The Regents of the University of California, Davis
Sacramento, California, 95817, United States
NCT Number: NCT05762835
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.
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Interventional
Not applicable
Sacramento, California, 95817, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Enrolling family units (which consists of INFANTS and PARENTS [SURVEYS]):
INFANT Inclusion
INFANT Exclusion
PARENTS [SURVEYS] Inclusion
PARENTS [SURVEYS] Exclusion
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).
Time frame: Length of neonatal intensive care unit [NICU] stay (assessed up to 396 days)
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.
Time frame: 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).
Time frame: Day 0 (post-NICU discharge)
Unit of measure: mean score; Measure/Tool: Family-Centered Care Experience (FACCE) (parent survey)
Time frame: Day 0 (post-NICU discharge)
Unit of measure: mean score; Measure/Tool: Parent-Patient Activation Measure (P-PAM) (parent survey)
Time frame: Day 0/30/60/90 (post-NICU discharge)
Unit of measure: mean score. Measure/Tool: PedsQL Family Impact Module (parent survey)
Time frame: Day 0 (post-NICU discharge)
Unit of measure: days in NICU. Obtained from electronic health record.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 30 (post-NICU discharge)
Defined as post-discharge revisits to any emergency department. Obtained from electronic health record and parent-reported survey.
Time frame: Day 30 (post-NICU discharge)
Defined as post-discharge unplanned readmissions to any hospital. Obtained from electronic health record and parent-reported survey.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
University of California, Davis
Other
Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit: a Cluster Randomized Controlled Trial
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