RheumatologyRheumatologyNCT02205086
Empowering Physicians With Evidence-Based Decision Support for Pediatric Rheumatology
A study testing Diagnosis in people with Rheumatology, run by SimulConsult, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Rheumatology
- What is being tested?
- Diagnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Inclusion criteria: Clinicians in various medical specialties
Exclusion criteria: Non-clinician
Trial locations and contacts
1 site in 1 country.
United States1 site
SimulConsult
Brookline, Massachusetts, 02467
Robert M Sundel, MD
Michael M Segal, MD PhD
About this study
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.
Read the detailed description
The study uses written case vignettes, not decisions about patients seeking care from the study subjects (i.e., clinicians).
- Conditions
- Rheumatology
- Being tested
- Diagnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiagnosisOther
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 group | Role | What they receive |
|---|---|---|
| Diagnosis | Other | Test diagnostic decision support software Receives: Other: Diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Completion of each case vignette (typically ½ hour)
Secondary outcomes (1)
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.
Measured: Completion of each case vignette (typically in the same ½ hour as measure 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for RheumatologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SimulConsult, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael M Segal, MD PhD, Principal investigator, SimulConsult, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205086
- Sponsor's protocol ID
- SimulConsult2
- Acronym
- Rheumatology
- Status last verified
- Jul 2014
- First submitted
- 25 Jul 2014
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23576414Segal 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.
PubMed 22517101Segal 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.
PubMed 27964737
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Physicians With Evidence-Based Decision Support for Pediatric Rheumatology
- ClinicalTrials.gov ID
- NCT02205086
- Acronym / sponsor ID
- Rheumatology / SimulConsult2
- Conditions
- Rheumatology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- SimulConsult, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 31 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosis | Other | Other: DiagnosisTest diagnostic decision support software |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiagnosisUnaided: 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. | Other | Diagnosis |
Primary outcome
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.
1 secondary outcome
Measures of Patient workup effectiveness
Time frame: Completion of each case vignette (typically in the same ½ hour as measure 1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2014.
- Background: PubMed 23576414Segal 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.
- Background: PubMed 22517101Segal 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.
- Derived from this study: PubMed 27964737Segal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael M Segal, MD PhD principal investigator
SimulConsult, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnosis in people with Rheumatology, run by SimulConsult, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert M Sundel, MD ((617) 355-6524, robert.sundel@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measures of Diagnostic effectiveness (time frame: Completion of each case vignette (typically ½ hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02205086, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2014.