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

July 29, 2014 updated by: SimulConsult, Inc.
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

30

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 Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Brookline, Massachusetts, United States, 02467
        • SimulConsult
        • Sub-Investigator:
          • Robert M Sundel, MD
        • Principal Investigator:
          • Michael M Segal, MD PhD

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria: Clinicians in various medical specialties

Exclusion criteria: Non-clinician

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Diagnosis
Test diagnostic decision support software
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Completion of each case vignette (typically ½ hour)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Completion of each case vignette (typically in the same ½ hour as measure 1)

Collaborators and Investigators

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

Sponsor

SimulConsult, Inc.

Investigators

  • Principal Investigator: Michael M Segal, MD PhD, SimulConsult, Inc.

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

August 1, 2014

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

July 25, 2014

First Submitted That Met QC Criteria

July 29, 2014

First Posted (Estimate)

July 31, 2014

Study Record Updates

Last Update Posted (Estimate)

July 31, 2014

Last Update Submitted That Met QC Criteria

July 29, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • SimulConsult2

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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