GPS (Giving Parents Support): Parent Navigation After NICU Discharge

NCT02643472 | Completed Results

• 1 other identifier: IHS-1403-11567
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Parental Self-Efficacy

  Parental self-efficacy was measured using the Perceived Maternal Parenting Self-Efficacy Questionnaire (PMPS-E). Mean scores were determined and compared between groups. PMPS-E scores can range from 20-80, and higher scores indicate higher levels of parental self-efficacy.

  baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge

Secondary Outcomes (9)

• Parental Anxiety

  baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge

• Parental Stress

  baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge

• General Stress

  baseline, 1 week, 1 mo, 3 mo, 6 mo, 12 months after discharge

• Parental Stress in the Neonatal Intensive Care Unit

  Baseline

• Parental Depression

  baseline; 1 month, 3 months, 6 months, 12 months after discharge

Study Arms (2)

Care Notebook

OTHER

Parents of infants who were discharged from the Children's National NICU will be randomized to receive enhanced usual care by provision of a NICU care resource notebook. Parents will be notified about group assignment prior to discharge. Stratification will occur according to birth weight.

Behavioral: Care Notebook

Care Notebook + Parent Navigator

EXPERIMENTAL

Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation. Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight.

Behavioral: Parent Navigator; Behavioral: Care Notebook

Interventions

Parent Navigator BEHAVIORAL

Parents will be contacted by the parent navigator within 2 business days after discharge to assess how the family is coping, answer questions, and provide necessary resources. Navigators will be in touch with families monthly and according to the parent's needs. They will assist the parent in making and keeping appointments, answer questions about insurance coverage, medical equipment and supplies, and serve as a liaison between parent and healthcare providers. However, the specific PN intervention for each family will be based on each family's needs and therefore may differ.

Also known as: Peer to Peer Support

Care Notebook + Parent Navigator

Care Notebook BEHAVIORAL

A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates. It was based on peer to peer feedback from former NICU parents, in addition, to community resources developed by current Parent Navigator Program at Children's National Health System.

Care Notebook; Care Notebook + Parent Navigator

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's National Research Institute: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (3)

• Younge T, Jacobs M, Tuchman L, Streisand R, Soghier L, Fratantoni K. Sociodemographic risk factors, parental stress and social support in the neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed. 2023 Mar;108(2):165-169. doi: 10.1136/archdischild-2022-324119. Epub 2022 Sep 6.

  PMID: 36805477 DERIVED

• 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.

  PMID: 35260824 DERIVED

• 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.

  PMID: 29733982 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Dr. Karen Fratantoni
• Organization: Children's National Health System

kfratant@childrensnational.org

202-476-4793

Study Officials

• Karen Fratantoni, MD, MPH

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: December 31, 2015
• Study Start: January 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2018
• Last Updated: August 5, 2019
• Results First Posted: August 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)