Improving the Stewardship of Diagnostic Imaging Resources in Alberta Emergency Departments

August 29, 2016 updated by: Dr. Eddy S. Lang, University of Calgary
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

52058

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Recruiting
        • Peter Lougheed Centre
        • Contact:
      • Calgary, Alberta, Canada
        • Recruiting
        • South Health Campus
        • Contact:
      • Calgary, Alberta, Canada, T2N 2T9
      • Calgary, Alberta, Canada
        • Recruiting
        • Sheldom M. Chumir Centre
        • Contact:
      • Edmonton, Alberta, Canada
        • Recruiting
        • University of Alberta Hospital
        • Contact:
      • Edmonton, Alberta, Canada
        • Recruiting
        • Royal Alexandra Hospital
        • Contact:
      • Edmonton, Alberta, Canada
        • Recruiting
        • Grey Nuns CommunityHospital
        • Contact:
      • Edmontyon, Alberta, Canada
        • Recruiting
        • Misericordia Community Hospital
        • Contact:
      • Fort McMurray, Alberta, Canada
        • Recruiting
        • Northern Lights Regional Hospital
        • Contact:
      • Fort Saskatchewan, Alberta, Canada
        • Recruiting
        • Fort Saskatchewan Health Centre
        • Contact:
      • Grande Prairie, Alberta, Canada
        • Recruiting
        • Queen Elizabeth II Hospital
        • Contact:
      • Lethbridge, Alberta, Canada
        • Recruiting
        • Chinook Regional Hospital
        • Contact:
      • Medicine Hat, Alberta, Canada
        • Recruiting
        • Medicine Hat Regional Hospital
        • Contact:
      • Red Deer, Alberta, Canada
        • Recruiting
        • Red Deer Regional Hospital
        • Contact:
      • Sherwood Park, Alberta, Canada
        • Recruiting
        • Strathcona Community Hospital
        • Contact:
      • St. Albert, Alberta, Canada
        • Recruiting
        • Sturgeon Community Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)/
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)
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

Outcome Measure
Time Frame
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)
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)
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
Patients will be followed from presentation to the ED up until 30 days post-discharge from the ED

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Alberta Innovates Health Solutions

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

March 17, 2015

First Submitted That Met QC Criteria

April 7, 2015

First Posted (Estimate)

April 8, 2015

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10007399

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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