will review transmitted data daily and contact patients for any concerning findings.ResultsPrimary outcomes will include participant adherence to the protocol, time required for providers to review submissions, time from submission to provider review, and participant satisfaction. Secondary outcomes will include SSI detection and hospital readmission.ConclusionsHealth systems are increasingly dedicating efforts to transitional care improvement programs. This feasibility trial will confirm whether patients and their caregivers can learn to use a postdischarge wound monitoring smartphone app and will assess patient and provider satisfaction. This protocol will provide preliminary evidence for a shift in the delivery of postdischarge care in a patient-centered and cost-effective manner.Trial registrationClinicaltrials.gov NCT02735525; https://clinicaltrials.gov/ct2/show/NCT02735525 (Archived by WebCite at http://www.webcitation.org/6oIvN4Mab).

Dataset Information

Feasibility of a tapering opioids prescription program for trauma patients at high risk of chronic consumption (TOPP-trauma): protocol for a pilot randomized controlled trial.

Publications

Feasibility of a tapering opioids prescription program for trauma patients at high risk of chronic consumption (TOPP-trauma): protocol for a pilot randomized controlled trial.

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