Evaluating Parent Engagement, Attachment, Stress, and Satisfaction With Remote Rounding in the NICU

Parent Stress Clinical Trial

Official title:

Improving Family Engagement With Remote Rounding in the NICU

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04373915
• Other study ID #: STUDY20181178
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: January 2022
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The admission of a newborn child to the neonatal intensive care unit (NICU) is among the most distressing situations that parents can face. There are many sources of parental stress including loss of control and competing demands outside of the NICU involving work and other children. During a prolonged admission it is often difficult for families to be present at bedside rounds on a daily basis and thus more difficult to discuss and collaborate with families in the care of their child. Healthcare has been slower than many other fields to adapt to the availability of new technology. This study hypothesizes that the use of wireless technology to allow parents to remotely participate on rounds would improve parental stress and satisfaction, in addition to improving engagement and attachment to their infant.

Description:

Every year 10 to 15 percent of infants born in the United States, totaling roughly half a million babies, are admitted to a Neonatal Intensive Care Unit (NICU). Although survival rates are generally high, as many as half of these infants require a prolonged hospital stay. For parents, the admission of a newborn to the NICU is among the most emotionally distressing situations that they can face. A prolonged hospital stay can further impact the mother and family physically, psychologically, and financially.

During admission in the NICU it is often difficult for families to be present at bedside rounds on a daily basis due to transportation challenges or competing demands of work and care for siblings. Conflicting schedules between families and doctors make it more difficult to discuss and collaborate with families in the care of their child. The investigators hypothesize that this deficiency of communication and perceived loss of control can have significant impacts on maternal stress, satisfaction, engagement, and attachment.

Outside of the medical field, technology continues to advance as rapidly as ever. The medical field continues to struggle with adapting and using new technology and continue to lag behind many other fields. In recent years telemedicine has been used to facilitate patient care delivery, improve accessibility of health care services, and reduce healthcare costs however this use remains largely in the outpatient sector.

In the Neonatal Intensive Care Unit, Telemedicine has been used by one group to improve parent satisfaction in a variety of areas. A pilot study of the concept of remote or virtual rounding in a Pediatric Intensive Care Unit has been recently published in the literature. This project seeks to expand upon this knowledge to define and measure the impact on several aspects of neonatal care.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Parents with an infant admitted to the NICU/R4 with an anticipated length of stay of 2 weeks or more

2. Parent consents to study and answering questionnaires

3. English speaking

4. Infant is assigned to red or purple medical service team.

5. Infant age at enrollment: zero to 14 days old

Exclusion Criteria:

1. Parents with an infant admitted to the NICU/R4 with an anticipated length of stay less than 2 weeks

2. Parent is not willing to answer questionnaires

3. Non-English speaking

4. Patient is not assigned to red or purple medical service team.

5. Discharge to other than biological parents expected

Related Conditions & MeSH terms

• Parent Attachment
• Parent Engagement
• Parent Stress

Intervention

Behavioral:
• Remote Bedside Rounding
Parents of infants on the medical team utilizing remote rounding will have the opportunity to participate in rounds by video conferencing at the infant's bedside. Participation will be tracked and surveys regarding stress, satisfaction, and attachment will be completed by parents in both groups.

Locations

Country	Name	City	State
United States	Rainbow Babies and Children's Hospital	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	Case Western Reserve University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Epstein EG, Sherman J, Blackman A, Sinkin RA. Testing the Feasibility of Skype and FaceTime Updates With Parents in the Neonatal Intensive Care Unit. Am J Crit Care. 2015 Jul;24(4):290-6. doi: 10.4037/ajcc2015828. — View Citation

Gray JE, Safran C, Davis RB, Pompilio-Weitzner G, Stewart JE, Zaccagnini L, Pursley D. Baby CareLink: using the internet and telemedicine to improve care for high-risk infants. Pediatrics. 2000 Dec;106(6):1318-24. — View Citation

Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52. — View Citation

Müller ME. A questionnaire to measure mother-to-infant attachment. J Nurs Meas. 1994 Winter;2(2):129-41. — View Citation

Yager PH, Clark M, Cummings BM, Noviski N. Parent Participation in Pediatric Intensive Care Unit Rounds via Telemedicine: Feasibility and Impact. J Pediatr. 2017 Jun;185:181-186.e3. doi: 10.1016/j.jpeds.2017.02.054. Epub 2017 Mar 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parent Engagement	Calendars will be placed at each infant's bedside to record engagement events consisting of participation in rounds, phone calls, visits, and kangaroo care. Each parental interaction recorded on the calendar will be counted. The mean and standard deviation of interactions over the study period will be calculated for each arm.	up to 1 year.
Secondary	Parent Satisfaction: survey	A short investigator created satisfaction survey will be used to measure parent satisfaction. Each question on the parent satisfaction survey will be analyzed separately and compared between the two groups. A Mann-Whitney U test will be used for each of the 8 likert questions.	up to 6-10 weeks
Secondary	Parent Stress	The Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) will be used to measure parent stress. The instrument is a 46-item scale with 3 sub scales: infant behavior and appearance, parental role alteration, and sights and sounds. Each item is scored 1-5 on a likert scale (total sore range 46-230) with higher scores relating to higher stress. A standard t-test will be used.	up to 6-10 weeks
Secondary	Parent Attachment survey	The Maternal Attachment Inventory will be used to measure parent-infant attachment. This is a 26 item scale with each item scoring 1-4, for a total possible score of 26-104 with a higher score showing better attachment. Differences in attachment between the two arms will be assessed using a Wilcoxon rank sum test.	up to 6-10 weeks