Clinical trial NCT02643472: GPS (Giving Parents Support): Parent Navigation After NICU Discharge
Official title: GPS (Giving Parents Support): Parent Navigation After NICU Discharge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth of Newborn
Family
Immature Newborn
Newborn Morbidity
Infant Newborn Disease
Keywords: neonate
newborn
neonatal intensive care unit
NICU
NICU discharge
parent navigator
peer to peer
peer coaching
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-12-31
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: BACKGROUND: Annually \>400,000 US newborns require neonatal intensive care unit (NICU) care.1/3 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. Children's 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 parent's 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, and/or 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 Navigation/Intervention 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, 11.5% (\~460,000) were born preterm at \< 37 weeks gestation. The District of Columbia alone has a higher rate (12.8%) 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 (e.g., congenital anomalies) will require care in a neonatal intensive care unit (NICU), and \~30% of infants being discharged from the NICU ("NICU graduates") annually (110,000 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, Children's 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, n=18 participants), parent navigators (1 focus group n=3), parents (n=2), NICU social workers, case managers, and nurses (1 focus group, n=23); NICU providers (1 focus group, n=5) and community providers (n=2). The investigators' intervention is informed by this data.

Eligibility criteria: Inclusion Criteria:

* parents of neonates receiving care in the Children's National NICU

Exclusion Criteria:

* infant is not being discharged with a custodial parent (e.g., in custody of Child Protection Services)
* neither parent can complete an interview in English,
* the parent who will be providing most of the care is younger than 18 years of age,
* those with insufficient knowledge of English to participate in the telephone interviews
* the parent/caregiver has plans to leave the District of Columbia (DC) metropolitan area permanently within the following year.

Primary outcomes:
measure: Parental Self-Efficacy
timeFrame: baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge
Secondary outcomes:
measure: Parental Anxiety
timeFrame: baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge
measure: Parental Stress
timeFrame: baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge
measure: General Stress
timeFrame: baseline, 1 week, 1 mo, 3 mo, 6 mo, 12 months after discharge
measure: Parental Stress in the Neonatal Intensive Care Unit
timeFrame: Baseline
measure: Parental Depression
timeFrame: baseline; 1 month, 3 months, 6 months, 12 months after discharge
measure: ED Visits
timeFrame: One year
measure: Hospitalizations
timeFrame: One year
measure: Infant Immunization Status
timeFrame: One year
measure: Infant Developmental Status
timeFrame: One year
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Karen Fratantoni, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fratantoni K, Soghier L, Kritikos K, Jacangelo J, Herrera N, Tuchman L, Glass P, Streisand R, Jacobs M. Giving parents support: a randomized trial of peer support for parents after NICU discharge. J Perinatol. 2022 Jun;42(6):730-737. doi: 10.1038/s41372-022-01341-5. Epub 2022 Mar 8.
citation: Carty CL, Soghier LM, Kritikos KI, Tuchman LK, Jiggetts M, Glass P, Streisand R, Fratantoni KR. The Giving Parents Support Study: A randomized clinical trial of a parent navigator intervention to improve outcomes after neonatal intensive care unit discharge. Contemp Clin Trials. 2018 Jul;70:117-134. doi: 10.1016/j.cct.2018.05.004. Epub 2018 May 5.