Testing Pediatric Rheumatology Diagnostic Decision Support in Clinical Use

NCT03501667 | Unknown DMC

• 1 other identifier: IRB-P00027105
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Use of decision support tool

ACTIVE COMPARATOR

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 UpToDate

ACTIVE COMPARATOR

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

Interventions

Use of decision support tool OTHER

use of a decision support software during clinical assessment of a case

Also known as: Use of SimulConsult

Use of decision support tool

Use of UpToDate OTHER

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.

Also known as: Use of current literature

Use of UpToDate

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Opting out of the study (optional at any stage)

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 27964737 BACKGROUND

MeSH Terms

Conditions

Arthritis; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Amir A Kimia, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Robertson

CONTACT

(617)-919-6160; lauren.robertson@childrens.harvard.edu

Lindsey Rice

CONTACT

6179196160; Lindsey.Rice@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Comparing use of deision support group (intervention group) to use of common literature (control group) among pediatric trainees treating patients with possible rheumatologic disorder

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 18, 2018
• Study Start: January 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)