NCT05917899

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

August 10, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2024

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

10 months

First QC Date

June 6, 2023

Last Update Submit

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

EXPERIMENTAL

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

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.

Virtual Family-Centered Rounds

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

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.

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

Locations