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Improving the Stewardship of Diagnostic Imaging Resources in Alberta Emergency Departments

Primary Purpose

Brain Injuries, Pulmonary Embolism

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Clinical decision support
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Brain Injuries focused on measuring 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

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Foothills Medical Centre - C231Recruiting
  • Peter Lougheed CentreRecruiting
  • Sheldom M. Chumir CentreRecruiting
  • South Health CampusRecruiting
  • Grey Nuns CommunityHospitalRecruiting
  • Royal Alexandra HospitalRecruiting
  • University of Alberta HospitalRecruiting
  • Misericordia Community HospitalRecruiting
  • Northern Lights Regional HospitalRecruiting
  • Fort Saskatchewan Health CentreRecruiting
  • Queen Elizabeth II HospitalRecruiting
  • Chinook Regional HospitalRecruiting
  • Medicine Hat Regional HospitalRecruiting
  • Red Deer Regional HospitalRecruiting
  • Strathcona Community HospitalRecruiting
  • Sturgeon Community HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Decision-support for MTBI

Decision-support for PE

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Proportion of patients with mild traumatic brain injury who undergo a CT head
Proportion of patients with suspected Pulmonary Embolism who undergo a CTPA scan

Secondary Outcome Measures

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
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.
Proportion of patients who return to the ED within 30 days with the same presenting complaint and undergo a CT Head or CTPA

Full Information

First Posted
March 17, 2015
Last Updated
August 29, 2016
Sponsor
University of Calgary
Collaborators
Alberta Innovates Health Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT02410941
Brief Title
Improving the Stewardship of Diagnostic Imaging Resources in Alberta Emergency Departments
Official Title
Improving the Stewardship of Diagnostic Imaging Resources in Alberta Emergency Departments
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Alberta Innovates Health Solutions

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Unnecessary Procedures/economics, Physician's Practice Patterns/economics, Diffusion of innovation, Decision Support Models, Clinical Prediction Rules

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52058 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Decision-support for MTBI
Arm Type
Experimental
Arm Description
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.
Arm Title
Decision-support for PE
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Clinical decision support
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)/
Title
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 Measure Information:
Title
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)
Title
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)
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel W. Grigat
Phone
(403) 618-7369
Email
daniel.grigat@albertahealthservices.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eddy S. Lang, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew McRae, MD
Organizational Affiliation
University of Calgary
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
James Andruchow, MD
Organizational Affiliation
University of Calgary
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Grant Innes, MD
Organizational Affiliation
University of Calgary
Official's Role
Study Director
Facility Information:
Facility Name
Foothills Medical Centre - C231
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Grigat
Phone
403-6178-7369
Email
daniel.grigat@albertahealthservices.ca
Facility Name
Peter Lougheed Centre
City
Calgary
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Grigat
Phone
403-618-7369
Email
daniel.grigat@ahs.ca
Facility Name
Sheldom M. Chumir Centre
City
Calgary
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Grigat
Phone
403-618-7369
Email
daniel.grigat@ahs.ca
Facility Name
South Health Campus
City
Calgary
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Grigat
Phone
403-618-7369
Email
daniel.grigat@ahs.ca
Facility Name
Grey Nuns CommunityHospital
City
Edmonton
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Grigat
Phone
403-618-7369
Email
daniel.grigat@ahs.ca
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Grigat
Phone
403-618-7369
Email
daniel.grigat@ahs.ca
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Grigat
Phone
403-618-7369
Email
daniel.grigat@ahs.ca
Facility Name
Misericordia Community Hospital
City
Edmontyon
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Grigat
Phone
403-618-7369
Email
daniel.grigat@ahs.ca
Facility Name
Northern Lights Regional Hospital
City
Fort McMurray
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Grigat
Phone
403-618-7369
Email
daniel.grigat@ahs.ca
Facility Name
Fort Saskatchewan Health Centre
City
Fort Saskatchewan
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Grigat
Phone
403-618-7369
Email
daniel.grigat@ahs.ca
Facility Name
Queen Elizabeth II Hospital
City
Grande Prairie
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Grigat
Phone
403-618-7369
Email
daniel.grigat@ahs.ca
Facility Name
Chinook Regional Hospital
City
Lethbridge
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Grigat
Phone
403-618-7369
Email
daniel.grigat@ahs.ca
Facility Name
Medicine Hat Regional Hospital
City
Medicine Hat
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Grigat
Phone
403-619-7369
Email
daniel.grigat@ahs.ca
Facility Name
Red Deer Regional Hospital
City
Red Deer
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Grigat
Phone
403-618-7369
Email
daniel.grigat@ahs.ca
Facility Name
Strathcona Community Hospital
City
Sherwood Park
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Grigat
Phone
403-618-7369
Email
daniel.grigat@ahs.ca
Facility Name
Sturgeon Community Hospital
City
St. Albert
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Grigat
Phone
403-618-7369
Email
daniel.grigat@ahs.ca

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Improving the Stewardship of Diagnostic Imaging Resources in Alberta Emergency Departments

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