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Trial NCT00290875

Resource URI: http://static.linkedct.org/resource/trials/NCT00290875
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linkedct:brief_title Canadian C-Spine Rule Study
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/1060>
linkedct:condition <http://static.linkedct.org/resource/condition/3479>
linkedct:criteria Inclusion Criteria:All alert, stable adults presenting to the study hospital EDs after sustaining acute blunt trauma to the head or neck will be eligible and consecutive eligible trauma patients will be entered into the study. Patient eligibility will be determined based on these criteria at the time of arrival in the ED. a) "Trauma to the head and neck" will include patients with either: i) neck pain with any mechanism of injury (subjective complaint by the patient of any pain in the posterior midline or posterolateral aspect of the neck), or ii) no neck pain but all of: some visible injury above the clavicles, has not been ambulatory at any time, and associated with a high risk mechanism of injury (motor vehicle collision including motorcycle, pedestrian struck by a motor vehicle, bicycle collision, fall greater than or equal to 3 feet or 5 steps, diving, or contact sport with axial load to head and neck). b) "Alert" is defined as a Glasgow Coma Scale103 score of 15 (converses, fully oriented, and follows commands). c) "Stable" refers to normal vital signs as defined by the Revised Trauma Score24 (systolic blood pressure 90 mm Hg or greater and respiratory rate between 10 and 24 breaths per minute). d) "Acute" refers to injury within the past 48 hours. - Exclusion Criteria:a) Patients under the age of 16 years, b) Patients who do not satisfy the definition of "trauma to the head and neck" as defined above (for example, patients with neither neck pain nor visible injuries above the clavicles will be excluded), c) Patients with Glasgow Coma Scale score less than 15, d) Patients with unstable vital signs (systolic BP < 90; respiratory rate less than 10 or more than 24), e) Patients whose injury occurred more than 48 hours previously, f) Patients with penetrating trauma from stabbing or gunshot wound, g) Patients with acute paralysis (paraplegia, quadriplegia), h) Patients with known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, or previous cervical spine surgery), or i) Patients who return for reassessment of the same injury. -
linkedct:description Background: Physicians in Canadian emergency departments (EDs) annually treat 185,000 alert and stable trauma victims who are at risk for cervical spine (c-spine) injury. Only 0.9% of these patients have, however, suffered a cervical spine fracture. Current use of radiography is not efficient. More than 98% of c-spine radiographs are negative and there is considerable variation among hospitals and physicians in radiography use. C-spine radiographs are "little ticket" items, low cost procedures that significantly add to health care costs due to high volume. In addition, alert and stable trauma patients are often immobilized on a backboard with a rigid collar and sandbags for many hours. This leads to considerable patient discomfort and unnecessary use of valuable time and space in our crowded EDs. This renewal application builds on previous MRC/CIHR grants to determine feasibility (phase 0, MRC GR-13304D, 1995-96), develop a decision rule for c-spine radiography (phase I, MRC MT-13700, 1996-99, N=8,924), and prospectively validate this 'Canadian C-Spine Rule' (phase II, CIHR MT-13700, 1999-2002, N=8,000), all part of the University of Ottawa Group Grant in Decision Support Techniques (CIHR 2000-143). The Canadian C-Spine Rule is comprised of simple clinical variables (Figure 1) and allows physicians to be much more selective in ordering radiography (JAMA 2001). In the recently completed prospective validation (phase II), we confirmed the accuracy and reliability of the rule. Objectives: The goal of phase III is to evaluate the effectiveness and safety of an active strategy to implement the Canadian C-Spine Rule into physician practice. Specific objectives are to: 1) Determine clinical impact by comparing the intervention and control sites for: a) C-spine radiography rates, b) Missed fractures, c) Serious adverse outcomes, d) Length of stay in ED, and e) Patient satisfaction; 2) Determine sustainability of the impact; 3) Evaluate performance of the Canadian C-Spine Rule, with regards to: a) Accuracy, b) Physician accuracy in interpretation, and c) Physician comfort and compliance with use; 4) Conduct an economic evaluation to determine the potential for cost savings with widespread implementation. Methods: We propose a matched-pair cluster design study which compares outcomes during 3 consecutive 12-month 'before', 'after', and 'decay' periods at 6 pairs of 'intervention' and 'control' sites (Figure 3). These 12 hospital ED sites will be stratified as 'teaching' or 'community' hospitals, matched according to baseline c-spine radiography ordering rates, and then allocated within each pair to either intervention or control groups. During the 'after' period at the intervention sites, simple and inexpensive strategies will be employed to actively implement the Canadian C-Spine Rule: a) physician group discussion and consensus, b) educational initiatives (lecture, posters, pocket cards), and c) a process-of-care modification with a mandatory reminder of the Rule at the point of requisition for radiography. These outcomes will be assessed: 1) Measures of clinical impact will compare the changes from before to after between the intervention and control sites: a) C-spine radiography ordering proportions (the primary analysis); b) Number of missed fractures; c) Number of serious adverse outcomes; d) Length of stay in ED; e) Patient satisfaction. 2) Performance of the Canadian C-Spine Rule: a) Accuracy of the rule; b) Physician accuracy of interpretation; c) Physician comfort and compliance. 3) Economic evaluation measures: a) Radiography rate after discharge; b) Length of stay in ED and hospital; c) Hospital admission; d) Operative repair. During the 12-month 'decay' period, implementation strategies will continue, allowing us to evaluate the sustainability of the effect. We estimate a sample size of 4,800 patients in each period in order to have adequate power to evaluate the main outcomes. Importance: This implementation study (phase III) is an essential step in the process of developing a new clinical decision rule / guideline for health care practitioners. Phase I successfully derived the 'Canadian C-Spine Rule' and phase II confirmed the accuracy and safety of the rule and, hence, the potential for physicians to improve care. What remains unknown is the actual change in clinical behaviour that can be effected by implementation of the Canadian C-Spine Rule and whether implementation can be achieved with simple and inexpensive measures. We believe that the Canadian C-Spine Rule has the potential to significantly reduce health care costs and improve the efficiency of patient flow in busy Canadian EDs.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers Accepts Healthy Volunteers
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 16 Years
linkedct:end_date January 2008
linkedct:enrollment 14400 (xsd:int)
linkedct:firstreceived_date February 9, 2006
linkedct:id NCT00290875
rdfs:label Trial NCT00290875
linkedct:lastchanged_date July 25, 2007
linkedct:lead_sponsor_agency Ottawa Hospital Research Institute
linkedct:location <http://static.linkedct.org/resource/location/18772>
linkedct:nct_id NCT00290875
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Implementation of the Canadian C-Spine Rule: Phase III
linkedct:org_study_id 62795
linkedct:overall_contact_email cclement@ohri.ca
linkedct:overall_contact_last_name Cathy Clement, RN
linkedct:overall_contact_phone 613-798-5555
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/23500>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/415>
foaf:page <http://clinicaltrials.gov/show/NCT00290875>
linkedct:phase Phase 3
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/3504>
linkedct:secondary_id 2002174-01H
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/71375>
linkedct:source Ottawa Hospital Research Institute
linkedct:start_date January 2003
linkedct:study_design Diagnostic, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary Many thousands of trauma patients are seen in Canadian emergency departments each year. On rare occasions, such patients have a broken neck (cervical spine fracture) but in 98% of cases the x-rays ordered by the doctors are normal. The total cost of inexpensive but high volume tests such as neck x-rays adds considerably to rising health care costs. In addition, these patients are often immobilized with uncomfortable backboards and collars for many hours, tying up valuable space and time in our crowded emergency departments. This research group recently developed and tested a highly accurate and reliable guideline called the 'Canadian C-Spine Rule' to help physicians be much more selective in their use of neck x-rays and to minimize the period of immobilization. This research project will evaluate the true effectiveness of the Rule when implemented with simple and inexpensive measures. This study will involve 14,000 patients in 12 busy emergency departments across Canada. This Canadian C-Spine Rule is designed to allow physicians to be much more selective in their use of neck x-rays without the risk of missing a fracture or dislocation of the neck and to reduce the length of time of immobilization. Widespread use of the guideline could lead to large savings for our health care systems without jeopardizing patients and could greatly expedite care of trauma patients in our crowded emergency departments.
rdf:type linkedct:trials
linkedct:verification_date July 2007