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| Name | Class |
|---|---|
| The Ontario Spor Support Unit | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Phase | Other | Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule, but spinal immobilization using standard immobilization protocols (usual care). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canadian C-Spine Rule | Other | Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Transported With Spinal Immobilization | Through study completion. | |
| Proportion of Patients Feeling Uncomfortable | Measured on an ordinal scale from 1 to 10, with higher values indicating increasing discomfort. Values >=5 were considered to indicate discomfort. | At study completion |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With a Pain Score </= 5/10 | Measured on a 10-point ordinal scale with increasing values indicating greater pain. | At study completion |
| Time From Paramedic Arrival at Patient Side to ED Discharge or Admission to Hospital |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Vaillancourt, MD, MSc | Ottawa Hospital Research Insitute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ottawa Hospital Research Institute | Ottawa | Ontario | K1Y 4E9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32348267 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: Usual Care Months 1-3, Canadian C-Spine Rule Months 4-9 | Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule, but spinal immobilization using standard immobilization protocols (usual care) for months 1-3. Use of the Canadian C-Spine Rule to determine need for spinal immobilization for months 4-9. |
| FG001 | Sequence 2: Usual Care Months 1-6, Canadian C-Spine Rule Months 7-9 | Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule, but spinal immobilization using standard immobilization protocols (usual care) for months 1-6. Assessment using Canadian C-Spine Rule to determine need for spinal immobilization for transport for months 7-9. |
| FG002 | Sequence 3: Usual Care Months 1-9 | Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule, but spinal immobilization using standard immobilization protocols (usual care) for months 1-9. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Step 1: Months 1-3 |
| |||||||||||||
| Step 2: Months 4-6 |
| |||||||||||||
| Step 3: Months 7-9 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Phase (Usual Care) | Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule, but spinal immobilization using standard immobilization protocols (usual care). |
| BG001 | Canadian C-Spine Rule |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients Transported With Spinal Immobilization | Posted | Count of Participants | Participants | Through study completion. |
|
|
30 days from time of initial paramedic assessment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Phase (Usual Care) | Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule, but spinal immobilization using standard immobilization protocols (usual care). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manya Charette | Ottawa Hospital Research Institute | 613-798-5555 | 17758 | mancharette@ohri.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2016 | Mar 31, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019838 | Neck Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Time from paramedic arrival at patient side to ED discharge or admission to hospital
| At time of initial injury |
| Radiation Exposure | radiation exposure from diagnostic imaging tests of the spine conducted at initial visit or within 30 days of the initial visit | 30 days from initial injury |
| Number of Skin Pressure Injuries | through study completion (one year) |
| Number of Missed Cervical Spine Injuries | through study completion (one year) |
| Paramedic Field Time (Arrival at Patient Side Until Departure for Hospital) | arrival at patient side until departure for hospital | at time of initial injury |
| Paramedic Hospital Time | from arrival at emergency department to transfer of care to emergency department staff | through study completion (one year) |
| Subsequent Emergency Department Visits or Hospital Admissions | within 30 days of initial visit | through study completion (one year) |
| Subsequent Clinic or Family Physician Visits | within 30 days of initial visit | within 30 days of initial injury |
| Frequency of Cervical Spine Diagnostic Imaging | at initial visit or within 30 days of initial visit | within 30 days of initial injury |
| Cost Savings | incremental cost saving per one immobilization avoided | through study completion (one year) |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
Assessment using Canadian C-Spine Rule to determine need for spinal immobilization for transport.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Ontario Canada | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
|
| Primary | Proportion of Patients Feeling Uncomfortable | Measured on an ordinal scale from 1 to 10, with higher values indicating increasing discomfort. Values >=5 were considered to indicate discomfort. | Posted | Count of Participants | Participants | At study completion |
|
|
|
|
| Other Pre-specified | Proportion of Patients With a Pain Score </= 5/10 | Measured on a 10-point ordinal scale with increasing values indicating greater pain. | Posted | Count of Participants | Participants | At study completion |
|
|
|
|
| Other Pre-specified | Time From Paramedic Arrival at Patient Side to ED Discharge or Admission to Hospital | Time from paramedic arrival at patient side to ED discharge or admission to hospital | Not Posted | At time of initial injury | Participants |
| Other Pre-specified | Radiation Exposure | radiation exposure from diagnostic imaging tests of the spine conducted at initial visit or within 30 days of the initial visit | Not Posted | 30 days from initial injury | Participants |
| Other Pre-specified | Number of Skin Pressure Injuries | Not Posted | through study completion (one year) | Participants |
| Other Pre-specified | Number of Missed Cervical Spine Injuries | Not Posted | through study completion (one year) | Participants |
| Other Pre-specified | Paramedic Field Time (Arrival at Patient Side Until Departure for Hospital) | arrival at patient side until departure for hospital | Not Posted | at time of initial injury | Participants |
| Other Pre-specified | Paramedic Hospital Time | from arrival at emergency department to transfer of care to emergency department staff | Not Posted | through study completion (one year) | Participants |
| Other Pre-specified | Subsequent Emergency Department Visits or Hospital Admissions | within 30 days of initial visit | Not Posted | through study completion (one year) | Participants |
| Other Pre-specified | Subsequent Clinic or Family Physician Visits | within 30 days of initial visit | Not Posted | within 30 days of initial injury | Participants |
| Other Pre-specified | Frequency of Cervical Spine Diagnostic Imaging | at initial visit or within 30 days of initial visit | Not Posted | within 30 days of initial injury | Participants |
| Other Pre-specified | Cost Savings | incremental cost saving per one immobilization avoided | Not Posted | through study completion (one year) | Participants |
| 0 |
| 1,745 |
| 0 |
| 1,745 |
| 0 |
| 1,745 |
| EG001 | Canadian C-Spine Rule | Assessment using Canadian C-Spine Rule to determine need for spinal immobilization for transport. | 0 | 1,898 | 0 | 1,898 | 0 | 1,898 |
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