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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03505424
• Other study ID #: STU00207127
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 20, 2018
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.)

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• NICU
• Premature Birth
• Premature Infant

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Friends of Prentice

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

Glaser, B.G. and A.L. Strauss, Time for dying. 1968, Chicago, U.S.A.: Aldine

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. — View Citation

Heermann JA, Wilson ME, Wilhelm PA. Mothers in the NICU: outsider to partner. Pediatr Nurs. 2005 May-Jun;31(3):176-81, 200. — View Citation

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/ — View Citation

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. — View Citation

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. — View Citation

Strauss, A.L., et al., Social organization of medical work. 2nd ed. 1997, New Brunswick, London: Transaction Publishers.

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction with the hospitalization will be measured through survey.	We will use the Press Gainey Survey for this outcome.	2-3 months
Other	Patient satisfaction with the discharge will be measured through survey.	We will use the Press Gainey Survey for this outcome.	2-3 months
Other	Social support will be measured through survey.	We will use the MOS Survey for this outcome.	2-3 months
Other	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
Other	Readmission rates will be measure.	We will gather this information in our post discharge survey,	2-3 months
Primary	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	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
Secondary	Relationship quality will be measured through survey.	We will use the MOS Survey for this outcome.	2-3 months