Brain InjuriesNCT02410941
Improving the Stewardship of Diagnostic Imaging Resources in Alberta Emergency Departments
A study testing Clinical decision support in people with Brain Injuries and Pulmonary Embolism, run by University of Calgary at 16 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries, Pulmonary Embolism
- What is being tested?
- Clinical decision support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52,058 participants
- Where
- 16 sitesCanada
- Study dates
- Jan 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients under 16 years of age for CT head, under 18 or over 85 years of age for CT pulmonary angiography.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Canada16 sites, 16 recruiting
- Recruiting
Foothills Medical Centre - C231
Calgary, Alberta, T2N 2T9
Daniel Grigat, 403-6178-7369, daniel.grigat@albertahealthservices.ca
- Recruiting
Peter Lougheed Centre
Calgary, Alberta
Daniel Grigat, 403-618-7369, daniel.grigat@ahs.ca
- Recruiting
Sheldom M. Chumir Centre
Calgary, Alberta
Daniel Grigat, 403-618-7369, daniel.grigat@ahs.ca
- Recruiting
South Health Campus
Calgary, Alberta
Daniel Grigat, 403-618-7369, daniel.grigat@ahs.ca
- Recruiting
Grey Nuns CommunityHospital
Edmonton, Alberta
Daniel Grigat, 403-618-7369, daniel.grigat@ahs.ca
- Recruiting
Royal Alexandra Hospital
Edmonton, Alberta
Daniel Grigat, 403-618-7369, daniel.grigat@ahs.ca
- Recruiting
University of Alberta Hospital
Edmonton, Alberta
Daniel Grigat, 403-618-7369, daniel.grigat@ahs.ca
- Recruiting
Misericordia Community Hospital
Edmontyon, Alberta
Daniel Grigat, 403-618-7369, daniel.grigat@ahs.ca
- Recruiting
Northern Lights Regional Hospital
Fort McMurray, Alberta
Daniel Grigat, 403-618-7369, daniel.grigat@ahs.ca
- Recruiting
Fort Saskatchewan Health Centre
Ft Saskatchewan, Alberta
Daniel Grigat, 403-618-7369, daniel.grigat@ahs.ca
- Recruiting
Queen Elizabeth II Hospital
Grande Prairie, Alberta
Daniel Grigat, 403-618-7369, daniel.grigat@ahs.ca
- Recruiting
Chinook Regional Hospital
Lethbridge, Alberta
Daniel Grigat, 403-618-7369, daniel.grigat@ahs.ca
- Recruiting
Medicine Hat Regional Hospital
Medicine Hat, Alberta
Daniel Grigat, 403-619-7369, daniel.grigat@ahs.ca
- Recruiting
Red Deer Regional Hospital
Red Deer, Alberta
Daniel Grigat, 403-618-7369, daniel.grigat@ahs.ca
- Recruiting
Strathcona Community Hospital
Sherwood Park, Alberta
Daniel Grigat, 403-618-7369, daniel.grigat@ahs.ca
- Recruiting
Sturgeon Community Hospital
St. Albert, Alberta
Daniel Grigat, 403-618-7369, daniel.grigat@ahs.ca
About this study
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.
Read the detailed description
Background:
Imaging technology for the rapid diagnosis of medical conditions is an indispensable tool in the emergency department (ED). However, increasing and inappropriate use of costly and potentially dangerous imaging is a growing healthcare concern. The long-term health risks of radiation exposure, and the resources consumed by increased use, pose serious threats to the integrity of the investigators' health care system and the population at large. Computed tomography (CT) is frequently used in the emergency department setting to evaluate patients with mild traumatic brain injury (MTBI) and suspected pulmonary embolism (PE) to eliminate diagnostic uncertainty by either confirming or ruling out serious injury and illness. However, these tests are often used in lieu of alternate and safer strategies with equivalent accuracy and effectiveness. Fortunately, well-validated decision-support tools exist that can safely identify low risk patients who are unlikely to benefit from CT imaging, avoiding unnecessary diagnostic imaging and radiation exposure, and making better use of limited health system resources. However, decision-support is under-used in clinical practice, and research to optimize their uptake has yielded mixed results.
Study Objectives:
The investigators will conduct a cluster-randomized trial to evaluate whether the implementation of decision-support into standard clinical practice for ordering CTs will (a) decrease the number of CTs ordered, (b) increase the appropriateness of the CTs that are ordered (e.g. by increasing diagnostic yield but avoiding any missed diagnosis).
Scope:
The scope is to focus on two conditions for which validated decision-support exists: MTBI and PE.
These conditions were selected because internal AHS data shows significant variability (15-90%) in the ordering of CTs for patients presenting with these conditions, and because validated decision-support exists for these conditions (e.g. Canadian CT Head Rule, Well's Score, Pulmonary Embolism Rule-Out Criteria).
The scope includes all hospitals in Alberta with an ED and in-house CT. There are 17 of these hospitals in Alberta from Fort McMurray to Medicine Hat. The investigators have obtained operational approvals to conduct the researchers' study in all 17 hospitals from the Emergency Chief at each site, and from ED and Diagnostic Imaging leadership at the level of each Zone as well as the Province. The scope is limited to patients presenting to the ED.
Methods:
The study design is a cluster randomized trial. In the Calgary Zone, the investigators will randomize half of the investigators' ED physicians to receive decision-support for MTBI, and half to receive decision-support for PE.
Outside of the Calgary Zone, the investigators will randomize by site, so half of sites will receive decision-support for MTBI, and half will receive decision-support for PE. Each half of the randomization will serve as a control for the other group. The reason the investigators are randomizing by physician in the Calgary Zone is because the Computerized Physician Order Entry system in Calgary allows us to implement such a randomization, whereas outside of the Calgary Zone the heterogeneity of order entry systems does not make it feasible to randomize by physician, but it is feasible to randomize by site.
The implementation of decision-support for CT ordering will be mandatory and is supported by operational and clinical leadership. By integrating decision-support into the existing systems to order CTs, a physician (or site) randomized to MTBI or PE decision-support will have to consider those tools prior to ordering a CT. However, decision-support does not make decisions about who receives a CT; it merely provides additional information about how likely a CT is to be diagnostically useful. All decisions regarding diagnostic or therapeutic interventions are the sole responsibility of the physician in consultation with the patient. The primary outcomes measured by this study will be (a) the percentage of MTBI and PE patients receiving a CT scan, and (b) the "appropriateness" of CT scans ordered. This last point can be measured in a variety of ways, such as the percentage of low-risk patients (as defined by decision-support) receiving CT, as well as the diagnostic yield of the CTs that are ordered.
Procedure:
This study will be supported by several strategies including the integration of decision-support into CT ordering procedures in consultation with participating sites. This will also be supported by a voluntary pre-intervention Physician Survey to measure knowledge and attitudes towards CT ordering and decision-support, as well as the perceived barriers to implementing decision-support in their practice. Finally, throughout the intervention physicians and sites will be provided with "audit and feedback" (clinical informatics) on their CT ordering practices in relation to their peers. This feedback will be provided through existing AHS data systems through the Department of Data Integration, Measurement, and Reporting.
- Conditions
- Brain Injuries, Pulmonary Embolism
- Being tested
- Clinical decision support
- Keywords
- 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
- Medical subject headings
- Brain Injuries, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical decision supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Decision-support for MTBI | Experimental | 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. Receives: Behavioral: Clinical decision support |
| Decision-support for PE | Experimental | 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. Receives: Behavioral: Clinical decision support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with mild traumatic brain injury who undergo a CT head
Measured: All presenting patients for a period of 30 months (15 months pre-intervention administrative data, and 15 months of administrative date during the intervention)/
Proportion of patients with suspected Pulmonary Embolism who undergo a CTPA scan
Measured: 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 outcomes (3)
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
Measured: All presenting patients for a period of 30 months (15 months pre-intervention administrative data, and 15 months of administrative date during the intervention)
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.
Measured: All presenting patients for a period of 30 months (15 months pre-intervention administrative data, and 15 months of administrative date during the intervention)
Proportion of patients who return to the ED within 30 days with the same presenting complaint and undergo a CT Head or CTPA
Measured: Patients will be followed from presentation to the ED up until 30 days post-discharge from the ED
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52,058 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Innovates Health Solutions
- Responsible party
- Principal investigator, Dr. Eddy S. Lang, University of Calgary
- Investigators
- Eddy S. Lang, MD, Principal investigator, University of CalgaryAndrew McRae, MD, Study director, University of CalgaryJames Andruchow, MD, Study director, University of CalgaryGrant Innes, MD, Study director, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410941
- Sponsor's protocol ID
- 10007399
- Status last verified
- Aug 2016
- First submitted
- 17 Mar 2015
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kocher KE, Meurer WJ, Fazel R, Scott PA, Krumholz HM, Nallamothu BK. National trends in use of computed tomography in the emergency department. Ann Emerg Med. 2011 Nov;58(5):452-62.e3. doi: 10.1016/j.annemergmed.2011.05.020. Epub 2011 Aug 11.
PubMed 21835499Baker LC, Atlas SW, Afendulis CC. Expanded use of imaging technology and the challenge of measuring value. Health Aff (Millwood). 2008 Nov-Dec;27(6):1467-78. doi: 10.1377/hlthaff.27.6.1467.
PubMed 18997202Studdert DM, Mello MM, Sage WM, DesRoches CM, Peugh J, Zapert K, Brennan TA. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. JAMA. 2005 Jun 1;293(21):2609-17. doi: 10.1001/jama.293.21.2609.
PubMed 15928282Schattner A. Angst-driven medicine? QJM. 2009 Jan;102(1):75-8. doi: 10.1093/qjmed/hcn164.
PubMed 19095678Bishop TF, Federman AD, Keyhani S. Physicians' views on defensive medicine: a national survey. Arch Intern Med. 2010 Jun 28;170(12):1081-3. doi: 10.1001/archinternmed.2010.155. No abstract available.
PubMed 20585077Miller P, Kendrick D, Bentley E, Fielding K. Cost-effectiveness of lumbar spine radiography in primary care patients with low back pain. Spine (Phila Pa 1976). 2002 Oct 15;27(20):2291-7. doi: 10.1097/00007632-200210150-00021.
PubMed 12394910Berdahl CT, Vermeulen MJ, Larson DB, Schull MJ. Emergency department computed tomography utilization in the United States and Canada. Ann Emerg Med. 2013 Nov;62(5):486-494.e3. doi: 10.1016/j.annemergmed.2013.02.018. Epub 2013 May 14.
PubMed 23683773Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.
PubMed 18046031Brenner DJ, Hricak H. Radiation exposure from medical imaging: time to regulate? JAMA. 2010 Jul 14;304(2):208-9. doi: 10.1001/jama.2010.973. No abstract available.
PubMed 20628137Berrington de Gonzalez A, Mahesh M, Kim KP, Bhargavan M, Lewis R, Mettler F, Land C. Projected cancer risks from computed tomographic scans performed in the United States in 2007. Arch Intern Med. 2009 Dec 14;169(22):2071-7. doi: 10.1001/archinternmed.2009.440.
PubMed 20008689Smith-Bindman R, Lipson J, Marcus R, Kim KP, Mahesh M, Gould R, Berrington de Gonzalez A, Miglioretti DL. Radiation dose associated with common computed tomography examinations and the associated lifetime attributable risk of cancer. Arch Intern Med. 2009 Dec 14;169(22):2078-86. doi: 10.1001/archinternmed.2009.427.
PubMed 20008690Stiell IG, Greenberg GH, McKnight RD, Nair RC, McDowell I, Reardon M, Stewart JP, Maloney J. Decision rules for the use of radiography in acute ankle injuries. Refinement and prospective validation. JAMA. 1993 Mar 3;269(9):1127-32. doi: 10.1001/jama.269.9.1127.
PubMed 8433468Stiell IG, Greenberg GH, Wells GA, McDowell I, Cwinn AA, Smith NA, Cacciotti TF, Sivilotti ML. Prospective validation of a decision rule for the use of radiography in acute knee injuries. JAMA. 1996 Feb 28;275(8):611-5.
PubMed 8594242Hoffman JR, Mower WR, Wolfson AB, Todd KH, Zucker MI. Validity of a set of clinical criteria to rule out injury to the cervical spine in patients with blunt trauma. National Emergency X-Radiography Utilization Study Group. N Engl J Med. 2000 Jul 13;343(2):94-9. doi: 10.1056/NEJM200007133430203.
PubMed 10891516Stiell IG, Wells GA, Vandemheen KL, Clement CM, Lesiuk H, De Maio VJ, Laupacis A, Schull M, McKnight RD, Verbeek R, Brison R, Cass D, Dreyer J, Eisenhauer MA, Greenberg GH, MacPhail I, Morrison L, Reardon M, Worthington J. The Canadian C-spine rule for radiography in alert and stable trauma patients. JAMA. 2001 Oct 17;286(15):1841-8. doi: 10.1001/jama.286.15.1841.
PubMed 11597285
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Stewardship of Diagnostic Imaging Resources in Alberta Emergency Departments
- ClinicalTrials.gov ID
- NCT02410941
- Acronym / sponsor ID
- 10007399
- Conditions
- Brain Injuries, Pulmonary Embolism
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52,058 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Innovates Health Solutions
- Study start
- Jan 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 8 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Imaging technology for the rapid diagnosis of medical conditions is an indispensable tool in the emergency department (ED). However, increasing and inappropriate use of costly and potentially dangerous imaging is a growing healthcare concern. The long-term health risks of radiation exposure, and the resources consumed by increased use, pose serious threats to the integrity of the investigators' health care system and the population at large. Computed tomography (CT) is frequently used in the emergency department setting to evaluate patients with mild traumatic brain injury (MTBI) and suspected pulmonary embolism (PE) to eliminate diagnostic uncertainty by either confirming or ruling out serious injury and illness. However, these tests are often used in lieu of alternate and safer strategies with equivalent accuracy and effectiveness. Fortunately, well-validated decision-support tools exist that can safely identify low risk patients who are unlikely to benefit from CT imaging, avoiding unnecessary diagnostic imaging and radiation exposure, and making better use of limited health system resources. However, decision-support is under-used in clinical practice, and research to optimize their uptake has yielded mixed results.
Study Objectives:
The investigators will conduct a cluster-randomized trial to evaluate whether the implementation of decision-support into standard clinical practice for ordering CTs will (a) decrease the number of CTs ordered, (b) increase the appropriateness of the CTs that are ordered (e.g. by increasing diagnostic yield but avoiding any missed diagnosis).
Scope:
The scope is to focus on two conditions for which validated decision-support exists: MTBI and PE.
These conditions were selected because internal AHS data shows significant variability (15-90%) in the ordering of CTs for patients presenting with these conditions, and because validated decision-support exists for these conditions (e.g. Canadian CT Head Rule, Well's Score, Pulmonary Embolism Rule-Out Criteria).
The scope includes all hospitals in Alberta with an ED and in-house CT. There are 17 of these hospitals in Alberta from Fort McMurray to Medicine Hat. The investigators have obtained operational approvals to conduct the researchers' study in all 17 hospitals from the Emergency Chief at each site, and from ED and Diagnostic Imaging leadership at the level of each Zone as well as the Province. The scope is limited to patients presenting to the ED.
Methods:
The study design is a cluster randomized trial. In the Calgary Zone, the investigators will randomize half of the investigators' ED physicians to receive decision-support for MTBI, and half to receive decision-support for PE.
Outside of the Calgary Zone, the investigators will randomize by site, so half of sites will receive decision-support for MTBI, and half will receive decision-support for PE. Each half of the randomization will serve as a control for the other group. The reason the investigators are randomizing by physician in the Calgary Zone is because the Computerized Physician Order Entry system in Calgary allows us to implement such a randomization, whereas outside of the Calgary Zone the heterogeneity of order entry systems does not make it feasible to randomize by physician, but it is feasible to randomize by site.
The implementation of decision-support for CT ordering will be mandatory and is supported by operational and clinical leadership. By integrating decision-support into the existing systems to order CTs, a physician (or site) randomized to MTBI or PE decision-support will have to consider those tools prior to ordering a CT. However, decision-support does not make decisions about who receives a CT; it merely provides additional information about how likely a CT is to be diagnostically useful. All decisions regarding diagnostic or therapeutic interventions are the sole responsibility of the physician in consultation with the patient. The primary outcomes measured by this study will be (a) the percentage of MTBI and PE patients receiving a CT scan, and (b) the "appropriateness" of CT scans ordered. This last point can be measured in a variety of ways, such as the percentage of low-risk patients (as defined by decision-support) receiving CT, as well as the diagnostic yield of the CTs that are ordered.
Procedure:
This study will be supported by several strategies including the integration of decision-support into CT ordering procedures in consultation with participating sites. This will also be supported by a voluntary pre-intervention Physician Survey to measure knowledge and attitudes towards CT ordering and decision-support, as well as the perceived barriers to implementing decision-support in their practice. Finally, throughout the intervention physicians and sites will be provided with "audit and feedback" (clinical informatics) on their CT ordering practices in relation to their peers. This feedback will be provided through existing AHS data systems through the Department of Data Integration, Measurement, and Reporting.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision-support for MTBI | Experimental | Behavioral: Clinical decision supportClinical 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. |
| Decision-support for PE | Experimental | Behavioral: Clinical decision supportClinical 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients under 16 years of age for CT head, under 18 or over 85 years of age for CT pulmonary angiography.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical decision supportEstablish 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. | Behavioural | Decision-support for MTBI, Decision-support for PE |
Primary outcome
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)/
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)
3 secondary outcomes
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)
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)
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Background: PubMed 21835499Kocher KE, Meurer WJ, Fazel R, Scott PA, Krumholz HM, Nallamothu BK. National trends in use of computed tomography in the emergency department. Ann Emerg Med. 2011 Nov;58(5):452-62.e3. doi: 10.1016/j.annemergmed.2011.05.020. Epub 2011 Aug 11.
- Background: PubMed 18997202Baker LC, Atlas SW, Afendulis CC. Expanded use of imaging technology and the challenge of measuring value. Health Aff (Millwood). 2008 Nov-Dec;27(6):1467-78. doi: 10.1377/hlthaff.27.6.1467.
- Background: PubMed 15928282Studdert DM, Mello MM, Sage WM, DesRoches CM, Peugh J, Zapert K, Brennan TA. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. JAMA. 2005 Jun 1;293(21):2609-17. doi: 10.1001/jama.293.21.2609.
- Background: PubMed 19095678Schattner A. Angst-driven medicine? QJM. 2009 Jan;102(1):75-8. doi: 10.1093/qjmed/hcn164.
- Background: PubMed 20585077Bishop TF, Federman AD, Keyhani S. Physicians' views on defensive medicine: a national survey. Arch Intern Med. 2010 Jun 28;170(12):1081-3. doi: 10.1001/archinternmed.2010.155. No abstract available.
- Background: PubMed 12394910Miller P, Kendrick D, Bentley E, Fielding K. Cost-effectiveness of lumbar spine radiography in primary care patients with low back pain. Spine (Phila Pa 1976). 2002 Oct 15;27(20):2291-7. doi: 10.1097/00007632-200210150-00021.
- Background: PubMed 23683773Berdahl CT, Vermeulen MJ, Larson DB, Schull MJ. Emergency department computed tomography utilization in the United States and Canada. Ann Emerg Med. 2013 Nov;62(5):486-494.e3. doi: 10.1016/j.annemergmed.2013.02.018. Epub 2013 May 14.
- Background: PubMed 18046031Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.
- Background: PubMed 20628137Brenner DJ, Hricak H. Radiation exposure from medical imaging: time to regulate? JAMA. 2010 Jul 14;304(2):208-9. doi: 10.1001/jama.2010.973. No abstract available.
- Background: PubMed 20008689Berrington de Gonzalez A, Mahesh M, Kim KP, Bhargavan M, Lewis R, Mettler F, Land C. Projected cancer risks from computed tomographic scans performed in the United States in 2007. Arch Intern Med. 2009 Dec 14;169(22):2071-7. doi: 10.1001/archinternmed.2009.440.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eddy S. Lang, MD principal investigator
University of Calgary
Andrew McRae, MD study director
University of Calgary
James Andruchow, MD study director
University of Calgary
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical decision support in people with Brain Injuries and Pulmonary Embolism, run by University of Calgary at 16 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel W. Grigat ((403) 618-7369, daniel.grigat@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)/). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02410941, which also lists 47 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2016.