Neonatal Intensive Care Unit Virtual Family-Centered Rounds

Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit: a Cluster Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Disorder; Neonatal Disease
• Intervention / Treatment: Behavioral: Virtual family-centered rounds (FCR)

• Study Type: Interventional
• Enrollment (Estimated): 447
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer L Rosenthal, MD, MAS; Phone Number: 9167344719; Email: rosenthal@ucdavis.edu
• Study Contact Backup: Name: Elva Horath; Phone Number: 9168482005; Email: hs-telepeds@ucdavis.edu

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Recruiting
      • The Regents of the University of California, Davis
      • Contact: Contracts and Grants Analyst

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 year (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention (Virtual Family-Centered Rounds [FCR]); 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); 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).
No Intervention: Control (Usual Care); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent FCR attendance	Defined at the family unit level, accounting for the possibility of multiple enrolled infants per family and variable lengths of stay for each infant. The investigators will compute the total number of possible weekday FCR encounters per family (the 'denominator') and the number of those for which at least one parent was present virtually or in-person (the 'numerator'). Obtained from FCR weekday observations.	Length of neonatal intensive care unit [NICU] stay (assessed up to 396 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent experience	Unit of measure: mean score; Measure/Tool: Emergency Department CAHPS (Consumer Assessment of Healthcare Providers and Systems) (parent survey, 2 items measuring overall experience).	Day 0 (post-NICU discharge)
Family-Centered Care	Unit of measure: mean score; Measure/Tool: Family-Centered Care Experience (FACCE) (parent survey)	Day 0 (post-NICU discharge)
Parent Activation	Unit of measure: mean score; Measure/Tool: Parent-Patient Activation Measure (P-PAM) (parent survey)	Day 0 (post-NICU discharge)
Parent health-related quality of life	Unit of measure: mean score. Measure/Tool: PedsQL Family Impact Module (parent survey)	Day 0/30/60/90 (post-NICU discharge)
NICU length of stay	Unit of measure: days in NICU. Obtained from electronic health record.	Day 0 (post-NICU discharge)
Breastmilk feeding	Dichotomous outcomes. Include (a) breastmilk feeding initiation, (b) any breastmilk feeding at the time of discharge from the NICU (and 90 days later), and (c) exclusive breastmilk feeding at the time of discharge from the NICU (and 90 days later). Breastmilk feeding includes consuming milk from the birth parent via any delivery method (e.g., bottle, feeding tube, breast). Any breastmilk feeding will be defined as the infant consuming any amount of milk from the birth parent, with or without the addition of formula or fortifier. Exclusive breastmilk feeding will be defined as 100% of base feeding type as milk from the birth parent, with or without a bovine or human fortifier. Obtained from electronic health record (0 days) and parent survey (90 days).	Day 0/90 (post-NICU discharge)
Postnatal growth failure (dichotomous)	Measure/Tool: Sex-specific Fenton growth charts. This dichotomous outcome will define growth failure as a weight-for-gestational-age Z-score decline of more than 0.8 standard deviations (SD) from birth to discharge. Obtained from electronic health record.	Day 0 (post-NICU discharge)
Postnatal growth failure (categorical)	Measure/Tool: Sex-specific Fenton growth charts. This categorical outcome will classify the degree of growth failure as none (no decline or a decline </=0.8 SD), mild (>0.8 and </=1.2 SD), moderate (>1.2 and </=2 SD), or severe (>2 SD). Obtained from electronic health record.	Day 0 (post-NICU discharge)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal growth velocity	Continuous variable. Measure/Tool: Sex-specific Fenton growth charts. Calculate change in Z-score divided by number of days in the NICU. Obtained from electronic health record.	Day 0 (post-NICU discharge)
Adverse events and errors	Include the rates of harmful errors, non-harmful errors, and overall errors (harmful errors plus non-harmful errors). Obtained via review of data from electronic health record, incident report system, and solicited reports. Two neonatologists, blinded to the study arm, will independently categorize each event as a harmful error (preventable adverse event), non-harmful error, non-preventable adverse event, or exclusion.	Day 0 (post-NICU discharge)
30-day revisit	Defined as post-discharge revisits to any emergency department. Obtained from electronic health record and parent-reported survey.	Day 30 (post-NICU discharge)
30-day readmission	Defined as post-discharge unplanned readmissions to any hospital. Obtained from electronic health record and parent-reported survey.	Day 30 (post-NICU discharge)
Temperature instability	Dichotomous variable defined as any occurrence of a temperature below 36 degrees C during the NICU hospitalization. Obtained from electronic health record.	Day 0 (post-NICU discharge)
Central line-associated bloodstream infection	Dichotomous variable defined as any occurrence during the NICU hospitalization of a laboratory-confirmed bacterial or viral bloodstream infection that develops with a central line in place and is not related to an infection at another site. Obtained from electronic health record.	Day 0 (post-NICU discharge)
Central line days	Number of days among the total number of NICU days that the infant has an umbilical catheter or one or more central lines in place. Obtained from electronic health record.	Day 0 (post-NICU discharge)
Antibiotic days	Number of days among the total number of NICU days that the infant receives intramuscular or intravascular antibacterial or antifungal agents. Obtained from electronic health record.	Day 0 (post-NICU discharge)

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Jennifer L Rosenthal, MD, MAS, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Estimated): April 12, 2024
• Study Completion (Estimated): July 12, 2024

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Telemedicine; Pediatrics; Clinical Trial; Neonate; Patient Reported Outcome Measures; Patient-Centered Care; Neonatal Intensive Care Units
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases
• Other Study ID Numbers: 1234567890

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No