NICU2HOME+: Supporting Illinois Families

Premature Birth Clinical Trial

Official title: NICU2HOME+: Supporting Illinois Families of Premature Infants With Smartphone Technology

Status Active, not recruiting

Clinical Trial 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. Northwestern Medicine's Central DuPage Hospital (25 N.Winfield Rd., Winfield, IL)- NICU, Postpartum, and Research Offices

2. Northwest Community Hospital (800 W. Central Rd., Arlington Heights, IL)- NICU,Postpartum, and Research Offices

3. Rush University Medical Center (Chicago, IL)- NICU, Postpartum, and Research Offices

Clinical Trial Description

The investigators propose to address the goals of the Affordability Cures Initiative and promote health equity by developing NICU2HOME+, a smartphone app designed to support NICU parents in a culturally appropriate manner in community level III NICUs in Illinois and to include EMR integration. Mobile technology such as NICU2HOME+ offers an innovative way to reduce costs in two ways. First, parents who are better informed and supported, who feel more confident and competent in caring for their premature infants, may be more prepared for an earlier discharge. Second, cost savings may be realized after discharge, if better educated and more competent parents are less likely to inappropriately visit the ER or their infant's physicians as they know what to expect and can provide better, more competent care to their baby. At its center, NICU2HOME+is able to achieve four "rights" of adaptive personalization and parent-centric care: delivering the "right" information at the "right" time to the "right" person via the "right" medium. The ultimate goal of this proposal, therefore, is to develop a scalable, evidence-based.

Participants will be divided into two research groups based on when their infant was born. The first group, parents of infants born between June 15th and December 31st 2020, will receive the standard care provided in the NICU. The second group of participants, those with infants born between January 1 and July 31 2021, will also receive the NICU standard care and additionally be asked to use a smartphone app related to NICU and at-home care. Participation in the second groups requires ownership of a smartphone and the ability to use a smartphone app.

If the participant has been assigned to the first group, the investigators would like both parents to participate in the study independently and therefore complete individual consent forms. However, the investigators recognize not all families will have two parents that are interested or able to participate and ultimately participation from some families will include only one parent.

As part of the study, participants will be asked to complete four surveys. They will be administered at the time of admission, infant's discharge from the NICU, fourteen days after discharge and thirty days after discharge. For those families who have a longer stay in the NICU, the investigators will ask parents to complete two additional surveys; one 30 days after admission and one 60 days after admission.Each survey will take approximately five to ten minutes to complete. The main benefit of participation is that this research that may help improve the NICU experience for other families in the future. The primary risk of participation is the potential loss of confidentiality, but strict measures are in place to minimize the chance of this happening.

In addition, if participants agree to the option at the end of this Consent Form, participants may or may not be invited to participate in a separate research interview to take place during the participants NICU stay, around the time of the infant's discharge from the hospital, or within a year of the transition to home. These optional, voluntary interviews will be conducted at a time, location and method (phone or in-person) agreed upon by the parent. All interviews will be conducted with our research staff with experience interviewing parents of NICU graduates. While the investigators encourage both parents to participate in order to hear about differences in experiences, one or both parents can ultimately participate. The purpose of the research interview is to better understand participants' experience in the NICU and at home as the parent of a premature infant.

Participants will be divided into two research groups based on when their infant was born. The first group, parents of infants born between July 15th and December 31st 2020, will receive the standard care provided in the NICU. The second group of participants, those with infants born between January 1 and July 31 2021, will also receive the NICU standard care and additionally be asked to use a smartphone app related to NICU and at-home care. Participation in the second groups requires ownership of a smartphone and the ability to use a smartphone app.

If a participants are assigned to the first or second groups, the investigators would like both parents to participate in the study independently and therefore complete individual consent forms. However, the investigators recognize not all families will have two parents that are interested or able to participate and ultimately participation from some families will include only one parent.

As part of the study, participants will be asked to complete four surveys. They will be administered at the time of admission, infant's discharge from the NICU, fourteen days after discharge and thirty days after discharge. For those families who have a longer stay in the NICU, the investigators will ask parents to complete two additional surveys; one 30 days after admission and one 60 days after admission. Each survey will take approximately five to ten minutes to complete. The main benefit of participation is that this research that may help improve the NICU experience for other families in the future. The primary risk of participation is the potential loss of confidentiality, but strict measures are in place to minimize the chance of this happening.

In addition, if participants agree to the option at the end of this Consent Form, participants may or may not be invited to participate in a separate research interview to take place during the participants' NICU stay, around the time of the participants' infant's discharge from the hospital, or within a year of the participants transition home. These optional, voluntary interviews will be conducted at a time, location and method (phone or in-person) agreed upon by the parent. All interviews will be conducted with our research staff with experience interviewing parents of NICU graduates. While the investigators encourage both parents to participate in order to hear about differences in experiences, one or both parents can ultimately participate. The purpose of the research interview is to better understand the participants' experience in the NICU and at home as the parent of a premature infant.

Optional Interview:

In addition to the intervention study, optional qualitative interviews will be conducted with participants using a maximum variability approach. Interviews will focus on the following:

• Their overall experience of using the app

• Educational Content

• Relationship/communication through app with extended family/friends

• Readiness for discharge

• Empowerment, ability to communicate better with doctors and nurses, and being able to participate in child health care confidently

• Being ready to go home and did the app help

• Information, communication and support needs across the NICU stay, discharge and beyond

This voluntary interview will be described to parents at the time of consent. To maintain confidentiality all subjects will be given a unique study code (PIN) and all information collected for app development will be linked to that number, not to any other identifier. All documents that include identifiers will be stored in a locked, secure location that only key authorized study personnel (e.g. PI, research team members) will have access to.

The interviews will be audio recorded. The recordings will be given an Identification (ID) number and kept in locked cabinets and on secure computers. The audio recordings will be transcribed and kept on password protected computers. (There will be no personal identifiers (such as names) in the transcribed documents.) After the recordings are transcribed, the audio files will be erased.

Only the people listed on the Authorized Research Personnel list will have access to the data. All paper data will be kept in locked files and rooms. Electronic data will be kept in on password- encrypted computers and files with identifying information will be individually password protected. Names and contact information will be stored only for the purpose of contacting participants. This information will be stored separately from study data and the two will only be linked by a study ID, kept in a password protected document. Upon completion of data collection all name and contact information as will be destroyed by file deletion. All data collected for this study will be kept in a locked, secure location and anything that can be destroyed (deleted, shredded, etc.) after it has been coded, will be. ;

Related Conditions & MeSH terms

• Infant
• NICU
• Premature
• Premature Birth

• NCT number: NCT04480255
• Study type: Interventional
• Source: Northwestern University
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 3, 2020
• Completion date: December 31, 2024