Implementation of an Evidence Based Parentally Administered Intervention for Preterm Infants

NCT04555590 | Completed

• 2 other identifiers: PRO000356001R01HD098095-01A1
• Study Type: interventional
• Target: 1,882
• Locations: 1 country
• Sites: 4

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.

Conditions

Premature Infants; Parent-Child Relations

Keywords

Premature Infants; NICU; Parental Stress; Healthcare Costs

Outcome Measures

Primary Outcomes (7)

• Aim 1 Outcome Measure: Implementation Success (Percent Change in Sustainability throughout implementation)

  Change in % of instances of H-HOPE being offered

  Every 2 months from Executing through 6 months after supported implementation ends

• Aim 1 Outcome Measure: Implementation Success (Change in Reach throughout implementation)

  % of eligible parent-infant units receiving H-HOPE

  Every 2 months from Executing through 6 months after supported implementation ends

• Aim 1 Outcome Measure: Implementation Success (Degree of Implementation)

  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)

  Every 2 months from Executing through 6 months after supported implementation ends

• Aim 2 Outcome Measure: Effectiveness-(Change in Infant Head Circumference)

  Infant Primary: Infant Head Circumference, measured in centimeters.

  From birth to discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant)

• Aim 2 Outcome Measure: Effectiveness (Change in Infant Weight)

  Infant Primary: Weight, measured in kilograms

  From birth to discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant)

• Aim 2 Outcome Measure: Effectiveness (Change in Infant Length)

  Infant Primary: Length, measured in centimeters

  From birth to discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant)

• Aim 2 Outcome Measure: Effectiveness (Change in number of Acute Care Visits)

  Number of acute care visits (clinic or emergency department visit or re-hospitalization)

  At 6 weeks post discharge

Secondary Outcomes (2)

• Aim 2 Outcome Measure: Cost

  From infant enrollment through infant discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant)

• 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.

Other Outcomes (5)

• Aim 2 Exploratory Outcome Measure: # Parent NICU visits/days of hospitalization

  At discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant)

• Aim 2 Exploratory Outcome Measure: Parental Stress (Anxiety)

  At discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant) and 6 weeks corrected Age

• Aim 2 Exploratory Outcome Measure: Parental Stress (Depression)

  At discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant) and 6 weeks corrected Age

Study Arms (2)

Pre H-HOPE Cohort

NO INTERVENTION

The Pre-H-HOPE Comparison Cohort will not receive the H-HOPE intervention, and represents the prior standard (non-HOPE).

H-HOPE Cohort

EXPERIMENTAL

The H-HOPE Cohort will receive the H-HOPE intervention.

Behavioral: H-HOPE Intervention

Interventions

H-HOPE Intervention BEHAVIORAL

The H-HOPE intervention (Hospital to Home: Optimizing the Preterm Infant's Environment) to promote early infant development and parental engagement. H-HOPE includes ATVV, which provides Auditory (voice), Tactile (moderate touch massage), Visual (eye to eye), and Vestibular (rocking) stimulation with a parent-directed component which provides participatory guidance and social support to engage with their infants.

H-HOPE Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• years of age or older
• English or Spanish speaking

You may not qualify if:

• major brain injuries (e.g. cystic PVL)
• current sepsis
• intubated for mechanical ventilation at time of enrollment
• surgical necrotizing enterocolitis
• Ward of the State
• 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
• None
• less than 50% effort.
• does not provide direct patient care

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Duke University: collaborator
• University of Chicago: collaborator
• Wake Forest University Health Sciences: collaborator
• Children's Hospital and Health System Foundation, Wisconsin: collaborator

Study Sites (4)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Advocate Aurora Health

Park Ridge, Illinois, 60068, United States

Location

Duke Univesity

Durham, North Carolina, 27708, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

Related Publications (1)

• 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.

  PMID: 33761902 DERIVED

Related Links

• Complete List of Published Work in MyBibliography for Rosemary White-Traut

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Rosemary White-Traut, PhD,RN,FAAN

  Department of Nursing Research and Evidence-Based Practice Children's Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nursing Research and Evidence Based Practice

Model Details: This is an implementation study of the H-HOPE Intervention. The team uses a Stepped-Wedge Design for Implementation.

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: September 18, 2020
• Study Start: November 16, 2020
• Primary Completion: November 5, 2024
• Study Completion: November 5, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)