Limited English Proficiency Virtual Family-Centered Rounds
LEP vFCR
Virtual Family-Centered Rounds for Caregivers With Limited English Proficiency: A Feasibility Trial
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2023
CompletedFirst Posted
Study publicly available on registry
June 26, 2023
CompletedStudy Start
First participant enrolled
August 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2024
CompletedNovember 25, 2024
November 1, 2024
10 months
June 6, 2023
November 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Family-Centered Rounds Parent Attendance
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
From date of randomization until the date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)
Secondary Outcomes (6)
Patient length of stay
From 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)
Breastmilk feeding at discharge
Date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)
Medical errors and adverse events
Date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)
Patient Experience
Date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)
Patient Activation
Date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)
- +1 more secondary outcomes
Study Arms (1)
Virtual Family-Centered Rounds
EXPERIMENTALParents/guardians of the hospitalized infants will be invited to join family-centered rounds virtually plus usual care (usual care is the ability to join family-centered rounds in person or not to join at all).
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- Aged 18 years or older
- Preferred language that is other than English
- Have at least one infant enrolled in the trial
- Under age 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California Davis Medical Center
Sacramento, California, 95817, United States
Related Publications (1)
Hoyt-Austin AE, Zerda EN, Tancredi DJ, Marcin JP, Ketchersid A, Horath ET, Bushong TR, Merriott DS, Romano PS, Hoffman KR, Rosenthal JL. Protocol for a single-arm feasibility trial of virtual family-centered rounds: increasing opportunities for family engagement among caregivers with language preference other than English. Pilot Feasibility Stud. 2025 Feb 12;11(1):16. doi: 10.1186/s40814-025-01599-4.
PMID: 39940014DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2023
First Posted
June 26, 2023
Study Start
August 10, 2023
Primary Completion
June 14, 2024
Study Completion
June 14, 2024
Last Updated
November 25, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share