Recruiting

Observational Study

Sponsor:

University of Calgary

Code:

NCT02410941

Conditions

Brain Injuries

Pulmonary Embolism

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

Interventions

Clinical decision support

Study Details

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.

Conditions

Brain Injuries

Pulmonary Embolism

Study ID

NCT02410941

Start date

Jan, 2016

Status verified date

Aug, 2016

Completion date

Sep, 2017

Anticipated

Primary completion date

Sep, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

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 Design

Enrollment

52058 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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)/ ]
  • 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) ]

Central Contacts and Locations

Locations

Foothills Medical Centre - C231

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Peter Lougheed Centre

Recruiting

Calgary, Alberta, Canada

Contacts

Sheldom M. Chumir Centre

Recruiting

Calgary, Alberta, Canada

Contacts

South Health Campus

Recruiting

Calgary, Alberta, Canada

Contacts

Grey Nuns CommunityHospital

Recruiting

Edmonton, Alberta, Canada

Contacts

Royal Alexandra Hospital

Recruiting

Edmonton, Alberta, Canada

Contacts

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada

Contacts

Misericordia Community Hospital

Recruiting

Edmontyon, Alberta, Canada

Contacts

Northern Lights Regional Hospital

Recruiting

Fort McMurray, Alberta, Canada

Contacts

Fort Saskatchewan Health Centre

Recruiting

Fort Saskatchewan, Alberta, Canada

Contacts

Queen Elizabeth II Hospital

Recruiting

Grande Prairie, Alberta, Canada

Contacts

Chinook Regional Hospital

Recruiting

Lethbridge, Alberta, Canada

Contacts

Medicine Hat Regional Hospital

Recruiting

Medicine Hat, Alberta, Canada

Contacts

Red Deer Regional Hospital

Recruiting

Red Deer, Alberta, Canada

Contacts

Strathcona Community Hospital

Recruiting

Sherwood Park, Alberta, Canada

Contacts

Sturgeon Community Hospital

Recruiting

St. Albert, Alberta, Canada

Contacts

More Information

Sponsor

University of Calgary

Last update posted

Aug 30, 2016

Last verified

Aug, 2016

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2016-08-30.