Testing Pediatric Rheumatology Diagnostic Decision Support in Clinical Use

NCT ID: NCT04856956

Last Updated: 2022-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-20

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Diagnostic Skills for Rheumatologic Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a parallel-design, randomized, controlled study.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

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

Study Groups

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Intervention (Use of diagnostic decision support software)

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

Group Type EXPERIMENTAL

Diagnostic decision support software

Intervention Type 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

Control (Current process)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Diagnostic 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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role collaborator

PhenoSolve, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael M Segal, MD PhD

Role: STUDY_CHAIR

PhenoSolve, LLC

Robert P Sundel, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16970851 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27964737 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32029234 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23576414 (View on PubMed)

Other Identifiers

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BCH.SC.02

Identifier Type: -

Identifier Source: org_study_id

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