NICU2HOME+: Supporting Illinois Families

NCT04480255 | Completed

• 1 other identifier: STU00212196
• Study Type: interventional
• Target: 413
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this project is to provide a stepwise, methodical approach to developing and testing the ability of Neonatal Intensive Care Unit 2 Home (NICU2HOME+) to support diverse Illinois families of premature infants during and after their Neonatal Intensive Care Unit (NICU) stays in an effort to address health equity, improve parenting, and reduce costs. There are 3 objectives of the study: 1) Identify and assess the requirements for expansion of NICU2HOME+, a suite of mobile patient education and engagement applications with Electronic Medical Record (EMR) integration that is culturally appropriate and customized to the needs of a diverse population of patients and families to 3 additional level III Illinois NICUS; 2) develop and deploy NICU2HOME+ to these 3 additional NICUs; and 3)determine if it is effective in: a) addressing health equity issues, b) improving parenting self-efficacy and satisfaction, and c) improving NICU outcomes such as a reduced length of stay and lower readmission rates that result in lower healthcare costs. All research recruitment and participation will take place in the following spaces:

1. 1.Northwestern Medicine's Central DuPage Hospital (25 N.Winfield Rd., Winfield, IL)- NICU, Postpartum, and Research Offices
2. 2.Northwest Community Hospital (800 W. Central Rd., Arlington Heights, IL)- NICU,Postpartum, and Research Offices
3. 3.Rush University Medical Center (Chicago, IL)- NICU, Postpartum, and Research Offices

Conditions

Premature Birth; NICU; Premature; Infant

Keywords

Premature Infant; NICU; Premature Birth; Smartphone App; NICU

Outcome Measures

Primary Outcomes (2)

• Mobile Application Outcome 1

  The primary outcome measure understand how the smartphone application improves patient/parent experiences in the NICU. This will be measured through a survey.

  2-3 months

• Mobile Application Outcome 2

  The primary outcome measure will addressing the association of the smartphone application with parenting self-efficacy to improve infants' and parents' health outcomes. This will be measured through a survey.

  2-3 months

Secondary Outcomes (13)

• State-Trait Anxiety Inventory (STAI)

  2-3 months

• Parenting Sense of Competence Scale (PSOC)

  2-3 months

• Edinburgh Postnatal Depression Scale (EPDS)

  2-3 months

• Press Ganey Questionnaire (PG)

  2-3 months

• Healthcare encounters (HE)

  2-3 months

Study Arms (2)

Group 1: Standard of Care

ACTIVE COMPARATOR

Parents of infants born from date July 2020-December 2020

Other: Group 1: Standard of Care

Group 2: NICU2HOME+ app

ACTIVE COMPARATOR

Parents of infants born from mid Jan 2021-May2021

Other: Group 2: NICU2HOME+ app

Interventions

Group 1: Standard of Care OTHER

Those who are in Group 1 will receive the usual care which includes: 1. a welcome packet from the nursing staff 2. access to their infant's medical team including doctors and nurse 3. opportunities to ask any questions and understand the care their baby is receiving through participation in daily work rounds or through setting up family meetings with the medical team.

Group 1: Standard of Care

Group 2: NICU2HOME+ app OTHER

In addition to the usual care made available to Group 1 as described above, Group 2 parents will receive the smartphone app. Group 2 parents will be asked to download the NICU2HOME app.

Group 2: NICU2HOME+ app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents (including single parents) of premature infants (\<35 weeks) admitted to Central Dupage Hospital (CDH), Northwest Community Hospital (NCH), and Rush University Medical Center (RUSH)
• Infants born prematurely with a gestational age of \<35 weeks
• Minimum stay in NICU of 7 days
• Competent in English or Spanish (i.e. to fully understand the questions asked in the surveys)
• Smartphone owner

You may not qualify if:

• Non-adults unable to consent/Cognitively Impaired
• Prisoners or other detained individuals

Sponsors & Collaborators

• Northwestern University: lead
• Blue Cross Blue Shield: collaborator

Study Sites (3)

Northwest Community Hospital

Arlington Heights, Illinois, 60005, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Centra Dupage Hospital

Winfield, Illinois, 60192, United States

Location

Related Publications (15)

• Institute of Medicine (US) Committee on Understanding Premature Birth and Assuring Healthy Outcomes; Behrman RE, Butler AS, editors. Preterm Birth: Causes, Consequences, and Prevention. Washington (DC): National Academies Press (US); 2007. Available from http://www.ncbi.nlm.nih.gov/books/NBK11362/

  PMID: 20669423 BACKGROUND

• Garfield CF, Lee Y, Kim HN. Paternal and maternal concerns for their very low-birth-weight infants transitioning from the NICU to home. J Perinat Neonatal Nurs. 2014 Oct-Dec;28(4):305-12. doi: 10.1097/JPN.0000000000000021.

  PMID: 24927295 BACKGROUND

• Braveman P. What is health equity: and how does a life-course approach take us further toward it? Matern Child Health J. 2014 Feb;18(2):366-72. doi: 10.1007/s10995-013-1226-9.

  PMID: 23397099 BACKGROUND

• Blumenshine P, Egerter S, Barclay CJ, Cubbin C, Braveman PA. Socioeconomic disparities in adverse birth outcomes: a systematic review. Am J Prev Med. 2010 Sep;39(3):263-72. doi: 10.1016/j.amepre.2010.05.012.

  PMID: 20709259 BACKGROUND

• MacDorman MF. Race and ethnic disparities in fetal mortality, preterm birth, and infant mortality in the United States: an overview. Semin Perinatol. 2011 Aug;35(4):200-8. doi: 10.1053/j.semperi.2011.02.017.

  PMID: 21798400 BACKGROUND

• Pew Research Center: Internet Science & Technology. Mobile technology fact sheet. 2018; http://www.pewinternet.org/fact-sheet/mobile/. Accessed January 14, 2019, 2015.

  BACKGROUND

• Anderson-Lewis C, Darville G, Mercado RE, Howell S, Di Maggio S. mHealth Technology Use and Implications in Historically Underserved and Minority Populations in the United States: Systematic Literature Review. JMIR Mhealth Uhealth. 2018 Jun 18;6(6):e128. doi: 10.2196/mhealth.8383.

  PMID: 29914860 BACKGROUND

• Anoshiravani A, Gaskin G, Kopetsky E, Sandborg C, Longhurst CA. Implementing an Interoperable Personal Health Record in Pediatrics: Lessons Learned at an Academic Children's Hospital. J Particip Med. 2011 Jul 10;3:e30.

  PMID: 21853160 BACKGROUND

• Cooper LG, Gooding JS, Gallagher J, Sternesky L, Ledsky R, Berns SD. Impact of a family-centered care initiative on NICU care, staff and families. J Perinatol. 2007 Dec;27 Suppl 2:S32-7. doi: 10.1038/sj.jp.7211840.

  PMID: 18034178 BACKGROUND

• De Rouck S, Leys M. Information needs of parents of children admitted to a neonatal intensive care unit: a review of the literature (1990-2008). Patient Educ Couns. 2009 Aug;76(2):159-73. doi: 10.1016/j.pec.2009.01.014. Epub 2009 Mar 24.

  PMID: 19321288 BACKGROUND

• Escobar GJ, Joffe S, Gardner MN, Armstrong MA, Folck BF, Carpenter DM. Rehospitalization in the first two weeks after discharge from the neonatal intensive care unit. Pediatrics. 1999 Jul;104(1):e2. doi: 10.1542/peds.104.1.e2.

  PMID: 10390288 BACKGROUND

• Garfield CF, Lee YS, Kim HN, Rutsohn J, Kahn JY, Mustanski B, Mohr DC. Supporting Parents of Premature Infants Transitioning from the NICU to Home: A Pilot Randomized Control Trial of a Smartphone Application. Internet Interv. 2016 May;4(Pt 2):131-137. doi: 10.1016/j.invent.2016.05.004. Epub 2016 Jun 4.

  PMID: 27990350 BACKGROUND

• Kim HN, Garfield C, Lee YS. Paternal and maternal information and communication technology usage as their very low birth weight infants transition home from the NICU. Int J Hum Comput Interact. 2015;31(1):44-54.

  BACKGROUND

• Lee Y, Garfield C, Massey N, Chaysinh S, Hassan S. NICU-2-home: Supporting the transition to home from the neonatal intensive care unit using a mobile application. Conference on Human Factors in Computing Systems; May 7 - 11,

  BACKGROUND

• Gilmore L, Cuskelly M. Factor structure of the Parenting Sense of Competence scale using a normative sample. Child Care Health Dev. 2009 Jan;35(1):48-55. doi: 10.1111/j.1365-2214.2008.00867.x. Epub 2008 Oct 22.

  PMID: 18991983 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Joshua Santiago, MA

  Northwestern University

  STUDY DIRECTOR

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: Professor of Pediatrics; and Attending physician and neonatal hospitalist at the Lurie Children's Hospital of Chicago where he is the Director of Research for the Division

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 21, 2020
• Study Start: August 3, 2020
• Primary Completion: July 23, 2025
• Study Completion: July 23, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)