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Improving the Stewardship of Diagnostic Imaging Resources in Alberta Emergency Departments

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ClinicalTrials.gov Identifier: NCT02410941
Recruitment Status : Unknown
Verified August 2016 by Dr. Eddy S. Lang, University of Calgary.
Recruitment status was:  Recruiting
First Posted : April 8, 2015
Last Update Posted : August 30, 2016
Sponsor:
Collaborator:
Alberta Innovates Health Solutions
Information provided by (Responsible Party):
Dr. Eddy S. Lang, University of Calgary

Study Description
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Brief Summary:
Utilization of diagnostic imaging in the Emergency Department has increased dramatically over the past two decades, driven by an increased availability of advanced imaging, legal pressures to exclude serious diagnoses in low-risk patients, patient expectations, and the tendency to associate more testing with a higher quality of care. However, this rise in the use of diagnostic imaging, particularly in low-risk patients, may not be taking into account the risk of radiation exposure to patients, or the impact on finite health system resources. The objective of this project is to improve the appropriateness of CT imaging in Alberta Emergency Departments by advancing awareness of, and adherence to, evidence-based guidelines for CT imaging of patients with mild traumatic brain injury (MTBI) and suspected pulmonary embolism (PE). These two clinical scenarios have been selected because of evidence of significant variation in imaging practices across Alberta, and the robust evidence base that exists to guide CT imaging decisions such as the Canadian CT Head Rule and the Pulmonary Embolism Rule Out Criteria.

Condition or disease Intervention/treatment Phase
Brain Injuries Pulmonary Embolism Behavioral: Clinical decision support Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52058 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving the Stewardship of Diagnostic Imaging Resources in Alberta Emergency Departments
Study Start Date : January 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Decision-support for MTBI
Clinical decision support will be provided on ordering CT scans for patients suspected to have Minor Traumatic Brain Injury (MTBI) to treating physicians randomized into this group. This arm will also serve as a control for the PE group.
 Behavioral: Clinical decision support
Establish evidence-based standardized clinical pathways implemented by local communities of practice focused on imaging utilization in ED settings as models of participatory research and integrated knowledge translation.
Experimental: Decision-support for PE
Clinical decision support will be provided on ordering CT scans for patients suspected to have Pulmonary Embolism (PE) to treating physicians randomized into this group. This arm will also serve as a control for the MTBI group.
 Behavioral: Clinical decision support
Establish evidence-based standardized clinical pathways implemented by local communities of practice focused on imaging utilization in ED settings as models of participatory research and integrated knowledge translation.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients with mild traumatic brain injury who undergo a CT head [ Time Frame: All presenting patients for a period of 30 months (15 months pre-intervention administrative data, and 15 months of administrative date during the intervention)/ ]
  2. Proportion of patients with suspected Pulmonary Embolism who undergo a CTPA scan [ Time Frame: All presenting patients for a period of 30 months (15 months pre-intervention administrative data, and 15 months of administrative date during the intervention) ]

Secondary Outcome Measures :
  1. Proportion of patients with mild traumatic brain injury who undergo a CT Head for which a CT Head is recommended by the Canadian CT Head Rule [ Time Frame: All presenting patients for a period of 30 months (15 months pre-intervention administrative data, and 15 months of administrative date during the intervention) ]
  2. Proportion of patients with suspected pulmonary embolism who undergo a CTPA scan for which a CTPA scan is recommended after applying the Well's Score, the Pulmonary Embolism Rule-Out Criteria (PERC), and receiving D-Dimer test results. [ Time Frame: All presenting patients for a period of 30 months (15 months pre-intervention administrative data, and 15 months of administrative date during the intervention) ]
  3. Proportion of patients who return to the ED within 30 days with the same presenting complaint and undergo a CT Head or CTPA [ Time Frame: Patients will be followed from presentation to the ED up until 30 days post-discharge from the ED ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients: All patients presenting to pre-determined Alberta emergency departments with head injuries and suspected pulmonary embolism will be targeted for evaluation of CT appropriateness. For the CT Head, patients >16 with a CEDIS Triage code of "Head Injury" will be eligible. For the CT Pulmonary Angiography (CTPA) patients age 18-85 with CEDIS Triage codes of "Chest Pain (Noncardiac Features)", "Shortness of Breath", or "Syncope/Presyncope" will be eligible.
  • Health Professionals: Engagement in this project will fall within the professional responsibilities and mandate for many if not all of these individuals will be supported by zone leadership in each domain. The interventions proposed are educational and voluntary in nature; as there are clinical situations in which clinical judgement is expected to supersede clinical guidelines, and therefore no coercive measures will be taken to impose universal physician compliance.

Exclusion Criteria:

  • Patients under 16 years of age for CT head, under 18 or over 85 years of age for CT pulmonary angiography.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410941


Contacts
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Contact: Daniel W. Grigat (403) 618-7369 daniel.grigat@albertahealthservices.ca

Locations
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Canada, Alberta
Foothills Medical Centre - C231 Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Daniel Grigat    403-6178-7369    daniel.grigat@albertahealthservices.ca   
Peter Lougheed Centre Recruiting
Calgary, Alberta, Canada
Contact: Daniel Grigat    403-618-7369    daniel.grigat@ahs.ca   
Sheldom M. Chumir Centre Recruiting
Calgary, Alberta, Canada
Contact: Daniel Grigat    403-618-7369    daniel.grigat@ahs.ca   
South Health Campus Recruiting
Calgary, Alberta, Canada
Contact: Daniel Grigat    403-618-7369    daniel.grigat@ahs.ca   
Grey Nuns CommunityHospital Recruiting
Edmonton, Alberta, Canada
Contact: Daniel Grigat    403-618-7369    daniel.grigat@ahs.ca   
Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada
Contact: Daniel Grigat    403-618-7369    daniel.grigat@ahs.ca   
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada
Contact: Daniel Grigat    403-618-7369    daniel.grigat@ahs.ca   
Misericordia Community Hospital Recruiting
Edmontyon, Alberta, Canada
Contact: Daniel Grigat    403-618-7369    daniel.grigat@ahs.ca   
Northern Lights Regional Hospital Recruiting
Fort McMurray, Alberta, Canada
Contact: Daniel Grigat    403-618-7369    daniel.grigat@ahs.ca   
Fort Saskatchewan Health Centre Recruiting
Fort Saskatchewan, Alberta, Canada
Contact: Daniel Grigat    403-618-7369    daniel.grigat@ahs.ca   
Queen Elizabeth II Hospital Recruiting
Grande Prairie, Alberta, Canada
Contact: Daniel Grigat    403-618-7369    daniel.grigat@ahs.ca   
Chinook Regional Hospital Recruiting
Lethbridge, Alberta, Canada
Contact: Daniel Grigat    403-618-7369    daniel.grigat@ahs.ca   
Medicine Hat Regional Hospital Recruiting
Medicine Hat, Alberta, Canada
Contact: Daniel Grigat    403-619-7369    daniel.grigat@ahs.ca   
Red Deer Regional Hospital Recruiting
Red Deer, Alberta, Canada
Contact: Daniel Grigat    403-618-7369    daniel.grigat@ahs.ca   
Strathcona Community Hospital Recruiting
Sherwood Park, Alberta, Canada
Contact: Daniel Grigat    403-618-7369    daniel.grigat@ahs.ca   
Sturgeon Community Hospital Recruiting
St. Albert, Alberta, Canada
Contact: Daniel Grigat    403-618-7369    daniel.grigat@ahs.ca   
Sponsors and Collaborators
University of Calgary
Alberta Innovates Health Solutions
Investigators
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Principal Investigator: Eddy S. Lang, MD University of Calgary
Study Director: Andrew McRae, MD University of Calgary
Study Director: James Andruchow, MD University of Calgary
Study Director: Grant Innes, MD University of Calgary
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Eddy S. Lang, Doctor, associate professor, University of Calgary
ClinicalTrials.gov Identifier: NCT02410941    
Other Study ID Numbers: 10007399
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Keywords provided by Dr. Eddy S. Lang, University of Calgary:
Randomized controlled trial
Practice management
tomography, x-ray computed/adverse effects
Clinical decision support
Computerized clinical decision support
Decision support systems, clinical
Health Expenditures
 Physician's practice patterns
Unnecessary Procedures/economics
Physician's Practice Patterns/economics
Diffusion of innovation
Decision Support Models
Clinical Prediction Rules
Additional relevant MeSH terms:
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Pulmonary Embolism
Brain Injuries
Embolism
Emergencies
Disease Attributes
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases