Implementation of an Evidence Based Parentally Administered Intervention for Preterm Infants.

摘要 早期发展为基础的行为干预具有良好的积极作用，建议 作为支持早期大脑成熟、健康和发育的标准护理。然而，少数新生儿 重症监护室（NICU）提供了这种早期干预。H-HOPE（医院到家庭：优化 早产儿的环境）已经确立了疗效，并有一个标准化的协议，使其准备好 广泛实施。H-HOPE的婴儿导向组件提供听觉（声音）、触觉 （适度触摸按摩），视觉（眼对眼）和前庭（摇摆）刺激，从婴儿出生时开始 准备好社交互动。H-HOPE的家长指导部分包括参与性指导， 支持帮助父母在NICU中与婴儿接触并过渡到家中。在我们的NIH资助的 研究表明，H-HOPE改善了生长、发育成熟和母婴互动， 住院费用和6周矫正年龄的急性护理访视。这项研究测试了H- HOPE可以在五个不同的NICU中实施和维持，使用3型混合设计来评估 执行过程和有效性。具体目标是：1）确定 实施成功; 2）评估H-HOPE对婴儿的有效性，H-HOPE的住院费用 与实施前比较队列相比，入组至出院和父母;以及3） 确定与实施成功和H-HOPE相关的影响因素（促进因素和障碍） 在实施研究综合框架（CFIR）的指导下，有效性。一个不完整 阶梯楔形设计指导五个临床站点的交错展开。每个NICU完成CFIR 实施步骤（规划和参与，执行，反思和评估），然后是6 几个月的支持。对于目标1，每两个月确定一次执行成功的程度， 可持续性（仍提供H-HOPE）、覆盖范围（接受H-HOPE的合格父母/婴儿的百分比）和学位 （每个父母-婴儿单位接受的平均H-HOPE服务）（初步实施 成果）。对于目标2，使用广义线性混合模型对婴儿、成本和 父母结局（主要结局：出院时的婴儿生长和从出院到6岁的急性护理访视） 周校正年龄）。倾向得分分析用于使前，后实施 可比性对于目标3，我们使用混合方法分析来识别H-HOPE记录的影响， 与每个站点和跨站点的实施成功和有效性相关的访谈。 这是第一次在NICU中实施以循证CFIR框架为指导，结果 将对执行科学做出重大贡献。这项研究将产生一个基于证据的 执行战略和工具包。H-HOPE的广泛实施将使 临床实践的重大变化，改善早产儿的健康和医疗保健费用。

ABSTRACT Early developmentally-based behavioral intervention has well-established positive effects and is recommended as the standard of care to support early brain maturation, health, and development. However, few neonatal intensive care units (NICUs) provide this early intervention. H-HOPE (Hospital to Home: Optimizing the Preterm Infant’s Environment) has established efficacy, and has a standardized protocol, making it ready for widespread implementation. The infant-directed component of H-HOPE provides Auditory (voice), Tactile (moderate touch massage), Visual (eye to eye), and Vestibular (rocking) stimulation starting when infants are ready for social interaction. The parent-directed component of H-HOPE includes participatory guidance and support to help parents engage with their infants in the NICU and the transition to home. In our NIH-funded research, H-HOPE improved growth, developmental maturity and mother-infant interaction, and reduced initial hospitalization costs and acute care visits through 6-weeks corrected age. This research tests whether H- HOPE can be implemented and sustained in five diverse NICUs, using a Type 3 Hybrid design to evaluate both implementation processes and effectiveness. The specific aims are to: 1) Identify the degree of implementation success; 2) Evaluate the effectiveness of H-HOPE for infants, hospital costs from H-HOPE enrollment until discharge, and parents, compared to a pre-implementation comparison cohort; and 3) Determine influences (facilitators and barriers) associated with implementation success and H-HOPE effectiveness, guided by the Consolidated Framework for Implementation Research (CFIR). An incomplete stepped-wedge design guides staggered roll-out for five clinical sites. Each NICU completes the CFIR implementation steps (Planning and Engaging, Executing, and Reflecting and Evaluating), followed by 6 months of Sustaining. For Aim 1, degree of implementation success is determined every two months as Sustainability (still offering H-HOPE), Reach (% of eligible parent/infant dyads receiving H-HOPE) and Degree of Implementation (mean H-HOPE services received per parent-infant unit) (primary implementation outcomes). For Aim 2, effectiveness is analyzed using generalized linear mixed models for infant, cost, and parent outcomes (primary outcomes: infant growth at discharge and acute care visits from discharge to 6- weeks corrected age). Propensity score analysis is used to make the pre- and post-implementation comparable. For Aim 3, we use mixed methods analyses to identify influences from H-HOPE records and interviews that are associated with implementation success and effectiveness at each site and across sites. This is the first time implementation in a NICU is guided by the evidence-based CFIR framework, and results will make a major contribution to implementation science. This study will produce an evidence-based implementation strategy and Toolkit to disseminate nationwide. Widespread H-HOPE implementation will make a significant change in clinical practice and improve preterm infant health and health care costs.