NCT02410941

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52,058

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

16 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

1.7 years

First QC Date

March 17, 2015

Last Update Submit

August 29, 2016

Conditions

Keywords

Randomized controlled trialPractice managementtomography, x-ray computed/adverse effectsClinical decision supportComputerized clinical decision supportDecision support systems, clinicalHealth ExpendituresPhysician's practice patternsUnnecessary Procedures/economicsPhysician's Practice Patterns/economicsDiffusion of innovationDecision Support ModelsClinical Prediction Rules

Outcome Measures

Primary Outcomes (2)

  • Proportion of patients with mild traumatic brain injury who undergo a CT head

    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

    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

    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.

    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

    Patients will be followed from presentation to the ED up until 30 days post-discharge from the ED

Study Arms (2)

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.

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.

Behavioral: Clinical decision support

Interventions

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.

Decision-support for MTBIDecision-support for PE

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients under 16 years of age for CT head, under 18 or over 85 years of age for CT pulmonary angiography.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Foothills Medical Centre - C231

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

Peter Lougheed Centre

Calgary, Alberta, Canada

RECRUITING

Sheldom M. Chumir Centre

Calgary, Alberta, Canada

RECRUITING

South Health Campus

Calgary, Alberta, Canada

RECRUITING

Grey Nuns CommunityHospital

Edmonton, Alberta, Canada

RECRUITING

Royal Alexandra Hospital

Edmonton, Alberta, Canada

RECRUITING

University of Alberta Hospital

Edmonton, Alberta, Canada

RECRUITING

Misericordia Community Hospital

Edmontyon, Alberta, Canada

RECRUITING

Northern Lights Regional Hospital

Fort McMurray, Alberta, Canada

RECRUITING

Fort Saskatchewan Health Centre

Ft Saskatchewan, Alberta, Canada

RECRUITING

Queen Elizabeth II Hospital

Grande Prairie, Alberta, Canada

RECRUITING

Chinook Regional Hospital

Lethbridge, Alberta, Canada

RECRUITING

Medicine Hat Regional Hospital

Medicine Hat, Alberta, Canada

RECRUITING

Red Deer Regional Hospital

Red Deer, Alberta, Canada

RECRUITING

Strathcona Community Hospital

Sherwood Park, Alberta, Canada

RECRUITING

Sturgeon Community Hospital

St. Albert, Alberta, Canada

RECRUITING

Related Publications (47)

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MeSH Terms

Conditions

Brain InjuriesPulmonary Embolism

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesLung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Eddy S. Lang, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR
  • Andrew McRae, MD

    University of Calgary

    STUDY DIRECTOR
  • James Andruchow, MD

    University of Calgary

    STUDY DIRECTOR
  • Grant Innes, MD

    University of Calgary

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor, associate professor

Study Record Dates

First Submitted

March 17, 2015

First Posted

April 8, 2015

Study Start

January 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

August 30, 2016

Record last verified: 2016-08

Locations