RE-PACT: Respiratory Exacerbation Plans for Action and Care Transitions for Children with Severe CP

项目摘要/摘要 呼吸系统疾病是重症脑瘫儿童住院和死亡的主要原因 (CP)。改善这些结果是有限的，因为帮助照顾者识别和管理这些结果的干预措施 在正确的时间和背景下都不存在。严重的呼吸系统疾病，定义为呼吸道诊断 需要住院的，从儿童之家开始，那里的家庭是第一个排队管理这些 技术上具有挑战性和细微差别的活动。照顾者报告说，他们的知识、技能和信心有限 处理好他们。为了改善这些呼吸道死亡率和住院结果，父母需要临床团队 在适当的时间，在适当的情况下，即适时和适应性地提供适当的支持。 及时的适应性干预有望帮助患有呼吸系统疾病的CP儿童。我们的 以前有效的行为干预给患有复杂疾病的儿童的家庭，包括CP， 管理危机的行动计划和指导；然而，计划是预先指定的、静态的，没有调整到 实时问题。为了预防CP中的严重呼吸道疾病，应对措施必须是动态的，解决 不断变化的环境和导致这些疾病的合并症。此外，临床医生和家庭需要简单 当最需要关注的时候发出信号的工具，这是我们的mHealth平台旨在实现的。 本申请的目的是(1)改进和调整呼吸加剧行动计划和 重症脑瘫儿童严重呼吸道疾病的护理过渡(RE-PACT)干预计划 跨种族/民族和社会经济患者多样性的两个临床项目；以及(2)建立RE- PACT的可行性、可接受性和效果大小，为未来的全动力多站点随机 RE-PACT的对照试验。我们还将探索性地分析变化的调解影响 照顾者的能力、机会和动机对干预结果的检验理论干预 机制。利用基于证据的复制有效方案适应框架，RE-PACT将 增加对父母信心的纵向mHealth监测，以避免住院，触发及时 行动计划和教练信心低落的时候。具有目标家庭和临床团队的焦点小组 关爱患有严重脑瘫的儿童，一个国家设计和干预策略专家组将指导 干预修订。然后，对90名患有严重脑瘫的儿童的照顾者进行随机抽样，接受 重新约定或主动控制。结果数据将在6个月后收集，使用混合方法进行评估 干预：1)可行性，2)可接受性，3)保真度，4)初步疗效，由 与对照组相比，严重的呼吸道疾病。 这种干预提供了广泛传播和可伸缩性的高潜力，以解决关键的 公共卫生问题。此外，我们的长期目标是以重症CP为模型，进一步适应RE-CP。 与其他高度优先的疾病达成协议，依靠家庭在家里迅速处理病情恶化。

PROJECT SUMMARY / ABSTRACT Respiratory illness is the leading cause of hospitalization and death in children with severe cerebral palsy (CP). Improving these outcomes is limited because interventions to help caregivers identify and manage them at the right time and context are absent. Severe respiratory illnesses, defined as respiratory diagnoses requiring hospitalization, begin in the children’s homes, where families are the first in line to manage these technically challenging and nuanced events. Caregivers report limited knowledge, skill, and confidence to handle them. To improve these respiratory mortality and hospitalization outcomes, parents need clinical teams to provide the right support, at the right time, in the right context, i.e., just-in-time and adaptive. Just-in-time adaptive interventions hold promise to help children with CP with respiratory illness. Our previously efficacious behavioral intervention gave families of children with complex illnesses, including CP, action plans and coaching to manage crises; however, plans were pre-specified, static, and did not adjust to real-time issues. To prevent severe respiratory illness in CP, responses must be dynamic, addressing the changing contexts and comorbidities that drive these illnesses. Moreover, clinicians and families need simple tools to signal when attention is most needed, which our mHealth platform was designed to accomplish. The aims of this application are to (1) refine and adapt the Respiratory Exacerbation Plans for Action and Care Transitions (RE-PACT) intervention program to severe respiratory illness for children with severe CP across two clinical programs with racial/ethnic and socioeconomic patient diversity; and (2) establish RE- PACT’s feasibility, acceptability and effect sizes in preparation for a future fully powered multisite randomized controlled trial of RE-PACT. We will also conduct exploratory analyses of the mediating influence of changes in caregiver capability, opportunity and motivation on intervention outcomes to test the theoretical intervention mechanism. Using the evidence-based Replicating Effective Programs adaptation framework, RE-PACT will add longitudinal mHealth surveillance of parent confidence to avoid hospitalization, triggering just-in-time action planning and coaching when confidence of low. Focus groups with target family and clinical teams caring for children with severe CP, and a national Design and Intervention Strategy expert group will guide intervention revisions. A sample of 90 caregivers of children with severe CP will then be randomized to receive RE-PACT or active control. Outcome data will be collected at 6 months using mixed methods to evaluate intervention: 1) feasibility, 2) acceptability, 3) fidelity, and 4) preliminary efficacy, measured by differences in severe respiratory illnesses compared to control. This intervention offers a high potential for widespread dissemination and scalability to address a key public health problem. Moreover, our long-term goal is to use severe CP as a model, further adapting RE- PACT to other high-priority conditions relying on families to rapidly handle exacerbations at home.