Limited English Proficiency Virtual Family-Centered Rounds (LEP vFCR)

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

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Disorder
• Intervention / Treatment: Behavioral: Virtual Family-Centered Rounds

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria - PARENT:

• Under age 18 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Virtual Family-Centered Rounds; Parents/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).

Behavioral: Virtual 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient length of stay	Days in the neonatal intensive care unit. Obtained from electronic health record.	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	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)	Date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)
Medical errors and adverse events	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.	Date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)
Patient 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).	Date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)
Patient Activation	Unit of measure: mean score; Measure/Tool: Parent-Patient Activation Measure (P-PAM) (parent survey)	Date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)
Parent Quality of Life	Unit of measure: mean score. Measure/Tool: PedsQL Family Impact Module (parent survey)	Date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2023
• Primary Completion (Actual): June 14, 2024
• Study Completion (Actual): June 14, 2024

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1736147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No