Empowering Physicians With Evidence-Based Decision Support for Pediatric Rheumatology

Rheumatology Clinical Trial

— Rheumatology  

Official title:

Empowering Physicians With Evidence-Based Decision Support for Pediatric Rheumatology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02205086
• Other study ID #: SimulConsult2
• Status: Not yet recruiting
• Phase: N/A
• First received: July 25, 2014
• Last updated: July 29, 2014
• Start date: August 2014
• Est. completion date: October 2014

Study information

• Verified date: July 2014
• Source: SimulConsult, Inc.
• Contact: Robert M Sundel, MD
• Phone: (617) 355-6524
• Email: robert.sundel[@]childrens.harvard.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

The study uses written case vignettes, not decisions about patients seeking care from the study subjects (i.e., clinicians).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion criteria: Clinicians in various medical specialties

Exclusion criteria: Non-clinician

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Rheumatology

Intervention

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.

Locations

Country	Name	City	State
United States	SimulConsult	Brookline	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
SimulConsult, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Segal MM, Schiffmann R. Decision support for diagnosis: co-evolution of tools and resources. Neurology. 2012 May 15;78(20):1546-7. doi: 10.1212/WNL.0b013e3182563c36. Epub 2012 Apr 18. — View Citation

Segal MM, Williams MS, Gropman AL, Torres AR, Forsyth R, Connolly AM, El-Hattab AW, Perlman SJ, Samanta D, Parikh S, Pavlakis SG, Feldman LK, Betensky RA, Gospe SM Jr. Evidence-based decision support for neurological diagnosis reduces errors and unnecessary workup. J Child Neurol. 2014 Apr;29(4):487-92. doi: 10.1177/0883073813483365. Epub 2013 Apr 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measures of Diagnostic effectiveness	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.	Completion of each case vignette (typically ½ hour)	Yes
Secondary	Measures of Patient workup effectiveness	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.	Completion of each case vignette (typically in the same ½ hour as measure 1)	Yes