NCT04856956

Brief Summary

This study is designed to test the helpfulness of a diagnostic tool, SimulConsult, when clinicians are diagnosing pediatric rheumatic diseases. Trainees and nurse practitioners will use the software or not use it, and their differential diagnoses will be compared to those of attending physicians in the same clinical encounter, and then to definitive diagnoses weeks later after testing, if one is reached.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

April 20, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 4, 2022

Status Verified

September 1, 2022

Enrollment Period

2.7 years

First QC Date

March 17, 2021

Last Update Submit

September 30, 2022

Conditions

Diagnostic Skills for Rheumatologic Conditions

Outcome Measures

Primary Outcomes (1)

  • Performance against Gold Standard: Presence of Gold standard #1 diagnosis in trainee list

    The study will compare the trainee's differential diagnosis and workup plan to those of the attending physician seeing the same patient. The Attending is considered at this stage as the "gold standard" and we aim to answer the question "how well does a trainee with a DDSS (and traditional resources) approximate an experienced, specialist Attending vs. a trainee with access only to more traditional resources?".

    1 day

Secondary Outcomes (1)

  • Performance against definitive diagnosis: Presence of definitive diagnosis in trainee list

    6 weeks

Study Arms (2)

Intervention (Use of diagnostic decision support software)

EXPERIMENTAL

Trainee or nurse practitioner sees patient and uses diagnostic decision support software in developing their differential diagnosis and plan

Other: Diagnostic decision support software

Control (Current process)

NO INTERVENTION

Trainee or nurse practitioner sees patient but doesn't use diagnostic decision support software in developing their differential diagnosis and plan

Interventions

Diagnostic decision support softwareOTHER

Comparing use of decision support group (intervention group) to use only of common literature (control group) among pediatric trainees diagnosing patients with possible rheumatologic disorder

Intervention (Use of diagnostic decision support software)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

  • Segal MM. Mobile medical computing driven by the complexity of neurologic diagnosis. J Child Neurol. 2006 Jul;21(7):595-9. doi: 10.1177/08830738060210071601.

    PMID: 16970851BACKGROUND

  • 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: 27964737BACKGROUND

  • Staffa SJ, Zurakowski D. Strategies in adjusting for multiple comparisons: A primer for pediatric surgeons. J Pediatr Surg. 2020 Sep;55(9):1699-1705. doi: 10.1016/j.jpedsurg.2020.01.003. Epub 2020 Jan 23.

    PMID: 32029234BACKGROUND

  • 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: 23576414BACKGROUND

Study Officials

  • Michael M Segal, MD PhD

    PhenoSolve, LLC

    STUDY CHAIR

  • Robert P Sundel, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
No masking is possible for subjects, since they will know whether they are or are not using the software.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: This study is a parallel-design, randomized, controlled study.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2021

First Posted

April 23, 2021

Study Start

April 20, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

October 4, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

The results will be shared.

Shared Documents
CSR
Time Frame
2021-2022

Locations

US(1)