Testing Pediatric Rheumatology Diagnostic Decision Support in Clinical Use

Sponsor
PhenoSolve, LLC (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04856956
Collaborator
Boston Children's Hospital (Other)
15
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Study Details

Study Description

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
  • Other: Diagnostic decision support software
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study is a parallel-design, randomized, controlled study.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 :
Apr 20, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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

Primary Outcome Measures

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

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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 -
  1. 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

Locations

Site City State Country Postal Code
1 Boston Children's Hospital Boston Massachusetts United States 02115

Sponsors and Collaborators

  • PhenoSolve, LLC
  • Boston Children's Hospital

Investigators

  • Study Chair: Michael M Segal, MD PhD, PhenoSolve, LLC
  • Principal Investigator: Robert P Sundel, MD, Boston Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
PhenoSolve, LLC
ClinicalTrials.gov Identifier:
NCT04856956
Other Study ID Numbers:
  • BCH.SC.02
First Posted:
Apr 23, 2021
Last Update Posted:
Sep 10, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 10, 2021