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CompletedNCT03449862Updated Feb 28, 2018

Key Information Can Influence Clinician Ordering of Brain CTs

An interventional study of Simulation-based clinical decision on brain CT ordering in Clinical Decision-Making, sponsored by Clemson University. Completed. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-28.

Sponsored by Clemson University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
167
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Clinical Decision-Making
03

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • None
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
167 participants (actual)

Study arms

  • Experimental
    LEGAL-COST

    Clinicians were first presented malpractice case law summary information (which suggests clinician not likely to be sued for not ordering CT scan) then patient out-of-pocket cost information for brain CT image (which provides them insight into what the patient is likely to pay for the test)

    Other: Simulation-based clinical decision on brain CT ordering

  • Active comparator
    COST-LEGAL

    Clinicians were first presented with patient out-of-pocket cost information for brain CT image (which provides them insight into what the patient is likely to pay for the test) then malpractice case law summary information (which suggests clinician not likely to be sued for not ordering CT scan)

    Other: Simulation-based clinical decision on brain CT ordering

Interventions

  • OtherSimulation-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.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 30 days

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Gimbel RW, Pirrallo RG, Lowe SC, Wright DW, Zhang L, Woo MJ, Fontelo P, Liu F, Connor Z. Effect of clinical decision rules, patient cost and malpractice information on clinician brain CT image ordering: a randomized controlled trial. BMC Med Inform Decis Mak. 2018 Mar 12;18(1):20. doi: 10.1186/s12911-018-0602-1. PubMed 29530029 ↗

Study documents

  • Study protocol · Nov 16, 2016
  • Informed consent form · May 25, 2016
  • Statistical analysis plan · Feb 13, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03449862
Lead sponsor
Clemson University
Collaborators
Prisma Health-Upstate, Emory University
Responsible party
Sponsor
First posted
Feb 28, 2018
Start date
Aug 31, 2016
Primary completion
Apr 11, 2017
Completion
Feb 13, 2018
Last update
Feb 28, 2018

Study contacts

Ronald W. Gimbel, PHD
principal investigator · Clemson University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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