Ignite Creation Date:
2024-05-06 @ 7:58 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02643472
Status:
COMPLETED
Last Update Posted:
2019-08-05
First Post:
2015-12-22
Brief Title:
GPS Giving Parents Support Parent Navigation After NICU Discharge
Sponsor:
Childrens National Research Institute
Organization:
Childrens National Research Institute
Study Overview
Official Title:
GPS Giving Parents Support Parent Navigation After NICU Discharge
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GPS
Brief Summary:
BACKGROUND Annually 400000 US newborns require neonatal intensive care unit NICU care13 will require ongoing or specialty care after discharge Some NICU graduates can be classified as children with special health care needs CSHCN who will require health and related services of a type or amount beyond that required by children generally NICU parents report increased anxiety and stress during their stay and transition home from the NICU Short-term peer-to -peer programs during hospitalization decrease stress anxiety and depression for mothers however no studies have evaluated the effects of long term post-discharge peer support Childrens National CN provides medical home services to CSHCN through its Parent Navigator Program PNP Parent Navigators PNs are CSHCN parents who provide peer emotional support access to community resources and assistance with navigating complicated health systems NICU graduates and their caregivers may benefit from support provided by PNs after discharge No data regarding the impact of PNs on patient and family outcomes of the NICU graduate are available
OBJECTIVE To assess the impact of a PNP on a parents self-efficacy stress anxiety depression infant health care utilization and immunization status
METHODS 300 NICU graduates will be randomized to receive either PN for 12 months intervention group or usual care comparison group Baseline data at 1 week 1 3 6 and 12 months after discharge will be collected from caregivers in both groups including scales for self-efficacy stress anxiety and depression infant healthcare utilization and immunization status Outcomes will be compared at 12 months
PATIENT OUTCOMES PROJECTED The study outcomes are parental self-efficacy stress anxiety and depression infant health care utilization and immunization status
ANTICIPATED IMPACT Prior studies utilizing small samples have suggested that peer support in the NICU can reduce anxiety and depression in caregivers It is unclear whether peer support after discharge when a family is faced with the total care of their child without structured supports can significantly impact parents ability to care for their child The investigators anticipate that this simple intervention will increase self-efficacy in caregivers reduce stress anxiety and depression in turn resulting in improved health outcomes for their child
OBJECTIVE To assess the impact of a PNP on a parents self-efficacy stress anxiety depression infant health care utilization and immunization status
METHODS 300 NICU graduates will be randomized to receive either PN for 12 months intervention group or usual care comparison group Baseline data at 1 week 1 3 6 and 12 months after discharge will be collected from caregivers in both groups including scales for self-efficacy stress anxiety and depression infant healthcare utilization and immunization status Outcomes will be compared at 12 months
PATIENT OUTCOMES PROJECTED The study outcomes are parental self-efficacy stress anxiety and depression infant health care utilization and immunization status
ANTICIPATED IMPACT Prior studies utilizing small samples have suggested that peer support in the NICU can reduce anxiety and depression in caregivers It is unclear whether peer support after discharge when a family is faced with the total care of their child without structured supports can significantly impact parents ability to care for their child The investigators anticipate that this simple intervention will increase self-efficacy in caregivers reduce stress anxiety and depression in turn resulting in improved health outcomes for their child
Detailed Description:
Specific Aims
Infants who are discharged from the neonatal intensive care unit NICU almost invariably have high levels of health care needs in the first year after discharge requiring multiple sub specialist visits medications andor medical technology needs Parents of NICU infants are often overwhelmed by the needs of their infants after they are discharged home and frequently have few supports to help them cope This study will investigate the impact of peer to peer support through a Parent Navigation program for NICU graduates and their parents The study aims will be achieved through a randomized controlled trial of Parent Navigation using a care resource notebook as the control intervention
The specific aims of this study are to
1 Determine if Parent Navigation increases overall parental self-efficacy and decreases stress among parents caring for a child with a special health care need CSHCN when measured at repeated time points during the 12 months after NICU discharge
Hypothesis 1a Parent Navigation will increase parental self-efficacy when compared with the control group
Hypothesis 1b Parent Navigation will decrease parenting stress when compared with the control group
2 Determine if Parent Navigation improves overall levels of anxiety and depression in parents of children with special health care needs when measured repeatedly during the 12 months after NICU discharge
Hypothesis 2a Parent Navigation will improve parent anxiety compared with control group
Hypothesis 2b Parent Navigation will lessen parent depression compared with control group
3 Determine if Parent Navigation positively impacts on infant health outcomes during the 12 months after NICU discharge
Hypothesis 3a Parent NavigationIntervention group will have significantly fewer hospitalizations when compared with control group
Hypothesis 3b Parent Navigation will have significantly fewer emergency department ED visits when compared with control group
Hypothesis 3c Parent Navigation will result in improved immunization status when compared with control group
Hypothesis 3d By supporting parents emotional function infant developmental progress will be enhanced
Background
NICU parents experience high levels of stress anxiety and depression and low levels of self-efficacy Neonates comprise one of the largest groups of medically complex infants in the United States Of the 4 million live births in 2012 115 460000 were born preterm at 37 weeks gestation The District of Columbia alone has a higher rate 128 of preterm infants which is 11 higher than the national average The vast majority of infants born preterm and 1 of full term infants with significant illnesses at birth eg congenital anomalies will require care in a neonatal intensive care unit NICU and 30 of infants being discharged from the NICU NICU graduates annually 110000 babies require supplementary short -term or ongoing specialty care and have increased risk of long- term disability including cerebral palsy deafness blindness and neurodevelopmental impairment At discharge this large cohort of neonates and their families face tremendous challenges as they transition from a highly structured medical environment to a less structured home environment Some challenges identified include feeling unprepared to care for their infant at home despite extensive teaching in the NICU setting feeling socially isolated as the typical celebratory process of giving birth and going home with baby has been disrupted by a serious medical condition and prolonged hospital stay Additionally depression and anxiety among mothers of infants have been shown to be associated with infant feeding difficulties suboptimal parenting practices and altered health care utilization
Parent navigation is a unique patient -centered intervention in which parents with experience caring for their own child with special health care need offer peer to peer support and mentoring to another parent of a child with a special health care need In 2008 Childrens National instituted a Parent Navigation program in which Parent Navigators PNs who are parents of children with special health care needs are employed by CN to provide peer to peer support to other parents of children with special health care need These parents provide their own personal experience and expertise in navigating the often confusing and frustrating health care systems Although the PN model is based on self-efficacy and social support models there are no published studies on the impact of PN on parental self-efficacy depression stress and infant health outcomes The investigators believe that neonates and their caregivers would benefit from peer to peer support provided by PNs after discharge Currently there are no data regarding the impact of PNs on patient and family outcomes of the NICU graduate
Preliminary Studies
As a first phase of this study the investigators conducted focus groups with parents of recently discharged NICU infants 4 focus groups n18 participants parent navigators 1 focus group n3 parents n2 NICU social workers case managers and nurses 1 focus group n23 NICU providers 1 focus group n5 and community providers n2 The investigators intervention is informed by this data
Infants who are discharged from the neonatal intensive care unit NICU almost invariably have high levels of health care needs in the first year after discharge requiring multiple sub specialist visits medications andor medical technology needs Parents of NICU infants are often overwhelmed by the needs of their infants after they are discharged home and frequently have few supports to help them cope This study will investigate the impact of peer to peer support through a Parent Navigation program for NICU graduates and their parents The study aims will be achieved through a randomized controlled trial of Parent Navigation using a care resource notebook as the control intervention
The specific aims of this study are to
1 Determine if Parent Navigation increases overall parental self-efficacy and decreases stress among parents caring for a child with a special health care need CSHCN when measured at repeated time points during the 12 months after NICU discharge
Hypothesis 1a Parent Navigation will increase parental self-efficacy when compared with the control group
Hypothesis 1b Parent Navigation will decrease parenting stress when compared with the control group
2 Determine if Parent Navigation improves overall levels of anxiety and depression in parents of children with special health care needs when measured repeatedly during the 12 months after NICU discharge
Hypothesis 2a Parent Navigation will improve parent anxiety compared with control group
Hypothesis 2b Parent Navigation will lessen parent depression compared with control group
3 Determine if Parent Navigation positively impacts on infant health outcomes during the 12 months after NICU discharge
Hypothesis 3a Parent NavigationIntervention group will have significantly fewer hospitalizations when compared with control group
Hypothesis 3b Parent Navigation will have significantly fewer emergency department ED visits when compared with control group
Hypothesis 3c Parent Navigation will result in improved immunization status when compared with control group
Hypothesis 3d By supporting parents emotional function infant developmental progress will be enhanced
Background
NICU parents experience high levels of stress anxiety and depression and low levels of self-efficacy Neonates comprise one of the largest groups of medically complex infants in the United States Of the 4 million live births in 2012 115 460000 were born preterm at 37 weeks gestation The District of Columbia alone has a higher rate 128 of preterm infants which is 11 higher than the national average The vast majority of infants born preterm and 1 of full term infants with significant illnesses at birth eg congenital anomalies will require care in a neonatal intensive care unit NICU and 30 of infants being discharged from the NICU NICU graduates annually 110000 babies require supplementary short -term or ongoing specialty care and have increased risk of long- term disability including cerebral palsy deafness blindness and neurodevelopmental impairment At discharge this large cohort of neonates and their families face tremendous challenges as they transition from a highly structured medical environment to a less structured home environment Some challenges identified include feeling unprepared to care for their infant at home despite extensive teaching in the NICU setting feeling socially isolated as the typical celebratory process of giving birth and going home with baby has been disrupted by a serious medical condition and prolonged hospital stay Additionally depression and anxiety among mothers of infants have been shown to be associated with infant feeding difficulties suboptimal parenting practices and altered health care utilization
Parent navigation is a unique patient -centered intervention in which parents with experience caring for their own child with special health care need offer peer to peer support and mentoring to another parent of a child with a special health care need In 2008 Childrens National instituted a Parent Navigation program in which Parent Navigators PNs who are parents of children with special health care needs are employed by CN to provide peer to peer support to other parents of children with special health care need These parents provide their own personal experience and expertise in navigating the often confusing and frustrating health care systems Although the PN model is based on self-efficacy and social support models there are no published studies on the impact of PN on parental self-efficacy depression stress and infant health outcomes The investigators believe that neonates and their caregivers would benefit from peer to peer support provided by PNs after discharge Currently there are no data regarding the impact of PNs on patient and family outcomes of the NICU graduate
Preliminary Studies
As a first phase of this study the investigators conducted focus groups with parents of recently discharged NICU infants 4 focus groups n18 participants parent navigators 1 focus group n3 parents n2 NICU social workers case managers and nurses 1 focus group n23 NICU providers 1 focus group n5 and community providers n2 The investigators intervention is informed by this data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None