Collaborative care model for treatment of persistent symptoms after concussion among youth (CARE4PCS-II): Study protocol for a randomized, controlled trial
Collaborative care model for treatment of persistent symptoms after concussion among youth (CARE4PCS-II): Study protocol for a randomized, controlled trial
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DOI：
10.1186/s13063-019-3662-3
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发表时间：
2019-09-18
期刊：
影响因子：
2.5
通讯作者：
Rivara, Frederick P.
中科院分区：
文献类型：
--
作者：
McCarty, Carolyn A.;Zatzick, Douglas;Rivara, Frederick P.
背景 目前，指导针对遭受脑震荡并随后出现持续性脑震荡后症状 (PCS) 的青少年的干预和服务提供协调的证据有限（Lumba-Brown 等人 JAMA Pediatr 172(11):e182853, 2018；Lumba-Brown A 等人 JAMA Pediatr 172(11):e182847, 2018）。我们开发了一种协作护理干预措施，包括嵌入式认知行为疗法、护理管理和加强精神药物咨询，以解决持续性 PCS 和相关心理合并症。 CARE4PCS-II 研究旨在评估与常规护理（对照）条件相比，在运动相关脑震荡后出现持续症状的青少年在接受这种协作护理干预时是否会表现出更好的结果。方法/设计 这项调查是一项接受干预（协作护理）或对照（常规护理）的随机比较有效性试验。 200 名 11-18 岁的运动损伤男性和女性青少年将被随机招募并随机加入研究，这些青少年有 3 种或以上脑震荡后症状，且在受伤后持续至少 1 个月但不超过 9 个月。该试验的重点是在基线后 3、6 和 12 个月测量干预措施对脑震荡后、抑郁和焦虑症状的影响。讨论 CARE4PCS II 研究是一项大型比较有效性试验，旨在改善运动损伤青少年脑震荡后的症状。该研究的独特之处在于将协作护理模式广泛应用于初级保健、运动医学和学校环境。该调查纳入了新颖的元素，例如通过 HIPAA 投诉视频会议技术提供 CBT，如果有效性得到证明，则具有极好的广泛传播潜力。
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.