Active Injury Management (AIM) after Pediatric Concussion

项目摘要 脑震荡每年影响近200万儿童。这些患者中高达30%会出现症状 在受伤后持续数周至数月。目前的做法建议在脑震荡后严格休息24-48小时 然后在机器人的引导下恢复活动。新的证据表明，长时间的休息可能是有害的， 导致失调，阻碍大脑的新生愈合能力，和/或建立心理 复苏的障碍。我们最近发表了一项严格休息的随机对照试验（RCT）的结果， 急性脑震荡，发现那些被规定长时间休息的患者症状更严重， 恢复较慢。我们还发现，如果患者表现为术后， 脑震荡-只有在没有更严重的损伤迹象的情况下。据报道，锻炼有助于大脑 恢复和改善患者的症状，延长恢复。证据还表明， 患者在30天时持续性脑震荡后症状的发生率较低。的目的 建议是确定规定的低强度体力活动，行为管理，或两者兼而有之的好处， 与急诊科（艾德）急性脑震荡患者的标准休息相比。我们提出了一个 探索性II期临床试验，包括4个治疗组，以确定活动性损伤的影响 管理战略和并行的质量改进（QI）计划。本研究旨在：1）确定理想的 与活动和行为管理相关的出院建议，以及2）制定和实施 基于证据的决策支持脑震荡诊断，系列症状评估，并返回学习 指令在临床试验中，共有388名11-18岁的患者在48小时内到艾德就诊， 将在三年内从两个地点招募脑震荡患者参加脑震荡管理的随机对照试验。 将接受治疗的患者随机分配至四个治疗组之一：1）REST-规定休息24-48小时， 返回学校，并在耐受后尽快进行轻度身体和认知活动; 2）活动规定的活动 “受伤后第一周每天走10，000步”。3)mHEALTH APP-使用免费的“弹性”应用程序。4） ACTIVITY + mHEALTH应用程序。主要结局将是第14天的症状和恢复。次级 结果将包括活动水平（通过活动记录仪），每日症状（通过应用程序），3天症状（通过电话）， 第14天（随访时）的神经认知、前庭/眼运动和平衡障碍，以及儿童的 生活测量、症状消退时间以及1个月和2个月时恢复正常活动的时间（通过电话）。我们将 开展QI计划，以提高艾德患者护理的有效性和以患者为中心， 脑震荡：1）提高艾德评估的质量; 2）改善出院流程; 3）确保 适当的后续行动;和，3）为他们提供一个工具，使他们能够自我管理脑震荡， 门诊病人这一建议有可能将最初在艾德接受评估的患者的模式从休息转变为 积极管理，并证明临床医生在改善脑震荡结果方面的影响。

PROJECT SUMMARY Concussion impacts nearly 2 million children each year. Up to 30% of these patients will experience symptoms lasting weeks to months after injury. Current practice recommends strict rest for 24-48 hours post-concussion followed by a symptom-guided return to activity. Emerging evidence shows prolonged rest may be harmful by contributing to deconditioning, impeding the brain's nascent ability to heal, and/or setting up psychological barriers to recovery. We recently published results from a randomized controlled trial (RCT) of strict rest following acute concussion and found patients who were prescribed prolonged rest experienced greater symptoms and slower recovery. We also found that this negative effect was more pronounced if patients presented with post- concussive symptoms-only in the absence of more severe signs of injury. Exercise has been reported to aid brain recovery and improve symptoms in patients with prolonged recovery. Evidence also shows that early activity in patients is associated with lower rates of persistent post-concussive symptoms at 30 days. The objective of this proposal is to determine the benefit of prescribed low-intensity physical activity, behavioral management, or both, versus standard rest in acute concussion patients presenting to the Emergency Department (ED). We propose an exploratory phase II clinical trial with four treatment groups to determine the impact of an active injury management strategy and a parallel quality improvement (QI) initiative. This study aims to 1) determine the ideal discharge recommendations related to activity and behavioral management, and 2) develop and implement evidence-based decision support for concussion diagnosis, serial symptom assessment, and return to learn instructions. For the clinical trial, a total of 388 patients age 11-18 y/o presenting to the ED within 48 hours of a concussion will be recruited from two sites over three years to participate in a RCT of concussion management. Consented patients will be randomized to one of four treatment groups: 1) REST- prescribed rest for 24-48 hr with return to school and light physical and cognitive activity as soon as tolerated; 2) ACTIVITY-prescribed activity “10,000 steps per day by the first week post injury”. 3) mHEALTH APP- use of a free “resilience” app. 4) ACTIVITY + mHEALTH app. The primary outcomes will be symptoms and recovery at 14 days. The secondary outcomes will include activity levels (via actigraph), daily symptoms (via app), symptoms at 3 days (via phone), neurocognitive, vestibular/ocular motor, and balance impairment at 14 day (at follow-up), and pediatric quality of life measures, time to symptom resolution and return to normal activity at 1 and 2 months (via phone). We will conduct a QI initiative to improve the effectiveness and patient-centeredness of the care of patients in the ED with concussion by: 1) improving the quality of ED assessments; 2) improving the discharge process; 3) ensuring appropriate follow-up; and, 3) providing them with a tool to allow for the self-management of concussion as an outpatient. This proposal has potential to shift the paradigm for patients initially evaluated in the ED from rest to active management and demonstrate the impact clinicians can have in improving concussion outcomes.