Key Information Can Influence Clinician Ordering of Brain CTs

NCT ID: NCT03449862

Last Updated: 2018-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-02-13

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.

Conditions

Clinical Decision-Making

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: EXPERIMENTAL

Simulation-based clinical decision on brain CT ordering

Intervention Type: OTHER

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-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)

Group Type: ACTIVE_COMPARATOR

Simulation-based clinical decision on brain CT ordering

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• None

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prisma Health-Upstate

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

Clemson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald W. Gimbel, PHD

Role: PRINCIPAL_INVESTIGATOR

Clemson University

References

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.

Reference Type: DERIVED

PMID: 29530029 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Pro00054122

Identifier Type: -

Identifier Source: org_study_id