Clinical trial NCT04373915: Evaluating Parent Engagement, Attachment, Stress, and Satisfaction With Remote Rounding in the NICU
Official title: Improving Family Engagement With Remote Rounding in the NICU
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parent Engagement
Parent Attachment
Parent Stress
Keywords: NICU
parent engagement
parent attachment
parent stress
remote rounding
video rounding
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
First posted: 2020-05-05
Enrollment: 29
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single site prospective cohort study. Participants will be block randomized to standard rounding or availability of remote rounding based on their medical care team in the NICU. Parents using remote rounding will be compared to those who do not utilize remote rounding.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Parent Engagement
timeFrame: up to 1 year.
Secondary outcomes:
measure: Parent Satisfaction: survey
timeFrame: up to 6-10 weeks
measure: Parent Stress
timeFrame: up to 6-10 weeks
measure: Parent Attachment survey
timeFrame: up to 6-10 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Rainbow Babies and Children's Hospital
state: Ohio
Study officials:
affiliation: Rainbow Babies and Children's Hospital
name: Margaret Kuper-Sasse, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.
citation: Muller ME. A questionnaire to measure mother-to-infant attachment. J Nurs Meas. 1994 Winter;2(2):129-41.
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. doi: 10.1542/peds.106.6.1318.
citation: 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.
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.