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Testing Pediatric Rheumatology Diagnostic Decision Support in Clinical Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04856956
Recruitment Status : Enrolling by invitation
First Posted : April 23, 2021
Last Update Posted : September 10, 2021
Sponsor:
Collaborator:
Boston Children's Hospital
Information provided by (Responsible Party):
PhenoSolve, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diagnostic Skills for Rheumatologic Conditions Other: Diagnostic decision support software Not Applicable

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study is a parallel-design, randomized, controlled study.
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.
Primary Purpose: Diagnostic
Official Title: Testing Pediatric Rheumatology Diagnostic Decision Support in Clinical Use
Actual Study Start Date : April 20, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Other: 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
No Intervention: Control (Current process)
Trainee or nurse practitioner sees patient but doesn't use diagnostic decision support software in developing their differential diagnosis and plan


Outcome Measures
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Primary Outcome Measures :
  1. Performance against Gold Standard: Presence of Gold standard #1 diagnosis in trainee list [ Time Frame: 1 day ]
    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?".


Secondary Outcome Measures :
  1. Performance against definitive diagnosis: Presence of definitive diagnosis in trainee list [ Time Frame: 6 weeks ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04856956


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
PhenoSolve, LLC
Boston Children's Hospital
Investigators
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Study Chair: Michael M Segal, MD PhD PhenoSolve, LLC
Principal Investigator: Robert P Sundel, MD Boston Children's Hospital
More Information
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Publications:

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Responsible Party: PhenoSolve, LLC
ClinicalTrials.gov Identifier: NCT04856956    
Other Study ID Numbers: BCH.SC.02
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The results will be shared.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 2021-2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No