Limited English Proficiency Virtual Family-Centered Rounds

Pediatric Disorder Clinical Trial

— LEP vFCR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05917899
• Other study ID #: 1736147
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: August 2023
• Source: University of California, Davis
• Contact: Jennifer Rosenthal, MD, MAS
• Phone: 9167344719
• Email: rosenthal[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: September 30, 2024
• Est. primary completion date: September 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	University of California Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)