Emory University, Nell Hodgson Woodruff School of Nursing, 1520 Clifton Road, Atlanta, GA, 30322, USA.
Emory University Orthopaedic Surgery, Grady Memorial Hospital, 80 Jesse Hill Jr Drive SE, Atlanta, GA, 30303, USA.
Trials. 2021 Nov 27;22(1):858. doi: 10.1186/s13063-021-05841-1.
Orthopedic 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 orthopedic trauma.
In total, 200 orthopedic 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.
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 orthopedic 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.
ClinicalTrials.gov NCT04154384 . Registered on 11/6/2019 (last updated on 6/10/2021).
骨科创伤患者面临着复杂的疼痛管理需求，经常被开具阿片类药物，使他们面临长期使用阿片类药物的风险。迄今为止，创伤后疼痛管理研究对误用的个体化风险评估和系统实施非药物性疼痛管理策略重视不够。因此，成立了一个医疗机构-学术机构合作伙伴关系，旨在医疗保健领域设立一个新的职位（生活护理专家（LCS）），该专家将向患者传授阿片类药物的风险、逐渐减少使用、安全处置实践和减少伤害策略。此外，LCS 还教授患者基于行为的疼痛管理策略，利用应对和适应能力的描述性技术。本研究旨在确定 LCS 干预对骨科创伤后阿片类药物使用、疼痛控制和患者满意度的影响。
共有 200 名骨科创伤患者将被随机分配接受干预（LCS）或在城市一级创伤中心接受标准护理对照。所有患者将在手术后立即接受全面的社会决定因素和物质使用调查（基线）。术后 2、6 和 12 周将进行随访评估，包括疼痛药物使用（吗啡毫克当量）、疼痛评分和其他物质使用。此外，还将通过客观活动记录仪测量和患者报告的结果评估患者整体健康状况。最后，将收集患者对阿片类药物使用和误用风险的理解的调查，以评估 LCS 阿片类药物教育的影响。
在高风险人群（包括骨科创伤患者）中，个体化、多模式、非药物性、基于行为的疼痛管理干预在减轻阿片类药物相关风险方面的作用数据有限。这项随机对照试验的结果将为 LCS 干预的疗效和可行性提供科学和临床证据。此外，最终目标将提供早期证据，说明哪些患者最受益于 LCS 干预。
ClinicalTrials.gov NCT04154384。注册于 2019 年 11 月 6 日（最后更新于 2021 年 6 月 10 日）。
