Pediatric Heart Tranplantation: Transitioning to Adult Care

描述（由申请人提供）： 这项拟议的试点试验，过渡到成人护理（TRANSIT）的目的是开发和测试一种干预措施（即，一个标准化的、量身定制的过渡计划，重点是提高依从性），以改善儿童时期接受心脏移植并过渡到成人护理的新兴成人的结局。在过去的十年中，儿科心脏移植的数量和存活率都在缓慢增加。随着生存率的提高，越来越多的儿科心脏移植受者进入青年期并过渡到成人护理。过渡到成人护理通常发生在青春期后期和成年早期，这是一个脆弱的时期，其特征是判断力和决策能力差，冒险行为和情绪反应。“成年初显期”一词用于18-25岁这一时期，因为认识到成熟仍在发生，仍需要实现许多里程碑。令人震惊的是，文献表明，这些新兴的成年人没有得到必要的服务，成功地从儿科过渡到成人护理设施。实体器官移植新兴的成年人谁已经从儿科转移到成人中心的护理经历了不良的结果，降低了对医疗方案的依从性，导致意外的移植物丢失。鉴于过渡相关护理的缺乏以及从儿科过渡到成人护理后移植后结果不佳的风险，需要对最佳实践和结果分析进行研究。这项拟议研究的目的是（1）评估TRANSIT的可行性（随机分配至干预组的患者的过渡计划依从性和所有参与者的调查完成情况），TRANSIT是一项为期3个月的干预，重点是增加心脏移植知识、自我管理和自我宣传技能，并增强社会支持;（2）确定TRANSIT对患者水平结局的疗效（即，免疫抑制剂血液水平和目标范围内的水平的变化、对药物治疗方案的依从性的自我报告以及治疗的急性排斥的发作）和卫生保健资源的使用。我们将使用治疗依从性影响模型来了解我们的依从性增强干预对结局的影响。我们的干预将使用基于计算机的教育模块，并进行相关的自我测试，然后由移植协调员进行面对面的讨论和连续的电话随访。这些数据将为扩展的多中心随机对照试验的开发提供信息。我们的干预可能为其他新兴成年人群体提供一种过渡性护理模式（例如，先天性心脏病患者和其他实体器官移植）。

DESCRIPTION (provided by applicant): The purpose of this proposed pilot trial, Transitioning to Adult Care (TRANSIT), is to develop and test an intervention (i.e., a standardized, tailored transition program focused on enhancing adherence) to improve outcomes for emerging adults who underwent heart transplantation as children and transition to adult care. During the last decade, both pediatric heart transplant volume and survival rates have slowly increased. With better survival, more pediatric heart transplant recipients are entering young adulthood and transitioning to adult care. Transition to adult care typically occurs during late adolescence and early adulthood, a time of vulnerability, characterized by poor judgment and decision-making, risk-taking behaviors, and emotional reactivity. The term "emerging adulthood" has been used for this period between the ages of 18-25, recognizing that maturation is still occurring and many milestones still need to be achieved. Alarmingly, the literature has demonstrated that these emerging adults have not received the services necessary to successfully transition from pediatric to adult care facilities. Solid organ transplant emerging adults who have transferred care from pediatric to adult centers have experienced poor outcomes related to decreased adherence to the medical regimen, leading to unanticipated graft loss. Given the paucity of transition-related care and the risk for poor post transplant outcomes after transition from pediatric to adult care, research on best practices and outcomes analysis is needed. The aims of this proposed study are to (1) assess the feasibility (transition program adherence for those randomized to the intervention and survey completion for all participants) of TRANSIT, a 3 month long intervention, focusing on increasing heart transplant knowledge, self-management and self advocacy skills, and enhancing social support; and (2) determine the efficacy of TRANSIT on patient-level outcomes (i.e., variability of immunosuppressant blood levels and levels within target range, self-report of adherence to the medical regimen, and episodes of treated acute rejection) and use of health care resources. We will use the Treatment Adherence Impact model for understanding the impact of our adherence enhancing intervention on outcomes. Our intervention will use computer-based education modules with associated self-tests followed by face-to-face discussion and serial telephone follow-up by transplant coordinators. These data will inform development of an expanded multi-site randomized controlled trial. Our intervention may provide a model of transitional care for other populations of emerging adults (e.g., patients with congenital heart disease and transplantation of other solid organs).