Pragmatic Strategy Empowering Paramedics to Assess Low-Risk Trauma Patients With the Canadian C-Spine Rule and Selectively Transport Them Without Immobilization: Protocol for a Stepped-Wedge Cluster Randomized Trial
Open accessPublished version of a preprint
Abstract
BACKGROUND: Each year, half a million patients with a potential neck (c-spine) injury are transported to Ontario emergency departments (EDs). Less than 1.0% (1/100) of these patients have a neck bone fracture. Even less (1/200, 0.5%) have a spinal cord injury or nerve damage. Currently, paramedics transport all trauma victims (with or without an injury) by ambulance using a backboard, cervical collar, and head immobilizers. Importantly, prolonged immobilization is often unnecessary; it causes patient discomfort and pain, decreases community access to paramedics, contributes to ED crowding, and is very costly. We therefore developed the Canadian C-Spine Rule (CCR) for alert and stable trauma patients. This decision rule helps ED physicians and triage nurses to safely and selectively remove immobilization, without x-rays and missed injury. We successfully taught Ottawa paramedics to use the CCR in the field in a single-center study. OBJECTIVE: This study aimed to improve patient care and health system efficiency and outcomes by allowing paramedics to assess eligible low-risk trauma patients with the CCR and selectively transport them without immobilization to the ED. METHODS: We propose a pragmatic stepped-wedge cluster randomized design with health economic evaluation, designed collaboratively with knowledge users. Our 36-month study will consist of a 12-month setup and training period (year 1), followed by the stepped-wedge trial (year 2) and a 12-month period for study completion, analyses, and knowledge translation. A total of 12 Ontario paramedic services of various sizes distributed across the province will be randomly allocated to one of three sequences. Paramedic services in each sequence will cross from the control condition (usual care) to the intervention condition (CCR implementation) at intervals of 3 months until all communities have crossed to the intervention. Data will be collected on all eligible patients in each paramedic service for a total duration of 12 months. A major strength of our design is that each community will have implemented the CCR by the end of the study. RESULTS: Interim results are expected in December 2019 and final results in 2020. If this multicenter trial is successful, we expect the Ontario Ministry of Health will recommend that paramedics evaluate all eligible patients with the CCR in the Province of Ontario. CONCLUSIONS: We conservatively estimate that in Ontario, more than 60% of all eligible trauma patients (300,000 annually) could be transported safely and comfortably, without c-spine immobilization devices. This will significantly reduce patient pain and discomfort, paramedic intervention times, and ED length of stay, thereby improving access to paramedics and ED care. This could be achieved rapidly and with lower health care costs compared with current practices (possible cost saving of Can $36 [US $25] per immobilization or Can $10,656,000 [US $7,335,231] per year). TRIAL REGISTRATION: ClinicalTrials.gov NCT02786966; https://clinicaltrials.gov/ct2/show/NCT02786966. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16966.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The panel wrote and registered a protocol for the guideline development process involving 3 main elements: (1) rapid review, (2) consensus-based meetings and surveys, and (3) a global survey of the trials community.
“The panel wrote and registered a protocol (available through the Open Science Framework at https://osf.io/ms8bz) 12 for the guideline development process involving 3 main elements: (1) rapid review, (2) consensus-based meetings and surveys, and (3) a global survey of the trials community.”
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Methods for the Economic Evaluation of Health Care Programmes
Drummond, M. E., Sculpher, M. J., Torrance, G. W., O’Brien, B. J., & Stoddart, G. L. (2005) · doi:10.1093/oso/9780198529446.001.0001 · Cited by 13,648 · see citing works
The Canadian C-Spine Rule for Radiography in Alert and Stable Trauma Patients
Stiell, I. G. (2001) · JAMA · doi:10.1001/jama.286.15.1841 · Cited by 1,289 · see citing works
Self-citationThe Canadian C-Spine Rule versus the NEXUS Low-Risk Criteria in Patients with Trauma
Stiell, I. G., Clement, C. M., McKnight, R. D., Brison, R. J., Schull, M. J., Rowe, B. H., Worthington, J. R., Eisenhauer, M. A., Cass, D., Greenberg, G. H., et al. (2003) · New England Journal of Medicine · doi:10.1056/nejmoa031375 · Cited by 645 · see citing works
Self-citationA Prospective Multicenter Study of Cervical Spine Injury in Children
Viccellio, P., Simon, H. K., Pressman, B. D., Shah, M. N., Mower, W. R., Hoffman, J. R., & for the NEXUS Group (2001) · PEDIATRICS · doi:10.1542/peds.108.2.e20 · Cited by 409 · see citing works
Prehospital Use of Cervical Collars in Trauma Patients: A Critical Review
Sundstrøm, T., Asbjørnsen, H., Habiba, S., Sunde, G. A., & Wester, K. G. (2013) · Journal of Neurotrauma · doi:10.1089/neu.2013.3094 · Cited by 193 · see citing works
Factors Associated With Cervical Spine Injury in Children After Blunt Trauma
Leonard, J. C., Kuppermann, N., Olsen, C. S., Babcock, L., Brown, K., Mahajan, P., Adelgais, K., Anders, J., Borgialli, D. A., Donoghue, A. J., et al. (2010) · Annals of Emergency Medicine · doi:10.1016/j.annemergmed.2010.08.038 · Cited by 165 · see citing works
Implementation of the Canadian C-Spine Rule: prospective 12 centre cluster randomised trial
Stiell, I. G., Clement, C. M., Grimshaw, J., Brison, R., Rowe, B. H., Schull, M. J., Lee, J. S., Brehaut, J., McKnight, R. D., Eisenhauer, M. A., et al. (2009) · BMJ · doi:10.1136/bmj.b4146 · Cited by 151 · see citing works
Self-citationWhite, C. C., IV, Domeier, R. M., Millin, M. G., & and the Standards and Clinical Practice Committee, N. A. O. E. P. (2014) · Prehospital Emergency Care · doi:10.3109/10903127.2014.884197 · Cited by 105 · see citing works
The Out-of-Hospital Validation of the Canadian C-Spine Rule by Paramedics
Vaillancourt, C., Stiell, I. G., Beaudoin, T., Maloney, J. P., Anton, A. R., Bradford, P., Cain, E., Travers, A., Stempien, M., Lees, M., et al. (2009) · Annals of Emergency Medicine · doi:10.1016/j.annemergmed.2009.03.008 · Cited by 101 · see citing works
Self-citationSingletary, E. M., Zideman, D. A., Buck, E. D. J. D., Chang, W., Jensen, J. L., Swain, J., Woodin, J. A., Blanchard, I. E., Herrington, R. A., Pellegrino, J. L., et al. (2015) · Circulation · doi:10.1161/cir.0000000000000278 · Cited by 77 · see citing works
Routine spinal immobilization in trauma patients: What are the advantages and disadvantages?
Abram, S. G. F., & Bulstrode, C. J. K. (2010) · The Surgeon · doi:10.1016/j.surge.2010.01.002 · Cited by 71 · see citing works
Stiell, I. G., Clement, C. M., O'Connor, A. M. C., Davies, B., Leclair, C., Sheehan, P. J., Clavet, T., Beland, C., MacKenzie, T., & Wells, G. A. (2010) · Canadian Medical Association Journal · doi:10.1503/cmaj.091430 · Cited by 53 · see citing works
Self-citationThe “best balance” allocation led to optimal balance in cluster-controlled trials
Hoop, E. O., Teerenstra, S., van Gaal, B. G. I., Moerbeek, M., & Borm, G. F. (2011) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2011.05.006 · Cited by 45 · see citing works
Burns, E., & Yanchar, N. L. (2011) · Canadian Journal of Emergency Medicine · doi:10.2310/8000.2011.100220 · Cited by 35 · see citing works
Greene, E. J. (2017) · Journal of Statistical Software · doi:10.18637/jss.v077.c01 · Cited by 33 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
Orkin, A. M., Gill, P. J., Ghersi, D., Campbell, L., Sugarman, J., Emsley, R., Steg, P. G., Weijer, C., Simes, J., Rombey, T., et al. (2021) · JAMA · doi:10.1001/jama.2021.9941 · Cited by 299 · see citing works
Triage tools for detecting cervical spine injury in paediatric trauma patients
Tavender, E. J., Eapen, N., Wang, J., Rausa, V. C., Babl, F. E., & Phillips, N. T. (2024) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd011686.pub3 · Cited by 13 · see citing works
Mota, M., Melo, F., Henriques, C., Matos, A. C., Castelo-Branco, M., Monteiro, M., Cunha, M., & Santos, M. R. (2023) · International Emergency Nursing · doi:10.1016/j.ienj.2023.101375 · Cited by 8 · see citing works
Pragmatic clinical trial design in emergency medicine: Study considerations and design types
Gettel, C. J., Yiadom, M. Y. A. B., Bernstein, S. L., Grudzen, C. R., Nath, B., Li, F., Hwang, U., Hess, E. P., & Melnick, E. R. (2022) · Academic Emergency Medicine · doi:10.1111/acem.14513 · Cited by 8 · see citing works
Mota, M., Cunha, M., Santos, E. J. F., Abrantes, T., Melo, F., Monteiro, M., & Santos, M. R. (2022) · JBI Evidence Synthesis · doi:10.11124/jbies-22-00021 · Cited by 4 · see citing works
D’Aragon, F., Selzner, M., Breau, R., Masse, M.-H., Lamontagne, F., Masse, M., Chassé, M., Carrier, F. M., Cardinal, H., Chaudhury, P. K., et al. (2024) · BMJ Open · doi:10.1136/bmjopen-2024-086777 · Cited by 3 · see citing works
Mota, M., Melo, F., Santos, E. J. F., Abrantes, T., Monteiro, M., Cunha, M., & Santos, M. R. (2024) · Journal of Trauma Nursing · doi:10.1097/jtn.0000000000000821 · Cited by 3 · see citing works
Prehospital spinal and cervical motor restriction in adult trauma patients: a narrative review
Gheri, F., Toppi, N., Bortoli, N., Forni, M., Celi, S., Romano, R., Bocchi, I., Coraci, G., Petta, D., & Floccare, D. J. (2025) · Emergency Care Journal · doi:10.4081/ecj.2025.14088 · Cited by 2 · see citing works
Ouyang, Y., Vaillancourt, C., Heath, A., Taljaard, M., & Macarthur, C. (2025) · Injury Prevention · doi:10.1136/ip-2025-045788 · Cited by 1 · see citing works
Self-citationGüler, L. M., & Ekşi, A. (2025) · Hastane Öncesi Dergisi · doi:10.54409/hod.1561721
- Authors
- Vaillancourt, C., Charette, M., Taljaard, M., Thavorn, K., Hall, E., McLeod, B., Fergusson, D., Brehaut, J., Graham, I., Calder, L., Ramsay, T., Tugwell, P., Kelly, P., Cheskes, S., Saskin, R., Plint, A., Osmond, M., Macarthur, C., Straus, S., Rochon, P., Prud'homme, D., Dahrouge, S., Marlin, S., & Stiell, I. G.
- Affiliations
- University of Ottawa (CA)
- Ottawa Hospital Research Institute (CA)
- Canadian Medical Protective Association (CA)
- University of Toronto (CA)
- Institute for Clinical Evaluative Sciences (CA)
- Children's Hospital of Eastern Ontario (CA)
- Hospital for Sick Children (CA)
- St. Michael's Hospital (CA)
- Women’s College Hospital Research and Innovation Institute (CA)
- Bruyère (CA)
- Clinical Trials Ontario (CA)
- Corresponding author
- Vaillancourt, Christian
- ORCID
- Vaillancourt, Christian
- Charette, Manya
- Taljaard, Monica
- Thavorn, Kednapa
- Hall, Elizabeth
- McLeod, Brent
- Fergusson, Dean
- Brehaut, Jamie
- Graham, Ian
- Calder, Lisa
- Ramsay, Tim
- Tugwell, Peter
- Kelly, Peter
- Cheskes, Sheldon
- Saskin, Refik
- Plint, Amy
- Osmond, Martin
- Macarthur, Colin
- Straus, Sharon
- Rochon, Paula
- Prud'homme, Denis
- Dahrouge, Simone
- Marlin, Susan
- Stiell, Ian G
- Venue
- JMIR Research Protocols
- Publisher
- JMIR Publications Inc.
- Published
- 2020-06-01
- Volume
- 9
- Issue
- 6
- Pages
- e16966
- ISSN
- 1929-0748 (ISSN-L)
- PMC
- PMC7296410
- OpenAlex
- W3022363742
- Cited by
- 10
- References
- 15
- Citations by year
- 2025: 3 · 2024: 3 · 2023: 1 · 2022: 2 · 2021: 1
- FWCI
- 0.96
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- JMIR Research Protocols (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Health Sciences › Medicine › Emergency Medicine › Trauma and Emergency Care Studies
- Health Sciences › Medicine › Emergency Medicine › Emergency and Acute Care Studies
- Health Sciences › Medicine › Surgery › Spinal Fractures and Fixation Techniques
- Keywords
- Canadian C-Spine Rule, cervical spine injury, paramedics, emergency medical services, cervical spine immobilization, emergency department overcrowding, health system efficiency, knowledge translation, health economic evaluation, stepped-wedge cluster randomized trial, paramedic education
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
