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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03449862
Other study ID # Pro00054122
Secondary ID
Status Completed
Phase N/A
First received February 14, 2018
Last updated February 22, 2018
Start date August 31, 2016
Est. completion date February 13, 2018

Study information

Verified date February 2018
Source Clemson University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The frequency of head computed tomography (CT) imaging for mild head trauma patients has raised safety and cost concerns. Validated clinical decision rules exist in the published literature and on-line sources to guide medical image ordering but are often not used by emergency department (ED) clinicians. Using simulation, we explored whether the presentation of a clinical decision rule (i.e. Canadian CT Head Rule - CCHR), findings from malpractice cases related to clinicians not ordering CT imaging in mild head trauma cases, and estimated patient out-of-pocket cost might influence clinician brain CT ordering. Understanding what type and how information may influence clinical decision making in the ordering advanced medical imaging is important in shaping the optimal design and implementation of related clinical decision support systems.


Description:

Multi-center, double-blinded simulation-based randomized controlled trial. Following standardized clinical vignette presentation, clinicians made an initial imaging decision for the patient. This was followed by additional information on decision support rules, malpractice outcome review, and patient cost; each with opportunity to modify their initial order. The malpractice and cost information differed by assigned group to test the any temporal relationship. The simulation closed with a second vignette and an imaging decision.


Recruitment information / eligibility

Status Completed
Enrollment 167
Est. completion date February 13, 2018
Est. primary completion date April 11, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Clinician (physician, nurse practitioner, physician assistant) licensed to deliver health care.

- Actively employed to deliver health care in the emergency department of Greenville health System (South Carolina) or Emory University (Georgia)

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Simulation-based clinical decision on brain CT ordering
Clinicians asked to make decision on medical imaging for their simulated patient after presentation of clinical case then additional information. At each presentation of new information the clinician may modify their image order.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Clemson University Emory University, Greenville Health System

Outcome

Type Measure Description Time frame Safety issue
Primary brain CT medical image order At each decision point clinician asked to decide on which image to order for patient among three choices:
CT Head without/with contrast
CT Head without contrast
No medical imaging
30 days
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