Canadian Computed Tomography (CT) Head Rule Study
Canadian Computed Tomography (CT) Head Rule Study
Each year, Canadian emergency department physicians treat 600,000 patients with head injury.
 Many of these are adults with "minor head injury", i.e. loss of consciousness or amnesia and
 a Glasgow Coma Scale (GCS) score of 13-15. Only 6.2% of these "minor" patients have some
 acute injury on computed tomography (CT scan) and only 0.5% have an epidural hematoma
 requiring surgery. Among Canadian teaching hospital emergency departments, we have shown a
 fourfold variation in use of CT and that a small but important number of intracranial
 hematomas are missed at the first visit.
Background: Each year, Canadian emergency department physicians treat 600,000 patients with
 head injury. Many of these are adults with "minor head injury", i.e. loss of consciousness or
 amnesia and a Glasgow Coma Scale (GCS) score of 13-15. Only 6.2% of these "minor" patients
 have some acute injury on computed tomography (CT scan) and only 0.5% have an epidural
 hematoma requiring surgery. Among Canadian teaching hospital emergency departments, we have
 shown a fourfold variation in use of CT and that a small but important number of intracranial
 hematomas are missed at the first visit. This renewal application builds on previous MRC/CIHR
 Health Services Research Committee funded grants to determine feasibility (phase 0, MRC
 GR-13304D, 1995-96), develop a clinical decision rule for CT in minor head injury (phase I,
 MRC MT-13700, 1996-99, N=3,121), and prospectively validate this Canadian CT Head Rule (phase
 II, CIHR #42521, 2000-03, N=2,707), all part of the U of Ottawa Group Grant in Decision
 Support Techniques (CIHR 2000-143). The Canadian CT Head Rule is comprised of simple clinical
 variables and allows physicians to be much more accurate in their diagnosis of brain injury
 and will standardize the use of CT without jeopardizing patient care (The Lancet 2001). In
 the recently completed prospective validation (phase II), we confirmed the accuracy and
 reliability of the rule in 2,707 additional patients.

 Objectives: The goal of phase III is to evaluate the effectiveness and safety of an active
 strategy to implement the Canadian CT Head Rule into physician practice. Specific objectives
 are to: 1) Determine clinical impact by comparing the intervention and control sites for: a)
 CT Head ordering rates, b) Missed neurological intervention cases, c) Missed brain injuries,
 d) Number of deaths, d) Length of stay in ED, and e) Patient satisfaction; 2) Determine
 sustainability of the impact; 3) Evaluate performance of the Canadian CT Head 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; 5) Conduct an exploratory psychological process
 evaluation to examine whether physicians' intentions and behaviours can be predicted.

 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. These 12 hospital ED sites will be stratified as 'teaching' or 'community'
 hospitals, matched according to baseline CT head 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 CT Head 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) CT Head ordering proportions (the
 primary analysis); b) Number of missed brain injuries; c) Number of serious adverse outcomes;
 d) Length of stay in ED; e) Patient satisfaction. 2) Performance of the Canadian CT Head
 Rule: a) Accuracy of the rule; b) Physician accuracy of interpretation; c) Physician comfort
 and compliance. 3) Economic evaluation measures: a) CT head rate after discharge; b) Length
 of stay in ED and hospital; c) Hospital admission; d) Neurological intervention; e) Number of
 transfers. 4) Psychological Process Evaluation: Mail surveys of physicians before and after
 the intervention. 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 2,400 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 CT Head 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 CT Head Rule and whether implementation can be achieved with simple and inexpensive
 measures. We believe that the Canadian CT Head Rule has the potential to significantly limit
 health care costs and improve the efficiency of patient flow in busy Canadian EDs.
Inclusion Criteria:

 Consecutive adult patients presenting to one of the study hospital EDs after sustaining
 acute minor head injury will be enrolled into the study. Eligibility as an 'acute minor
 head injury' case will be determined by the patient having all of the following
 characteristics upon arrival in the ED.

 1. Blunt trauma to the head resulting in witnessed loss of consciousness, definite
 amnesia, or witnessed disorientation, no matter how brief; this may be determined from
 the patient or from the report of a witness (the patient will be asked specific
 questions: 'do you remember the accident?', 'how did you get to the hospital?', 'have
 you talked to me before?').

 2. Initial ED GCS score of 13 or greater as ascertained by the attending physician (e.g.
 opens eyes spontaneously, obeys commands, but speech may include only comprehensible
 but inappropriate words).

 3. Injury within the past 24 hours.

 Exclusion Criteria:

 1. less than 16 years,

 2. 'minimal' head injury i.e. no loss of consciousness, amnesia, or disorientation,

 3. no clear history of trauma as the primary event (for example primary seizure or
 syncope),

 4. GCS score of less than 13,

 5. head injury occurred more than 24 hours previously,

 6. obvious penetrating skull injury or depressed fracture,

 7. acute focal neurological deficit (motor or cranial nerve) that cannot be ascribed to
 an extracerebral cause, for example, traumatic mydriasis or peripheral neuropathy,

 8. have suffered a seizure prior to assessment in the ED,

 9. a bleeding disorder or current use of oral anticoagulants,125 or

 10. returned for reassessment of the same head injury