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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Pediatric Trauma Center | Other | Telehealth |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Transfer Rates | Transfer rates from the referring emergency department to the trauma center will be compared between the control and intervention groups. | Transfer from initial ED visit to UCDH |
| 30-Day Healthcare Utilization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California-Davis | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36575536 | Derived | 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. |
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The "Virtual Pediatric Trauma Center" (VPTC) is a model of care that utilizes telemedicine for acutely injured children presenting to non-pediatric trauma center hospitals to obtain consultations from pediatric trauma specialists. This randomized controlled trial compared the standard of care (telephone consultation from a referring non-pediatric trauma center connected to a pediatric trauma specialist at a level I pediatric trauma center) to the VPTC model of care (telemedicine consultation between the referring facility and pediatric specialist) for pediatric trauma injuries. Data comparing the two models was collected to assess parent/family experience of care and distress, transfer rates, healthcare utilization, and financial impact on parents/families. 595 children were enrolled during the two-year active study period and data was collected from parent/family surveys and the electronic health record (EHR).
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.
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.
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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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Pediatric Trauma Center (Intervention) | The Virtual Pediatric Trauma Center uses telehealth for consultation with a pediatric trauma specialist. |
| FG001 | Telephone Consultation (Control) | Telephone consultations uses audio-only to connect with a pediatric trauma specialist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
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| Start of Standard of Care: 8-week Period |
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| Hospital Randomization Phase 12 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Pediatric Trauma Center (Intervention) | The Virtual Pediatric Trauma Center uses telehealth for consultation with a pediatric trauma specialist. |
| BG001 | Telephone Consultation (Control) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 days after emergency department visit |
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Virtual Pediatric Trauma Center | The Virtual Pediatric Trauma Center (VPTC), uses live video, or telehealth, to bring the expertise of a Level I pediatric trauma center virtually to patients at a hospital emergency department. Virtual Pediatric Trauma Center: Telehealth |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raynald Dizon | UC Davis Health | 9167344736 | rodizon@ucdavis.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2022 | Feb 10, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Stepped-wedge
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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.
| 30 days after emergency department visit |
| 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. | 3 days after emergency department visit |
| 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. | 30 days after emergency department visit |
| 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. | 30 days after emergency department visit using Intention-to-Treat analysis. |
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Telephone consultations uses audio-only to connect with a pediatric trauma specialist.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Insurance Type | Count of Participants | Participants |
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| Language | Count of Participants | Participants |
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| Injury Severity Score | Injury Severity Scores range from 1 to 75. A score of 75 is derived from either three Abbreviated Injury Scale 5 injuries or from one Abbreviated Injury Scale 6 injury. Any Abbreviated Injury Scale 6 (maximal) injury is an automatic maximal Injury Severity Score of 75, regardless of any other injuries that may also be found. Data in the table represent the number of patients that scored within the respective ranges. | Count of Participants | Participants |
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| Glasgow Coma Scale Score | A Glasgow Coma Scale (GCS) score of 15 is the best possible score, indicating that a patient is fully awake, alert, and responsive. A score of 8 or fewer usually indicates a coma, with lower scores indicating deeper comas. A score of 3 is the worst possible score, indicating that the patient is completely unresponsive. The data below indicates the number of patients that either scored 15 on the Glasgow Coma Scale, or patients that scored below 15. | Count of Participants | Participants |
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| Distance in miles from outlying hospital | Mean | Standard Deviation | Miles |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 days after emergency department visit |
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| Secondary | Transfer Rates | Transfer rates from the referring emergency department to the trauma center will be compared between the control and intervention groups. | 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. | Posted | Count of Participants | Participants | No | Transfer from initial ED visit to UCDH |
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| 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. | Healthcare Utilization of patients evaluated at 30-days after discharge following an ER visit, Intention-to-Treat analysis used. | Posted | Mean | Standard Deviation | Dollars | 30 days after emergency department visit |
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| 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. | Modified Intention-to-Treat analysis of patients that reported 3-day Out-of-Pocket cost data. | Posted | Mean | Standard Deviation | Dollars | 3 days after emergency department visit |
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| 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. | Modified Intention-to-Treat analysis of patients that reported 30-day out of pocket cost data. | Posted | Mean | Standard Deviation | Dollars | 30 days after emergency department visit |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 30 days after emergency department visit using Intention-to-Treat analysis. |
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| 0 |
| 369 |
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| 369 |
| 0 |
| 369 |
| EG001 | Telephone Consultation | Telephone consultation to a pediatric trauma specialist | 0 | 226 | 0 | 226 | 0 | 226 |
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| Admitted to the Ward |
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| Admitted to the ICU |
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| Taken to Operating Room |
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| Total 30-Day Charges in Dollars |
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| 3-Day Total Out-of-Pocket Costs in Dollars |
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| 30-Day Total Out-of-Pocket Costs in Dollars |
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