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CT and Radiologist RCT

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ClinicalTrials.gov Identifier: NCT03121131
Recruitment Status : Active, not recruiting
First Posted : April 19, 2017
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Mike K Liang, The University of Texas Health Science Center, Houston

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hernia Other: Clinical Exam Findings Other: Inaccurate Clinical Exam Findings Other: No clinical exam findings Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : May 5, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
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.

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

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




Primary Outcome Measures :
  1. Hernia detected on CT [ Time Frame: CT taken within 1 year ]
    proportion of hernias detected on CT



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Participants are radiologists at LBJ Hospital.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03121131


Locations
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United States, Texas
UT Health at Lyndon B. Johnson General Hospital
Houston, Texas, United States, 77026
Sponsors and Collaborators
The University of Texas Health Science Center, Houston

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mike K Liang, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03121131     History of Changes
Other Study ID Numbers: HSC-MS-17-0277
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical