Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00290875
Status:
COMPLETED
Last Update Posted:
2015-04-22
First Post:
2006-02-09
Brief Title:
Implementation of the Canadian C-Spine Rule
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
Implementation of the Canadian C-Spine Rule Phase III
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 percent of cases the xrays 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 14000 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 xrays 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
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 14000 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 xrays 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
Detailed Description:
Background Physicians in Canadian emergency departments EDs annually treat 185000 alert and stable trauma victims who are at risk for cervical spine c-spine injury Only 09 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 MRCCIHR 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 N8924 and prospectively validate this Canadian C-Spine Rule phase II CIHR MT13700 1999-2002 N8000 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 4800 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
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 4800 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2002174-01H | None | None | None |