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Testing Pediatric Rheumatology Diagnostic Decision Support in Clinical Use

Testing Pediatric Rheumatology Diagnostic Decision Support in Clinical Use

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04856956
Enrollment
15
Registered
2021-04-23
Start date
2021-04-20
Completion date
2023-12-31
Last updated
2022-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnostic Skills for Rheumatologic Conditions

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.

Detailed description

The study aims to assess improvement in the clinical performance of trainees evaluating patients with a suspected rheumatologic disorder. The Intervention is the use of Diagnostic Decision Support Software (DDSS) already available as a Boston Children's Hospital resource. * Main objective: To assess if the use of the DDSS by trainees and nurse practitioners can improve their diagnostic performance in developing a differential diagnosis and plan in real clinical use. (Studies have shown in prior research that the use of the DDSS does so for case vignettes, lowering diagnostic errors of trainees by 75%). The study will compare how closely the differential diagnosis and plan of the trainees and nurse practitioners approximate those of their senior Pediatric Rheumatology attending physician colleagues. * Secondary objective: To assess how frequently the differential diagnosis of the trainees and nurse practitioners includes the definitive diagnosis by doing a manual chart review weeks after the visit. (Studies have shown in prior research that if the definitive diagnosis is in the initial differential diagnosis, the right tests get ordered, and diagnostic errors are avoided.) The design is a parallel one, comparing subjects (trainees and nurse practitioners) using the DDSS (Intervention Arm) to subjects who do not use the DDSS (Control Arm). In both study arms, subjects may use all other traditional resources. Arm assignment will be by patient case rather than trainee / nurse practitioner to reduce variation due to each subject's different capabilities (years of training and familiarity with pediatric rheumatology).

Interventions

OTHERDiagnostic decision support software

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

Sponsors

Boston Children's Hospital
CollaboratorOTHER
PhenoSolve, LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

No masking is possible for subjects, since they will know whether they are or are not using the software.

Intervention model description

This study is a parallel-design, randomized, controlled study.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

The subjects are trainees (rheumatology and rotating fellows) and nurse practitioners, not patients. The Attendings participate in their supervisory role, and their clinical judgments are recorded as a preliminary gold standard, but they are not research subjects. * Trainees seeing new pediatric patients with a potential rheumatologic disorder are eligible. They will be drawn from the pool of Rheumatology fellows (3), Allergy/Immunology fellows (6), rotating pediatric and occasional adult residents (1 - 2) per month) * Nurse practitioners in Rheumatology (2). * Rheumatology Attendings for these new patient visits will also be asked to participate but will be supervisory participants in the study, not subjects. We anticipate 15 trainees plus nurse practitioners will participate. There are no

Exclusion criteria

, and we do not anticipate screen failures; however, trainees and nurse practitioners may decline to participate for individual patients or the entire study.

Design outcomes

Primary

MeasureTime frameDescription
Performance against Gold Standard: Presence of Gold standard #1 diagnosis in trainee list1 dayThe 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?.

Secondary

MeasureTime frameDescription
Performance against definitive diagnosis: Presence of definitive diagnosis in trainee list6 weeksThe study will do a manual chart review of the cases to find the definitive diagnosis (where available) to measure the frequency with which the definitive diagnosis was in the trainee's initial DDx.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026