Neonatal Intensive Care Unit Virtual Family-Centered Rounds

Study Overview
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Brief Summary
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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.

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

Conditions
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Pediatric Disorder, Neonatal Disease

Intervention / Treatment
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* Behavioral: Virtual family-centered rounds (FCR)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (Virtual Family-Centered Rounds [FCR])<br>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)<br>* 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).<br>|
| No Intervention: Control (Usual Care)<br>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?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonate, Pediatrics, Neonatal Intensive Care Units, Clinical Trial, Telemedicine, Patient-Centered Care, Patient Reported Outcome Measures