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Clinical Trials/NCT03449862
NCT03449862CompletedNot Applicable

Effect of Clinical Decision Rules, Patient Cost and Malpractice Information on Clinician Brain CT Image Ordering: a Randomized Controlled Trial

Clemson University0 sites167 target enrollmentStarted: August 31, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
167
Primary Endpoint
brain CT medical image order

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Masking Description

Electronic web-based simulation study with built-in randomization tool

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
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

  • Not provided

Arms & Interventions

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)

Intervention: Simulation-based clinical decision on brain CT ordering (Other)

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)

Intervention: Simulation-based clinical decision on brain CT ordering (Other)

Outcomes

Primary Outcomes

brain CT medical image order

Time Frame: 30 days

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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