Department of Emergency Medicine, University of North Carolina at Chapel Hill, Houpt Bldg, 170 Manning Dr, Chapel Hill, NC, 27599, USA.
Department of Anesthesiology, University of North Carolina Hospitals, Chapel Hill, NC, USA.
Trials. 2020 Jul 6;21(1):615. doi: 10.1186/s13063-020-04552-3.
Chronic musculoskeletal pain (MSP) affects more than 40% of adults aged 50 years and older and is the leading cause of disability in the USA. Older adults with chronic MSP are at risk for analgesic-related side effects, long-term opioid use, and functional decline. Recognizing the burden of chronic MSP, reducing the transition from acute to chronic pain is a public health priority. In this paper, we report the protocol for the Brief EducaTional Tool to Enhance Recovery (BETTER) trial. This trial compares two versions of an intervention to usual care for preventing the transition from acute to chronic MSP among older adults in the emergency department (ED).
Three hundred sixty patients from the ED will be randomized to one of three arms: full intervention (an interactive educational video about pain medications and recovery-promoting behaviors, a telecare phone call from a nurse 48 to 72 h after discharge from the ED, and an electronic communication containing clinical information to the patient's primary care provider); video-only intervention (the interactive educational video but no telecare or primary care provider communication); or usual care. Data collection will occur at baseline and at 1 week and 1, 3, 6, and 12 months after study enrollment. The primary outcome is a composite measure of pain severity and interference. Secondary outcomes include physical function, overall health, opioid use, healthcare utilization, and an assessment of the economic value of the intervention.
This trial is the first patient-facing ED-based intervention aimed at helping older adults to better manage their MSP and reduce their risk of developing chronic pain. If effective, future studies will examine the effectiveness of implementation strategies.
ClinicalTrials.gov NCT04118595 . Registered on 8 October 2019.
慢性肌肉骨骼疼痛(MSP)影响超过 40%的 50 岁及以上成年人,是美国残疾的主要原因。患有慢性 MSP 的老年人有出现阿片类药物相关副作用、长期使用阿片类药物和功能下降的风险。鉴于慢性 MSP 的负担,减少从急性疼痛向慢性疼痛的转变是公共卫生的重点。在本文中,我们报告了简短教育工具增强康复(BETTER)试验的方案。该试验比较了两种干预措施与常规护理在急诊科(ED)中预防老年人从急性疼痛向慢性 MSP 转变的效果。
将 360 名 ED 患者随机分为三组:全面干预组(一个关于疼痛药物和促进恢复行为的互动教育视频,ED 出院后 48 至 72 小时的护士电话随访,以及包含临床信息的电子通讯给患者的初级保健提供者);视频干预组(互动教育视频,但无电话随访或初级保健提供者沟通);或常规护理。数据收集将在基线和研究入组后 1 周和 1、3、6 和 12 个月进行。主要结局是疼痛严重程度和干扰的综合指标。次要结局包括身体功能、总体健康、阿片类药物使用、医疗保健利用以及干预的经济价值评估。
该试验是首个针对急诊科患者的基于患者的干预措施,旨在帮助老年人更好地管理他们的 MSP,并降低他们发展慢性疼痛的风险。如果有效,未来的研究将检查实施策略的有效性。
ClinicalTrials.gov NCT04118595,于 2019 年 10 月 8 日注册。