NCT03449862

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Status
completed

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

Study Start

First participant enrolled

August 31, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 14, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

7 months

First QC Date

February 14, 2018

Last Update Submit

February 22, 2018

Conditions

Outcome Measures

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

    30 days

Study Arms (2)

LEGAL-COST

EXPERIMENTAL

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

COST-LEGAL

ACTIVE COMPARATOR

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

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.

COST-LEGALLEGAL-COST

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Study Officials

  • Ronald W. Gimbel, PHD

    Clemson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Electronic web-based simulation study with built-in randomization tool
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Multi-center, double-blinded simulation-based randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2018

First Posted

February 28, 2018

Study Start

August 31, 2016

Primary Completion

April 11, 2017

Study Completion

February 13, 2018

Last Updated

February 28, 2018

Record last verified: 2018-02