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

项目概要/摘要 呼吸系统疾病是导致重症脑瘫患儿住院和死亡的主要原因 （CP）。改善这些结果是有限的，因为干预措施，以帮助照顾者确定和管理他们 在正确的时间和背景是缺席。严重呼吸道疾病，定义为呼吸道诊断 需要住院治疗，开始在儿童之家，在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事件。护理人员报告说，他们的知识、技能和信心有限， 处理他们。为了改善这些呼吸死亡率和住院治疗结果，父母需要临床团队 在正确的时间，在正确的背景下提供正确的支持，即，及时和适应性。 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 以前有效的行为干预使患有复杂疾病的儿童家庭，包括CP， 行动计划和指导，以管理危机;然而，计划是预先规定的，静态的，并没有调整， 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， 不断变化的环境和合并症导致了这些疾病。此外，临床医生和家庭需要简单的 工具，以表明何时最需要关注，我们的移动健康平台旨在实现这一目标。 本申请的目的是（1）完善和调整呼吸加重行动计划， 针对重度CP儿童的重度呼吸道疾病的护理过渡（RE-PACT）干预计划 在两个具有种族/民族和社会经济患者多样性的临床项目中;以及（2）建立RE- PACT的可行性、可接受性和效应量，为未来的充分把握度多中心随机 RE-PACT的对照试验。我们还将探索性地分析 护理人员能力、机会和动机对干预结果的影响，以检验理论干预 机制利用循证推广有效方案适应框架，RE-PACT将 增加纵向移动健康监测父母的信心，以避免住院，及时触发 当信心不足时的行动计划和辅导。与目标家庭和临床团队的焦点小组 照顾患有严重CP的儿童，国家设计和干预战略专家组将指导 干预修订。然后将90名重度CP儿童的照顾者随机接受 RE-PACT或主动控制。将在6个月时使用混合方法收集结局数据，以评价 干预：1）可行性，2）可接受性，3）保真度，4）初步疗效，通过差异测量， 与对照组相比，严重的呼吸道疾病。 这种干预措施为广泛传播和可扩展性提供了很大的潜力，以解决一个关键问题， 公共卫生问题。此外，我们的长期目标是使用严重CP作为模型，进一步适应RE- PACT用于其他高度优先的疾病，依赖家庭在家中快速处理病情加重。

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.