Testing Pediatric Rheumatology Diagnostic Decision Support in Clinical Use

Boston Children's Hospital

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).

Study Overview

• Status: Unknown
• Conditions: Pediatric Rheumatological Condition (i.e., Arthritis, SLE, Kawasaki's Disaese)
• Intervention / Treatment: Other: Use of decision support tool; Other: Use of UpToDate

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).

• Study Type: Interventional
• Enrollment (Anticipated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Robertson; Phone Number: (617)-919-6160; Email: lauren.robertson@childrens.harvard.edu
• Study Contact Backup: Name: Lindsey Rice; Phone Number: 6179196160; Email: lindsey.rice@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Lindsey Rice; Phone Number: 6179196160; Email: lindsey.rice@childrens.harvard.edu
      • Contact: Lauren Robertson; Phone Number: 617-919-1526; Email: lauren.robertson@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Use of decision support tool; Trainee using decision support tool while assessing a clinical case. This intervention will affect the study participant fund of knowledge on the case.	Other: Use of decision support tool; use of a decision support software during clinical assessment of a case; Other Names: Use of SimulConsult
Active Comparator: Use of UpToDate; 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.	Other: Use of UpToDate; 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.; Other Names: Use of current literature

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing DDx with that of the attending physician (gold standard)	Comparing DDx provided by the trainee with that of the attending physician (gold standard)	through study completion, an average of 1 year
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)	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Amir A Kimia, MD, Boston Children's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: IRB-P00027105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No