Clinical trial NCT02786966: A Pragmatic Evaluation of the Canadian C-Spine Rule by Paramedics
Official title: A Pragmatic Strategy Empowering Paramedics to Assess Low-Risk Trauma Patients With the Canadian C-Spine Rule and Selectively Transport Them Without Immobilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Injuries
Keywords: Cervical spine injuries
Canadian C-spine Rule
Emergency Medical Services
Paramedic
Cervical spine fracture
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: The Ontario Spor Support Unit
First posted: 2016-06-01
Enrollment: 6560
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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 actually 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.

The investigators 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.

The investigators will evaluate the possibility and benefits of allowing paramedics to use the CCR in the field in 12 new communities from across Ontario. Patients have suggested the investigators include measures of pain and discomfort from being immobilized during transport as important patient-centred outcomes. The investigators will also measure the impact on the ED, and how much money could be saved if more paramedics were allowed to use the CCR. The investigators will also assess if sex, age, language barriers, or living far from the hospital (long transport time) will affect the outcomes of the study.

Detailed description: Paramedics in participating Ontario communities will all receive standardized training on the application of the Canadian C-Spine Rule (CCR). Once the training has been completed, paramedics will begin using the CCR to evaluate patients with potential c-spine injuries. For the first three months of the evaluation period, paramedics will use the CCR to evaluate eligible patients, but continue to use spinal immobilization for transport according to their existing protocols. After this validation period, participating services will be randomized in stepped wedge fashion in clusters of 4 services to actively use the CCR and selectively immobilize according to the CCR.

Eligibility criteria: Inclusion Criteria:

* Alert (Glasgow Coma Scale 15)
* Stable: Adult (16+): systolic blood pressure greater than or equal to 90 mmHg, respiratory rate 10-24 breaths/minute; Child (8-15): systolic blood pressure greater than or equal to 90 mmHg + (2 X age in years), respiratory rate 14-20 breaths/minute
* Acute blunt injury (within 48 hours of paramedic contact)

Exclusion Criteria:

* Age \<8 years of age
* Penetrating trauma from stabbing or gunshot wound
* Acute paralysis (paraplegia, quadriplegia)
* Known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, previous c-spine surgery)
* Referred from another hospital

Primary outcomes:
measure: Proportion of patients transported with spinal immobilization
timeFrame: through study completion (one year)
measure: Proportion of patients feeling comfortable
timeFrame: through study completion (one year)
Secondary outcomes:
Other outcomes:
measure: Proportion of patients with a pain score </= 4/10
timeFrame: through study completion (one year)
measure: Time from paramedic arrival at patient side to ED discharge or admission to hospital
timeFrame: through study completion (one year)
measure: Radiation Exposure
timeFrame: through study completion (one year)
measure: Number of skin pressure injuries
timeFrame: through study completion (one year)
measure: Number of missed cervical spine injuries
timeFrame: through study completion (one year)
measure: Paramedic Field Time (arrival at patient side until departure for hospital)
timeFrame: through study completion (one year)
measure: Paramedic Hospital Time
timeFrame: through study completion (one year)
measure: Subsequent emergency department visits or hospital admissions
timeFrame: through study completion (one year)
measure: Subsequent clinic or family physician visits
timeFrame: through study completion (one year)
measure: Frequency of Cervical Spine diagnostic imaging
timeFrame: through study completion (one year)
measure: Cost Savings
timeFrame: through study completion (one year)
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Insitute
name: Christian Vaillancourt, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 IG. 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. JMIR Res Protoc. 2020 Jun 1;9(6):e16966. doi: 10.2196/16966.