Pediatric DisorderNCT05593900
Nurse-To-Family Telehealth
A study testing Nurse-to-Family Video Chat 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 to allow nurses to connect with parents/guardians of pediatric patients who are being transferred between hospitals. Read more about this study
- Who is it for?
- Ages 8 days and older
- Conditions the study is for
- Pediatric Disorder
- What is being tested?
- Nurse-to-Family Video Chat
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2023to 23 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children who:
- are aged 8 days to <=18 years
- present to a participating community hospital ED
- are accepted for inter-facility transfer to UC Davis
- are assigned to UC Davis unit D10, D7, or T6
- have an English-speaking adult parent/guardian at the bedside
Show all 9Show fewer
- are parents/guardians of the eligible patients (described above)
- are age 18 years and older
- are English-speaking
Who cannot join
- does not have an English-speaking adult parent/guardian at the bedside
- For parent surveys --
- are age less than 18 years
- have a preferred language that is other than English
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: Nurse-to-Family Telehealth for Pediatric Transfers: A Randomized Controlled Pilot Trial
This study will be a pilot test of using telehealth to allow nurses to connect with parents/guardians of pediatric patients who are being transferred between hospitals.
- Conditions
- Pediatric Disorder
- Being tested
- Nurse-to-Family Video Chat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-to-Family Video ChatBehavioural
A Nurse-To-Family Video Chat will be offered to parents/guardians to virtually connect with their post-transfer nurse; this intervention is changing the behavior of how providers deliver healthcare and how parents/guardians engage in their child's care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Parents have the option to use telehealth to virtually connect with the nurse before transfer Receives: Behavioral: Nurse-to-Family Video Chat |
| Control | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assignment Adherence
Percentage of eligible patients for whom the protocol assignment (telehealth vs standard of care) was followed
Measured: Day 0
Secondary outcomes (2)
Fidelity: Percentage of Telehealth Initiated Before Arrival
Whether or not a telehealth connection was initiated prior to patient's arrival to UC Davis hospital. Time of telehealth initiation, if applicable, was obtained from the ExtendedCare (telehealth platform) reporting system. Time of patient arrival was obtained from the electronic health record.
Measured: Day 0
Survey Completion Rate (%)
Percentage of completed surveys among eligible respondents
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start3 Jan 2023
- Primary completion2 Jul 2023
- Study completion23 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 291 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
- NCT05593900
- Sponsor's protocol ID
- 1062184
- Status last verified
- Jan 2025
- First submitted
- 18 Oct 2022
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rosenthal JL, Hoyt-Austin AE, Ketchersid A, Sanders A, Harper TA, Tancredi DJ, Young HM, Romano PS, Marcin JP. Nurse-to-family telehealth for pediatric transfers: protocol for a feasibility and pilot cluster randomized controlled trial. Pilot Feasibility Stud. 2023 Apr 11;9(1):57. doi: 10.1186/s40814-023-01292-4.
PubMed 37041600
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-to-Family Telehealth for Pediatric Transfers: A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT05593900
- Acronym / sponsor ID
- 1062184
- Conditions
- Pediatric Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 2 Jul 2023 (actual)
- Study completion
- 23 Jul 2023 (actual)
- First posted
- 26 Oct 2022 (actual)
- Results
- Posted 14 Jan 2025
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 to allow nurses to connect with parents/guardians of pediatric patients who are being transferred between hospitals.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Nurse-to-Family Video ChatParents have the option to use telehealth to virtually connect with the nurse before transfer |
| Control | No intervention | –Standard of care |
Who may qualify
- Ages
- 8 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- are aged 8 days to <=18 years
- present to a participating community hospital ED
- are accepted for inter-facility transfer to UC Davis
- are assigned to UC Davis unit D10, D7, or T6
- have an English-speaking adult parent/guardian at the bedside
Key exclusion criteria (4 listed)
- does not have an English-speaking adult parent/guardian at the bedside
- For parent surveys --
- are age less than 18 years
- have a preferred language that is other than English
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 |
|---|---|---|
| Nurse-to-Family Video ChatA Nurse-To-Family Video Chat will be offered to parents/guardians to virtually connect with their post-transfer nurse; this intervention is changing the behavior of how providers deliver healthcare and how parents/guardians engage in their child's care. | Behavioural | Intervention |
Primary outcome
Assignment Adherence
Time frame: Day 0
Percentage of eligible patients for whom the protocol assignment (telehealth vs standard of care) was followed
2 secondary outcomes
Fidelity: Percentage of Telehealth Initiated Before Arrival
Time frame: Day 0
Survey Completion Rate (%)
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37041600Rosenthal JL, Hoyt-Austin AE, Ketchersid A, Sanders A, Harper TA, Tancredi DJ, Young HM, Romano PS, Marcin JP. Nurse-to-family telehealth for pediatric transfers: protocol for a feasibility and pilot cluster randomized controlled trial. Pilot Feasibility Stud. 2023 Apr 11;9(1):57. doi: 10.1186/s40814-023-01292-4.
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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 Nurse-to-Family Video Chat 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 9 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 14 Jan 2025. 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?
Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Assignment Adherence (time frame: Day 0). 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 NCT05593900, 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 14 Jan 2025.