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Testing Pediatric Rheumatology Diagnostic Decision Support in Clinical Use

Primary Purpose

Pediatric Rheumatological Condition (i.e., Arthritis, SLE, Kawasaki's Disaese)

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of decision support tool
Use of UpToDate
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pediatric Rheumatological Condition (i.e., Arthritis, SLE, Kawasaki's Disaese)

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A trainee at Boston Children's residency program (pediatrics, emergency medicine, pediatric emergency medicine, pediatric rheumatology)

Exclusion Criteria:

Opting out of the study (optional at any stage)

Sites / Locations

  • Boston Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Use of decision support tool

Use of UpToDate

Arm Description

Trainee using decision support tool while assessing a clinical case. This intervention will affect the study participant fund of knowledge on the case.

Control group, participants using current literature prior to assessing a clinical case. Allowing 10 minutes to read on a topic during clinical care is an active intervention in the study participant fund of knowledge.

Outcomes

Primary Outcome Measures

Comparing DDx with that of the attending physician (gold standard)
Comparing DDx provided by the trainee with that of the attending physician (gold standard)
Comparing evaluation plan with that of the attending physician (gold standard)
Comparing evaluation plan laid out by the trainee with that of the attending physician (gold standard)

Secondary Outcome Measures

Full Information

First Posted
April 4, 2018
Last Updated
July 2, 2020
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03501667
Brief Title
Testing Pediatric Rheumatology Diagnostic Decision Support in Clinical Use
Official Title
Boston Children's Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Boston Children's Hospital resources include SimulConsult which is a decision support tool available for use of BCH provider through the library portal. It is offered along other resources on that webpage (UpToDate, Micromedex, and VisualDx). See addendum 1. Recently, a pediatric rheumatology arm was added to the expertise of SimulConsult, guided by our co-PI, Dr. Robert Sundel. As this tool is being offered and used, the investigators would like to assess metric of performance of this tool in enhancing participant trainees knowledge about the work up of patients with a potential rheumatologic disorder. See also www.ncbi.nlm.gov/pubmed/27964737 The investigators are conducting a clinical research to assess improvement in the clinical performance of study participants evaluating patients with a potential rheumatologic disorder. The intervention involved in using a computerized decision support tool already available in the Boston Children's Hospital domain. The outcome will be comparing this performance to that of an attending physician as the gold standard. We will assess the study participants performance across two locations: Emergency Department and Rheumatology clinic. Care to patients remains unchanged, as the workup plan and care is provided by an attending across both domains. The investigators main hypothesis is that using a decision support tool will result in a higher agreement rate between study participants' differential diagnosis and work up plan compared with the gold standard (attending differential diagnosis and research plan).
Detailed Description
Boston Children's Hospital resources include SimulConsult which is a decision support tool available for use of BCH provider through the library portal. It is offered along other resources on that webpage (UpToDate, Micromedex, and VisualDx). See addendum 1. Recently, a pediatric rheumatology arm was added to the expertise of SimulConsult, guided by our co-PI, Dr. Robert Sundel. As this tool is being offered and used, the investigators would like to assess metric of performance of this tool in enhancing study participants (trainees) knowledge about the work up of patients with a potential rheumatologic disorder. See also www.ncbi.nlm.gov/pubmed/27964737 The investigators are conducting a clinical research to assess improvement in the clinical performance of trainees evaluating patients with a potential rheumatologic disorder. The intervention involved in using a computerized decision support tool already available in the Boston Children's Hospital domain. The outcome will be comparing this performance to that of an attending physician as the gold standard. The investigators will assess the study participants performance across two locations: Emergency Department and Rheumatology clinic. Care to patients remains unchanged, as the workup plan and care is provided by an attending across both domains. Our main hypothesis is that using a decision support tool will result in a higher agreement rate between study participants' differential diagnosis and work up plan compared with the gold standard (attending differential diagnosis and research plan).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Rheumatological Condition (i.e., Arthritis, SLE, Kawasaki's Disaese)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparing use of deision support group (intervention group) to use of common literature (control group) among pediatric trainees treating patients with possible rheumatologic disorder
Masking
InvestigatorOutcomes Assessor
Masking Description
Data collected by an RA, PI and outcome assessment (I.e., data analyst) are blinded to which arm the participant was assigned to. Given use of software, the participant cannot be blinded to the arm he/she was assigned
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Use of decision support tool
Arm Type
Active Comparator
Arm Description
Trainee using decision support tool while assessing a clinical case. This intervention will affect the study participant fund of knowledge on the case.
Arm Title
Use of UpToDate
Arm Type
Active Comparator
Arm Description
Control group, participants using current literature prior to assessing a clinical case. Allowing 10 minutes to read on a topic during clinical care is an active intervention in the study participant fund of knowledge.
Intervention Type
Other
Intervention Name(s)
Use of decision support tool
Other Intervention Name(s)
Use of SimulConsult
Intervention Description
use of a decision support software during clinical assessment of a case
Intervention Type
Other
Intervention Name(s)
Use of UpToDate
Other Intervention Name(s)
Use of current literature
Intervention Description
Control group, participants using current literature prior to assessing a clinical case. Allowing 10 minutes to read on a topic during clinical care is an active intervention in the study participant fund of knowledge.
Primary Outcome Measure Information:
Title
Comparing DDx with that of the attending physician (gold standard)
Description
Comparing DDx provided by the trainee with that of the attending physician (gold standard)
Time Frame
through study completion, an average of 1 year
Title
Comparing evaluation plan with that of the attending physician (gold standard)
Description
Comparing evaluation plan laid out by the trainee with that of the attending physician (gold standard)
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A trainee at Boston Children's residency program (pediatrics, emergency medicine, pediatric emergency medicine, pediatric rheumatology) Exclusion Criteria: Opting out of the study (optional at any stage)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Robertson
Phone
(617)-919-6160
Email
lauren.robertson@childrens.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsey Rice
Phone
6179196160
Email
Lindsey.Rice@childrens.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir A Kimia, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Robertson
Phone
617-919-1526
Email
lauren.robertson@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
Lindsey Rice
Phone
6179196160
Email
lindsey.rice@childrens.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27964737
Citation
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.
Results Reference
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Testing Pediatric Rheumatology Diagnostic Decision Support in Clinical Use

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