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

摘要 早期基于发展的行为干预具有公认的积极效果，建议 作为支持大脑早期成熟、健康和发育的护理标准。然而，很少有新生儿 重症监护病房(NICU)提供这种早期干预。H-HOPE(医院到家：优化 早产儿环境)已经确立了疗效，并有标准化的方案，使其为 广泛实施。H-HOPE的婴儿导向组件提供听觉(声音)、触觉 (中度触摸按摩)、视觉(眼睛对眼睛)和前庭(摇摆)刺激，从婴儿开始 准备好进行社交互动。H-HOPE以家长为导向的组成部分包括参与性指导和 支持父母与NICU中的婴儿接触，并帮助他们过渡到家。在我们由NIH资助的 研究表明，H-HOPE改善了生长、发育成熟度和母婴互动，并减少了最初 经过6周校正年龄的住院费用和急诊护理。这项研究测试了H- 希望可以在五个不同的NICU中实施和维持，使用类型3混合设计来评估 实施过程和有效性。具体目标是：1)确定 实施成功；2)评价H-HOPE对婴儿的效果，H-HOPE的住院费用 与实施前的比较队列相比，登记到出院的人数和父母人数；以及3) 确定与实施成功和H-希望相关的影响(促进者和障碍) 有效性，由执行研究综合框架(CFIR)指导。一个不完整的 阶梯式楔形设计指导五个临床站点交错推出。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 持续了几个月。对于目标1，实施成功的程度每两个月确定为 可持续性(仍提供H-HOPE)、覆盖范围(获得H-HOPE的合格父母/婴儿的百分比)和学位 执行情况(平均每个亲子单位收到的H-HOPE服务)(主要执行情况 结果)。对于目标2，使用广义线性混合模型对婴儿、成本和 父母结果(主要结果：婴儿出院时的生长发育和出院至6岁的急性护理 周经修正的年龄)。采用倾向性评分分析方法，对实施前后进行评价 具有可比性。对于目标3，我们使用混合方法分析来确定H-HOPE记录和 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NICU首次在循证CFIR框架下实施，并取得了成果 将对实施科学做出重大贡献。这项研究将产生一个基于证据的 实施战略和工具包将在全国范围内传播。广泛的H-HOPE实施将使 临床实践的重大变化和改善早产儿的健康和医疗保健成本。

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.