Supporting All Families of Premature Infants at Prentice Women's Hospital From Admission Through Discharge

The objective of this study is to determine the extent to which the SMART NICU2HOME (including EMR interface) and the NICU2HOME apps, mobile applications designed for parents of premature infants to receive daily, real-time information about their infants and personalized education material based on parents' anticipated concerns and their infant's clinical status, is effective in: 1) improving parents' competency in caring for their sick infants, 2) reducing stress, 3) supporting parents' social supports and 3) improving NICU outcomes (parent satisfaction, length of stay, readmission rates.)

Study Overview

• Status: Active, not recruiting
• Conditions: Premature Birth; Premature Infant; NICU
• Intervention / Treatment: Other: Group 1: Standard of Care; Other: Group 2: NICU2HOME app; Other: Group 3: SMART NICU2HOME app

Detailed Description

There will be four groups of participants based on when the infant is in the NICU.

Parents of infants born from April -Mid-August 2018 (Group 1) Group 1 participants will receive 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.

At NICU admission, parents in Group 1 will be asked to complete a brief demographics form and several standardized surveys that measure stress and life experiences. Surveys will again be administered 7-10 days later, the day before discharge, two weeks after discharge and 30 days after discharge. These surveys will be available both via on paper or an email link.

Parents of infants born from Mid-August - January 2019 (Group 2) At NICU admission, parents in Group 2 will be asked to complete a brief demographics form and several standardized surveys that measure stress and life experiences. Surveys will again be administered 7-10 days later, the day before discharge, two weeks after discharge and 30 days after discharge. These surveys will be available both via on paper or an email link.

In addition to the usual care made available to Group 1 and described above, Group 2 parents will also be asked to download the NICU2HOME app from a given website where they will enter MRN, DOB, name, gender, and due date of their infant into the smartphone app. In case there are difficulties downloading or using the app, the research team will be available to assist parents with any questions or concerns.

Parent of infants born from February 2019- June 2019 (Group 3) At NICU admission, parents in Group 3 will be asked to complete a brief demographics form and several standardized surveys that measure stress and life experiences. Surveys will again be administered 7-10 days later, the day before discharge, two weeks after discharge and 30 days after discharge. These surveys will be available both via on paper or an email link. In addition to the usual care made available to Group 1, Group 3 parents will also be asked to download the SMART NICU2HOME app from a given website where they will enter MRN, DOB, name, gender, and due date of their infant into the smartphone app.

Parent of infants born from November 2019- December 2020 (Group 4) At NICU admission, parents in Group 4 will be asked to complete a brief demographics form and several standardized surveys that measure stress and life experiences as well as parental efficacy. Surveys will again be administered 30 and 60 days later depending on the gestational age of the baby, the day of discharge, two weeks after discharge and 30 days after discharge. These surveys will be available through an email link.

In addition to the usual care made available to Group 1 and described above, Group 4 parents will also be asked to download the NICU2HOME app from a given website where they will enter MRN, DOB, name, gender, and due date of their infant into the smartphone app. In case there are difficulties downloading or using the app, the research team will be available to assist parents with any questions or concerns. Participants in Group 4 will not be paid for their contribution to the research.

Each participant (in both groups) will be asked to complete the surveys independently without sharing responses. If completed on paper, the research team will arrange either to pick the survey up at the NICU if the baby is still in the hospital, via a pre-paid stamped envelope provided, or over the phone. Online surveys will be automatically returned.

Optional Interview:

In addition to the intervention study, an optional qualitative interviews will be conducted with 30 families from group 2 and group 3 for about 30-45 minutes. Patients will have the option to opt to participate in the interviews when consenting to the main study by signing their initials on the "Optional Elements" to be interviewed. Consenting to be interviewed also means that they have agreed to let us audio record the interview for research purposes. Of those who opted to be interviewed, only 30 families will be randomly selected to partake in the interviews.

Using maximum variation sampling method, the interview will occur around 1-2 days prior to discharge (final thoughts, use patterns) with approximately 5 families per gestational age bracket: <28 weeks; 28-<30 weeks; 30-<32 weeks; 32-<34 weeks; 34-<37 weeks. The interviews will be semi-structured, one-on-one phone on in-person interviews (option is the family's) designed to elicit feature feedback reasons for their level of usage. With consent, all interviews will be audio-recorded, transcribed, coded, and analyzed for themes to improve further iterations. These audio recordings (either in voice or transcription) may be used in scholarly presentations or publications serve to help other professionals understand the research. No identifiers will be present when sharing the recordings to maintain anonymity, and recordings will be saved with a study ID number rather than name.

NICU2HOME app was created for parents of premature infants to meet their demands. The app will teach parents about their baby and the NICU. It will allow them to receive educational material every day that is specifically geared towards their baby's journey in the NICU. The app will also all parents to connect with their friends and family allowing them to privately and safely share and post among themselves.

SMART NICU2HOME app includes the same features and functions as the NICU2HOME app stated above; however, it also allows parents to receive a daily update of the clinically benign information of their infant directly from the EPIC EMR, such as, days of life, adjusted gestational age, weight, length, etc.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Craig Garfield, MD; Phone Number: (312)503-5463; Email: c-garfield@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Parents of premature infants (<37 weeks) admitted to Prentice NICU
• Competent in English (i.e. to fully understand the questions asked in the surveys)
• Smartphone owner

Exclusion Criteria:

• None Adults unable to consent/Cognitively Impaired
• Pregnant women (where the activities of the research may affect the pregnancy or the fetus)
• Prisoners or other detained individuals

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: Standard of Care; Parents of infants born from April -mid-August 2018 (Group 1)	Other: Group 1: Standard of Care; Those who are in Group 1 will receive the usual care which includes: a welcome packet from the nursing staff; access to their infant's medical team including doctors and nurse; 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.
Active Comparator: Group 2: NICU2HOME app; Parents of infants born from mid-August 2018- January 2019 (Group 2)	Other: Group 2: NICU2HOME app; 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.
Active Comparator: Group 3: SMART NICU2HOME app; Parents of infants born from February- June 2019 (Group 3)	Other: Group 3: SMART NICU2HOME app; In addition to the usual care made available to Group 1 as described above, Group 2 parents will receive the smartphone app. Group 3 parents will be asked to download the SMART NICU2HOME app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome measure will be the level of confidence caring for their premature infants while in the NICU and once at home measured through a survey.	We will use the PSOC Survey for this outcome.	2-3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome measure will be the level of stress caring for their premature infants while in the NICU and once at home measured through a survey.	We will use the PSS Survey for this outcome.	2-3 months
Relationship quality will be measured through survey.	We will use the MOS Survey for this outcome.	2-3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction with the hospitalization will be measured through survey.	We will use the Press Gainey Survey for this outcome.	2-3 months
Patient satisfaction with the discharge will be measured through survey.	We will use the Press Gainey Survey for this outcome.	2-3 months
Social support will be measured through survey.	We will use the MOS Survey for this outcome.	2-3 months
Length of Stay will be measure.	We will calculate the length of stay in the hospital on the admission and discharge collection sheets.	2-3 months
Readmission rates will be measure.	We will gather this information in our post discharge survey,	2-3 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Friends of Prentice

Publications and helpful links

General Publications

• 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/
• 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.
• 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.
• Hamilton BE Ph D, Martin JA, Osterman MJ M H S, Curtain SC M A. Births: Preliminary Data for 2014. Natl Vital Stat Rep. 2015 Jun;64(6):1-19.
• Obeidat HM, Bond EA, Callister LC. The parental experience of having an infant in the newborn intensive care unit. J Perinat Educ. 2009 Summer;18(3):23-9. doi: 10.1624/105812409X461199.
• Strauss, A.L., et al., Social organization of medical work. 2nd ed. 1997, New Brunswick, London: Transaction Publishers.
• Glaser, B.G. and A.L. Strauss, Time for dying. 1968, Chicago, U.S.A.: Aldine
• Ward K. Perceived needs of parents of critically ill infants in a neonatal intensive care unit (NICU). Pediatr Nurs. 2001 May-Jun;27(3):281-6.
• Heermann JA, Wilson ME, Wilhelm PA. Mothers in the NICU: outsider to partner. Pediatr Nurs. 2005 May-Jun;31(3):176-81, 200.
• Dhillon AS, Albersheim SG, Alsaad S, Pargass NS, Zupancic JA. Internet use and perceptions of information reliability by parents in a neonatal intensive care unit. J Perinatol. 2003 Jul-Aug;23(5):420-4. doi: 10.1038/sj.jp.7210945.
• Kowalski WJ, Leef KH, Mackley A, Spear ML, Paul DA. Communicating with parents of premature infants: who is the informant? J Perinatol. 2006 Jan 1;26(1):44-8. doi: 10.1038/sj.jp.7211409.
• Garfield CF, Kerrigan E, Christie R, Jackson KL, Lee YS. A Mobile Health Intervention to Support Parenting Self-Efficacy in the Neonatal Intensive Care Unit from Admission to Home. J Pediatr. 2022 May;244:92-100. doi: 10.1016/j.jpeds.2022.01.004. Epub 2022 Jan 13.
• Garfield CF, Lee YS, Warner-Shifflett L, Christie R, Jackson KL, Miller E. Maternal and Paternal Depression Symptoms During NICU Stay and Transition Home. Pediatrics. 2021 Aug;148(2):e2020042747. doi: 10.1542/peds.2020-042747. Epub 2021 Jun 18.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2018
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: March 30, 2018
• First Submitted That Met QC Criteria: April 20, 2018
• First Posted (Actual): April 23, 2018

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: NICU; Premature Birth; Premature Infant; Smartphone App
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: STU00207127

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No