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

NCT04373915 | Terminated

• 1 other identifier: STUDY20181178
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Parent Engagement; Parent Attachment; Parent Stress

Keywords

NICU; parent engagement; parent attachment; parent stress; remote rounding; video rounding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Parent Satisfaction: survey

  up to 6-10 weeks

• Parent Stress

  up to 6-10 weeks

• Parent Attachment survey

  up to 6-10 weeks

Study Arms (2)

Standard Bedside Rounding

NO INTERVENTION

Remote Bedside Rounding

EXPERIMENTAL

Parents of infants on one care team will have the opportunity to participate in rounds via secure remote video software.

Behavioral: Remote Bedside Rounding

Interventions

Remote Bedside Rounding BEHAVIORAL

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.

Remote Bedside Rounding

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents with an infant admitted to the NICU/R4 with an anticipated length of stay of 2 weeks or more
• Parent consents to study and answering questionnaires
• English speaking
• Infant is assigned to red or purple medical service team.
• Infant age at enrollment: zero to 14 days old

You may not qualify if:

• Parents with an infant admitted to the NICU/R4 with an anticipated length of stay less than 2 weeks
• Parent is not willing to answer questionnaires
• Non-English speaking
• Patient is not assigned to red or purple medical service team.
• Discharge to other than biological parents expected

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Case Western Reserve University: collaborator

Study Sites (1)

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Related Publications (5)

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

  PMID: 8506163 BACKGROUND

• Muller ME. A questionnaire to measure mother-to-infant attachment. J Nurs Meas. 1994 Winter;2(2):129-41.

  PMID: 7780768 BACKGROUND

• 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.

  PMID: 11099583 BACKGROUND

• 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.

  PMID: 26134328 BACKGROUND

• 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.

  PMID: 28363361 BACKGROUND

Study Officials

• Margaret Kuper-Sasse, MD

  Rainbow Babies and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatology Fellow

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: May 5, 2020
• Study Start: July 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: February 15, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)