Pediatric DisorderLEP vFCRNCT05917899
Limited English Proficiency Virtual Family-Centered Rounds
A study testing Virtual Family-Centered Rounds in people with Pediatric Disorder, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatric Disorder
- What is being tested?
- Virtual Family-Centered Rounds
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2023to 14 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
- Aged 18 years or older
- Preferred language that is other than English
- Have at least one infant enrolled in the trial
Who cannot join
- 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
- Under age 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Medical Center
Sacramento, California, 95817
About this study
Official title: 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.
- Conditions
- Pediatric Disorder
- Being tested
- Virtual Family-Centered Rounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Family-Centered RoundsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Virtual Family-Centered Rounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Days in the neonatal intensive care unit. Obtained from electronic health record.
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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)
Measured: Date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start10 Aug 2023
- Primary completion14 Jun 2024
- Study completion14 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric DisorderStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917899
- Sponsor's protocol ID
- 1736147
- Acronym
- LEP vFCR
- Status last verified
- Nov 2024
- First submitted
- 6 Jun 2023
- Last updated
- 25 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39940014
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Family-Centered Rounds for Caregivers With Limited English Proficiency: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT05917899
- Acronym / sponsor ID
- LEP vFCR / 1736147
- Conditions
- Pediatric Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Family-Centered Rounds | Experimental | Behavioral: Virtual Family-Centered RoundsParents/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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
- Aged 18 years or older
- Preferred language that is other than English
- Have at least one infant enrolled in the trial
Key exclusion criteria (4 listed)
- 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
- Under age 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Family-Centered RoundsThe 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. | Behavioural | Virtual Family-Centered Rounds |
Primary outcome
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
6 secondary outcomes
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)
Breastmilk feeding at discharge
Time frame: Date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)
Medical errors and adverse events
Time frame: Date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)
Patient Experience
Time frame: Date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)
Patient Activation
Time frame: Date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)
Parent Quality of Life
Time frame: Date of disposition from the neonatal intensive care unit for any cause (assessed up to 396 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Derived from this study: PubMed 39940014Hoyt-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Family-Centered Rounds in people with Pediatric Disorder, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05917899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.