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

NCT04469036 | Completed Results

• 1 other identifier: 1623230
• Study Type: interventional
• Target: 595
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trauma; Injuries

Outcome Measures

Primary Outcomes (2)

• Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale

  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: "When your child was admitted to this emergency department" (Yes, definitely; Yes, somewhat; No), "Your experience with nurses" (Never, Sometimes, Usually, Always), "Your experience with doctors" (Never, Sometimes, Usually, Always), "Your experience with providers" (Never, Sometimes, Usually, Always), "When your child left this hospital" (Yes, definitely; Yes, somewhat; No)

  3 days after emergency department visit

• 3-Day State-Trait Anxiety Inventory Form Y

  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.

  3 days after emergency department visit

Secondary Outcomes (5)

• Transfer Rates

  Transfer from initial ED visit to UCDH

• 30-Day Healthcare Utilization

  30 days after emergency department visit

• 3-Day Out-of-Pocket Costs

  3 days after emergency department visit

• 30-Day Out-of-Pocket Costs

  30 days after emergency department visit

• 30-Day State-Trait Anxiety Inventory Form Y

  30 days after emergency department visit using Intention-to-Treat analysis.

Study Arms (2)

Telephone Consultation (Control)

NO INTERVENTION

Telephone consultation to a pediatric trauma specialist.

Virtual Pediatric Trauma Center (Intervention)

EXPERIMENTAL

The Virtual Pediatric Trauma Center uses telehealth to consult a pediatric trauma specialist.

Other: Virtual Pediatric Trauma Center

Interventions

Virtual Pediatric Trauma Center OTHER

Telehealth

Virtual Pediatric Trauma Center (Intervention)

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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\*
• Parents/guardians of the above patients will be contacted to complete surveys

You may not qualify if:

• Pediatric patients who are wards of the state
• Pediatric patients who die before the 3-day survey is administered
• Pediatric patients receiving cardiopulmonary resuscitation prior to presentation to either the outside or UC Davis emergency department

Sponsors & Collaborators

• University of California, Davis: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of California-Davis

Sacramento, California, 95817, United States

Location

Related Publications (1)

• Marcin JP, Tancredi DJ, Galante JM, Rinderknecht TN, Haus BM, Leshikar HB, Zwienenberg M, Rosenthal JL, Grether-Jones KL, Hamline MY, Hoch JS, Kuppermann N. 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. Trials. 2022 Dec 27;23(1):1051. doi: 10.1186/s13063-022-06996-1.

  PMID: 36575536 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Limitations and Caveats

* Expanding the existing clinical workflow to conduct telehealth visits was not universally supported given the limited physician staff. * Intervention intended to inform clinical-decision making, but was adapted towards supporting parents. Nurse practitioners became the primary initiator of consultations instead of the trauma surgeons. * Partner sites had more unique needs and workflows as the program was expanding, requiring unique solutions.

Results Point of Contact

• Title: Raynald Dizon
• Organization: UC Davis Health

rodizon@ucdavis.edu

9167344736

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped-wedge

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 13, 2020
• Study Start: November 30, 2020
• Primary Completion: November 27, 2022
• Study Completion: November 27, 2022
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: All study data housed at the University of California Davis Health will be destroyed after seven years after completion of the study. Once study data has been deposited in the ICPSR repository, ICPSR will maintain the full data package following their established routine procedures for restricted-use classification.
• Access Criteria: Data collected for this project includes information gathered from participant surveys and the UCDH EHR; this data will be deposited and housed in the ICPSR repository in perpetuity. The VPTC model of care is an innovative intervention designed to address access disparities that were exacerbated by regionalization of Level I pediatric trauma centers. The intervention leveraged telemedicine to facilitate real-time consultations and care coordination between non-pediatric emergency departments and level I pediatric trauma centers. Data from this study may be of interest to practitioners, payors, policy makers, and patients.

Locations

US (1)