Neonatal Intensive Care Unit Virtual Family-Centered Rounds

Sponsor

University of California, Davis (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05762835

Collaborator

(none)

447

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Disorder Neonatal Disease	Behavioral: Virtual family-centered rounds (FCR)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

447 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Parent experience [Day 0 (post-NICU discharge)]
Unit of measure: mean score; Measure/Tool: Emergency Department CAHPS (Consumer Assessment of Healthcare Providers and Systems) (parent survey, 2 items measuring overall experience).
Family-Centered Care [Day 0 (post-NICU discharge)]
Unit of measure: mean score; Measure/Tool: Family-Centered Care Experience (FACCE) (parent survey)
Parent Activation [Day 0 (post-NICU discharge)]
Unit of measure: mean score; Measure/Tool: Parent-Patient Activation Measure (P-PAM) (parent survey)
Parent health-related quality of life [Day 0/30/60/90 (post-NICU discharge)]
Unit of measure: mean score. Measure/Tool: PedsQL Family Impact Module (parent survey)
NICU length of stay [Day 0 (post-NICU discharge)]
Unit of measure: days in NICU. Obtained from electronic health record.
Breastmilk feeding [Day 0/90 (post-NICU discharge)]
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).
Postnatal growth failure (dichotomous) [Day 0 (post-NICU discharge)]
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.
Postnatal growth failure (categorical) [Day 0 (post-NICU discharge)]
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.

Other Outcome Measures

Neonatal growth velocity [Day 0 (post-NICU discharge)]
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.
Adverse events and errors [Day 0 (post-NICU discharge)]
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.
30-day revisit [Day 30 (post-NICU discharge)]
Defined as post-discharge revisits to any emergency department. Obtained from electronic health record and parent-reported survey.
30-day readmission [Day 30 (post-NICU discharge)]
Defined as post-discharge unplanned readmissions to any hospital. Obtained from electronic health record and parent-reported survey.
Temperature instability [Day 0 (post-NICU discharge)]
Dichotomous variable defined as any occurrence of a temperature below 36 degrees C during the NICU hospitalization. Obtained from electronic health record.
Central line-associated bloodstream infection [Day 0 (post-NICU discharge)]
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.
Central line days [Day 0 (post-NICU discharge)]
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.
Antibiotic days [Day 0 (post-NICU discharge)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Days to 365 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion

Infants aged less than 365 days who are admitted to the NICU
Have at least one adult parent or guardian with English proficiency

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