Empowering Physicians With Evidence-Based Decision Support for Pediatric Rheumatology

NCT02205086 | Unknown

• 1 other identifier: SimulConsult2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatology

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Measures of Patient workup effectiveness

  Completion of each case vignette (typically in the same ½ hour as measure 1)

Study Arms (1)

Diagnosis

OTHER

Test diagnostic decision support software

Other: Diagnosis

Interventions

Diagnosis OTHER

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.

Diagnosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• SimulConsult, Inc.: lead

Study Sites (1)

SimulConsult

Brookline, Massachusetts, 02467, United States

Location

Related Publications (3)

• 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.

  PMID: 23576414 BACKGROUND

• 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. No abstract available.

  PMID: 22517101 BACKGROUND

• Segal MM, Athreya B, Son MB, Tirosh I, Hausmann JS, Ang EY, Zurakowski D, Feldman LK, Sundel RP. Evidence-based decision support for pediatric rheumatology reduces diagnostic errors. Pediatr Rheumatol Online J. 2016 Dec 13;14(1):67. doi: 10.1186/s12969-016-0127-z.

  PMID: 27964737 DERIVED

Study Officials

• Michael M Segal, MD PhD

  SimulConsult, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert M Sundel, MD

CONTACT

(617) 355-6524; robert.sundel@childrens.harvard.edu

Lynn Feldman, MBA

CONTACT

617-879-1670; rheumatologystudy@simulconsult.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2014
• First Posted: July 31, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 31, 2014

Record last verified: 2014-07

Locations

US (1)