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| Name | Class |
|---|---|
| Boston Children's Hospital | OTHER |
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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.
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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic decision support software | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Performance against definitive diagnosis: Presence of definitive diagnosis in trainee list | The 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. | 6 weeks |
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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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Michael M Segal, MD PhD | PhenoSolve, LLC | Study Chair |
| Robert P Sundel, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16970851 | Background | 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. | |
| 27964737 | 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. |
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The results will be shared.
2021-2022
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This study is a parallel-design, randomized, controlled study.
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No masking is possible for subjects, since they will know whether they are or are not using the software.
| 32029234 | Background | 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. |
| 23576414 | Background | 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. |