青少年脑震荡后持续性症状治疗的协作护理模式（CARE4PCS-II）：一项随机对照试验的研究方案。
Collaborative care model for treatment of persistent symptoms after concussion among youth (CARE4PCS-II): Study protocol for a randomized, controlled trial.
机构信息
Seattle Children's Research Institute, P.O. Box 5371, M/S: CW8-5, Seattle, WA, 98145-5005, USA.
Department of Pediatrics, University of Washington, Seattle, USA.
出版信息
Trials. 2019 Sep 18;20(1):567. doi: 10.1186/s13063-019-3662-3.
BACKGROUND
Currently, there is limited evidence to guide intervention and service delivery coordination for youth who suffer a concussion and subsequently experience persistent post-concussive symptoms (PCS) (Lumba-Brown et al. JAMA Pediatr 172(11):e182853, 2018; Lumba-Brown A et al. JAMA Pediatr 172(11):e182847, 2018). We have developed a collaborative care intervention with embedded cognitive-behavioral therapy, care management, and stepped-up psychotropic medication consultation to address persistent PCS and related psychological comorbidities. The CARE4PCS-II study was designed to assess whether adolescents with persistent symptoms after sports-related concussion will demonstrate better outcomes when receiving this collaborative care intervention compared to a usual care (control) condition.
METHODS/DESIGN: This investigation is a randomized comparative effectiveness trial to receive intervention (collaborative care) or control (usual care). Two hundred sports-injured male and female adolescents aged 11-18 years with three or more post-concussive symptoms that persist for at least 1 month but less than 9 months after injury will be recruited and randomized into the study. The trial focuses on the effects of the intervention on post-concussive, depressive, and anxiety symptoms measured 3, 6, and 12 months after baseline.
DISCUSSION
The CARE4PCS II study is a large comparative effectiveness trial targeting symptomatic improvements in sports injured adolescents after concussion. The study is unique in its adaptation of the collaborative care model to a broad spectrum of primary care, sports medicine, and school settings. The investigation incorporates novel elements such as the delivery of CBT through HIPAA complaint video conferenceing technology and has excellent widespread dissemination potential should effectiveness be demonstrated.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03034720 . Registered on January 27, 2017.
背景
目前，针对遭受脑震荡后持续出现脑震荡后症状（PCS）的青少年，干预和服务提供协调的证据有限（Lumba-Brown 等人，JAMA Pediatr 172(11):e182853，2018 年；Lumba-Brown 等人，JAMA Pediatr 172(11):e182847，2018 年）。我们已经开发了一种协作式护理干预措施，其中嵌入了认知行为疗法、护理管理和增加精神药物咨询，以解决持续的 PCS 和相关的心理合并症。CARE4PCS-II 研究旨在评估患有运动相关性脑震荡后持续症状的青少年在接受这种协作式护理干预与常规护理（对照组）条件相比是否会表现出更好的结果。
方法/设计：这是一项随机对照效果试验，接受干预（协作护理）或对照（常规护理）。将招募并随机分配 200 名年龄在 11-18 岁的运动受伤的男性和女性青少年到研究中，他们在受伤后至少 1 个月但不到 9 个月有三个或更多的脑震荡后症状持续存在。该试验重点关注干预措施对脑震荡后、抑郁和焦虑症状的影响，分别在基线后 3、6 和 12 个月进行测量。
讨论
CARE4PCS II 研究是一项针对运动受伤后青少年脑震荡症状改善的大型对照效果试验。该研究的独特之处在于将协作式护理模式适应于广泛的初级保健、运动医学和学校环境。该研究采用了通过 HIPAA 合规的视频会议技术提供 CBT 等新颖元素，并具有良好的广泛传播潜力，如果证明有效。
试验注册
ClinicalTrials.gov，NCT03034720。于 2017 年 1 月 27 日注册。
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