N/A
N=300
GPS (Giving Parents Support): Parent Navigation After NICU Discharge
Premature Birth of Newborn · Family · Immature Newborn · Newborn Morbidity · Infant Newborn Disease
Bottom Line
View on ClinicalTrials.gov: NCT02643472 ↗Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Parental Self-Efficacy — 74.94; 74.75; 72.7; 72.6 score on a scale — p=0.73
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Parent Navigator (Behavioral); Care Notebook (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Children's National Research Institute
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Parental Self-Efficacy |
74.94; 74.75; 72.7; 72.6; 73.8; 73.6 | 0.73 |
| SECONDARY Parental Anxiety |
29.55; 31.14; 31.0; 32.5; 30.2; 31.8 | 0.12 |
| SECONDARY Parental Stress |
27.47; 29.29; 28.6; 30.4; 28.0; 29.8 | 0.03 sig |
| SECONDARY General Stress |
12.51; 13.74; 14.3; 15.5; 13.3; 14.5 | — |
| SECONDARY Parental Stress in the Neonatal Intensive Care Unit |
2.11; 1.99 | — |
| SECONDARY Parental Depression |
6.04; 6.98; 6.9; 7.8; 5.3; 6.2 | 0.06 |
| SECONDARY ED Visits |
0; 0 | 0.43 |
| SECONDARY Hospitalizations |
0; 0 | 0.64 |
| SECONDARY Infant Immunization Status |
107; 98; 36; 38 | 0.60 |
| SECONDARY Infant Developmental Status |
97.83; 98.13; 88.49; 86.89; 91.26; 91.79 | 0.92 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02643472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.