Canadian Computed Tomography (CT) Head Rule Study

Head Injury Clinical Trial

Official title:

Evaluation of an Active Strategy to Implement the Canadian CT Head Rule: Phase III

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993252
• Other study ID #: 42521
• Secondary ID: 2003165-01H
• Status: Completed
• Phase: Phase 3
• First received: April 21, 2008
• Last updated: October 13, 2010
• Start date: September 2003
• Est. completion date: March 2009

Study information

• Verified date: October 2010
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4531
• Est. completion date: March 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Head Injury

Intervention

Procedure:
• CT Scan
CT scan

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	St. Thomas Hospital	Elgin	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	The Ottawa Hospital Civic Campus	Ottawa	Ontario
Canada	Credit Valley Hospital	Toronto	Ontario
Canada	Sunnybrook and Women's College HSC	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Royal Columbian Hospital	Westminster	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Computed tomography ordering proportions		January 2009	No
Secondary	Number of missed CTs		January 2009	Yes
Secondary	Number of serious adverse outcomes		January 2009	Yes
Secondary	Length of stay in emergency department (ED)		January 2009	Yes
Secondary	Patient satisfaction		January 2009	Yes
Secondary	Sustainability of the intervention		January 2009	Yes
Secondary	Performance of the Canadian CT Head Rule		January 2009	Yes
Secondary	Economic evaluation measures		January 2009