Neonatal Intensive Care Unit Virtual Family-Centered Rounds

NCT05762835 | Completed Results DMC

• 1 other identifier: 1764454
• Study Type: interventional
• Target: 514
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the impact of virtual family-centered rounds in the neonatal intensive care unit on parental and neonatal outcomes.

Conditions

Pediatric Disorder; Neonatal Disease

Keywords

Pediatrics; Neonatal Intensive Care Units; Neonate; Clinical Trial; Telemedicine; Patient-Centered Care; Patient Reported Outcome Measures

Outcome Measures

Primary Outcomes (1)

• Parent FCR Attendance

  Obtained from FCR weekday observations. Defined at family unit level, accounting for possibility of multiple enrolled infants per family and variable eligible FCR encounters for each infant. We will compute the total number of possible weekday FCR encounters per family ('denominator') and the number of those for which at least 1 parent is present virtually or in-person ('numerator'). The outcome measure will be reported as a proportion (numerator/denominator). For example, if a family has 2 infants, 1 whose NICU hospitalization included 5 eligible FCR encounters and another whose NICU hospitalization includes 7 eligible FCR encounters, that family will be counted as having twelve eligible FCR encounters ('denominator'). If at least 1 parent is present for 4 of the first infant's encounters and 6 of the second infant's encounters, the family would be counted as having attended 10 ('numerator') of the 12 eligible FCR encounters. The proportion for that family unit is 0.83.

  Length of neonatal intensive care unit [NICU] stay (assessed up to 396 days)

Secondary Outcomes (8)

• Parent Experience

  Day 0 (post-NICU discharge)

• Family-Centered Care

  Day 0 (post-NICU discharge)

• Parent Activation

  Day 0 (post-NICU discharge)

• Parent Health-related Quality of Life

  Day 0/30/60/90 (post-NICU discharge)

• NICU Length of Stay

  Day 0 (post-NICU discharge)

Other Outcomes (8)

• Neonatal Growth Velocity

  Day 0 (post-NICU discharge)

• Adverse Events and Errors

  Day 0 (post-NICU discharge)

• 30-day Revisit

  Day 30 (post-NICU discharge)

Study Arms (2)

Intervention (Virtual Family-Centered Rounds [FCR])

EXPERIMENTAL

Virtual FCR-arm parents/guardians (referred to as "parents" hereafter) will have the option use have the option to use telehealth for virtual rounds. Parents can participate in virtual FCR as much, or as little, as they choose. Parents also will have the option to attend FCR in person or to not attend FCR.

Behavioral: Virtual family-centered rounds (FCR)

Control (Usual Care)

NO INTERVENTION

Usual care-arm parents will receive usual care. Usual care-arm parents will have the option to attend FCR in person or to not attend FCR.

Interventions

Virtual family-centered rounds (FCR) BEHAVIORAL

Parents will be given the option to join FCR virtually or in-person; this intervention is changing the behavior of how providers deliver healthcare and how parents engage in their child's care. The NICU team members will use a computer with a speaker and pan-tilt-zoom camera, mounted on a stand with wheels to launch telehealth connections using the secure application called ExtendedCare. From within this telehealth connection, a NICU team member will send an electronic message (e.g. via text or email) to the subscribed parent(s) and wait for the parent to join the visit to establish a secure videoconference. The message to the parent includes a link that can be clicked to open a browser that allows the parent to join the telehealth visit. FCR will then proceed in usual fashion with the NICU team members and - if in attendance - parent(s).

Intervention (Virtual Family-Centered Rounds [FCR])

Eligibility Criteria

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

Enrolling family units (which consists of INFANTS and PARENTS \[SURVEYS\]): INFANT Inclusion * Infants aged less than 365 days who are admitted to the NICU * Have at least one adult parent or guardian with English proficiency INFANT Exclusion * Have restrictions placed by child protective services, including visitation restrictions or restricted access to patient information * Infants with a previous NICU admission (and enrollment) during the trial period PARENTS \[SURVEYS\] Inclusion * Parents/guardians of the eligible infants (described above) * Age 18 years and older PARENTS \[SURVEYS\] Exclusion * Age less than 18 years * Non-English speaking

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

The Regents of the University of California, Davis

Sacramento, California, 95817, United States

Location

Related Publications (2)

• Rosenthal JL, Tancredi DJ, Marcin JP, Ketchersid A, Horath ET, Zerda EN, Bushong TR, Merriott DS, Romano PS, Young HM, Hoffman KR. Virtual family-centered hospital rounds in the neonatal intensive care unit: protocol for a cluster randomized controlled trial. Trials. 2023 May 16;24(1):331. doi: 10.1186/s13063-023-07340-x.

  PMID: 37194089 DERIVED

• Rosenthal JL, Tancredi DJ, Marcin JP, Ketchersid A, Horath ET, Zerda EN, Bushong TR, Merriott DS, Romano PS, Young HM, Hoffman KR. Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit: Protocol for a Cluster Randomized Controlled Trial. Res Sq [Preprint]. 2023 Apr 17:rs.3.rs-2644794. doi: 10.21203/rs.3.rs-2644794/v1.

  PMID: 37131689 DERIVED

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Jennifer Rosenthal
• Organization: University of California at Davis

rosenthal@ucdavis.edu

9167344719

Study Officials

• Jennifer L Rosenthal, MD, MAS

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 10, 2023
• Study Start: March 13, 2023
• Primary Completion: April 12, 2024
• Study Completion: July 13, 2024
• Last Updated: August 17, 2025
• Results First Posted: August 17, 2025

Record last verified: 2025-07

Locations

US (1)