The Effect of a Life Care Specialist on Pain Management and Opioid-Related Outcomes Among Patients with Orthopaedic Trauma: Study Protocol for a Randomized Controlled Trial

Abstract Background:Orthopaedic trauma patients face complex pain management needs and are frequently prescribed opioids, leaving them at-risk for prolonged opioid use. To date, post-trauma pain management research has placed little emphasis on individualized risk assessments for misuse and systematically implementing non-pharmacologic pain management strategies. Therefore, a community-academic partnership was formed to design a novel position in the healthcare field (Life Care Specialist (LCS)), who will educate patients on the risks of opioids, tapering usage, safe disposal practices, and harm reduction strategies. In addition, the LCS teaches patients behavior-based strategies for pain management, utilizing well-described techniques for coping and resilience. This study aims to determine the effects of LCS intervention on opioid utilization, pain control, and patient satisfaction in the aftermath of orthopaedic trauma.Methods: In total, 200 orthopaedic trauma patients will be randomized to receive an intervention (LCS) or a standard-of-care control at an urban level 1 trauma center. All patients will be assessed with comprehensive social determinants of health and substance use surveys immediately after surgery (baseline). Follow-up assessments will be performed at 2-, 6-, and 12-weeks postoperatively, and will include pain medication utilization (morphine milligram equivalents), pain scores, and other substance use. In addition, overall patient wellness will be evaluated with objective actigraphy measures and patient-reported outcomes. Finally, a survey of patient understanding of risks of opioid use and misuse will be collected, to assess the influence of LCS opioid education.Discussion: There is limited data on the role of individualized, multimodal, non-pharmacologic, behavioral-based pain management intervention in opioid related risk-mitigation in high-risk populations, including the orthopaedic trauma patients. The findings from this randomized controlled trial will provide scientific and clinical evidence on the efficacy and feasibility of the LCS intervention. Moreover, the final aim will provide early evidence into which patients benefit most from LCS intervention. Trial registration: ClinicalTrials.gov NCT04154384. Registered on 11/6/2019 (last updated on 6/10/2021). https://clinicaltrials.gov/ct2/show/NCT04154384?term=life+care+specialist&draw=2&rank=1