Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 7, 2019
Date Accepted: Dec 31, 2019
Date Submitted to PubMed: Apr 29, 2020
A Pragmatic Strategy Empowering Paramedics to Assess Low-Risk Trauma Patients with the Canadian C-Spine Rule and Selectively Transport them Without Immobilization: Study Protocol for a Stepped Wedge Cluster Randomized Trial
ABSTRACT
Background:
Each year, half a million patients with a potential neck (c-spine) injury are transported to Ontario emergency departments (ED). Less than 1% of all these patients have a neck bone fracture. Even less (0.5%) have a spinal cord injury or nerve damage. These injuries usually occur at the time of initial trauma and not during transport to the ED. Currently, paramedics transport all trauma victims (with or without an injury) by ambulance using a backboard, collar, and head immobilizers. Trauma victims can stay immobilized for hours until an ED bed is made available or until x-rays are completed. Importantly, long immobilization is often unnecessary, it causes patient discomfort and pain, decreases community access to paramedics, contributes to ED crowding, and is very costly. We 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 have recently taught Ottawa paramedics to use the CCR in the field. This allows them to transport eligible patients to the hospital without immobilization devices. They have evaluated 3,854 patients, 60% were transported without immobilization, and all those with a c-spine injury were correctly identified and immobilized.
Objective:
The overall goals of this study are 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 set-up 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 3 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 multicentre trial is successful, we expect the Ontario Ministry of Health will recommend that paramedics evaluate all eligible patients with the Canadian C-Spine Rule 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, therefore improving access to paramedics and ED care. This could be achieved rapidly and with lower healthcare costs compared to current practices (possible cost saving of Can$36 per immobilization, or Can$10,656,000 per year). Clinical Trial: ClinicalTrials.gov NCT02786966; https://clinicaltrials.gov/ct2/show/NCT02786966
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