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Implementation of an Evidence Based Parentally Administered Intervention for Preterm Infants.

Award Number: R01HD098095
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/15/2020
PERIOD OF PERFORMANCE END DATE: 03/31/2026

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Implementation of an Evidence Based Parentally Administered Intervention for Preterm Infants. - ABSTRACT 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 their infants in the NICU and the transition to home. In our 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, we use mixed methods analyses 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	CHILDREN'S HOSPITAL OF WISCONSIN, INC.	9000 W WISCONSIN AVE	MILWAUKEE	WI	53226	MILWAUKEE	USA	Child Health and Human Development Extramural Research	000	5	1/31/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $582,612 )
2024	2024	CHILDREN'S HOSPITAL OF WISCONSIN, INC.	9000 W WISCONSIN AVE	MILWAUKEE	WI	53226	MILWAUKEE	USA	Child Health and Human Development Extramural Research	001	5	5/3/2024	NON-COMPETING CONTINUATION	$52,964
2024	2024	CHILDREN'S HOSPITAL OF WISCONSIN, INC.	9000 W WISCONSIN AVE	MILWAUKEE	WI	53226	MILWAUKEE	USA	Child Health and Human Development Extramural Research	000	5	3/25/2024	NON-COMPETING CONTINUATION	$529,648
														Subtotal = $582,612

Issue Date FY: 2023 ( Subtotal = $587,627 )
2023	2023	CHILDRENS HOSPITAL OF WISCONSIN INC	9000 W WISCONSIN AVE	MILWAUKEE	WI	53226	MILWAUKEE	USA	Child Health and Human Development Extramural Research	000	4	3/16/2023	NON-COMPETING CONTINUATION	$587,627
														Subtotal = $587,627

Issue Date FY: 2022 ( Subtotal = $625,443 )
2022	2022	CHILDRENS HOSPITAL OF WISCONSIN INC	9000 W WISCONSIN AVE	MILWAUKEE	WI	53226	MILWAUKEE	USA	Child Health and Human Development Extramural Research	000	3	4/19/2022	NON-COMPETING CONTINUATION	$625,443
														Subtotal = $625,443

Issue Date FY: 2021 ( Subtotal = $630,224 )
2021	2021	CHILDRENS HOSPITAL OF WISCONSIN INC	9000 W WISCONSIN AVE	MILWAUKEE	WI	53226	MILWAUKEE	USA	Child Health and Human Development Extramural Research	000	2	4/8/2021	NON-COMPETING CONTINUATION	$630,224
														Subtotal = $630,224

Issue Date FY: 2020 ( Subtotal = $664,940 )
2020	2020	CHILDRENS HOSPITAL OF WISCONSIN INC	9000 W WISCONSIN AVE	MILWAUKEE	WI	53226	MILWAUKEE	USA	Child Health and Human Development Extramural Research	000	1	4/15/2020	NEW	$664,940
														Subtotal = $664,940

Grand Total All Awards = $3,090,846

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Implementation of an Evidence Based Parentally Administered Intervention for Preterm Infants.

Award Number: R01HD098095

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/15/2020

PERIOD OF PERFORMANCE END DATE: 03/31/2026

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