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

项目摘要 每年，超过100万6至18岁的美国青少年体育参与者被诊断患有脑震荡。 在急性脑震荡后症状得到解决后，临床医生经常会纠结于如何讨论如何恢复 体育与家庭停止体育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。该决定中的影响因素包括临床变异性（例如，损伤严重度，恢复 轨迹，损伤后功能障碍的类型，先前损伤之间的间隔，损伤发生的年龄 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耐受性相关 相对于他们所认为的重返体育运动的好处， 和替代活动的好处，以及体育退役的心理准备。使这一问题更加复杂 谈话是缺乏关于接触性运动的潜在长期风险的确切证据， 年轻人脑震荡风险增加。为了应对这些挑战，我们寻求 开发和评估决策辅助工具，帮助青少年及其父母/监护人与他们的临床医生 对脑震荡后的体育参与做出明智和价值驱动的决定。我们将专注于 在两种情况下帮助共同决策：（1）临床医生认为决策中存在平衡 关于是否返回或停止参与接触/碰撞运动，以及（2）临床医生认为 接触/碰撞运动停止在医学上是有益的，但运动取消资格不是强制性的， 目前的共识指导方针。这将通过（1）完成一个基于网络的模块来完成 分别由家长和青少年进行预访，分享风险信息，并对支持价值观进行澄清 与体育参与有关，以及（2）为临床医生提供实施支持，以促进访视期间的讨论， 优先次序和决策。为了开发一个最有用的决策辅助工具，我们将邀请一个多元化的团队， 家庭和临床医生在发展过程中，并将重点满足低收入家庭的需要， 健康素养。因此，以下目标将被解决：（1）开发一个决策辅助工具，以支持共享 使用用户参与内容的过程做出关于脑震荡后运动参与的决策 规范和设计;（2）在临床环境中进行决策辅助的可用性测试;（3）进行试点 在前往西雅图儿童医院就诊的不同家庭样本中测试这种决策辅助的功效 脑震荡后的护理初步临床试验的主要结果将是决策后悔。其次， 三个月后，该工具对体育参与、身体活动和心理社会结果的影响， 决定将进行探讨。实现拟议的目标将导致决策援助，是可以接受的， 目标人群，并有初步证据表明其有效性，促进更高质量的决策 脑震荡后这将为随后的R 01应用程序提供基础，以评估 多中心随机对照试验中工具的有效性。 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