BACKGROUND: Multi-sensory behavioral interventions for preterm infants have the potential to accelerate feeding, growth, and optimize developmental trajectories and increase parents' interactive engagement with their infants . However, few neonatal intensive care units (NICUs) provide evidence-based standardized early behavioral interventions as routine care . Lack of implementation is a major gap between research and clinical practice . H-HOPE, is a standardized behavioral intervention with an infant- directed component (Massage+) and a parent-directed component (four participatory guidance sessions that focus on preterm infants' behaviors and appropriate responses). H-HOPE has well documented efficacy . The purpose of this implementation study is to establish H-HOPE as the standard of care in 5 NICUs .

METHODS: The study employs a Type 3 Hybrid design to simultaneously examine the implementation process and effectiveness in five NICUs . To stagger implementation across the clinical sites, we use an incomplete stepped wedge design . The five participating NICUs were purposively selected to represent different acuity levels, number of beds, locations and populations served . Our implementation strategy integrates our experience conducting H-HOPE and a well-established implementation model, the Consolidated Framework for Implementation Research (CFIR). 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 . NICUs will use the CFIR process, which includes three phases: Planning and Engaging, Executing, and Reflecting and Evaluating . Because sustaining is a critical goal of implementation, we modify the CFIR implementation process by adding a final phase of Sustaining .

DISCUSSION: This study builds on the CFIR, adding Sustaining H-HOPE to observe what happens when sites begin to maintain implementation without outside support, and extends its use to the NICU acute care setting . Our mixed methods analysis systematically identifies key facilitators and barriers of implementation success and effectiveness across the five domains of the CFIR . Long term benefits have not yet been studied but may include substantial health and developmental outcomes for infants, more optimal parent-child relationships, reduced stress and costs for families, and substantial indirect societal benefits including reduced health care and special education costs .

TRIAL REGISTRATION: ClinicalTrials.gov registration number NCT04555590, Registered on 8/19/2020.