Implementation of an Evidence Based Parentally Administered Intervention for Preterm Infants
- Conditions
- Premature InfantsParent-Child Relations
- Interventions
- Behavioral: H-HOPE Intervention
- Registration Number
- NCT04555590
- Lead Sponsor
- Medical College of Wisconsin
- Brief Summary
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 infants in the NICU and the transition to home. In this 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, a mixed methods analyses is used 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1882
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description H-HOPE Cohort H-HOPE Intervention The H-HOPE Cohort will receive the H-HOPE intervention.
- Primary Outcome Measures
Name Time Method Aim 1 Outcome Measure: Implementation Success (Percent Change in Sustainability throughout implementation) Every 2 months from Executing through 6 months after supported implementation ends Change in % of instances of H-HOPE being offered
Aim 1 Outcome Measure: Implementation Success (Change in Reach throughout implementation) Every 2 months from Executing through 6 months after supported implementation ends % of eligible parent-infant units receiving H-HOPE
Aim 1 Outcome Measure: Implementation Success (Degree of Implementation) Every 2 months from Executing through 6 months after supported implementation ends In-Hospital:
Infant: Mean number of ATVV interventions received per eligible day (Range 0-2)
Transition to home:
Parents: # received participatory guidance sessions (2 pre-discharge and 2 screen time visits at 2-3 days and 7-15 days post-discharge; Range: 0-3) Infant: Mean number of ATVV interventions received by per eligible day since discharge (Range 0-2; provided and reported by parent)Aim 2 Outcome Measure: Effectiveness-(Change in Infant Head Circumference) From birth to discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant) Infant Primary: Infant Head Circumference, measured in centimeters.
Aim 2 Outcome Measure: Effectiveness (Change in Infant Weight) From birth to discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant) Infant Primary: Weight, measured in kilograms
Aim 2 Outcome Measure: Effectiveness (Change in Infant Length) From birth to discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant) Infant Primary: Length, measured in centimeters
Aim 2 Outcome Measure: Effectiveness (Change in number of Acute Care Visits) At 6 weeks post discharge Number of acute care visits (clinic or emergency department visit or re-hospitalization)
- Secondary Outcome Measures
Name Time Method Aim 2 Outcome Measure: Cost From infant enrollment through infant discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant) Mean hospitalization cost/day (direct costs) from entry into H-HOPE through discharge, adjusted by adding the cost per H-HOPE infant to implement H-HOPE (training, coordinating, time to deliver H-HOPE and to arrange screen time visits)
Aim 3 Outcome Measure: CFIR influences (Number of facilitators and barriers to implementation) From the completion of the first site's Sustaining Phase through Final Analysis of all site data, estimated to be 39 months. Aim 3 uses mixed methods analyses to integrate data collected for this aim regarding influences (facilitators or barriers) in each of the 5 CFIR domains with data from Aim 1 (implementation success) and Aim 2 (effectiveness for the primary infant outcomes).
Trial Locations
- Locations (4)
University of Chicago
🇺🇸Chicago, Illinois, United States
Advocate Aurora Health
🇺🇸Park Ridge, Illinois, United States
Duke Univesity
🇺🇸Durham, North Carolina, United States
Children's Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States