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

Not Applicable

Terminated

• Conditions: Parent Stress; Parent Engagement; Parent Attachment
• Interventions: Behavioral: Remote Bedside Rounding

• Registration Number: NCT04373915
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-04-18
• Study Start: 2019-07-01
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-05
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote Bedside Rounding	Remote Bedside Rounding	Parents of infants on one care team will have the opportunity to participate in rounds via secure remote video software.

Primary Outcome Measures

Name	Time	Method
Parent Engagement	up to 1 year.	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.

Secondary Outcome Measures

Name	Time	Method
Parent Attachment survey	up to 6-10 weeks	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.
Parent Satisfaction: survey	up to 6-10 weeks	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.
Parent Stress	up to 6-10 weeks	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.

Trial Locations

Locations (1)

Rainbow Babies and Children's Hospital; 🇺🇸 Cleveland, Ohio, United States