Evaluation of the Communication Plan Early through End-of-Life (COMPLETE) Intervention

大多数癌症儿童（>60%）在生命结束时（EOL）经历疼痛和情感痛苦， 他们的父母会感到痛苦这些孩子没有参加临终关怀，有很高的徒劳率，高- 强化医疗干预（例如，ICU入院）。相比之下，大多数父母更喜欢一个家， 为孩子而死。有强有力的证据表明，在成年癌症患者中，临终关怀的登记可以减少疼痛 和情感痛苦，减少高强度的医疗干预，并减少照顾者的痛苦。在成年人中， 早期EOL讨论有助于延长临终关怀登记时间，这与更好的EOL护理评级相关 并且与患者偏好一致。与癌症儿童父母的早期EOL讨论 希望和情感支持，减少不确定性。然而，没有任何基于证据的干预措施， 促进早期临终关怀登记或减少晚期癌症儿童的疼痛和情感痛苦。的 长期目标是确定有效的干预措施，以提高儿童在终末期生活质量和减轻父母的痛苦。 该应用程序的总体目标是评估COMPLENT（沟通计划：早期 直到生命结束），由孩子的主要MD/RN二人组提供的一系列定制讨论，开始于 诊断，并整合视觉辅助工具，以同情地促进与父母关于预后的对话， 希望和目标的护理在癌症的连续性。核心假设是，竞争将促进 当治愈不现实时，提供者和父母之间的护理目标一致，导致早期临终关怀 招募，减少高强度医疗干预的使用，减少疼痛和情感痛苦， 孩子们在EOL和减少父母的痛苦。这些假设是基于申请人的试点研究 （NIHR 21; NR 011071 -02）：COMPLENT导致临终关怀招募增加（83%招募> 30天， 高强度医疗干预的使用率较低（17%对60%）。相比 基线，儿童的疼痛和情绪痛苦明显减少，父母的疼痛和情绪痛苦明显减少。 痛苦和不确定性以及更多的希望。该项目的基本原理是，如果竞争法有效， 迅速转化为临床实践，以支持早期临终关怀招募并改善儿童的结局 癌症患者和他们的父母在这项针对癌症儿童的多中心随机分组对照试验中， 预后< 25%的生存和他们的父母，我们的目的是确定疗效的COMPRESSION与注意 控制到：1.促进早期临终关怀登记（主要目的）; 2.减少高强度的医疗干预， 减少儿童在EOL时的疼痛和情感痛苦;以及，3.减少父母的痛苦和不确定性 改善希望。这项研究的创新包括使用肿瘤学MD/RN团队， 使用视觉辅助工具进行诊断和持续对话，帮助制定现实的护理目标，促进 临终关怀早期登记本研究的意义在于有望获得MD/RN的证据 团队需要在EOL时为儿童和家长带来更好的结果。

The majority of children with cancer (>60%) experience pain and emotional suffering at end of life (EOL) and their parents experience distress. These children are not enrolled in hospice and have high rates of futile, high- intensity medical interventions (e.g., ICU admission) at EOL. In contrast, most parents would prefer a home death for their child. There is strong evidence in adults with cancer that hospice enrollment results in less pain and emotional suffering, fewer high-intensity medical interventions, and reduced caregiver distress. In adults, early EOL discussions facilitate longer hospice enrollment which is associated with better ratings of EOL care and is congruent with patient preferences. Early EOL discussions with parents of children with cancer fosters hope and emotional support and reduces uncertainty. However, no evidence-based interventions exist that foster early hospice enrollment or reduce the pain and emotional suffering in children with terminal cancer. The long-term goal is to identify effective interventions to improve child QOL at EOL and lessen parents’ distress. The overall objective of this application is to evaluate the efficacy of COMPLETE (Communication Plan: Early through End of Life), a series of tailored discussions delivered by the child’s primary MD/RN dyad, that begin at diagnosis, and integrates visual aids, to empathically facilitate conversations with parents about prognosis, hopes, and goals-of-care across the cancer continuum. The central hypothesis is that COMPLETE will foster alignment of goals of care between providers and parents when cure is unrealistic, leading to earlier hospice enrollment, reduced use of high-intensity medical interventions, and less pain and emotional suffering in children at EOL and less distress in parents. The hypotheses are based on the applicants’ pilot studies (NIHR21; NR011071-02): COMPLETE resulted in increased hospice enrollment (83% enrolled > 30 days vs 40% nationally), and lower use of high-intensity medical interventions (17% vs 60% nationally). Compared to baseline, children had significantly less pain and emotional suffering, and parents had significantly lower distress and uncertainty and more hope. The project rationale is that, if COMPLETE is efficacious, it can be rapidly translated into clinical practice to support earlier hospice enrollment and improve outcomes of children with cancer and their parents at EOL. In this multisite cluster-randomized controlled trial of children with cancer prognosis of < 25% survival and their parents, we aim to determine the efficacy of COMPLETE vs. Attention control to: 1. Foster earlier hospice enrollment (Primary Aim); 2. Decrease high- intensity medical interventions, decrease pain and emotional suffering in children at EOL; and, 3. Reduce parental distress and uncertainty and improve hope. The study innovations include using the oncology MD/RN team to engage parents from diagnosis and ongoing conversations using visual aids to help establish realistic goals of care that promote earlier hospice enrollment at EOL. The study significance is that it is expected to yield the evidence MD/RN teams need to promote better outcomes for children and parents at EOL.