Injuries, Trauma
Conditions
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
Telehealth
Sponsors
Study design
Intervention model description
Stepped-wedge
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\* * 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
| Measure | Time frame | Description |
|---|---|---|
| Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale | 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: 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 Y | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-Day Out-of-Pocket Costs | 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. |
| Transfer Rates | 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. |
| 30-Day State-Trait Anxiety Inventory Form Y | 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. |
| 30-Day Out-of-Pocket Costs | 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 Healthcare Utilization | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 595 |
Baseline characteristics
| Characteristic | Virtual Pediatric Trauma Center (Intervention) | Telephone Consultation (Control) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 369 Participants | 226 Participants | 595 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8.1 years STANDARD_DEVIATION 5.2 | 8 years STANDARD_DEVIATION 5.1 | 8 years STANDARD_DEVIATION 5.1 |
| Distance in miles from outlying hospital | 38.2 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 Participants | 208 Participants | 553 Participants |
| Glasgow Coma Scale Score 3 - 14 | 24 Participants | 18 Participants | 42 Participants |
| Injury Severity Score 0 - 8 (minor injuries) | 290 Participants | 159 Participants | 449 Participants |
| Injury Severity Score 24 (severe injuries) | 24 Participants | 15 Participants | 39 Participants |
| Injury Severity Score 9 - 15 (moderate injuries) | 55 Participants | 52 Participants | 107 Participants |
| Insurance Type Commercial | 129 Participants | 82 Participants | 211 Participants |
| Insurance Type Medicaid | 240 Participants | 144 Participants | 384 Participants |
| Language English | 331 Participants | 208 Participants | 539 Participants |
| Language Other/Missing | 15 Participants | 3 Participants | 18 Participants |
| Language Spanish | 23 Participants | 15 Participants | 38 Participants |
| Race/Ethnicity, Customized Hispanic | 125 Participants | 74 Participants | 199 Participants |
| Race/Ethnicity, Customized Non-Hispanic, Black | 27 Participants | 18 Participants | 45 Participants |
| Race/Ethnicity, Customized Non-Hispanic, Other | 47 Participants | 25 Participants | 72 Participants |
| Race/Ethnicity, Customized Non-Hispanic, White | 170 Participants | 109 Participants | 279 Participants |
| Sex: Female, Male Female | 142 Participants | 81 Participants | 223 Participants |
| Sex: Female, Male Male | 227 Participants | 145 Participants | 372 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 369 | 0 / 226 |
| other Total, other adverse events | 0 / 369 | 0 / 226 |
| serious Total, serious adverse events | 0 / 369 | 0 / 226 |
Outcome results
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Pediatric Trauma Center (Intervention) | 3-Day State-Trait Anxiety Inventory Form Y | 1.775 score on a scale | Standard Deviation 0.594 |
| Telephone Consultation (Control) | 3-Day State-Trait Anxiety Inventory Form Y | 1.812 score on a scale | Standard Deviation 0.62 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Virtual Pediatric Trauma Center (Intervention) | Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale | Overall patient experience of care | 0.769 score on a scale | Standard Deviation 0.209 |
| Virtual Pediatric Trauma Center (Intervention) | Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale | When Your Child Was Admitted to this Hospital | 0.735 score on a scale | Standard Deviation 0.335 |
| Virtual Pediatric Trauma Center (Intervention) | Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale | Your Experience with Nurses at [hospital name] | 0.878 score on a scale | Standard Deviation 0.205 |
| Virtual Pediatric Trauma Center (Intervention) | Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale | Your Experience with Doctors at [hospital name] | 0.872 score on a scale | Standard Deviation 0.23 |
| Virtual Pediatric Trauma Center (Intervention) | Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale | Your Experience with Providers at [hospital name] | 0.859 score on a scale | Standard Deviation 0.208 |
| Virtual Pediatric Trauma Center (Intervention) | Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale | When Your Child Left the ED at [hospital name] | 0.645 score on a scale | Standard Deviation 0.331 |
| Telephone Consultation (Control) | Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale | Your Experience with Providers at [hospital name] | 0.875 score on a scale | Standard Deviation 0.203 |
| Telephone Consultation (Control) | Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale | Overall patient experience of care | 0.775 score on a scale | Standard Deviation 0.223 |
| Telephone Consultation (Control) | Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale | Your Experience with Doctors at [hospital name] | 0.865 score on a scale | Standard Deviation 0.254 |
| Telephone Consultation (Control) | Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale | When Your Child Was Admitted to this Hospital | 0.747 score on a scale | Standard Deviation 0.357 |
| Telephone Consultation (Control) | Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale | When Your Child Left the ED at [hospital name] | 0.632 score on a scale | Standard Deviation 0.359 |
| Telephone Consultation (Control) | Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale | Your Experience with Nurses at [hospital name] | 0.890 score on a scale | Standard Deviation 0.214 |
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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Virtual Pediatric Trauma Center (Intervention) | 30-Day Healthcare Utilization | Total Post-Transfer Initial Care Charges in Dollars | 77,805 Dollars |
| Virtual Pediatric Trauma Center (Intervention) | 30-Day Healthcare Utilization | Total Subsequent Care Charges in Dollars | 3,228 Dollars |
| Virtual Pediatric Trauma Center (Intervention) | 30-Day Healthcare Utilization | Total 30-Day Charges in Dollars | 81,032 Dollars |
| Telephone Consultation (Control) | 30-Day Healthcare Utilization | Total Post-Transfer Initial Care Charges in Dollars | 79,468 Dollars |
| Telephone Consultation (Control) | 30-Day Healthcare Utilization | Total Subsequent Care Charges in Dollars | 976 Dollars |
| Telephone Consultation (Control) | 30-Day Healthcare Utilization | Total 30-Day Charges in Dollars | 90,443 Dollars |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Virtual Pediatric Trauma Center (Intervention) | 30-Day Out-of-Pocket Costs | 30-Day Non-Medical Out-of-Pocket Costs in Dollars | 625 Dollars | — |
| Virtual Pediatric Trauma Center (Intervention) | 30-Day Out-of-Pocket Costs | 30-Day Medical Out-of-Pocket Costs in Dollars | 247 Dollars | Standard Deviation 926 |
| Virtual Pediatric Trauma Center (Intervention) | 30-Day Out-of-Pocket Costs | 30-Day Total Out-of-Pocket Costs in Dollars | 872 Dollars | — |
| Telephone Consultation (Control) | 30-Day Out-of-Pocket Costs | 30-Day Medical Out-of-Pocket Costs in Dollars | 3,293 Dollars | — |
| Telephone Consultation (Control) | 30-Day Out-of-Pocket Costs | 30-Day Non-Medical Out-of-Pocket Costs in Dollars | 216 Dollars | Standard Deviation 411 |
| Telephone Consultation (Control) | 30-Day Out-of-Pocket Costs | 30-Day Total Out-of-Pocket Costs in Dollars | 3,509 Dollars | — |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Pediatric Trauma Center (Intervention) | 30-Day State-Trait Anxiety Inventory Form Y | 1.776 score on a scale | Standard Deviation 0.647 |
| Telephone Consultation (Control) | 30-Day State-Trait Anxiety Inventory Form Y | 1.798 score on a scale | Standard Deviation 0.621 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Virtual Pediatric Trauma Center (Intervention) | 3-Day Out-of-Pocket Costs | 3-Day Medical Out-of-Pocket Costs in Dollars | 151 Dollars | — |
| Virtual Pediatric Trauma Center (Intervention) | 3-Day Out-of-Pocket Costs | 3-Day Non-Medical Out-of-Pocket Costs in Dollars | 228 Dollars | Standard Deviation 405 |
| Virtual Pediatric Trauma Center (Intervention) | 3-Day Out-of-Pocket Costs | 3-Day Total Out-of-Pocket Costs in Dollars | 379 Dollars | — |
| Telephone Consultation (Control) | 3-Day Out-of-Pocket Costs | 3-Day Medical Out-of-Pocket Costs in Dollars | 507 Dollars | — |
| Telephone Consultation (Control) | 3-Day Out-of-Pocket Costs | 3-Day Non-Medical Out-of-Pocket Costs in Dollars | 335 Dollars | Standard Deviation 735 |
| Telephone Consultation (Control) | 3-Day Out-of-Pocket Costs | 3-Day Total Out-of-Pocket Costs in Dollars | 842 Dollars | — |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Virtual Pediatric Trauma Center (Intervention) | Transfer Rates | Discharged Home from UCDH ED | 127 Participants |
| Virtual Pediatric Trauma Center (Intervention) | Transfer Rates | Admitted to the ICU | 32 Participants |
| Virtual Pediatric Trauma Center (Intervention) | Transfer Rates | Admitted to the Ward | 107 Participants |
| Virtual Pediatric Trauma Center (Intervention) | Transfer Rates | Taken to Operating Room | 72 Participants |
| Virtual Pediatric Trauma Center (Intervention) | Transfer Rates | Transferred to UCDH | 338 Participants |
| Telephone Consultation (Control) | Transfer Rates | Taken to Operating Room | 36 Participants |
| Telephone Consultation (Control) | Transfer Rates | Transferred to UCDH | 212 Participants |
| Telephone Consultation (Control) | Transfer Rates | Discharged Home from UCDH ED | 73 Participants |
| Telephone Consultation (Control) | Transfer Rates | Admitted to the Ward | 71 Participants |
| Telephone Consultation (Control) | Transfer Rates | Admitted to the ICU | 32 Participants |