Improving Family-Centered Pediatric Trauma Care: The Standard of Care Versus the Virtual Pediatric Trauma Center
Phase: NA
Conditions: Trauma, Injuries
Sponsor: University of California, Davis

PROTOCOL TITLE: Virtual Pediatric Trauma Center 
Page 1 of 11 
 
HRP-503-PTOTOCOL TEMPLATE-General 
 
 
Template Revision: January 17, 2020 
ClinicalTrials.gov – Study Protocol and Statistical Analysis Plan 
 
 
 
 
 
 
 
 
 
 
 
 
 
Title: Improving Family-Centered Pediatric Trauma Care: The 
Standard of Care Versus the Virtual Pediatric Trauma Center 
NCT Number: NCT04469036 
Document Date: 09/22/2022

PROTOCOL TITLE: Virtual Pediatric Trauma Center 
Page 2 of 11 
 
HRP-503-PTOTOCOL TEMPLATE-General 
 
 
Template Revision: January 17, 2020 
Protocol Title 
Title:  Virtual Pediatric Trauma Center 
Protocol Version Date: 2022-09-22 
1) 
Objectives 
• Aim #1a: To compare the parent/family experience of care and distress at 3-days 
and 30-days following a childhood injury requiring an emergency department 
visit in a non-pediatric trauma center under the current standard model of care and 
the VPTC model of care. 
o Null Hypothesis: Measures of parent/family experience of care and 
measures of distress will be similar between the two models of care. 
• 
Aim #1b: To compare the frequency of potentially avoidable transfers (PAT) and 
transfers in a non-pediatric trauma center under the current standard model of care 
and the VPTC model of care. 
o Null hypothesis: Frequency of PATs and transfers will be similar between 
the two models of care.  
• 
Aim #2: To compare 30-day healthcare utilization between injured children cared 
for under the current standard model of care and the VPTC model of care. 
o Null Hypothesis: Hospitalizations, re-hospitalizations, primary and 
specialty care visits will be similar between the two models of care. 
• 
Aim #3: To compare the out-of-pocket costs and financial burdens experienced 
by parents/families at 3-days and 30-days following a childhood injury requiring 
an emergency department visit in a non-pediatric trauma center under the current 
standard model of care and the VPTC model of care. 
o Null Hypothesis: Out-of-pocket costs and financial burdens for 
parent/families will be similar between the two models of care.  
 
2) Background 
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,1 these standards outline 
the five levels of trauma facilities that define varying levels of commitment, readiness, 
resources, policies, patient care, and performance improvement.1 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.2,3 

PROTOCOL TITLE: Virtual Pediatric Trauma Center 
Page 3 of 11 
 
HRP-503-PTOTOCOL TEMPLATE-General 
 
 
Template Revision: January 17, 2020 
While the regionalization of trauma care has resulted in improved outcomes,4,5 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.6 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.7,8  
 
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.9-12 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.12,13 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.14  
 
3) 
Inclusion and Exclusion Criteria 
Inclusion 
Estimated Percentage of Children With Adequate Access to Pediatric Trauma Care, 
Living within 30 Miles of a Pediatric Trauma Center, by State 

PROTOCOL TITLE: Virtual Pediatric Trauma Center 
Page 4 of 11 
 
HRP-503-PTOTOCOL TEMPLATE-General 
 
 
Template Revision: January 17, 2020 
 
 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 
*Adventist Health Lodi, Adventist Health Rideout, Marshall Medical Center, 
Mayers Memorial Hospital, Mercy Medical Center Redding, Mercy Methodist 
Hospital, Mercy San Juan Medical Center, Oroville Hospital, Tahoe Forest 
Hospital, Woodland Memorial Hospital, Barton Memorial Hospital  
ExclusionThe following patients will be excluded from recruitment for 
survey completion but included in the dataset:  
 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 
 
4) 
Study Timelines 
Data will be abstracted for all patients with transfer center consultations from  
eligible emergency departments* between November 30th, 2020 and March 31st, 
2024. 
Parents/guardians of eligible patients will be contacted within 3-days of the 
eligible emergency department visit to complete the first survey. They will then 
be asked to complete surveys at 30-, 60-, and 90-days after the eligible emergency 
department visit. They will be given until 104 days after the eligible emergency 
department visit to complete the final survey.  
The study team will complete primary analyses by May 31st, 2023.  
 
5) 
Study Endpoints 
Transfer consultation data will be collected until March 31st, 2024. 
Surveys will be collected until March 14th, 2023.  
 
6) 
Procedures Involved 
Systems Level Intervention 
To compare our parent, family, community and provider informed outcomes 
between the current standard of care and the VPTC, we will use a prospective stepped-
wedge trial design,62 which has important advantages over alternative designs. First, with 
the stepped-wedge design, changes in the quality and standards of pediatric trauma care 
over time can be accounted for, unlike a simple pre-test, post-test study design where 

PROTOCOL TITLE: Virtual Pediatric Trauma Center 
Page 5 of 11 
 
HRP-503-PTOTOCOL TEMPLATE-General 
 
 
Template Revision: January 17, 2020 
changes in care could be confounded by temporal changes and secular trends. Second, in 
common with a cluster randomized design, and in contrast to patient-randomized designs, 
our design minimizes contamination bias that could arise among researchers and 
participants when patients at the same site have been concurrently randomized to two 
different models of care. In addition, the stepped-wedge design has an important 
statistical power advantage over a parallel-groups cluster-randomized trial. The latter 
design suffers a loss of statistical power that arises from within-cluster correlation (ICC), 
even when ICC is as modest as 5%, a typical value for process-of-care outcomes.63 The 
presence of positive intra-cluster correlation has the opposite effect in a stepped-wedge 
design, because in that design, the contrast of interest is a “within-cluster” contrast, so 
that the cluster serves as its own control, increasing the effective sample size and 
resulting statistical power.64   
After a six-month pre-implementation period, the study will begin with all 
hospitals beginning in the standard of care condition and with patients enrolled for 13 
consecutive 8-week periods. At the end of each of the 8-week periods, one hospital ED 
will switch to the VPTC model of care condition, according to its randomly assigned 
enumeration. Following the 2-year (13 x 8 weeks) data collection period, there will be a 
six-month post-implementation period for data analysis and dissemination. 
 
Stepped-Wedge Trial Design: 
Hospital 
6-Month Period 
8-Week Periods 
6-Month 
Period 
 
Pre-
Implementation 
Standard 
of Care 
One of ten hospitals is randomized to VPTC 
according to stratification 
Full VPTC 
Data 
Analysis 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Of note, after starting the study, one of the hospitals declined to further participate 
and will be replaced by another similar hospital. The replacement protocol has 
been approved by the senior statistician on the project. 
In order to ensure that we can fully evaluate this systems level intervention we 
will abstract the following variables from the UC Davis EMR: Sending hospital, 
Glascow Coma Score (GCS) at time of consultation & at time of departure from 
OSH, encounter number, outcome of the transfer center call, time of transfer call, 
reasons for transfer, which trauma/ortho/neuro/other specialist took call, mode of 
transport, length and frequency of OR visit , ICD-10-CM/PCS codes, CPT codes, 
Epic imaging order codes, admitting service, critical care use, specific UCD 
provider completing telehealth visit, type of primary service admitted, disposition, 
location and time of discharge; Patient characteristics: MRN, patient name, age, 
Data analysis
Standard of care
VPTC
Pre-implementation

PROTOCOL TITLE: Virtual Pediatric Trauma Center 
Page 6 of 11 
 
HRP-503-PTOTOCOL TEMPLATE-General 
 
 
Template Revision: January 17, 2020 
race/ethnicity, sex, language, insurance, parent/guardian phone/e-mail, home 
address 
Parent/Guardian Survey 
Parents/guardians of patients from above will be approached either by 
StudyPages, phone, e-mail, or in-person and asked to complete surveys (either 
electronic, via REDCap, or phone (entered directly into REDCap by a study team 
member)) at 3-, 30-, 60-, and 90-days after the after the eligible emergency 
department visit.  
The surveys will contain no identifying information and are attached in IRBNet.  
The primary risk to this study is loss of confidentiality. All information will be 
stored in REDCap, StudyPages, or in password protected databases on secure UC 
Davis servers. 
Retrospective Data Entry 
Upon approval of 3/18/2021 protocol version, Barton Memorial Hospital patients 
will be entered into REDCap dating back to 11/30/2020. Depending on the 
patient’s survey timeline, research staff will recruit patients to complete their 
prospective 3-, 30-, 60-, 90- day surveys. 
 
7) 
Data and/or Specimen Management and Confidentiality 
☒ I understand that if this study involves the use of  the UC Davis Health 
Electronic Health Record (EMR/EPIC) also contains the clinical data for 
Marshall Medical Center (MMC). I understand that MMC patient data 
cannot be accessed for research purposes and that I must take the 
necessary steps to ensure that MMC data is not accessed, used, or 
disclosed for UC Davis Health research purposes. 
☐ I undersand that if this study involves use of UC Davis students’ 
educational records (including records in the PI’s own possession such as 
course exams/assignments), I must consult with the Registrar’s office to 
see if all requirements of the Family Educational Rights and Privacy Act 
(FERPA) are satisfied.   
This study is evaluating a systems-level intervention; a system-level intervention means 
that we are doing an intervention on how we deliver healthcare. In other words, our 
intervention is a test of change to the healthcare system. Because we are doing a systems 
level intervention, we need to evaluate outcomes on all the eligible patient transfer 
consultations. Our outcomes include transfers and potentially avoidable transfers. We 
therefore need to know if all the transfers, among our eligible patients were "avoidable or 
potentially avoidable" or not. The outcome data (and our research study) would be not 
useful if we can only gather data the patients who were consented. It is not feasible to get 
consent from every patient's parent.  
Doing a systems intervention and only evaluating the outcomes on the patients who 
return a HIPAA authorization would make the study not valid. It is therefore not possible 

PROTOCOL TITLE: Virtual Pediatric Trauma Center 
Page 7 of 11 
 
HRP-503-PTOTOCOL TEMPLATE-General 
 
 
Template Revision: January 17, 2020 
to do the research without the waiver, because a systems intervention study requires 
evaluating the outcomes on all the patients involved in order to be valid. 
In summary, rationale for the waiver of HIPAA and waiver of consent for the data 
abstraction include: (1) The use or disclosure of protected health care information 
involves no more than minimal risk; (2) the research could not practicably be conducted 
without the waiver or alteration; and (3) the research could not practicably be conducted 
without access to and use of the PHI.  
All study personnel involved in this proposed project have received Human Subjects 
Protection and HIPAA education. 
Data Analysis Plan/Statistical Procedures: 
Regression analyses will be conducted within a generalized linear mixed model 
framework for multilevel data (patients nested within hospitals), with random 
effects for hospitals specified to account for unmeasured sources of between-unit 
heterogeneity.65-67 A within-site time-varying binary indicator (VPTC vs. standard 
of care) will be included in the model to permit estimating the key contrasts of 
interest. For linear-normal mixed models (e.g., experience of care and distress), 
effect sizes will be adjusted mean differences; for binary and count outcomes 
fitted with logistic and Poisson regression models, respectively, effect sizes will 
be adjusted odds and rate ratios, respectively. For outcomes assessed at both 3-
days and 30-days after injury, we anticipate estimating time point-specific 
contrasts of the VPTC vs. standard of care groups. To do this, models will also 
include a binary indicator for time point (3 day vs. 30 day) as well as interactions 
of time point with the time-varying treatment group indicator. Additional 
independent variables will include a parsimonious and pre-specified set of patient-
level effects to account for study design effects and to improve the precision of 
estimated effects, accounting for known sources of heterogeneity.66,68,69 To 
account for confounding by calendar time in our stepped-wedge design,62 we will 
compute each patient’s date at enrollment in the study and use fractional 
polynomial modeling to determine the order of polynomial (linear, quadratic, 
cubic, etc.) to specify the calendar date of enrollment effects, to account for 
temporal effects.70 A senior health economist will conduct the economic analyses 
relevant to the financial burdens experienced by parent/family members. 
Additional details for each aim and outcome are provided below. 
 
8) 
Data and/or Specimen Banking 
N/A 
9) 
Provisions to Monitor the Data to Ensure the Safety of Subjects 
N/A 
10) Withdrawal of Subjects 
No patients will be withdrawn from this study without their consent. 

PROTOCOL TITLE: Virtual Pediatric Trauma Center 
Page 8 of 11 
 
HRP-503-PTOTOCOL TEMPLATE-General 
 
 
Template Revision: January 17, 2020 
11) Risks to Subjects 
There is the potential risk of loss of confidentiality; however, for all data, only 
study personnel will have access to these materials. All data will be destroyed 7 
years after completion of the study. 
Because this specific intervention has never been tested at UC Davis (though 
telemedicine has been used in these emergency departments for many years for 
other pediatric patients), it is possible that there are unforeseen risks to the 
intervention. This is why monitoring the implementation outcomes are 
important—the study team will be closely observing the implementation for any 
unforeseen risks and will take immediate action if any risks are identified. Based 
on prior studies that have used this technology, it is highly unlikely that this 
intervention will cause any risk. 
 
12) Potential Benefits to Subjects 
Patients who receive a telemedicine consultation may find benefit.  
 
13) Multi-Site Research 
N/A 
 
14) Community-Based Participatory Research 
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. 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.”15 Recent data derived on 
adult patients have documented the impact that telemedicine can have on clinical 
outcomes in a variety of trauma settings.16-21 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. 

PROTOCOL TITLE: Virtual Pediatric Trauma Center 
Page 9 of 11 
 
HRP-503-PTOTOCOL TEMPLATE-General 
 
 
Template Revision: January 17, 2020 
 
15) Sharing of Results with Subjects 
Results will not be shared with subjects. 
 
16) Prior Approvals 
N/A  
 
17) Provisions to Protect the Privacy Interests of Subjects 
All information will be kept in secure REDCap database and StudyPages.  
Only members of the research team will have access to the data. 
As described above, doing a systems intervention and only evaluating the outcomes 
on the patients who return a HIPAA authorization would make the study not 
valid. It is therefore not possible to do the research without the waiver, because a 
systems intervention study requires evaluating the outcomes on all the patients 
involved in order to be valid. The rationale for the waiver of HIPAA and waiver of 
consent include: (1) The use or disclosure of protected health care information involves 
no more than minimal risk; (2) the research could not practicably be conducted without 
the waiver or alteration; and (3) the research could not practicably be conducted without 
access to and use of the PHI.  
 
18) Compensation for Research-Related Injury 
N/A 
 
19) Economic Burden to Subjects 
N/A 
 
20) Drugs or Devices 
N/A 
 
21) Review Requirements 
        Are there any contractual obligations or other considerations that 
require IRB review of this research, or review at intervals other 

PROTOCOL TITLE: Virtual Pediatric Trauma Center 
Page 10 of 11 
 
HRP-503-PTOTOCOL TEMPLATE-General 
 
 
Template Revision: January 17, 2020 
than those required by the Common Rule or FDA? If yes, check 
box: 
 
 Yes 
 
X No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
References 
 
1. 
American College of Surgeons. Committee on Trauma. Resources for optimal 
care of the injured patient. Chicago, Ill.: American College of Surgeons, 
Committee on Trauma; 2014. 
2. 
MacKenzie EJ, Rivara FP, Jurkovich GJ, et al. A national evaluation of the effect 
of trauma-center care on mortality. N Engl J Med. 2006;354(4):366-378. 
3. 
Cudnik MT, Newgard CD, Sayre MR, Steinberg SM. Level I versus Level II 
trauma centers: an outcomes-based assessment. J Trauma. 2009;66(5):1321-1326. 
4. 
Brown JB, Rosengart MR, Billiar TR, Peitzman AB, Sperry JL. Geographic 
distribution of trauma centers and injury-related mortality in the United States. J 
Trauma Acute Care Surg. 2016;80(1):42-50. 
5. 
Sasser SM, Hunt RC, Faul M, et al. Guidelines for field triage of injured patients: 
recommendations of the National Expert Panel on Field Triage, 2011. MMWR 
Recomm Rep. 2012;61(RR-1):1-20. 
6. 
Gausche-Hill M, Ely M, Schmuhl P, et al. A national assessment of pediatric 
readiness of emergency departments. JAMA Pediatr. 2015;169(6):527-534. 
7. 
Nance ML, Carr BG, Branas CC. Access to pediatric trauma care in the United 
States. Arch Pediatr Adolesc Med. 2009;163(6):512-518. 
8. 
United States Government Accountability Office Availability, Outcomes, and 
Federal Support Related to Pediatric Trauma Care. 2017. 
9. 
Fallat MG, B; Haley, K; Meredith, J; Mooney, D; Upperman, J; The Childress 
Summit II Work Groups. Proceedings of the second Childress Summit on 
pediatric trauma: Operationalizing the vision. J Trauma Acute Care Surg. 
2016;81(4):795-801. 

PROTOCOL TITLE: Virtual Pediatric Trauma Center 
Page 11 of 11 
 
HRP-503-PTOTOCOL TEMPLATE-General 
 
 
Template Revision: January 17, 2020 
10. 
Gaines BH, K; McKenna, C; McMahon, M; Meredith, J; Mooney, D; Snow, S; 
Upperman, J; Childress Summit of the Pediatric Trauma Society Work Groups. 
Report from the Childress Summit of the Pediatric Trauma Society, April 22–24, 
2013. J Trauma Acute Care Surg. 2014;77(3):504-509. 
11. 
Segui-Gomez M, Chang DC, Paidas CN, Jurkovich GJ, Mackenzie EJ, Rivara FP. 
Pediatric trauma care: an overview of pediatric trauma systems and their practices 
in 18 US states. J Pediatr Surg. 2003;38(8):1162-1169. 
12. 
Kim PT, Falcone RA, Jr. The use of telemedicine in the care of the pediatric 
trauma patient. Semin Pediatr Surg. 2017;26(1):47-53. 
13. 
American Hospital Association Annual Survey Fact Sheet: Telehealth. 
https://www.aha.org/system/files/2018-01/fs-telehealth.pdf. Published 2018. 
Accessed. 
14. 
Bashshur RL, Howell JD, Krupinski EA, Harms KM, Bashshur N, Doarn CR. The 
Empirical Foundations of Telemedicine Interventions in Primary Care. Telemed J 
E Health. 2016;22(5):342-375. 
15. 
PCORI Scientific Program Area Rural Trauma Care. 
http://www.pcori.org/assets/PCORI-Addressing-Disparities-Topic-Brief-10-
0416132.pdf. Published April 16, 2013. Accessed December 2015, 2015. 
16. 
Esposito TJ, Sanddal ND, Dean JM, Hansen JD, Reynolds SA, Battan K. Analysis 
of preventable pediatric trauma deaths and inappropriate trauma care in Montana. 
J Trauma. 1999;47(2):243-251; discussion 251-243. 
17. 
Lewis ER, Thomas CA, Wilson ML, Mbarika VW. Telemedicine in acute-phase 
injury management: a review of practice and advancements. Telemed J E Health. 
2012;18(6):434-445. 
18. 
Ricci MA, Caputo M, Amour J, et al. Telemedicine reduces discrepancies in rural 
trauma care. Telemed J E Health. 2003;9(1):3-11. 
19. 
Rogers FB, Ricci M, Caputo M, et al. The use of telemedicine for real-time video 
consultation between trauma center and community hospital in a rural setting 
improves early trauma care: preliminary results. J Trauma. 2001;51(6):1037-
1041. 
20. 
Latifi R. Telepresence and telemedicine in trauma and emergency. Stud Health 
Technol Inform. 2008;131:275-280. 
21. 
Lambrecht CJ. Telemedicine in trauma care: description of 100 trauma 
teleconsults. Telemed J. 1997;3(4):265-268.