The high cost of preterm birth. Premature birth is associated with immaturity of major organs and regulatory behaviors, feeding difficulties, and slower early growth, leading to longer initial hospitalization and increased economic costs [1-14]. Parents of preterm infants also experience an increase in stress, anxiety, depressive symptoms, and lack of confidence about parenting, which also leads to less optimal parent-infant interaction and adversely impacts infant growth and development [15-25]. Preterm births account for only 10-12% of births in the US, but the cost of preterm birth accounts for more than 40% of the total costs of birth hospitalizations [1, 5, 7, 26, 27]. Post-discharge, 19% of preterm infants experience ongoing medical conditions, increasing average outpatient costs in the first year to approximately $10,000, and prescription costs to approximately $1,800 [27, 28]. The first year total health care costs for preterm infants are three times higher when compared to full-term infants, reaching $14 billion in 2017 [29]. For very preterm infant survivors (28-31 weeks gestation), and extremely preterm infant survivors (<28 weeks gestation), these medical costs are even higher.
Early developmental interventions have the potential to improve outcomes for preterm infants and families. Importantly, early investment in preterm infant development has high potential impact on infant short and long term outcomes, parent-infant relationships and public health and education costs [5, 7, 27, 30]. The Physical Environment Exploratory Group endorses use of sensory interventions, including massage, as standard care after 30–31 weeks post-menstrual age (PMA, calculated as gestational age at birth plus chronological age) [31]. A large body of evidence supports that these interventions accelerate early brain development and maturation of visual function, improve feeding ability and growth factors, as well as health, long-term language, motor, and cognitive development. For the parents, the interventions increase interactive engagement with their infants and parent-infant interaction, which may mitigate the effects of increased parental stress [18, 31-47]. Multi-sensory developmental interventions that have a behavioral focus have been found especially effective in accelerating feeding, growth, and development [31, 32, 42, 48, 49]. However, few neonatal intensive care units (NICUs) provide evidence-based standardized parent directed early developmental interventions that have a behavioral focus as routine care. Lack of implementation is a major gap between research and clinical practice.
H-HOPE is a standardized intervention ready for dissemination. Our team developed the H-HOPE intervention (Hospital to Home: Optimizing the Preterm Infant’s Environment) to promote early infant development and parental engagement. H-HOPE consists of two components, one infant-directed and one parent-directed. Together, these components simultaneously address the needs of both preterm infants and their parents, especially their need for mutual engagement in NICUs. Our early research documented the efficacy of H-HOPE’s infant-directed component, the ATVV, which provides Auditory (voice), Tactile (moderate touch massage), Visual (eye to eye), and Vestibular (rocking) stimulation. We renamed the ATVV as Massage+ to be more readily understood by parents. Massage+ is initiated when infants are ready for social interaction around 31-32 weeks. When tested with infants at varying degrees of risk, Massage+ improved infant oral feeding and social interactive skills prior to and during feeding, improved their capacity to attain alert behavioral states more optimal for feeding and parent-infant interaction, in-hospital growth (weight gain) and development, and reduced length of hospital stay [11-14, 50-54]. However, Massage+ alone did not address parents’ reported distress and their need for participatory guidance and social support to engage with their infants, despite the infants’ immature behaviors. To meet parents’ needs, we developed the parent-directed component of H-HOPE, which consists of 4 participatory guidance sessions for parents, 2 during the NICU stay and 2 during the transition to home.
Together, H-HOPE’s components optimize early infant behavior and parental capacity to engage in social interaction. In previous research, we found improved developmental maturation (more mature behavioral states, increased frequency of orally directed behaviors, faster transition from gavage to oral feeding, improved sucking organization and motor development), greater in-hospital growth (weight gain and length), and enhanced engagement, social interaction and infant responsivity [42, 48, 49, 55]. Additionally, H-HOPE reduced initial in-hospital costs (net savings of $13,976 per infant after adjusting for the mean intervention cost of $680) [56] and health care use from discharge through 6-weeks corrected age (CA, chronological age corrected for weeks born preterm) [57]. With established efficacy and a manualized standardized protocol, H-HOPE is ready for widespread implementation, making H-HOPE uniquely suited as an early behavioral intervention for preterm infants in NICUs.
Preparing NICUs to adapt H-HOPE as the standard of care
To reduce the gap between research and implementation, clinicians need a strategy to introduce an early behavioral intervention involving parents within the high-acuity NICU. Our implementation strategy integrates our experience conducting H-HOPE and a well-established implementation model, the Consolidated Framework for Implementation Research (CFIR) [58]. The CFIR identifies influences (facilitators and barriers) that affect successful implementation within five domains: intervention characteristics, outer setting (the hospital and external events and stakeholders), inner setting (NICU), implementers’ individual characteristics, and the implementation process. We selected the CFIR because the framework integrates the best features of previous models [58] and captures the complexity of real-world implementation to identify site-specific factors and patterns across cases [59, 60]. The framework has been used for diverse interventions in inpatient, clinic and community settings. A systematic review in 2016 identified 26 empirical studies using the CFIR, [61] and there are numerous studies published since then [42, 62-70]. However, only two previous studies occurred in a high acuity inpatient setting (adult acute care units) [62, 69] and no prior studies include the NICU setting. The CFIR provides a systematic approach that will be used to guide the process of implementing H-HOPE in NICUs, to recognize facilitators of successful implementation, and to identify and address implementation barriers across different sites. NICUs will use the CFIR process, which includes three phases: Planning and Engaging, Executing, and Reflecting and Evaluating. We modified the CFIR implementation process by added a final phase of sustaining H-HOPE without continued support from the research team, because sustaining is a critical goal of implementation [71, 72].
In addition to adopting an implementation model, we modified the H-HOPE protocol used in the efficacy study to further facilitate implementation of H-HOPE as the standard of care for this initial study, nationwide and eventually globally. We expanded infant and parent eligibility criteria to reach a wider range of preterm infants and their parents who can benefit from an early behavioral intervention. In collaboration with Pathways.org, an organization dedicated to early childhood development, we developed a web-based support package of training webinars, Massage+ videos and downloadable materials for H-HOPE providers and trainers (www.Pathways.org). We replaced costly post-discharge home visits with screen time (e.g. FaceTime). Through regular interactive consultation at each site, the research team will share their experiences to support implementation and lessons learned across sites will be incorporated into the web-based support package. Because every NICU represents a different context, we view the implementation process as a collaboration that balances fidelity to intervention core components to maintain H-HOPE’s effectiveness, while adapting non-essential aspects (e.g. training format, who provides services) to fit each site’s unique set of needs [73, 74].