Clinical trial NCT04555590: Implementation of an Evidence Based Parentally Administered Intervention for Preterm Infants
Official title: Implementation of an Evidence Based Parentally Administered Intervention for Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Infants
Parent-Child Relations
Keywords: Premature Infants
NICU
Parental Stress
Healthcare Costs
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Duke University
name: University of Chicago
name: Wake Forest University Health Sciences
name: Children's Hospital and Health System Foundation, Wisconsin
First posted: 2020-09-18
Enrollment: 1882
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an implementation study of the H-HOPE Intervention. The team uses a Stepped-Wedge Design for Implementation.
Primary purpose: TREATMENT

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.


Eligibility criteria: There are two cohorts of infants and parents: the Pre-H-HOPE Comparison Cohort and H-HOPE Cohort. H-HOPE is a family intervention, so parent(s) and infants are recruited together and must meet both parent and infant eligibility criteria. Infant and parent eligibility criteria are the same for both cohorts (Pre-H-HOPE and H-HOPE). Additionally, there are criteria for hospital personnel.

Inclusion criteria for the infant:

* born between 23-35 weeks gestational age (GA)
* have reached 31-32 weeks post menstrual age (PMA)
* clinically stable
* male or female
* could be receiving oxygen or intravenous therapy
* could have been previously intubated for mechanical ventilation
* assessed as ready to begin social interaction Infants of multiple births will be eligible to participate but data from only one randomly selected infant will be used in analysis of Aim 2.

Inclusion criteria for the parent (up to 2 per infant can be in the study:

* mother, father, other family member, or surrogate parent regardless of age, race/ethnicity, gender, or sexual orientation, or biological relationship to the infant
* intends to act in the role of parent
* 18 years of age or older
* English or Spanish speaking

Inclusion criteria for hospital personnel:

Hospital Administrator - staff member with an administrative role outside of the NICU leadership who is knowledgeable about the activities of the NICU NICU Manager - Nurse or physician with an administrative role in the NICU (e.g. medical director or nurse manager) H-HOPE Team member - staff member who is part of the H-HOPE Team NICU Staff Nurse - registered nurse who provides direct patient care and works a minimum of 50% in the NICU Exclusion Criteria We will not be limiting any participants based on sex/gender, or ethnic/racial identity. Differences due to race and gender will be accounted for during data analysis. We will be limiting enrollment to English or Spanish speaking parents due to the limited availability of valid measures for data collection in languages other than English and Spanish. However, we anticipate that we will still be able to recruit an ethnically diverse group of parents because of the ethnic composition of the parents at the sites and our prior experience.

Exclusion criteria for the infant:

* major brain injuries (e.g. cystic PVL)
* current sepsis
* intubated for mechanical ventilation at time of enrollment
* surgical necrotizing enterocolitis
* Ward of the State

Exclusion criteria for the parent:

* positive drug screen for illegal substances
* planning to surrender custody of the infant or legal custody remove
* primary parent does not have legal guardianship of the infant
* Mental health diagnosis such as Psychosis, Bipolar Disease Exclusion Criteria Hospital Personnel
* None

Exclusion Criteria for NICU Staff Nurses:

* less than 50% effort.
* does not provide direct patient care

Primary outcomes:
measure: Aim 1 Outcome Measure: Implementation Success (Percent Change in Sustainability throughout implementation)
timeFrame: Every 2 months from Executing through 6 months after supported implementation ends
measure: Aim 1 Outcome Measure: Implementation Success (Change in Reach throughout implementation)
timeFrame: Every 2 months from Executing through 6 months after supported implementation ends
measure: Aim 1 Outcome Measure: Implementation Success (Degree of Implementation)
timeFrame: Every 2 months from Executing through 6 months after supported implementation ends
measure: Aim 2 Outcome Measure: Effectiveness-(Change in Infant Head Circumference)
timeFrame: From birth to discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant)
measure: Aim 2 Outcome Measure: Effectiveness (Change in Infant Weight)
timeFrame: From birth to discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant)
measure: Aim 2 Outcome Measure: Effectiveness (Change in Infant Length)
timeFrame: From birth to discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant)
measure: Aim 2 Outcome Measure: Effectiveness (Change in number of Acute Care Visits)
timeFrame: At 6 weeks post discharge
Secondary outcomes:
measure: Aim 2 Outcome Measure: Cost
timeFrame: From infant enrollment through infant discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant)
measure: Aim 3 Outcome Measure: CFIR influences (Number of facilitators and barriers to implementation)
timeFrame: From the completion of the first site's Sustaining Phase through Final Analysis of all site data, estimated to be 39 months.
Other outcomes:
measure: Aim 2 Exploratory Outcome Measure: # Parent NICU visits/days of hospitalization
timeFrame: At discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant)
measure: Aim 2 Exploratory Outcome Measure: Parental Stress (Anxiety)
timeFrame: At discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant) and 6 weeks corrected Age
measure: Aim 2 Exploratory Outcome Measure: Parental Stress (Depression)
timeFrame: At discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant) and 6 weeks corrected Age
measure: Aim 2 Exploratory Outcome Measure: Parental Stress (Child Health Worry Scale)
timeFrame: At discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant) and 6 weeks corrected Age
measure: Aim 2 Exploratory Outcome Measure: Confidence in Care
timeFrame: At discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant) and 6 weeks corrected Age
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Aurora Health
state: Illinois
city: Durham
country: United States
facility: Duke Univesity
state: North Carolina
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Department of Nursing Research and Evidence-Based Practice Children's Wisconsin
name: Rosemary White-Traut, PhD,RN,FAAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: White-Traut R, Brandon D, Kavanaugh K, Gralton K, Pan W, Myers ER, Andrews B, Msall M, Norr KF. Protocol for implementation of an evidence based parentally administered intervention for preterm infants. BMC Pediatr. 2021 Mar 24;21(1):142. doi: 10.1186/s12887-021-02596-1.