CT and Radiologist RCT

April 10, 2020 updated by: Mike K Liang, The University of Texas Health Science Center, Houston

How Important is a Clinical Data for a Radiologist? A Double-Blinded Randomized Controlled Trial of Radiologic Interpretation of Ventral Hernias Following Selectively-Provided Clinical Information

The use of computed tomography (CT) imaging is rapidly increasing in healthcare. Despite physicians' growing reliance on radiological assessments, however, the reliability and accuracy of reads are highly variable. Inconsistencies may result from multiple factors.

The researchers hypothesize that the presence and quality of clinical information will affect radiologist's assessment of CT scans for the presence/absence of a ventral hernia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77026
        • UT Health at Lyndon B. Johnson General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Participants are radiologists at LBJ Hospital.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Accurate Clinical Exam Findings
Radiologists will be provided with accurate clinical exam data.
Other: Clinical Exam Findings
Findings found on clinical exam of a patient the radiologist will be reading CT scans of.
Other: Inaccurate Clinical Exam Findings
Radiologists will be provided with purposefully incorrect clinical exam data
Other: Inaccurate Clinical Exam Findings
Inaccurate findings are given to the radiologists
Other: No Clinical Exam Findings
Radiologists will be not be provided with any clinical exam data
Other: No clinical exam findings
No clinical exam findings are given to the radiologists

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hernia detected on CT
Time Frame: CT taken within 1 year
proportion of hernias detected on CT
CT taken within 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2017

Primary Completion (Actual)

April 10, 2020

Study Completion (Actual)

April 10, 2020

Study Registration Dates

First Submitted

April 14, 2017

First Submitted That Met QC Criteria

April 18, 2017

First Posted (Actual)

April 19, 2017

Study Record Updates

Last Update Posted (Actual)

April 13, 2020

Last Update Submitted That Met QC Criteria

April 10, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-17-0277

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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