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

• Sponsor: Children's National Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02643472
• Collaborator: Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 300
• Location: 1
• Arms: 2
• Actual Duration (Months): 26
• Patients Per Site Per Month: 11.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Birth of Newborn; Family; Immature Newborn; Newborn Morbidity; Infant Newborn Disease	Behavioral: Parent Navigator; Behavioral: Care Notebook	N/A

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.

1. 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.

1. 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.

Study Design

• Study Type: Interventional
• 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: Jan 1, 2016
• Actual Primary Completion Date: Feb 1, 2017
• Actual Study Completion Date: Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 Names: 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.

Outcome Measures

Primary Outcome Measures

1. Parental Self-Efficacy [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 [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 [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 [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 [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 [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 [One year]

   Infant ED visits were parent-reported and totaled over a period of 12 months.

7. Hospitalizations [One year]

   Infant hospitalizations were parent-reported and totaled over a period of 12 months.

8. Infant Immunization Status [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

• Principal Investigator: Karen Fratantoni, MD, MPH, Children's National Research Institute

Study Documents (Full-Text)

• Study Protocol - Feb 15, 2017
• Statistical Analysis Plan - Feb 15, 2017

More Information

Publications

None provided.

• Responsible Party: Karen Fratantoni, MD, Children's National Research Institute
• ClinicalTrials.gov Identifier: NCT02643472
• Other Study ID Numbers: IHS-1403-11567
• First Posted: Dec 31, 2015
• Last Update Posted: Aug 5, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Karen Fratantoni, MD, 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: Premature Birth

Study Results

Participant Flow

Arm/Group Title	Care Notebook	Care Notebook + Parent Navigator
Arm/Group 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. 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.	Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation (PN). Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight. 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. The specific PN intervention for each family will be based on each family's needs and therefore may differ. 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.
Period Title: Overall Study
STARTED	150	150
COMPLETED	123	116
NOT COMPLETED	27	34

Baseline Characteristics

Arm/Group Title	Care Notebook	Care Notebook + Parent Navigator	Total
Arm/Group 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. 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.	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. 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. The specific PN intervention for each family will be based on each family's needs and therefore may differ. 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.	Total of all reporting groups
Overall Participants	150	150	300
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.4 (6.5)	29.9 (6.5)	30.1 (6.5)
Sex: Female, Male (Count of Participants)
Female	129 86%	138 92%	267 89%
Male	21 14%	12 8%	33 11%
Race/Ethnicity, Customized (Count of Participants)
American Indian/Pacific Islander	6 4%	2 1.3%	8 2.7%
Asian	11 7.3%	6 4%	17 5.7%
Black	66 44%	67 44.7%	133 44.3%
White	56 37.3%	61 40.7%	117 39%
Mixed race/not reported	11 7.3%	14 9.3%	25 8.3%
Region of Enrollment (participants) [Number]
United States	150 100%	150 100%	300 100%
Education (Count of Participants)
High school or less	34 22.7%	43 28.7%	77 25.7%
Trade/vocational/some college	46 30.7%	41 27.3%	87 29%
College degree or more	70 46.7%	66 44%	136 45.3%
Relationship (Count of Participants)
Single	22 14.7%	27 18%	49 16.3%
Married/partnered	128 85.3%	123 82%	251 83.7%
Other children (Count of Participants)
No other children at home	68 45.3%	61 40.7%	129 43%
At least one other child	82 54.7%	89 59.3%	171 57%
Infant gestational age (Count of Participants)
<32 weeks	39 26%	33 22%	72 24%
32-36 weeks	23 15.3%	36 24%	59 19.7%
>=37 weeks	88 58.7%	81 54%	169 56.3%
Infant birth weight (Count of Participants)
<1500 grams	32 21.3%	31 20.7%	63 21%
1500-2499 grams	34 22.7%	29 19.3%	63 21%
>=2500 grams	84 56%	90 60%	174 58%
Infant sex (Count of Participants)
Male	88 58.7%	86 57.3%	174 58%
Female	62 41.3%	64 42.7%	126 42%
Infant length of stay category (Count of Participants)
<=1 week	40 26.7%	38 25.3%	78 26%
8-17 days	32 21.3%	41 27.3%	73 24.3%
18-47 days	38 25.3%	37 24.7%	75 25%
>=48 days	40 26.7%	34 22.7%	74 24.7%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Care Notebook	Care Notebook + Parent Navigator
Arm/Group 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. 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.	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. 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. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and
Measure Participants	123	115
Predicted means: main effect of group	74.94	74.75
Estimated scores: 1-week	72.7	72.6
Estimated scores: 1-month	73.8	73.6
Estimated scores: 3-month	76.0	75.9
Estimated scores: 6-month	78.0	77.9
Estimated scores: 12-month	76.9	76.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Care Notebook, Care Notebook + Parent Navigator
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.73
	Comments
	Method	Generalized Estimating Equations
	Comments	In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Care Notebook	Care Notebook + Parent Navigator
Arm/Group 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. 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.	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. 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. The specific PN intervention for each family will be based on each family's needs and therefore may differ. 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.
Measure Participants	123	115
Predicted means: main effect of group	29.55	31.14
Estimated scores: 1-week	31.0	32.5
Estimated scores: 1-month	30.2	31.8
Estimated scores: 3-month	28.7	30.2
Estimated scores: 6-month	27.4	28.9
Estimated scores: 12-month	28.7	30.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Care Notebook, Care Notebook + Parent Navigator
	Comments	STAI Y-1 data was used in these statistical analyses.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.12
	Comments
	Method	Generalized Estimating Equations
	Comments	In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Care Notebook	Care Notebook + Parent Navigator
Arm/Group 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. 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.	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. 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. The specific PN intervention for each family will be based on each family's needs and therefore may differ. 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.
Measure Participants	123	115
Predicted means: main effect of group	27.47	29.29
Estimated scores: 1-week	28.6	30.4
Estimated scores: 1-month	28.0	29.8
Estimated scores: 3-month	26.7	28.5
Estimated scores: 6-month	25.7	27.5
Estimated scores: 12-month	27.1	28.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Care Notebook, Care Notebook + Parent Navigator
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	Generalized Estimating Equations
	Comments	In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Care Notebook	Care Notebook + Parent Navigator
Arm/Group 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. 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.	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. 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. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and
Measure Participants	123	115
Predicted means: main effect of group	12.51	13.74
Estimated scores: 1-week	14.3	15.5
Estimated scores: 1-month	13.3	14.5
Estimated scores: 3-month	11.2	12.4
Estimated scores: 6-month	9.6	10.8
Estimated scores: 12-month	11.9	13.0

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Care Notebook	Care Notebook + Parent Navigator
Arm/Group 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. 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.	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. 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. The specific PN intervention for each family will be based on each family's needs and therefore may differ. 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.
Measure Participants	148	148
Mean (Standard Deviation) [score on a scale]	2.11 (0.92)	1.99 (0.80)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Care Notebook	Care Notebook + Parent Navigator
Arm/Group 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. 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.	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. 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. The specific PN intervention for each family will be based on each family's needs and therefore may differ. 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.
Measure Participants	123	116
Predicted means: main effect of group	6.04	6.98
Estimated scores: 1-month	6.9	7.8
Estimated scores: 3-month	5.3	6.2
Estimated scores: 6-month	4.0	5.0
Estimated scores: 12-month	6.2	7.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Care Notebook, Care Notebook + Parent Navigator
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.06
	Comments
	Method	Generalized Estimating Equations
	Comments	In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.

7. Secondary Outcome

Title	ED Visits
Description	Infant ED visits were parent-reported and totaled over a period of 12 months.
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Care Notebook	Care Notebook + Parent Navigator
Arm/Group 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. 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.	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. 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. The specific PN intervention for each family will be based on each family's needs and therefore may differ. 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.
Measure Participants	147	145
Median (Inter-Quartile Range) [ED visits]	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Care Notebook, Care Notebook + Parent Navigator
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.43
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

8. Secondary Outcome

Title	Hospitalizations
Description	Infant hospitalizations were parent-reported and totaled over a period of 12 months.
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Care Notebook	Care Notebook + Parent Navigator
Arm/Group 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. 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.	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. 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. The specific PN intervention for each family will be based on each family's needs and therefore may differ. 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.
Measure Participants	147	145
Median (Inter-Quartile Range) [Hospitalizations]	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Care Notebook, Care Notebook + Parent Navigator
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.64
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Care Notebook	Care Notebook + Parent Navigator
Arm/Group 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. 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.	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. 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. The specific PN intervention for each family will be based on each family's needs and therefore may differ. 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.
Measure Participants	143	136
Fully immunized	107 71.3%	98 65.3%
Not fully immunized	36 24%	38 25.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Care Notebook, Care Notebook + Parent Navigator
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.60
	Comments
	Method	Chi-squared
	Comments

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Care Notebook	Care Notebook + Parent Navigator
Arm/Group 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. 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.	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. 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. The specific PN intervention for each family will be based on each family's needs and therefore may differ. 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.
Measure Participants	65	62
Cognitive	97.83 (16.25)	98.13 (17.13)
Language	88.49 (15.33)	86.89 (17.49)
Motor	91.26 (16.02)	91.79 (18.98)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Care Notebook, Care Notebook + Parent Navigator
	Comments	Infant development status was evaluated with Bayley subscales. Cognitive subscale.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.92
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Care Notebook, Care Notebook + Parent Navigator
	Comments	Infant development status was evaluated with Bayley subscales. Language subscale.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.58
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Care Notebook, Care Notebook + Parent Navigator
	Comments	Infant development status was evaluated with Bayley subscales. Motor subscale.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.87
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	Adverse event data were collected throughout the study period of 12 months.
Adverse Event Reporting Description	The deaths of these infants were unrelated to our study. This study was minimal risk, offering peer support after NICU discharge, and did not involve any medical procedures or interventions.
Arm/Group Title	Care Notebook		Care Notebook + Parent Navigator
Arm/Group 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. 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.		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. 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. The specific PN intervention for each family will be based on each family's needs and therefore may differ. 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.
All Cause Mortality
	Care Notebook		Care Notebook + Parent Navigator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/150 (1.3%)		5/150 (3.3%)
Serious Adverse Events
	Care Notebook		Care Notebook + Parent Navigator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/150 (0%)		0/150 (0%)
Other (Not Including Serious) Adverse Events
	Care Notebook		Care Notebook + Parent Navigator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/150 (0%)		0/150 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.