Active Injury Management (AIM) after Pediatric Concussion

项目总结 脑震荡每年影响近200万儿童。其中高达30%的患者会出现症状 受伤后持续数周至数月。目前的做法建议脑震荡后严格休息24-48小时 然后在症状引导下恢复活动。新出现的证据表明，长时间休息可能会对身体健康有害 有助于解除条件，阻碍大脑新生的康复能力，和/或建立心理 复苏的障碍。我们最近发表了一项严格跟踪休息的随机对照试验(RCT)的结果 急性脑震荡，发现长期休息的患者出现更严重的症状和 复苏速度较慢。我们还发现，如果患者出现术后症状，这种负面影响会更加明显。 脑震荡症状--只有在没有更严重的受伤迹象的情况下。据报道，锻炼有助于大脑 对恢复时间较长的患者进行康复并改善症状。证据还表明，早期的活动在 患者在30天内持续性脑震荡后症状的发生率较低。这样做的目的是 提案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益处， 与急诊科(ED)的急性脑震荡患者的标准休息相比。我们提出了一个 包括四个治疗组的探索性II期临床试验，以确定活动损伤的影响 管理战略和并行的质量改进(QI)倡议。这项研究的目的是1)确定理想 履行与活动和行为管理相关的建议，以及2)制定和实施 脑震荡诊断、系列症状评估和回归学习的循证决策支持 指示。在临床试验中，共有388名年龄在11-18岁之间的患者在发病后48小时内到急诊室就诊。 脑震荡将在三年内从两个地点招募，参加脑震荡治疗的随机对照试验。 同意的患者将被随机分为四个治疗组之一：1)规定休息24-48小时， 尽快回到学校，并尽快减少身体和认知活动；2)活动-规定的活动 “受伤后第一周每天走10,000步”。3)mHealth应用程序--使用免费的“弹性”应用程序。4) Activity+mHealth应用程序。主要结果将是14天后出现症状和恢复。第二个 结果将包括活动水平(通过Actigraph)、日常症状(通过APP)、3天的症状(通过电话)、 14天(随访时)的神经认知、前庭/眼睛运动和平衡障碍，以及儿童的质量 生活测量，症状缓解的时间和在1个月和2个月时恢复正常活动(通过电话)。我们会 推行质素改善措施，以提高急症室病人的护理成效和以病人为本。 脑震荡：1)提高急救评估质量；2)改进出院流程；3)确保 适当的后续行动；以及，3)为他们提供一个工具，使他们能够自我管理脑震荡作为 门诊部。这一建议有可能将急诊室最初评估的患者的范式从REST转变为 积极治疗，并展示临床医生在改善脑震荡预后方面的影响。

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.