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

开发一种工具来支持青少年、家长和临床医生之间脑震荡后的共同决策

• 批准号: 9977466
• 负责人: Emily Grace Kroshus
• 金额: $ 24.02万
• 依托单位: SEATTLE CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9977466
• 关键词: Acute; Address; Adolescent; Age; Behavioral; Benefits and Risks; Brain Concussion; Caring; Clinical; Clinical Trials; Communication; Consensus; Data; Decision Aid; Decision Making; Development; Diagnosis; Equipoise; Family; Foundations; Future; Guidelines; Health; Health Personnel; Impairment; Influentials; Injury; Institute of Medicine (U.S.); Interview; Manufactured football; Medical; Methods; Minority; Modeling; Modification; Nature; Neurologic; Online Systems; Outcome; Parents; Participant; Patients; Pediatric Hospitals; Phase; Physical activity; Play; Post-Concussion Syndrome; Process; Prospective cohort; Randomized Controlled Trials; Readiness; Recording of previous events; Recovery; Regrets; Reporting; Resolution; Retirement; Risk; Role; Sampling; Severities; Site; Soccer; Social Functioning; Sports; Target Populations; Testing; Triad Acrylic Resin; Uncertain Risk; Visit; Youth; base; concussive symptom; design; effectiveness evaluation; efficacy evaluation; efficacy testing; experience; functional disability; head impact; health literacy; improved; meetings; preadolescence; primary outcome; psychosocial; return to sport; risk sharing; shared decision making; tool; usability; youth sports

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

项目摘要 每年，超过一百万的美国青年运动参与者被诊断出接受咨询。 急性脑震荡症状已经解决后，临床医生经常在讨论返回的方式上挣扎 与家人一起运动。停止运动的决定非常个性化，不能简化为一个 数字截止。该决定中的影响因素包括临床变异性（例如，损伤严重程度，恢复 受伤后的轨迹，功能障碍的类型，先前受伤之间的间隔，受伤的年龄 发生了，病前健康状况），对不确定危害风险的不同家庭容忍 相对于他们认为重返运动的好处的额外咨询，风险 替代活动的好处，以及体育退休的心理社会准备就绪。进一步使它复杂化 对话是缺乏关于接触运动潜在长期风险和 随后在青年中进行咨询，风险增加。解决这些挑战，我们寻求 制定和评估一种决策援助，以帮助青少年及其父母/监护人与临床医生 在脑后做出有关体育参与的知情和价值驱动的决定。我们将重点关注 在两种情况下帮助共享决策：（1）临床认为这项决定有平气 关于是返回还是停止参与联系/碰撞运动，以及（2）临床认为 接触/碰撞运动戒烟在医学上是有益的，但体育取消资格并不是强制性的 根据当前的共识准则。这将通过（1）一个基于网络的模块完成 由父母和青少年进行访问，共享风险信息并支持价值澄清 与体育参与有关，以及（2）对临床医生的实施支持，以促进参观讨论， 优先级和决策。为了制定最佳有用的决策援助，我们将与一个多元化的团体互动 在开发过程中的家庭和临床医生的工作 健康素养。这将解决以下目标：（1）制定决定援助以支持共享 使用用户参与内容的过程，关于体育参与的决策 规格和设计； （2）在临床环境中对决策援助进行可用性测试； （3）进行飞行员 测试该决策效率的效率 用于脑后护理。试点临床试验的主要结果将是决策的。次要 该工具对运动参与，体育锻炼和社会心理成果的影响三个月后 - 决定将被探讨。实现拟议的目标将导致决策辅助 目标人群，并具有其有效性的初步证据，从而有助于更高质量的决策 脑后。这将为随后的R01申请提供基础，以评估 该工具在多中心群集随机对照试验中的有效性。 1