Cargando…

Protocol for implementation of an evidence based parentally administered intervention for preterm infants

BACKGROUND: Multi-sensory behavioral interventions for preterm infants have the potential to accelerate feeding, growth, and optimize developmental trajectories and increase parents’ interactive engagement with their infants. However, few neonatal intensive care units (NICUs) provide evidence-based...

Descripción completa

Detalles Bibliográficos
Autores principales: White-Traut, Rosemary, Brandon, Debra, Kavanaugh, Karen, Gralton, Karen, Pan, Wei, Myers, Evan R., Andrews, Bree, Msall, Michael, Norr, Kathleen F.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7988259/
https://www.ncbi.nlm.nih.gov/pubmed/33761902
http://dx.doi.org/10.1186/s12887-021-02596-1
_version_ 1783668759923261440
author White-Traut, Rosemary
Brandon, Debra
Kavanaugh, Karen
Gralton, Karen
Pan, Wei
Myers, Evan R.
Andrews, Bree
Msall, Michael
Norr, Kathleen F.
author_facet White-Traut, Rosemary
Brandon, Debra
Kavanaugh, Karen
Gralton, Karen
Pan, Wei
Myers, Evan R.
Andrews, Bree
Msall, Michael
Norr, Kathleen F.
author_sort White-Traut, Rosemary
collection PubMed
description BACKGROUND: Multi-sensory behavioral interventions for preterm infants have the potential to accelerate feeding, growth, and optimize developmental trajectories and increase parents’ interactive engagement with their infants. However, few neonatal intensive care units (NICUs) provide evidence-based standardized early behavioral interventions as routine care. Lack of implementation is a major gap between research and clinical practice. H-HOPE, is a standardized behavioral intervention with an infant- directed component (Massage+) and a parent-directed component (four participatory guidance sessions that focus on preterm infants’ behaviors and appropriate responses). H-HOPE has well documented efficacy. The purpose of this implementation study is to establish H-HOPE as the standard of care in 5 NICUs. METHODS: The study employs a Type 3 Hybrid design to simultaneously examine the implementation process and effectiveness in five NICUs. To stagger implementation across the clinical sites, we use an incomplete stepped wedge design. The five participating NICUs were purposively selected to represent different acuity levels, number of beds, locations and populations served. Our implementation strategy integrates our experience conducting H-HOPE and a well-established implementation model, the Consolidated Framework for Implementation Research (CFIR). The CFIR identifies influences (facilitators and barriers) that affect successful implementation within five domains: intervention characteristics, outer setting (the hospital and external events and stakeholders), inner setting (NICU), implementers’ individual characteristics, and the implementation process. NICUs will use the CFIR process, which includes three phases: Planning and Engaging, Executing, and Reflecting and Evaluating. Because sustaining is a critical goal of implementation, we modify the CFIR implementation process by adding a final phase of Sustaining. DISCUSSION: This study builds on the CFIR, adding Sustaining H-HOPE to observe what happens when sites begin to maintain implementation without outside support, and extends its use to the NICU acute care setting. Our mixed methods analysis systematically identifies key facilitators and barriers of implementation success and effectiveness across the five domains of the CFIR. Long term benefits have not yet been studied but may include substantial health and developmental outcomes for infants, more optimal parent-child relationships, reduced stress and costs for families, and substantial indirect societal benefits including reduced health care and special education costs. TRIAL REGISTRATION: ClinicalTrials.gov registration number NCT04555590, Registered on 8/19/2020.
format Online
Article
Text
id pubmed-7988259
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-79882592021-03-24 Protocol for implementation of an evidence based parentally administered intervention for preterm infants White-Traut, Rosemary Brandon, Debra Kavanaugh, Karen Gralton, Karen Pan, Wei Myers, Evan R. Andrews, Bree Msall, Michael Norr, Kathleen F. BMC Pediatr Study Protocol BACKGROUND: Multi-sensory behavioral interventions for preterm infants have the potential to accelerate feeding, growth, and optimize developmental trajectories and increase parents’ interactive engagement with their infants. However, few neonatal intensive care units (NICUs) provide evidence-based standardized early behavioral interventions as routine care. Lack of implementation is a major gap between research and clinical practice. H-HOPE, is a standardized behavioral intervention with an infant- directed component (Massage+) and a parent-directed component (four participatory guidance sessions that focus on preterm infants’ behaviors and appropriate responses). H-HOPE has well documented efficacy. The purpose of this implementation study is to establish H-HOPE as the standard of care in 5 NICUs. METHODS: The study employs a Type 3 Hybrid design to simultaneously examine the implementation process and effectiveness in five NICUs. To stagger implementation across the clinical sites, we use an incomplete stepped wedge design. The five participating NICUs were purposively selected to represent different acuity levels, number of beds, locations and populations served. Our implementation strategy integrates our experience conducting H-HOPE and a well-established implementation model, the Consolidated Framework for Implementation Research (CFIR). The CFIR identifies influences (facilitators and barriers) that affect successful implementation within five domains: intervention characteristics, outer setting (the hospital and external events and stakeholders), inner setting (NICU), implementers’ individual characteristics, and the implementation process. NICUs will use the CFIR process, which includes three phases: Planning and Engaging, Executing, and Reflecting and Evaluating. Because sustaining is a critical goal of implementation, we modify the CFIR implementation process by adding a final phase of Sustaining. DISCUSSION: This study builds on the CFIR, adding Sustaining H-HOPE to observe what happens when sites begin to maintain implementation without outside support, and extends its use to the NICU acute care setting. Our mixed methods analysis systematically identifies key facilitators and barriers of implementation success and effectiveness across the five domains of the CFIR. Long term benefits have not yet been studied but may include substantial health and developmental outcomes for infants, more optimal parent-child relationships, reduced stress and costs for families, and substantial indirect societal benefits including reduced health care and special education costs. TRIAL REGISTRATION: ClinicalTrials.gov registration number NCT04555590, Registered on 8/19/2020. BioMed Central 2021-03-24 /pmc/articles/PMC7988259/ /pubmed/33761902 http://dx.doi.org/10.1186/s12887-021-02596-1 Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
White-Traut, Rosemary
Brandon, Debra
Kavanaugh, Karen
Gralton, Karen
Pan, Wei
Myers, Evan R.
Andrews, Bree
Msall, Michael
Norr, Kathleen F.
Protocol for implementation of an evidence based parentally administered intervention for preterm infants
title Protocol for implementation of an evidence based parentally administered intervention for preterm infants
title_full Protocol for implementation of an evidence based parentally administered intervention for preterm infants
title_fullStr Protocol for implementation of an evidence based parentally administered intervention for preterm infants
title_full_unstemmed Protocol for implementation of an evidence based parentally administered intervention for preterm infants
title_short Protocol for implementation of an evidence based parentally administered intervention for preterm infants
title_sort protocol for implementation of an evidence based parentally administered intervention for preterm infants
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7988259/
https://www.ncbi.nlm.nih.gov/pubmed/33761902
http://dx.doi.org/10.1186/s12887-021-02596-1
work_keys_str_mv AT whitetrautrosemary protocolforimplementationofanevidencebasedparentallyadministeredinterventionforpreterminfants
AT brandondebra protocolforimplementationofanevidencebasedparentallyadministeredinterventionforpreterminfants
AT kavanaughkaren protocolforimplementationofanevidencebasedparentallyadministeredinterventionforpreterminfants
AT graltonkaren protocolforimplementationofanevidencebasedparentallyadministeredinterventionforpreterminfants
AT panwei protocolforimplementationofanevidencebasedparentallyadministeredinterventionforpreterminfants
AT myersevanr protocolforimplementationofanevidencebasedparentallyadministeredinterventionforpreterminfants
AT andrewsbree protocolforimplementationofanevidencebasedparentallyadministeredinterventionforpreterminfants
AT msallmichael protocolforimplementationofanevidencebasedparentallyadministeredinterventionforpreterminfants
AT norrkathleenf protocolforimplementationofanevidencebasedparentallyadministeredinterventionforpreterminfants