Clinical trial NCT04469036: Improving Family-Centered Pediatric Trauma Care: The Standard of Care Versus the Virtual Pediatric Trauma Center
Official title: Improving Family-Centered Pediatric Trauma Care: The Standard of Care Versus the Virtual Pediatric Trauma Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Injuries
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2020-07-13
Enrollment: 595
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped-wedge
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: The American College of Surgeons Committee on Trauma (ACS-COT) has been committed to improving the care provided to injured patients since 1922. An essential component of their efforts has been the creation of minimum standards for trauma facilities and a tiered trauma care system. As detailed in the ACS-COT published guidelines, Resources for Optimal Care of the Injured Patient, these standards outline the five levels of trauma facilities that define varying levels of commitment, readiness, resources, policies, patient care, and performance improvement. A Level I trauma center is the highest designation and is only granted to hospitals that are able to provide the highest level of care to all injured patients. The ACS-COT Trauma Center Verification process has been instrumental in improving outcomes among injured children and adults, and has become the national model of trauma care coordination as well as the prototype for trauma care on an international level.

While the regionalization of trauma care has resulted in improved outcomes, the current standard of care has created disparities in access for patients injured in geographically isolated locations. When children living in remote communities are injured and present to a non-pediatric trauma center emergency department (ED), they are transferred to the regionalized Level I pediatric trauma center. In more than half of the states in the US, a majority of children live more than 30 miles from a designated Level I pediatric trauma center. Currently, there are more than 41 million children in the US that have poor access to care, living more than 30 miles from a pediatric trauma center, and it is these children who would benefit the most from a re-engineered system of care that addresses the disparities in access for injured children.

Because the current regionalization of trauma centers has created disparities in access, many pediatric trauma experts, including health policy makers, health services researchers, and front line clinicians, have advocated for the use of telemedicine so that the Level I pediatric trauma center expertise can be transmitted to the receiving EDs where a majority of pediatric trauma patients initially present. This newer system of care has been commonly referred to as the "Virtual Pediatric Trauma Center" (VPTC) and is increasingly used by many hospitals and EDs throughout the country. The VPTC creates a model of care that connects EDs in non-Level I trauma centers using telemedicine to bring expert pediatric trauma care to the bedside of injured children, no matter which hospital the patient presents to first. While this newer model of care enables participation of parents/families in the initial trauma care, there is conflicting and limited literature comparing this model to the current standard of care as it relates to parent/family-experience and distress, healthcare utilization, and financial impact on parents/families.

As evidence, in preparation for the original proposal for this study, we conducted three meetings with community advisory boards, which laid the foundation for the study design and evaluation (see: Community and Stakeholder Involvement During Study Development below). For the resubmission of that proposal, we reconvened with members from each of these boards to focus more on parent/family-centered measures. Our team of clinical investigators, consortium hospital partners, as well as our two broadly representative community advisory boards, are confident that these two models of care can be effectively compared, and that the results will provide important solutions to problems facing families wanting to improve specialized trauma care for children. As highlighted in the PCORI Research Prioritization Topic Brief entitled, "Rural Trauma Care," improving rural trauma care is a "high-impact target."20 Recent data derived on adult patients have documented the impact that telemedicine can have on clinical outcomes in a variety of trauma settings. Having the core members of a regionalized Level I pediatric trauma center available virtually at the bedside of injured children has the potential to have a positive impact on the parent and family involvement in shared decision making, which may reduce unnecessary and financially burdensome transfers. Alternatively, parents and families may prefer to err on the side of safety and have an injured child immediately transferred to the regional Level I pediatric trauma center, so delaying or avoiding the transfer of an injured child to a better equipped and staffed facility could result in increased parent/family distress, healthcare utilization, and out-of-pocket costs. Hence, a rigorous comparison of the two prevailing models of care is needed to inform the choice between them.

Eligibility criteria: 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\*
* Parents/guardians of the above patients will be contacted to complete surveys

Exclusion Criteria:

* 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

Primary outcomes:
measure: Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale
timeFrame: 3 days after emergency department visit
measure: 3-Day State-Trait Anxiety Inventory Form Y
timeFrame: 3 days after emergency department visit
Secondary outcomes:
measure: Transfer Rates
timeFrame: Transfer from initial ED visit to UCDH
measure: 30-Day Healthcare Utilization
timeFrame: 30 days after emergency department visit
measure: 3-Day Out-of-Pocket Costs
timeFrame: 3 days after emergency department visit
measure: 30-Day Out-of-Pocket Costs
timeFrame: 30 days after emergency department visit
measure: 30-Day State-Trait Anxiety Inventory Form Y
timeFrame: 30 days after emergency department visit using Intention-to-Treat analysis.
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California-Davis
state: California
Study officials:
References: