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Limited English Proficiency Virtual Family-Centered Rounds

Virtual Family-Centered Rounds for Caregivers With Limited English Proficiency: A Feasibility Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05917899
Acronym
LEP vFCR
Enrollment
36
Registered
2023-06-26
Start date
2023-08-10
Completion date
2024-06-14
Last updated
2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Disorder

Brief summary

This study will be a pilot test of using telehealth with an interpreter as an additional option for parents with limited English proficiency to join family-centered rounds in the neonatal intensive care unit.

Interventions

BEHAVIORALVirtual Family-Centered Rounds

The care team will use a computer with a speaker camera, mounted on a stand with wheels to launch telehealth visits using the application ExtendedCare. This platform meets HIPAA security rules and launches from the patient's electronic health record. From within this telehealth visit, a care team member will send a message (via text or email) to the parent(s) that includes a link that can be clicked to open a browser that allows the parent to join the telehealth visit. Parent do not need to download or use an application. The care team will invite the video interpreter to join the visit if a parent is present. Family-centered rounds will then proceed in usual fashion with the care team and \[if in attendance\] parent(s). Parents can participate in virtual family-centered rounds as much, or as little, as they choose.

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

We will enroll family units. Family units consist of the hospitalized infant and their eligible parents/guardians. Inclusion Criteria - INFANT: * Infants aged less than 365 days who are admitted to the neonatal intensive care unit * Have at least one eligible parent or guardian (see below for parent eligibility criteria)

Exclusion criteria

- INFANT: * Have restrictions placed by child protective services, including visitation restrictions or restricted access to patient information * Infants with a previous neonatal intensive care unit admission (and enrollment) during the trial period * Infants already enrolled in a different trial that includes a virtual family-centered rounds intervention Inclusion Criteria - PARENT: * Aged 18 years or older * Preferred language that is other than English * Have at least one infant enrolled in the trial

Design outcomes

Primary

MeasureTime frameDescription
Family-Centered Rounds Parent AttendanceFrom date of randomization until the date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)Proportion of the number of weekday round encounters with at least one parent present - either virtually or in-person - divided by the infant's total number of weekday round encounters

Secondary

MeasureTime frameDescription
Breastmilk feeding at dischargeDate of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)Dichotomous outcomes. Include (a) breastmilk feeding initiation, (b) any breastmilk feeding at the time of discharge from the neonatal intensive care unit, and (c) exclusive breastmilk feeding at the time of discharge from the neonatal intensive care unit. 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)
Medical errors and adverse eventsDate of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)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 and solicited reports. Two neonatologists will independently categorize each event as a harmful error (preventable adverse event), non-harmful error, non-preventable adverse event, or exclusion.
Patient length of stayFrom date of admission to the neonatal intensive care unit until the date of disposition from the unit for any cause (assessed up to 396 days)Days in the neonatal intensive care unit. Obtained from electronic health record.
Patient ActivationDate of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)Unit of measure: mean score; Measure/Tool: Parent-Patient Activation Measure (P-PAM) (parent survey)
Parent Quality of LifeDate of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)Unit of measure: mean score. Measure/Tool: PedsQL Family Impact Module (parent survey)
Patient ExperienceDate of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)Unit of measure: mean score; Measure/Tool: Emergency Department CAHPS (Consumer Assessment of Healthcare Providers and Systems) (parent survey, 2 items measuring overall experience).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026