Implementation of the Canadian C-Spine Rule: Phase III
Overview
Many thousands of trauma patients are seen in Canadian emergency departments each year. On rare occasion 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 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.
Principal Investigator: Dr. Ian Stiell
Co-Investigators: Dr. George Wells, Dr. Jeremy Grimshaw, Doug Coyle, Dr. Howard Lesiuk
Duration of Study: Enrollment complete; currently being submitted for publication
For more information, please contact Cathy Clement.
Protocol Summary
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 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.
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.
Additional Information
Stiell IG, Clement CM, Grimshaw J, Brison R, Rowe BH, Schull MJ, Lee J, Brehaut J, McKnight D, Eisenhauer MA, Dreyer J, Letovsky E, Rutledge T, MacPhail I, Ross S, Perry JJ, Holroyd BR, Ip U, Lesiuk H, Wells GA. Implementation of the Canadian C-Spine Rule: A Prospective 12-Centre Cluster Randomized Trial. British Medical Journal 2009. BMJ. 2009 Oct 29;339:b4146.
Team Members
- OHRI members:
-
Dr. Ian Stiell Principal Investigator
Cathy Clement Senior Research Program Manager / Associate
Christine Leclair Research Assistant
Dr. George Wells Co-Investigator
Dr. Jeremy Grimshaw, Co-Investigator
Doug Coyle, Co-Investigator, University of Ottawa
Dr. Howard Lesiuk, Co-Investigator, The Ottawa Hospital
Erica Battram, Research Assistant
Kim Bradbury, Research Assistant
- Study Sites/Staff:
-
Dr. Douglas McKnight, Vancouver General Hospital
Dr. Marcia Edmonds, London HSC
Dr. Scott Ross, Sturgeon
Dr. Tim Rutledge, North York General Hospital
Dr. Anne Clarke, Surrey Memorial Hospital
Dr. Brian Rowe, University of Alberta
Dr. Jacques Lee & Dr. Michael Schull, Sunnybrook and Women's College HSC
Dr. Robert Brison, Kingston General Hospital
Dr. Iain MacPhail, Royal Columbian Hospital
Dr. Eric Letovsky, Credit Valley Hospital
Dr. Amit Shah, St. Thomas Elgin Hospital