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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04469036
Enrollment
595
Registered
2020-07-13
Start date
2020-11-30
Completion date
2022-11-27
Last updated
2025-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injuries, Trauma

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.

Interventions

OTHERVirtual Pediatric Trauma Center

Telehealth

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
University of California, Davis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Stepped-wedge

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale3 days after emergency department visit19 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-Day State-Trait Anxiety Inventory Form Y3 days after emergency department visitState-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.

Secondary

MeasureTime frameDescription
3-Day Out-of-Pocket Costs3 days after emergency department visitAt 3-days, surveys requested parents of patients to self-report medical and non-medical Out-of-Pocket costs following their ED visit.
Transfer RatesTransfer from initial ED visit to UCDHTransfer rates from the referring emergency department to the trauma center will be compared between the control and intervention groups.
30-Day State-Trait Anxiety Inventory Form Y30 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.
30-Day Out-of-Pocket Costs30 days after emergency department visitAt 30-days, surveys requested parents of patients to self-report medical and non-medical Out-of-Pocket costs following their ED visit.
30-Day Healthcare Utilization30 days after emergency department visitHealthcare 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.

Countries

United States

Participant flow

Recruitment details

Recruitment for this project began on 11/30/2020. Electronic medical record data was collected from a Transfer Center report that included children who presented to one of the participating sites with a transfer consultation to UC Davis Trauma, Orthopedics, or Neurosurgery services.

Pre-assignment details

We used a prospective stepped-wedge trial design. After 6-month pre-implementation, study began with all 10 hospitals beginning in standard of care and patients enrolled for 13, 8-week periods. 706 patients were assessed for eligibility, 73 patients did not meet inclusion criteria and 38 were excluded from the study. 595 enrolled patients were then randomized to the study. Parents (not enrolled in the study) of the patients were then contacted to complete surveys.

Participants by arm

ArmCount
Virtual Pediatric Trauma Center (Intervention)
The Virtual Pediatric Trauma Center uses telehealth for consultation with a pediatric trauma specialist.
369
Telephone Consultation (Control)
Telephone consultations uses audio-only to connect with a pediatric trauma specialist.
226
Total595

Baseline characteristics

CharacteristicVirtual Pediatric Trauma Center (Intervention)Telephone Consultation (Control)Total
Age, Categorical
<=18 years
369 Participants226 Participants595 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous8.1 years
STANDARD_DEVIATION 5.2
8 years
STANDARD_DEVIATION 5.1
8 years
STANDARD_DEVIATION 5.1
Distance in miles from outlying hospital38.2 Miles
STANDARD_DEVIATION 36.3
48.8 Miles
STANDARD_DEVIATION 52.4
42.3 Miles
STANDARD_DEVIATION 43.4
Glasgow Coma Scale Score
15
345 Participants208 Participants553 Participants
Glasgow Coma Scale Score
3 - 14
24 Participants18 Participants42 Participants
Injury Severity Score
0 - 8 (minor injuries)
290 Participants159 Participants449 Participants
Injury Severity Score
24 (severe injuries)
24 Participants15 Participants39 Participants
Injury Severity Score
9 - 15 (moderate injuries)
55 Participants52 Participants107 Participants
Insurance Type
Commercial
129 Participants82 Participants211 Participants
Insurance Type
Medicaid
240 Participants144 Participants384 Participants
Language
English
331 Participants208 Participants539 Participants
Language
Other/Missing
15 Participants3 Participants18 Participants
Language
Spanish
23 Participants15 Participants38 Participants
Race/Ethnicity, Customized
Hispanic
125 Participants74 Participants199 Participants
Race/Ethnicity, Customized
Non-Hispanic, Black
27 Participants18 Participants45 Participants
Race/Ethnicity, Customized
Non-Hispanic, Other
47 Participants25 Participants72 Participants
Race/Ethnicity, Customized
Non-Hispanic, White
170 Participants109 Participants279 Participants
Sex: Female, Male
Female
142 Participants81 Participants223 Participants
Sex: Female, Male
Male
227 Participants145 Participants372 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 3690 / 226
other
Total, other adverse events
0 / 3690 / 226
serious
Total, serious adverse events
0 / 3690 / 226

Outcome results

Primary

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.

Time frame: 3 days after emergency department visit

Population: All participants who received either Virtual Pediatric Model of Care or a Telephone Consultation that reported State-trait anxiety scores at 3-days, data analyzed as Intention-to-Treat.

ArmMeasureValue (MEAN)Dispersion
Virtual Pediatric Trauma Center (Intervention)3-Day State-Trait Anxiety Inventory Form Y1.775 score on a scaleStandard Deviation 0.594
Telephone Consultation (Control)3-Day State-Trait Anxiety Inventory Form Y1.812 score on a scaleStandard Deviation 0.62
Primary

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)

Time frame: 3 days after emergency department visit

Population: All participants who received either Virtual Pediatric Model of Care or a Telephone Consultation that reported Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey scores, data analyzed as Intention-to-Treat.

ArmMeasureGroupValue (MEAN)Dispersion
Virtual Pediatric Trauma Center (Intervention)Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication SubscaleOverall patient experience of care0.769 score on a scaleStandard Deviation 0.209
Virtual Pediatric Trauma Center (Intervention)Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication SubscaleWhen Your Child Was Admitted to this Hospital0.735 score on a scaleStandard Deviation 0.335
Virtual Pediatric Trauma Center (Intervention)Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication SubscaleYour Experience with Nurses at [hospital name]0.878 score on a scaleStandard Deviation 0.205
Virtual Pediatric Trauma Center (Intervention)Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication SubscaleYour Experience with Doctors at [hospital name]0.872 score on a scaleStandard Deviation 0.23
Virtual Pediatric Trauma Center (Intervention)Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication SubscaleYour Experience with Providers at [hospital name]0.859 score on a scaleStandard Deviation 0.208
Virtual Pediatric Trauma Center (Intervention)Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication SubscaleWhen Your Child Left the ED at [hospital name]0.645 score on a scaleStandard Deviation 0.331
Telephone Consultation (Control)Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication SubscaleYour Experience with Providers at [hospital name]0.875 score on a scaleStandard Deviation 0.203
Telephone Consultation (Control)Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication SubscaleOverall patient experience of care0.775 score on a scaleStandard Deviation 0.223
Telephone Consultation (Control)Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication SubscaleYour Experience with Doctors at [hospital name]0.865 score on a scaleStandard Deviation 0.254
Telephone Consultation (Control)Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication SubscaleWhen Your Child Was Admitted to this Hospital0.747 score on a scaleStandard Deviation 0.357
Telephone Consultation (Control)Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication SubscaleWhen Your Child Left the ED at [hospital name]0.632 score on a scaleStandard Deviation 0.359
Telephone Consultation (Control)Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication SubscaleYour Experience with Nurses at [hospital name]0.890 score on a scaleStandard Deviation 0.214
Secondary

30-Day Healthcare Utilization

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.

Time frame: 30 days after emergency department visit

Population: Healthcare Utilization of patients evaluated at 30-days after discharge following an ER visit, Intention-to-Treat analysis used.

ArmMeasureGroupValue (MEAN)
Virtual Pediatric Trauma Center (Intervention)30-Day Healthcare UtilizationTotal Post-Transfer Initial Care Charges in Dollars77,805 Dollars
Virtual Pediatric Trauma Center (Intervention)30-Day Healthcare UtilizationTotal Subsequent Care Charges in Dollars3,228 Dollars
Virtual Pediatric Trauma Center (Intervention)30-Day Healthcare UtilizationTotal 30-Day Charges in Dollars81,032 Dollars
Telephone Consultation (Control)30-Day Healthcare UtilizationTotal Post-Transfer Initial Care Charges in Dollars79,468 Dollars
Telephone Consultation (Control)30-Day Healthcare UtilizationTotal Subsequent Care Charges in Dollars976 Dollars
Telephone Consultation (Control)30-Day Healthcare UtilizationTotal 30-Day Charges in Dollars90,443 Dollars
Secondary

30-Day Out-of-Pocket Costs

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

Time frame: 30 days after emergency department visit

Population: Modified Intention-to-Treat analysis of patients that reported 30-day out of pocket cost data.

ArmMeasureGroupValue (MEAN)Dispersion
Virtual Pediatric Trauma Center (Intervention)30-Day Out-of-Pocket Costs30-Day Non-Medical Out-of-Pocket Costs in Dollars625 Dollars
Virtual Pediatric Trauma Center (Intervention)30-Day Out-of-Pocket Costs30-Day Medical Out-of-Pocket Costs in Dollars247 DollarsStandard Deviation 926
Virtual Pediatric Trauma Center (Intervention)30-Day Out-of-Pocket Costs30-Day Total Out-of-Pocket Costs in Dollars872 Dollars
Telephone Consultation (Control)30-Day Out-of-Pocket Costs30-Day Medical Out-of-Pocket Costs in Dollars3,293 Dollars
Telephone Consultation (Control)30-Day Out-of-Pocket Costs30-Day Non-Medical Out-of-Pocket Costs in Dollars216 DollarsStandard Deviation 411
Telephone Consultation (Control)30-Day Out-of-Pocket Costs30-Day Total Out-of-Pocket Costs in Dollars3,509 Dollars
Secondary

30-Day State-Trait Anxiety Inventory Form Y

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.

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

Population: All participants who received either Virtual Pediatric Model of Care or a Telephone Consultation that reported State-trait anxiety scores at 30-days, data analyzed as Intention-to-Treat.

ArmMeasureValue (MEAN)Dispersion
Virtual Pediatric Trauma Center (Intervention)30-Day State-Trait Anxiety Inventory Form Y1.776 score on a scaleStandard Deviation 0.647
Telephone Consultation (Control)30-Day State-Trait Anxiety Inventory Form Y1.798 score on a scaleStandard Deviation 0.621
Secondary

3-Day Out-of-Pocket Costs

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

Time frame: 3 days after emergency department visit

Population: Modified Intention-to-Treat analysis of patients that reported 3-day Out-of-Pocket cost data.

ArmMeasureGroupValue (MEAN)Dispersion
Virtual Pediatric Trauma Center (Intervention)3-Day Out-of-Pocket Costs3-Day Medical Out-of-Pocket Costs in Dollars151 Dollars
Virtual Pediatric Trauma Center (Intervention)3-Day Out-of-Pocket Costs3-Day Non-Medical Out-of-Pocket Costs in Dollars228 DollarsStandard Deviation 405
Virtual Pediatric Trauma Center (Intervention)3-Day Out-of-Pocket Costs3-Day Total Out-of-Pocket Costs in Dollars379 Dollars
Telephone Consultation (Control)3-Day Out-of-Pocket Costs3-Day Medical Out-of-Pocket Costs in Dollars507 Dollars
Telephone Consultation (Control)3-Day Out-of-Pocket Costs3-Day Non-Medical Out-of-Pocket Costs in Dollars335 DollarsStandard Deviation 735
Telephone Consultation (Control)3-Day Out-of-Pocket Costs3-Day Total Out-of-Pocket Costs in Dollars842 Dollars
Secondary

Transfer Rates

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

Time frame: Transfer from initial ED visit to UCDH

Population: 338 patients transferred to UC Davis Health, numbers reported in the table indicate patient disposition from UC Davis Health Emergency Department, data was analyzed using Intention-to-Treat analysis.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Virtual Pediatric Trauma Center (Intervention)Transfer RatesDischarged Home from UCDH ED127 Participants
Virtual Pediatric Trauma Center (Intervention)Transfer RatesAdmitted to the ICU32 Participants
Virtual Pediatric Trauma Center (Intervention)Transfer RatesAdmitted to the Ward107 Participants
Virtual Pediatric Trauma Center (Intervention)Transfer RatesTaken to Operating Room72 Participants
Virtual Pediatric Trauma Center (Intervention)Transfer RatesTransferred to UCDH338 Participants
Telephone Consultation (Control)Transfer RatesTaken to Operating Room36 Participants
Telephone Consultation (Control)Transfer RatesTransferred to UCDH212 Participants
Telephone Consultation (Control)Transfer RatesDischarged Home from UCDH ED73 Participants
Telephone Consultation (Control)Transfer RatesAdmitted to the Ward71 Participants
Telephone Consultation (Control)Transfer RatesAdmitted to the ICU32 Participants

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026