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Empowering Physicians With Evidence-Based Decision Support for Pediatric Rheumatology (Rheumatology)

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ClinicalTrials.gov Identifier: NCT02205086
Recruitment Status : Unknown
Verified July 2014 by SimulConsult, Inc..
Recruitment status was:  Not yet recruiting
First Posted : July 31, 2014
Last Update Posted : July 31, 2014
Sponsor:
Information provided by (Responsible Party):
SimulConsult, Inc.

Tracking Information
First Submitted Date  ICMJE July 25, 2014
First Posted Date  ICMJE July 31, 2014
Last Update Posted Date July 31, 2014
Study Start Date  ICMJE August 2014
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
Measures of Diagnostic effectiveness [ Time Frame: Completion of each case vignette (typically ½ hour) ]
Each clinician subject reviews each case vignette and lists their differential diagnosis ("Unaided"). Then the clinician subject uses the diagnostic decision support software and then lists a revised differential diagnosis ("Aided"). The match between the clinician subject's differential diagnosis and a Gold Standard differential diagnosis list for each case is measured, looking at rank order of correct diseases and omissions.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
Measures of Patient workup effectiveness [ Time Frame: Completion of each case vignette (typically in the same ½ hour as measure 1) ]
Each clinician subject reviews each case vignette and lists their initial workup ("Unaided"). Then the clinician subject uses the diagnostic decision support software and then lists a revised initial workup ("Aided"). The match between the clinician subject's initial workup and a Gold Standard workup list for each case is measured, looking at rank order of correct diseases and omissions.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Empowering Physicians With Evidence-Based Decision Support for Pediatric Rheumatology
Official Title  ICMJE Empowering Physicians With Evidence-Based Decision Support for Pediatric Rheumatology
Brief Summary This study compares the ability of clinicians to make diagnoses with or without the assistance of diagnostic decision support software. The area of clinical focus is primarily rheumatology.
Detailed Description The study uses written case vignettes, not decisions about patients seeking care from the study subjects (i.e., clinicians).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Rheumatology
Intervention  ICMJE Other: Diagnosis

Unaided: The testers will record a differential diagnosis consisting of a list of diseases and their ranking and a prioritized list of test orders, as well as the most appropriate referral for further evaluation and treatment of the patient.

Aided: Then testers will enter the case into diagnostic decision support software and after getting advice from the software, the testers will record the same information as in Unaided, but allowing for the possibility that responses could differ as a result of using the software.

Study Arms  ICMJE Diagnosis
Test diagnostic decision support software
Intervention: Other: Diagnosis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 29, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2014
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria: Clinicians in various medical specialties

Exclusion criteria: Non-clinician

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02205086
Other Study ID Numbers  ICMJE SimulConsult2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SimulConsult, Inc.
Study Sponsor  ICMJE SimulConsult, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael M Segal, MD PhD SimulConsult, Inc.
PRS Account SimulConsult, Inc.
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP