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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02643472
Recruitment Status : Completed
First Posted : December 31, 2015
Results First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Karen Fratantoni, Children's National Research Institute

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.


Condition or disease Intervention/treatment Phase
Premature Birth of Newborn Family Immature Newborn Newborn Morbidity Infant Newborn Disease Behavioral: Parent Navigator Behavioral: Care Notebook Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: GPS (Giving Parents Support): Parent Navigation After NICU Discharge
Actual Study Start Date : January 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : March 2018

Arm Intervention/treatment
Care Notebook
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
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.

Experimental: Care Notebook + Parent Navigator
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
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.
Other Name: Peer to Peer Support

Behavioral: Care Notebook
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.




Primary Outcome Measures :
  1. Parental Self-Efficacy [ Time Frame: baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge ]
    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.


Secondary Outcome Measures :
  1. Parental Anxiety [ Time Frame: baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge ]
    Parental anxiety was measured using the State Trait Anxiety Inventory (STAI). Mean scores were determined and compared between groups. The trait portion (Y-2) was only administered at baseline, while the state portion (Y-1) was administered at every interval and used for longitudinal analyses. STAI scores can range from 20-80, and higher scores indicate higher levels of anxiety.

  2. Parental Stress [ Time Frame: baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge ]
    Parental stress was measured using the Parental Stress Scale (PSS). Mean scores were determined and compared between groups. PSS scores can range from 18-90, and higher scores indicate higher levels of parental stress.

  3. General Stress [ Time Frame: baseline, 1 week, 1 mo, 3 mo, 6 mo, 12 months after discharge ]
    General stress was measured using the Perceived Stress Scale (PSS-10), a 10-item instrument which asks respondents to consider their feelings and thoughts during the last month. Total scores range from 0-40, with higher scores indicating higher levels of stress

  4. Parental Stress in the Neonatal Intensive Care Unit [ Time Frame: Baseline ]
    The Parental Stressor Scale:Neonatal Intensive Care Unit (PSS:NICU) was used to measure NICU-specific stress. Mean total and subscale scores were determined using Metric 1 (applicable stress) and compared between groups. PSS:NICU scores can range from 1-5, and higher scores indicate higher levels of NICU-specific stress.

  5. Parental Depression [ Time Frame: baseline; 1 month, 3 months, 6 months, 12 months after discharge ]
    Parental depression was measured using the 10-item Center for Epidemiological Study Depression Scale (CES-D 10). Mean scores were determined and compared between groups. CES-D 10 scores can range from 0-30, and a score >=10 indicates the presence of depressive symptoms.

  6. ED Visits [ Time Frame: One year ]
    Infant ED visits were parent-reported and totaled over a period of 12 months.

  7. Hospitalizations [ Time Frame: One year ]
    Infant hospitalizations were parent-reported and totaled over a period of 12 months.

  8. Infant Immunization Status [ Time Frame: One year ]
    Infant immunization status was either provider-reported or accessed via a state registry. The number of neonates with a complete immunization series within 12 months after discharge were compared between groups. Complete immunization status was defined as receipt of 3 diphtheria tetanus acellular pertussis (DTaP) vaccines, 3 pneumococcal conjugate vaccines (PCV13), and either 2 or 3 Hemophilus influenzae b (HIB) vaccines, depending on vaccine type (e.g. PedvaxHIB at 2 and 4 months, ActHIB at 2, 4, and 6 months).

  9. Infant Developmental Status [ Time Frame: One year ]
    Infant developmental status was measured using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley III). The Bayley III was administered between 11-13 months of study follow-up, and it used corrected infant age to account for prematurity. Composite scores for cognitive, language, and motor domains were determined and compared between groups. Bayley scores can range from 40-160, and higher scores indicate higher levels of infant development.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643472


Locations
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United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Children's National Research Institute
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Karen Fratantoni, MD, MPH Children's National Research Institute
  Study Documents (Full-Text)

Documents provided by Karen Fratantoni, Children's National Research Institute:
Study Protocol  [PDF] February 15, 2017
Statistical Analysis Plan  [PDF] February 15, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Karen Fratantoni, MD, Children's National Research Institute
ClinicalTrials.gov Identifier: NCT02643472    
Other Study ID Numbers: IHS-1403-11567
First Posted: December 31, 2015    Key Record Dates
Results First Posted: August 5, 2019
Last Update Posted: August 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Karen Fratantoni, Children's National Research Institute:
neonate
newborn
neonatal intensive care unit
NICU
NICU discharge
parent navigator
peer to peer
peer coaching
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications