Developing a tool to support shared decision making post-concussion between adolescents, parents and clinicians

项目总结 每年有100多万6岁至18岁的美国青少年运动参与者被诊断出脑震荡。 在急性脑震荡后症状缓解后，临床医生经常纠结于如何讨论恢复到 和家人一起运动。停止运动的决定是非常个人化的，不能简化为一个单一的决定 数字截止值。这一决定的影响因素包括临床变异性(例如，损伤严重程度、恢复情况 轨迹、损伤后功能损害的类型、先前损伤之间的间隔、损伤的年龄 发生和发病前的健康状况)，不同的家庭对不确定的伤害风险的容忍度相关 与他们所认为的重返运动的好处相比，由于持续额外的脑震荡，风险 和替补活动的好处，以及对运动退役的心理社会准备。使情况进一步复杂化 对话是缺乏关于接触性运动的潜在长期风险的确凿证据 年轻人随后发生脑震荡的风险逐渐增加。应对这些挑战，我们寻求 开发和评估帮助青少年和他们的父母/监护人与临床医生进行决策的辅助工具 对脑震荡后的运动参与做出明智和价值驱动的决定。我们将重点关注 在两种情况下帮助共享决策：(1)临床医生认为决策是均衡的 关于是否重新参加接触/碰撞运动，以及(2)临床医生认为 停止接触/碰撞运动在医学上是有益的，但运动取消资格并不是强制性的 根据目前的共识指导方针。这将通过(1)完成一个基于Web的模块来完成 分别由家长和青少年预访，分享风险信息和支持价值观澄清 与运动参与有关，以及(2)为临床医生提供实施支持，以促进访问中的讨论， 确定优先顺序和制定决策。为了开发最有用的决策辅助工具，我们将让不同的群体参与进来 正在开发过程中的家庭和临床医生，并将重点满足低收入家庭的需求 健康素养。因此，将解决以下目标：(1)开发支持共享的决策辅助 基于用户参与内容过程的脑震荡后运动参与决策研究 规范和设计；(2)在临床环境中进行决策辅助工具的可用性测试；(3)进行试点 在西雅图儿童医院就诊的不同家庭样本中测试该决策辅助工具的有效性 用于脑震荡后的护理。试点临床试验的主要结果将是做出决定的后悔。其次， 3个月后该工具对运动参与、体力活动和心理社会结果的影响 我们将探讨如何做出决定。实现提议的目标将产生一个为 目标人群，并有初步证据表明其有助于更高质量的决策 脑震荡后。这将为后续的R01应用程序评估 该工具在多中心整群随机对照试验中的有效性。 1

PROJECT SUMMARY Every year, more than one million U.S. youth sport participants ages 6 to 18 are diagnosed with a concussion. After acute post-concussive symptoms have resolved, clinicians often struggle with how to discuss returning to sport with families. The decision to cease sport is very individualized and cannot be reduced to a single numeric cut-off. Influential factors in this decision include clinical variability (e.g., injury severity, recovery trajectory, type of functional impairment post-injury, the interval between prior injuries, the age at which injuries occurred, and premorbid health conditions), different family tolerance for the uncertain risk of harm associated with sustaining an additional concussion relative to what they see as the benefits of returning to sport, the risks and benefits of substitute activities, and psychosocial readiness for sport retirement. Further complicating this conversation is the lack of definitive evidence about about the potential long-term risks of contact sport and the incremental increase in risk with subsequent concussions among youth. Addressing these challenges, we seek to develop and evaluate a decision aid that helps adolescents and their parents/guardians with their clinician make an informed and value-driven decision about sport participation post-concussion. We will focus on helping shared decision making in two situations: (1) the clinician believes there is equipoise in the decision about whether to return to or cease participation in contact/collision sport, and (2) the clinician believes contact/collision sport cessation would be medically beneficial but sport disqualification is not mandatory based on current consensus guidelines. This will be accomplished with a (1) a web-based module to be completed separately by parents and adolescents pre-visit, sharing risk information and supporting values clarification related to sport participation, and (2) implementation support for clinicians to facilitate within -visit discussion, prioritization and decision-making. To develop an optimally useful decision aid, we will engage a diverse group of families and clinicians in the development process and will focus on meeting the needs of families with low health literacy. Thus, the following aims will be addressed: (1) Develop a decision aid to support shared decision-making about sport participation post-concussion using a process of user-engaged content specification and design; (2) Conduct usability testing of the decision aid in a clinical setting; (3) Conduct a pilot test of the efficacy of this decision aid in a diverse sample of families presenting to Seattle Children’s Hospital for post-concussion care. The primary outcome of the pilot clinical trial will be decisional regret. Secondarily, the impact of the tool on sport participation, physical activity and psychosocial outcomes three months post- decision will be explored. Achieving the proposed aims will result in a decision aid that is acceptable to the target populations and that has preliminary evidence of its efficacy facilitating higher quality decision making post-concussion. This will provide the foundation for a subsequent R01 application to evaluate the effectiveness of the tool in a multicenter cluster randomized controlled trial. 1