- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05593900
Nurse-To-Family Telehealth
January 10, 2025 updated by: University of California, Davis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
291
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- University of California Davis Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 week to 18 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
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
Exclusion Criteria:
- does not have an English-speaking adult parent/guardian at the bedside
For parent surveys --
Inclusion Criteria:
- are parents/guardians of the eligible patients (described above)
- are age 18 years and older
- are English-speaking
Exclusion Criteria:
- are age less than 18 years
- have a preferred language that is other than English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Standard of care
|
|
|
Experimental: Intervention
Parents have the option to use telehealth to virtually connect with the nurse before transfer
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assignment Adherence
Time Frame: Day 0
|
Percentage of eligible patients for whom the protocol assignment (telehealth vs standard of care) was followed
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fidelity: Percentage of Telehealth Initiated Before Arrival
Time Frame: Day 0
|
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.
|
Day 0
|
|
Survey Completion Rate (%)
Time Frame: Day 0
|
Percentage of completed surveys among eligible respondents
|
Day 0
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Family-Centered Care
Time Frame: Day 0
|
Unit of measure: mean score Measure/Tool: Family-Centered Care Experience (FACCE)
|
Day 0
|
|
Family Experience
Time Frame: Day 0
|
Unit of measure: mean score Measure/Tool: Emergency Department CAHPS (Consumer Assessment of Healthcare Providers and Systems) 2 items measuring overall experience
|
Day 0
|
|
Parent Acute Stress
Time Frame: Day 0
|
Unit of measure: mean score Measure/Tool: (parent-reported survey) PROMIS 7-item Emotional Distress: Anxiety
|
Day 0
|
|
Parent Distress
Time Frame: Day 30
|
Unit of measure: mean score Measure/Tool: (parent-reported survey) PROMIS 7-item Emotional Distress: Anxiety
|
Day 30
|
|
Change in Level of Care
Time Frame: Day 0
|
Unit of measure: Percentage of subjects with change in level of care among eligible subjects. subjects - Definition: (chart review dichotomous outcome) Switching from an acute care unit or service to an intensive care unit or service, and vice versa. |
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 3, 2023
Primary Completion (Actual)
July 2, 2023
Study Completion (Actual)
July 23, 2023
Study Registration Dates
First Submitted
October 18, 2022
First Submitted That Met QC Criteria
October 22, 2022
First Posted (Actual)
October 26, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 10, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 1062184
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pediatric Disorder
-
Ataturk UniversityCompleted
-
University of California, DavisCompletedPediatric DisorderUnited States
-
Necmettin Erbakan UniversityRecruitingPelvic Floor Muscle Training and Dynamic Neuromuscular Stabilization Exercises in Pediatric PatientsPediatric Disorder | UrologyTurkey (Türkiye)
-
Children's Hospital of Fudan UniversityCompleted
-
Children's Hospital of Fudan UniversityCompletedPediatric Disorder | Capsule EndoscopyChina
-
Massachusetts General HospitalTerminatedPediatric Bipolar Disorder | Pediatric OCDUnited States
-
CoapTechChildren's Hospital of Philadelphia; Columbia University; Children's National...RecruitingGastrostomy | Pediatric Disorder | Ultrasound | Gastrostomy ComplicationsUnited States
-
Baylor Research InstituteBaylor Scott and White HealthNot yet recruiting
-
Boston Children's HospitalRecruitingPediatric ALL | Motility DisorderUnited States
-
Lundquist Institute for Biomedical Innovation at...TerminatedA Comparison of Accuvein to Standard IV Access in Children 0 to 24 Months of Age in the Pediatric EDPediatric DisorderUnited States
Clinical Trials on Nurse-to-Family Video Chat
-
Mayo ClinicNational Heart, Lung, and Blood Institute (NHLBI)CompletedChronic Obstructive Pulmonary DiseaseUnited States
-
University of California, Santa BarbaraNational Institute on Aging (NIA); Rendever, Inc.CompletedQuality of Life | Dementia | Alzheimer Disease | Mental Health Wellness 1 | Loneliness | Caregiver Burnout | Family RelationshipUnited States
-
The University of Hong KongActive, not recruiting
-
Harvard School of Public Health (HSPH)University of Chicago; Abdul Latif Jameel Poverty Action LabActive, not recruitingPreterm Birth | Injuries | Maternal BehaviorUnited States
-
Oslo Metropolitan UniversityUniversity of Oslo; Norwegian Institute of Public Health; Norwegian Center for... and other collaboratorsRecruitingInjuries | Violence | Maternal Behavior | Mental Health WellnessNorway
-
University of Colorado, DenverYale University; Columbia University; Nationwide Children's Hospital; University...TerminatedPregnancy, High Risk | Post Partum Depression | Child DevelopmentUnited States
-
Yakup AkyüzCompletedPostoperative Anxiety | Transfer Anxiety | Intensive Care Unit Discharge | Cardiac Surgery Recovery | Critical Care TransitionTurkey
-
TalkspaceUniversity of WashingtonCompletedDepressive Disorder | Study AdherenceUnited States
-
University of South CarolinaUniversity of Vermont; University of TennesseeCompleted
-
TalkspaceUniversity of WashingtonCompletedDepression | AnxietyUnited States