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OpenTrials
Completed

NCT Number: NCT05917899

Limited English Proficiency Virtual Family-Centered Rounds

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.

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Key information

Conditions

Pediatric Disorder

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Family-Centered Rounds

Behavioral

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.

Primary outcomes

  1. Family-Centered Rounds Parent Attendance

    Time frame: From 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 outcomes

  1. Patient length of stay

    Time frame: 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)

    Days in the neonatal intensive care unit. Obtained from electronic health record.

  2. Breastmilk feeding at discharge

    Time frame: Date 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)

  3. Medical errors and adverse events

    Time frame: Date 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.

  4. Patient Experience

    Time frame: Date 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).

  5. Patient Activation

    Time frame: Date 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)

  6. Parent Quality of Life

    Time frame: Date 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)

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Acronym: LEP vFCR

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 26, 2023
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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