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

Primary Purpose

Premature Birth of Newborn, Family, Immature Newborn

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent Navigator
Care Notebook
Sponsored by
Children's National Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature Birth of Newborn focused on measuring neonate, newborn, neonatal intensive care unit, NICU, NICU discharge, parent navigator, peer to peer, peer coaching

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's National Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Care Notebook

Care Notebook + Parent Navigator

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Parental Anxiety
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.
Parental Stress
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.
General Stress
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
Parental Stress in the Neonatal Intensive Care Unit
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.
Parental Depression
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.
ED Visits
Infant ED visits were parent-reported and totaled over a period of 12 months.
Hospitalizations
Infant hospitalizations were parent-reported and totaled over a period of 12 months.
Infant Immunization Status
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).
Infant Developmental Status
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.

Full Information

First Posted
December 22, 2015
Last Updated
June 20, 2019
Sponsor
Children's National Research Institute
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02643472
Brief Title
GPS (Giving Parents Support): Parent Navigation After NICU Discharge
Acronym
GPS
Official Title
GPS (Giving Parents Support): Parent Navigation After NICU Discharge
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's National Research Institute
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Care Notebook
Arm Type
Other
Arm Description
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.
Arm Title
Care Notebook + Parent Navigator
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Parent Navigator
Other Intervention Name(s)
Peer to Peer Support
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Care Notebook
Intervention Description
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 Measure Information:
Title
Parental Self-Efficacy
Description
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.
Time Frame
baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge
Secondary Outcome Measure Information:
Title
Parental Anxiety
Description
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.
Time Frame
baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge
Title
Parental Stress
Description
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.
Time Frame
baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge
Title
General Stress
Description
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
Time Frame
baseline, 1 week, 1 mo, 3 mo, 6 mo, 12 months after discharge
Title
Parental Stress in the Neonatal Intensive Care Unit
Description
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.
Time Frame
Baseline
Title
Parental Depression
Description
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.
Time Frame
baseline; 1 month, 3 months, 6 months, 12 months after discharge
Title
ED Visits
Description
Infant ED visits were parent-reported and totaled over a period of 12 months.
Time Frame
One year
Title
Hospitalizations
Description
Infant hospitalizations were parent-reported and totaled over a period of 12 months.
Time Frame
One year
Title
Infant Immunization Status
Description
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).
Time Frame
One year
Title
Infant Developmental Status
Description
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.
Time Frame
One year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Fratantoni, MD, MPH
Organizational Affiliation
Children's National Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35260824
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. Erratum In: J Perinatol. 2022 Apr 21;:
Results Reference
derived
PubMed Identifier
29733982
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.
Results Reference
derived

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

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