Implementation of an Evidence Based Parentally Administered Intervention for Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1882 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-16

Study Completion Date

2024-11-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Premature Infants Parent-Child Relations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pre H-HOPE Cohort

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

Group Type NO_INTERVENTION

No interventions assigned to this group

H-HOPE Cohort

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

Group Type EXPERIMENTAL

H-HOPE Intervention

Intervention Type 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.

Interventions

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H-HOPE Intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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
* 18 years of age or older
* English or Spanish speaking

Exclusion Criteria

* 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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes