Feasibility of a tapering opioids prescription program for trauma patients at high risk of chronic consumption (TOPPtrauma): 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.