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NCT04469036

Improving Family-Centered Pediatric Trauma Care: The Standard of Care Versus the Virtual Pediatric Trauma Center

Completed NA Results posted Last updated 4 March 2025
What this trial tests

NA trial testing Virtual Pediatric Trauma Center in Trauma in 595 participants. Completed in 27 November 2022.

Timeline
30 November 2020
Primary endpoint
27 November 2022
27 November 2022

Quick facts

Lead sponsorUniversity of California, Davis
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposehealth services research
Enrollment595
Start date30 November 2020
Primary completion27 November 2022
Estimated completion27 November 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, Davis

Who can join

Under 17, any sex, with Trauma or Injuries. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale Primary · 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. We created an "Overall" score representing the sum of the subscales. Analyses compared normalized scores (from 0 to 1) for the overall score and each of the subscale scores, which higher scores implying improved experiences of care. Adjusted mean differences were calculated using mixed-effects regression models, accounting for a small number of potential confounders, with splines to adjust for calendar time. We collected data on the following measures:

Overall patient experience of care
GroupValue95% CI
Virtual Pediatric Trauma Center (Intervention)0.769± 0.209
Telephone Consultation (Control)0.775± 0.223
When Your Child Was Admitted to this Hospital
GroupValue95% CI
Virtual Pediatric Trauma Center (Intervention)0.735± 0.335
Telephone Consultation (Control)0.747± 0.357
Your Experience with Nurses at [hospital name]
GroupValue95% CI
Virtual Pediatric Trauma Center (Intervention)0.878± 0.205
Telephone Consultation (Control)0.890± 0.214
Your Experience with Doctors at [hospital name]
GroupValue95% CI
Virtual Pediatric Trauma Center (Intervention)0.872± 0.230
Telephone Consultation (Control)0.865± 0.254
Your Experience with Providers at [hospital name]
GroupValue95% CI
Virtual Pediatric Trauma Center (Intervention)0.859± 0.208
Telephone Consultation (Control)0.875± 0.203
When Your Child Left the ED at [hospital name]
GroupValue95% CI
Virtual Pediatric Trauma Center (Intervention)0.645± 0.331
Telephone Consultation (Control)0.632± 0.359
3-Day State-Trait Anxiety Inventory Form Y Primary · 3 days after emergency department visit

State-Trait Anxiety Inventory measures state anxiety levels in adults. Responses for the State Anxiety scale assess intensity of current feelings "at this moment". Participant response choices include: 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Data below represent total mean and standard deviation scores between the two groups.

GroupValue95% CI
Virtual Pediatric Trauma Center (Intervention)1.775± 0.594
Telephone Consultation (Control)1.812± 0.620
Transfer Rates Secondary · Transfer from initial ED visit to UCDH

Transfer rates from the referring emergency department to the trauma center will be compared between the control and intervention groups.

Transferred to UCDH
GroupValue95% CI
Virtual Pediatric Trauma Center (Intervention)338
Telephone Consultation (Control)212
Discharged Home from UCDH ED
GroupValue95% CI
Virtual Pediatric Trauma Center (Intervention)127
Telephone Consultation (Control)73
Admitted to the Ward
GroupValue95% CI
Virtual Pediatric Trauma Center (Intervention)107
Telephone Consultation (Control)71
Admitted to the ICU
GroupValue95% CI
Virtual Pediatric Trauma Center (Intervention)32
Telephone Consultation (Control)32
Taken to Operating Room
GroupValue95% CI
Virtual Pediatric Trauma Center (Intervention)72
Telephone Consultation (Control)36
30-Day Healthcare Utilization Secondary · 30 days after emergency department visit

Healthcare utilization included hospitalization and re-hospitalization as measures. Two analyses were done to study 30-day healthcare utilization comparing the intervention and control group. First, the VPTC model of care was compared to the standard of care with respect to ED and hospital use, including transfer and subsequent care needed following initial injury. Second, the VPTC model of care was compared to the standard of care with respect to healthcare (hospital) charges.

Total Post-Transfer Initial Care Charges in Dollars
GroupValue95% CI
Virtual Pediatric Trauma Center (Intervention)77,805± 93,219
Telephone Consultation (Control)79,468± 103,570
Total Subsequent Care Charges in Dollars
GroupValue95% CI
Virtual Pediatric Trauma Center (Intervention)3,228± 37,330
Telephone Consultation (Control)976± 8,495
Total 30-Day Charges in Dollars
GroupValue95% CI
Virtual Pediatric Trauma Center (Intervention)81,032± 105,762
Telephone Consultation (Control)90,443± 104,401
3-Day Out-of-Pocket Costs Secondary · 3 days after emergency department visit

At 3-days, surveys requested parents of patients to self-report medical and non-medical Out-of-Pocket costs following their ED visit.

3-Day Medical Out-of-Pocket Costs in Dollars
GroupValue95% CI
Virtual Pediatric Trauma Center (Intervention)151± 1,521
Telephone Consultation (Control)507± 4,478
3-Day Non-Medical Out-of-Pocket Costs in Dollars
GroupValue95% CI
Virtual Pediatric Trauma Center (Intervention)228± 405
Telephone Consultation (Control)335± 735
3-Day Total Out-of-Pocket Costs in Dollars
GroupValue95% CI
Virtual Pediatric Trauma Center (Intervention)379± 1,572
Telephone Consultation (Control)842± 4,596
30-Day Out-of-Pocket Costs Secondary · 30 days after emergency department visit

At 30-days, surveys requested parents of patients to self-report medical and non-medical Out-of-Pocket costs following their ED visit.

30-Day Medical Out-of-Pocket Costs in Dollars
GroupValue95% CI
Virtual Pediatric Trauma Center (Intervention)247± 926
Telephone Consultation (Control)3,293± 31,945
30-Day Non-Medical Out-of-Pocket Costs in Dollars
GroupValue95% CI
Virtual Pediatric Trauma Center (Intervention)625± 4,670
Telephone Consultation (Control)216± 411
30-Day Total Out-of-Pocket Costs in Dollars
GroupValue95% CI
Virtual Pediatric Trauma Center (Intervention)872± 4,747
Telephone Consultation (Control)3,509± 32,022
30-Day State-Trait Anxiety Inventory Form Y Secondary · 30 days after emergency department visit using Intention-to-Treat analysis.

State-Trait Anxiety Inventory was used to measure state anxiety levels. Responses for the State Anxiety scale assess intensity of current feelings "at this moment". Participant choices included: 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Data below represent total mean and standard deviation scores between the two groups.

GroupValue95% CI
Virtual Pediatric Trauma Center (Intervention)1.776± 0.647
Telephone Consultation (Control)1.798± 0.621

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Enhancing the Implementation of the Virtual Pediatric Trauma Center Using Practical, Robust, Implementation and Sustainability Model: A Mixed-Methods Study.
    Rosenthal JL, Haynes SC, Bonilla B, Rominger K, et al · · 2022 · cited 5× · PMID 36185467 · DOI 10.1089/tmr.2022.0020
  2. Measuring the impact of a "Virtual Pediatric Trauma Center" (VPTC) model of care using telemedicine for acutely injured children versus the standard of care: study protocol for a prospective stepped-wedge trial.
    Marcin JP, Tancredi DJ, Galante JM, Rinderknecht TN, et al · · 2022 · cited 1× · PMID 36575536 · DOI 10.1186/s13063-022-06996-1

Verify or expand the search:

Other recruiting trials for Trauma

Currently open trials in the same condition.

Other University of California, Davis trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04469036.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing