- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04469036
Improving Family-Centered Pediatric Trauma Care: The Standard of Care Versus the Virtual Pediatric Trauma Center
More than 41 million children, or 55 percent of all children in the United States, live more than 30 minutes away from a pediatric trauma center. The management of pediatric trauma requires medical expertise that is only available at Level I pediatric trauma centers, which are specialized pediatric referral hospitals located in large urban cities. Smaller hospitals lack pediatric trauma expertise and resources to properly care for these children. When a small hospital receives a child with trauma, the standard of care is to conduct a telephone consultation to a pediatric trauma specialist, err on the side of safety, and transfer the child to the regional Level I pediatric trauma center.
A newer model of care, the Virtual Pediatric Trauma Center (VPTC), uses live video, or telemedicine, to bring the expertise of a Level I pediatric trauma center virtually to patients at any hospital emergency department. While the VPTC model is being used more frequently, the advantages and disadvantages of these two systems of care remain unknown, particularly with regard to parent/family-centered outcomes.
The goal of this study is to optimize the patient and family experience and to minimize distress, healthcare utilization, and out-of-pocket costs following the injury of a child. The results of this project will help to optimize communication, confidence, and shared decision making between parents/families and clinical staff from both the transferring and receiving hospitals.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- University of California-Davis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pediatric patients (<18 years old) with an acute injury at the time of a transfer consultation call to UC Davis Trauma Surgery, Orthopedic Surgery, or Neurosurgery from eleven outside emergency departments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Telephone consultation
Telephone consultation to a pediatric trauma specialist
|
|
Experimental: Virtual Pediatric Trauma Center
The Virtual Pediatric Trauma Center (VPTC), uses live video, or telehealth, to bring the expertise of a Level I pediatric trauma center virtually to patients at a hospital emergency department.
|
Telehealth
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CAHPS Communication Subscale
Time Frame: 3 days after emergency department visit
|
19 questions from the Communication with Parent Subscale of the Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey; specifically, we will report the following measures: Communication between you and your child's nurses (composite measure); Communication between you and your child's doctors (composite measure); Communication about your child's medicines (composite measure); Keeping you informed about your child's care (composite measure) Privacy when talking with doctors, nurses, and other providers (single-item measure); Preparing you and your child to leave the hospital (composite measure); Keeping you informed about your child's care in the Emergency Room (single-item measure).
Higher scores are better; 0 (minimum) - 100 (maximum)
|
3 days after emergency department visit
|
State-Trait Anxiety Inventory Form Y
Time Frame: 3 days after emergency department visit
|
State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own.
Responses for the State Anxiety scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so.
Range of scores for each subtest is 20-80, the higher score indicating greater anxiety.
A cut point of 39-40 has been suggested to detect clinically significant symptoms.
|
3 days after emergency department visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Transfer Rates
Time Frame: 48 hours after emergency department visit
|
Transfer rates from the referring emergency department to the trauma center will be compared between the control and intervention groups
|
48 hours after emergency department visit
|
30-day healthcare utilization
Time Frame: 30 days after emergency department visit
|
Healthcare utilization will include measures such as hospitalization, re-hospitalization, primary and specialty healthcare visits, and diagnostics; these rates will be compared between the control and intervention groups
|
30 days after emergency department visit
|
3-day Out of Pocket Costs
Time Frame: 3 days after emergency department visit
|
The iMTA Productivity Cost Questionnaire (iPCQ) will be used, which includes three modules measuring productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work
|
3 days after emergency department visit
|
30-day Out of Pocket Costs
Time Frame: 30 days after emergency department visit
|
The iMTA Productivity Cost Questionnaire (iPCQ) will be used, which includes three modules measuring productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work
|
30 days after emergency department visit
|
State-Trait Anxiety Inventory Form Y
Time Frame: 30 days after emergency department visit
|
State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own.
Responses for the State Anxiety scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so.
Range of scores for each subtest is 20-80, the higher score indicating greater anxiety.
A cut point of 39-40 has been suggested to detect clinically significant symptoms.
|
30 days after emergency department visit
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1623230
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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