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

大多数患有癌症的儿童(60%)在生命末期(EOL)和 他们的父母经历了痛苦。这些儿童没有登记在临终关怀中心，并且有很高的无效率，高- EOL的强化医疗干预(例如，ICU入院)。相比之下，大多数父母更希望有个家 为他们的孩子送命。有强有力的证据表明，成年癌症患者参加临终关怀可以减轻疼痛。 和情感痛苦，更少的高强度医疗干预，以及减少照顾者的痛苦。在成年人中， 早期的EOL讨论有助于延长临终关怀登记的时间，这与EOL护理的更高评级相关 并且与患者的喜好是一致的。与患有癌症寄养儿童的父母进行早期EOL讨论 希望和情感支持，减少不确定性。然而，不存在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痛苦和情感痛苦。这个 长期目标是确定有效的干预措施，以改善EOL儿童的生活质量，减轻父母的痛苦。 此应用程序的总体目标是评估Complete(沟通计划：早期)的效果 到生命结束)，由儿童的主要MD/RN二元组提供的一系列量身定做的讨论，从 诊断，并集成视觉辅助工具，以同理心促进与父母关于预后的对话， 希望，以及整个癌症连续体的护理目标。中心假设是完整的将培养 当治愈不现实时，提供者和父母之间的护理目标保持一致，导致更早的临终关怀 注册，减少使用高强度的医疗干预，并减少痛苦和精神痛苦 孩子们在EOL，父母的痛苦更少。这些假设是基于申请者的初步研究。 (NIHR21；NR011071-02)：完整导致临终关怀登记人数增加(83%登记&>30天比 全国为40%)，较少使用高强度医疗干预措施(17%与全国60%)。与.相比 在基线上，孩子的痛苦和情感痛苦明显较少，父母的痛苦和情感痛苦明显较少 痛苦、不确定和更多的希望。该项目的基本原理是，如果完成是有效的，它可以是 迅速转化为临床实践，以支持更早的临终关怀登记并改善儿童的结局 与癌症和他们在EOL的父母在一起。在这项针对癌症儿童的多点整群随机对照试验中 对于存活率为25%的患者及其父母的预后，我们的目标是确定完全关注与关注的疗效 控制：1.促进更早的临终关怀登记(主要目标)；2.减少高强度的医疗干预， 减少EOL儿童的痛苦和情绪痛苦；以及，3.减少父母的痛苦和不确定性 并改善希望。这项研究的创新包括使用肿瘤学MD/RN团队让父母从 使用视觉辅助工具进行诊断和持续对话，以帮助建立现实的护理目标，从而促进 在EOL较早的临终关怀登记。其研究意义在于可望给出MD/RN的证据 团队需要在EOL为孩子和父母带来更好的结果。

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.