Skip to main content
Top
Published in: Trials 1/2022

Open Access 01-12-2022 | Care | Study protocol

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

Authors: James P. Marcin, Daniel J. Tancredi, Joseph M. Galante, Tanya N. Rinderknecht, Brian M. Haus, Holly B. Leshikar, Marike Zwienenberg, Jennifer L. Rosenthal, Kendra L. Grether-Jones, Michelle Y. Hamline, Jeffrey S. Hoch, Nathan Kuppermann

Published in: Trials | Issue 1/2022

Login to get access

Abstract

Background

The current standard of care in the treatment of children with physical trauma presenting to non-designated pediatric trauma centers is consultation with a pediatric trauma center by telephone. This includes contacting a pediatric trauma specialist and transferring any child with a potentially serious injury to a regionalized level I pediatric trauma center. This approach to care frequently results in medically unnecessary transfers and may place undue burdens on families. A newer model of care, the “Virtual Pediatric Trauma Center” (VPTC), uses telemedicine to make the expertise of a level I pediatric trauma center virtually available to any hospital. While the use of the VPTC model of care is increasing, there have been no studies comparing the VPTC to standard care of injured children at non-designated trauma centers with respect to patient- and family-centered outcomes. The goal of this study is to compare the current standard of care to the VPTC with respect to family-centered outcomes developed by parents and community advisory boards.

Methods

We will use a stepped-wedge trial design to enroll children with physical trauma presenting to ten hospitals, including level II, level III, and non-designated trauma centers. The primary outcome measures are parent/family experience of care and distress 3 days following injury. Secondary aims include 30-day healthcare utilization, parent/family out-of-pocket costs at 3 days and 30 days after injury, transfer rates, and parent/family distress 30 days following injury. We expect at least 380 parents/families of children will be eligible for the study following an emergency department physician’s request for a level I pediatric trauma center consultation. We will evaluate parent/family experience of care and distress using previously validated instruments, healthcare utilization by family recollection and medical record abstraction, and out-of-pocket costs using standard economic analyses.

Discussion

We expect that the findings from this study will inform other level I pediatric trauma centers and non-pediatric trauma centers on how to improve their systems of care for injured children. The results will help to optimize communication, confidence, and shared decision-making between parents/families and clinical staff from both the transferring and receiving hospitals.

Trial registration

ClinicalTrials.gov Identifier: NCT04469036. Registered July 13, 2020 before start of inclusion.
Literature
1.
go back to reference American College of Surgeons. Resources for optimal care of the injured patient. 2022 standards. Chicago: American College of Surgeons; 2022. American College of Surgeons. Resources for optimal care of the injured patient. 2022 standards. Chicago: American College of Surgeons; 2022.
2.
go back to reference MacKenzie EJ, Rivara FP, Jurkovich GJ, Nathens AB, Frey KP, Egleston BL, et al. A national evaluation of the effect of trauma-center care on mortality. N Engl J Med. 2006;354(4):366–78.CrossRef MacKenzie EJ, Rivara FP, Jurkovich GJ, Nathens AB, Frey KP, Egleston BL, et al. A national evaluation of the effect of trauma-center care on mortality. N Engl J Med. 2006;354(4):366–78.CrossRef
3.
go back to reference Garwe T, Cowan LD, Neas B, Cathey T, Danford BC, Greenawalt P. Survival benefit of transfer to tertiary trauma centers for major trauma patients initially presenting to nontertiary trauma centers. Acad Emerg Med. 2010;17(11):1223–32.CrossRef Garwe T, Cowan LD, Neas B, Cathey T, Danford BC, Greenawalt P. Survival benefit of transfer to tertiary trauma centers for major trauma patients initially presenting to nontertiary trauma centers. Acad Emerg Med. 2010;17(11):1223–32.CrossRef
4.
go back to reference 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.CrossRef 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.CrossRef
5.
go back to reference Sasser SM, Hunt RC, Faul M, Sugerman D, Pearson WS, Dulski T, 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. Sasser SM, Hunt RC, Faul M, Sugerman D, Pearson WS, Dulski T, 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.
go back to reference Nance ML, Carr BG, Branas CC. Access to pediatric trauma care in the United States. Arch Pediatr Adolesc Med. 2009;163(6):512–8.CrossRef Nance ML, Carr BG, Branas CC. Access to pediatric trauma care in the United States. Arch Pediatr Adolesc Med. 2009;163(6):512–8.CrossRef
7.
go back to reference United States Government Accountability Office Availability, Outcomes, and federal support related to pediatric trauma care. 2017. United States Government Accountability Office Availability, Outcomes, and federal support related to pediatric trauma care. 2017.
8.
go back to reference Byrne JP, Nance ML, Scantling DR, Holena DN, Kaufman EJ, Nathens AB, et al. Association between access to pediatric trauma care and motor vehicle crash death in children: an ecologic analysis of United States counties. J Trauma Acute Care Surg. 2021;91(1):84–92.CrossRef Byrne JP, Nance ML, Scantling DR, Holena DN, Kaufman EJ, Nathens AB, et al. Association between access to pediatric trauma care and motor vehicle crash death in children: an ecologic analysis of United States counties. J Trauma Acute Care Surg. 2021;91(1):84–92.CrossRef
9.
go back to reference Fallat ME, Gaines BA, Haley K, Meredith J, Mooney D, Upperman J, et al. Proceedings of the second Childress Summit on pediatric trauma: Operationalizing the vision. J Trauma Acute Care Surg. 2016;81(4):795–801.CrossRef Fallat ME, Gaines BA, Haley K, Meredith J, Mooney D, Upperman J, et al. Proceedings of the second Childress Summit on pediatric trauma: Operationalizing the vision. J Trauma Acute Care Surg. 2016;81(4):795–801.CrossRef
10.
go back to reference Gaines BA, Hansen K, McKenna C, McMahon M, Meredith J, Mooney D, et al. Report from the Childress Summit of the Pediatric Trauma Society, April 22–24, 2013. J Trauma Acute Care Surg. 2014;77(3):504–9.CrossRef Gaines BA, Hansen K, McKenna C, McMahon M, Meredith J, Mooney D, et al. Report from the Childress Summit of the Pediatric Trauma Society, April 22–24, 2013. J Trauma Acute Care Surg. 2014;77(3):504–9.CrossRef
11.
go back to reference 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):1162–9.CrossRef 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):1162–9.CrossRef
12.
go back to reference 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.CrossRef 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.CrossRef
13.
go back to reference Taylor MA, Lewis AE, Swendiman RA, Fenton SJ, Russell KW. Interest in improving access to pediatric trauma care through telemedicine. J Med Syst. 2021;45(12):108.CrossRef Taylor MA, Lewis AE, Swendiman RA, Fenton SJ, Russell KW. Interest in improving access to pediatric trauma care through telemedicine. J Med Syst. 2021;45(12):108.CrossRef
15.
go back to reference Taylor MA, Knochel ML, Proctor SJ, Brockmeyer DL, Runyon LA, Fenton SJ, et al. Pediatric trauma telemedicine in a rural state: lessons learned from a 1-year experience. J Pediatr Surg. 2021;56(2):385–9.CrossRef Taylor MA, Knochel ML, Proctor SJ, Brockmeyer DL, Runyon LA, Fenton SJ, et al. Pediatric trauma telemedicine in a rural state: lessons learned from a 1-year experience. J Pediatr Surg. 2021;56(2):385–9.CrossRef
16.
go back to reference Aucar J, Granchi T, Liscum K, Wall M, Mattox K. Is regionalization of trauma care using telemedicine feasible and desirable? Am J Surg. 2000;180(6):535–9.CrossRef Aucar J, Granchi T, Liscum K, Wall M, Mattox K. Is regionalization of trauma care using telemedicine feasible and desirable? Am J Surg. 2000;180(6):535–9.CrossRef
18.
go back to reference Farley H, Enguidanos ER, Coletti CM, Honigman L, Mazzeo A, Pinson TB, et al. Patient satisfaction surveys and quality of care: an information paper. Ann Emerg Med. 2014;64(4):351–7.CrossRef Farley H, Enguidanos ER, Coletti CM, Honigman L, Mazzeo A, Pinson TB, et al. Patient satisfaction surveys and quality of care: an information paper. Ann Emerg Med. 2014;64(4):351–7.CrossRef
19.
go back to reference Giordano LA, Elliott MN, Goldstein E, Lehrman WG, Spencer PA. Development, implementation, and public reporting of the HCAHPS survey. Med Care Res Rev. 2010;67(1):27–37.CrossRef Giordano LA, Elliott MN, Goldstein E, Lehrman WG, Spencer PA. Development, implementation, and public reporting of the HCAHPS survey. Med Care Res Rev. 2010;67(1):27–37.CrossRef
20.
go back to reference Sonis JD, White BA. Optimizing patient experience in the emergency department. Emerg Med Clin North Am. 2020;38(3):705–13.CrossRef Sonis JD, White BA. Optimizing patient experience in the emergency department. Emerg Med Clin North Am. 2020;38(3):705–13.CrossRef
21.
go back to reference Fischer D, Stewart AL, Bloch DA, Lorig K, Laurent D, Holman H. Capturing the patient’s view of change as a clinical outcome measure. JAMA. 1999;282(12):1157–62.CrossRef Fischer D, Stewart AL, Bloch DA, Lorig K, Laurent D, Holman H. Capturing the patient’s view of change as a clinical outcome measure. JAMA. 1999;282(12):1157–62.CrossRef
22.
go back to reference Spielberger C, Gorsuch R, Lushene R, Vagg P, Jacobs G. Manual for the State-Trait Anxiety Inventory. Palo Alto: Consulting Psychologists; 1983. Spielberger C, Gorsuch R, Lushene R, Vagg P, Jacobs G. Manual for the State-Trait Anxiety Inventory. Palo Alto: Consulting Psychologists; 1983.
23.
go back to reference Bouwmans C, Krol M, Severens H, Koopmanschap M, Brouwer W, Hakkaart-van Roijen L. The iMTA productivity cost questionnaire: a standardized instrument for measuring and valuing health-related productivity losses. Value Health. 2015;18(6):753–8.CrossRef Bouwmans C, Krol M, Severens H, Koopmanschap M, Brouwer W, Hakkaart-van Roijen L. The iMTA productivity cost questionnaire: a standardized instrument for measuring and valuing health-related productivity losses. Value Health. 2015;18(6):753–8.CrossRef
24.
go back to reference Rosenthal JL, Atolagbe O, Hamline MY, Li ST, Toney A, Witkowski J, et al. Developing and validating a pediatric potentially avoidable transfer quality metric. Am J Med Qual. 2020;35(2):163–70.CrossRef Rosenthal JL, Atolagbe O, Hamline MY, Li ST, Toney A, Witkowski J, et al. Developing and validating a pediatric potentially avoidable transfer quality metric. Am J Med Qual. 2020;35(2):163–70.CrossRef
25.
go back to reference Rosenthal JL, Lieng MK, Marcin JP, Romano PS. Profiling pediatric potentially avoidable transfers using procedure and diagnosis codes. Pediatr Emerg Care. 2021;37(11):e750–e6.CrossRef Rosenthal JL, Lieng MK, Marcin JP, Romano PS. Profiling pediatric potentially avoidable transfers using procedure and diagnosis codes. Pediatr Emerg Care. 2021;37(11):e750–e6.CrossRef
26.
go back to reference Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007;28(2):182–91.CrossRef Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007;28(2):182–91.CrossRef
27.
go back to reference Baio G, Copas A, Ambler G, Hargreaves J, Beard E, Omar RZ. Sample size calculation for a stepped wedge trial. Trials. 2015;16:354.CrossRef Baio G, Copas A, Ambler G, Hargreaves J, Beard E, Omar RZ. Sample size calculation for a stepped wedge trial. Trials. 2015;16:354.CrossRef
28.
go back to reference Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015;350:h391.CrossRef Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015;350:h391.CrossRef
29.
go back to reference Shieh G. A comparison of two approaches for power and sample size calculations in logistic regression models. Commun Stat-Simul C. 2000;29(3):763–91.CrossRef Shieh G. A comparison of two approaches for power and sample size calculations in logistic regression models. Commun Stat-Simul C. 2000;29(3):763–91.CrossRef
30.
go back to reference Fitzmaurice GM, Laird NM, Ware JH. Applied longitudinal analysis. 2nd ed. Hoboken: Wiley; 2011.CrossRef Fitzmaurice GM, Laird NM, Ware JH. Applied longitudinal analysis. 2nd ed. Hoboken: Wiley; 2011.CrossRef
31.
go back to reference Littell RC, Milliken GA, Stroup WW, Wolfinger RD, Schabenberger O. SAS for mixed models. 2nd ed. Cary: SAS Institute, Inc; 2006. Littell RC, Milliken GA, Stroup WW, Wolfinger RD, Schabenberger O. SAS for mixed models. 2nd ed. Cary: SAS Institute, Inc; 2006.
32.
go back to reference Dharmar M, Romano PS, Kuppermann N, Nesbitt TS, Cole SL, Andrada ER, et al. Impact of critical care telemedicine consultations on children in rural emergency departments. Crit Care Med. 2013;41(10):2388–95.CrossRef Dharmar M, Romano PS, Kuppermann N, Nesbitt TS, Cole SL, Andrada ER, et al. Impact of critical care telemedicine consultations on children in rural emergency departments. Crit Care Med. 2013;41(10):2388–95.CrossRef
33.
go back to reference Campbell MK, Fayers PM, Grimshaw JM. Determinants of the intracluster correlation coefficient in cluster randomized trials: the case of implementation research. Clin Trials. 2005;2(2):99–107.CrossRef Campbell MK, Fayers PM, Grimshaw JM. Determinants of the intracluster correlation coefficient in cluster randomized trials: the case of implementation research. Clin Trials. 2005;2(2):99–107.CrossRef
34.
go back to reference Woertman W, de Hoop E, Moerbeek M, Zuidema SU, Gerritsen DL, Teerenstra S. Stepped wedge designs could reduce the required sample size in cluster randomized trials. J Clin Epidemiol. 2013;66(7):752–8.CrossRef Woertman W, de Hoop E, Moerbeek M, Zuidema SU, Gerritsen DL, Teerenstra S. Stepped wedge designs could reduce the required sample size in cluster randomized trials. J Clin Epidemiol. 2013;66(7):752–8.CrossRef
36.
go back to reference Tluczek A, Henriques JB, Brown RL. Support for the reliability and validity of a six-item state anxiety scale derived from the State-Trait Anxiety Inventory. J Nurs Meas. 2009;17(1):19–28.CrossRef Tluczek A, Henriques JB, Brown RL. Support for the reliability and validity of a six-item state anxiety scale derived from the State-Trait Anxiety Inventory. J Nurs Meas. 2009;17(1):19–28.CrossRef
37.
go back to reference Bouwmans C, Krol M, Brouwer W, Severens JL, Koopmanschap MA, Hakkaart L. IMTA Productivity Cost Questionnaire (IPCQ). Value Health. 2014;17(7):A550.CrossRef Bouwmans C, Krol M, Brouwer W, Severens JL, Koopmanschap MA, Hakkaart L. IMTA Productivity Cost Questionnaire (IPCQ). Value Health. 2014;17(7):A550.CrossRef
38.
go back to reference Murray DM. Statistical models appropriate for designs often used in group-randomized trials. Stat Med. 2001;20:1373–85.CrossRef Murray DM. Statistical models appropriate for designs often used in group-randomized trials. Stat Med. 2001;20:1373–85.CrossRef
39.
go back to reference Murray DM, Hannan PJ, Wolfinger RD, Baker WL, Dwyer JH. Analysis of data from group-randomized trials with repeat observations on the same groups. Stat Med. 1998;17:1581–600.CrossRef Murray DM, Hannan PJ, Wolfinger RD, Baker WL, Dwyer JH. Analysis of data from group-randomized trials with repeat observations on the same groups. Stat Med. 1998;17:1581–600.CrossRef
40.
go back to reference McCulloch CE, Searle SR, Neuhaus JM. Generalized, linear, and mixed models, vol. xxv. 2nd ed. Hoboken: Wiley; 2008. p. 384. McCulloch CE, Searle SR, Neuhaus JM. Generalized, linear, and mixed models, vol. xxv. 2nd ed. Hoboken: Wiley; 2008. p. 384.
41.
go back to reference Murray DM, Blitstein JL. Methods to reduce the impact of intraclass correlation in group-randomized trials. Eval Rev. 2003;27:79–103.CrossRef Murray DM, Blitstein JL. Methods to reduce the impact of intraclass correlation in group-randomized trials. Eval Rev. 2003;27:79–103.CrossRef
42.
go back to reference Raudenbush SW, Martinez A, Spybrook J. Strategies for improving precision in group-randomized experiments. Educ Eval Policy Anal. 2007;29:5–29.CrossRef Raudenbush SW, Martinez A, Spybrook J. Strategies for improving precision in group-randomized experiments. Educ Eval Policy Anal. 2007;29:5–29.CrossRef
43.
go back to reference Kahan BC, Rushton H, Morris TP, Daniel RM. A comparison of methods to adjust for continuous covariates in the analysis of randomised trials. BMC Med Res Methodol. 2016;16:42.CrossRef Kahan BC, Rushton H, Morris TP, Daniel RM. A comparison of methods to adjust for continuous covariates in the analysis of randomised trials. BMC Med Res Methodol. 2016;16:42.CrossRef
44.
go back to reference White IR, Horton NJ, Carpenter J, Pocock SJ. Strategy for intention to treat analysis in randomised trials with missing outcome data. BMJ. 2011;342:d40.CrossRef White IR, Horton NJ, Carpenter J, Pocock SJ. Strategy for intention to treat analysis in randomised trials with missing outcome data. BMJ. 2011;342:d40.CrossRef
45.
go back to reference Little RJA, Rubin DB. Statistical analysis with missing data, vol. xv. 2nd ed. Hoboken: Wiley; 2002. p. 381.CrossRef Little RJA, Rubin DB. Statistical analysis with missing data, vol. xv. 2nd ed. Hoboken: Wiley; 2002. p. 381.CrossRef
Metadata
Title
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
Authors
James P. Marcin
Daniel J. Tancredi
Joseph M. Galante
Tanya N. Rinderknecht
Brian M. Haus
Holly B. Leshikar
Marike Zwienenberg
Jennifer L. Rosenthal
Kendra L. Grether-Jones
Michelle Y. Hamline
Jeffrey S. Hoch
Nathan Kuppermann
Publication date
01-12-2022
Publisher
BioMed Central
Keywords
Care
Telemedicine
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06996-1

Other articles of this Issue 1/2022

Trials 1/2022 Go to the issue