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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04469036
• Other study ID #: 1623230
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: June 1, 2025

Study information

• Verified date: November 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 344
• Est. completion date: June 1, 2025
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Injuries
• Trauma
• Wounds and Injuries

Intervention

Other:
• Virtual Pediatric Trauma Center
Telehealth

Locations

Country	Name	City	State
United States	University of California-Davis	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAHPS Communication Subscale	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
Primary	State-Trait Anxiety Inventory Form Y	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	Transfer Rates	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
Secondary	30-day healthcare utilization	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
Secondary	3-day Out of Pocket Costs	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
Secondary	30-day Out of Pocket Costs	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
Secondary	State-Trait Anxiety Inventory Form Y	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