Plain English Summary
Background and study aims
This study will investigate an electronic decision support system (ISABEL) and its ability to reduce diagnostic errors made by clinicians. These systems use data on the symptoms that patients may present to a clinician with, and short keywords, to suggest possible diagnoses to clinicians. The ability of an electronic decision support (EDS) to reduce diagnostic error is likely to depend on the stage in the diagnostic process at which it is used, the degree of expertise of the clinician using the EDS, and its acceptability to the user.
This study aims to identify whether the use of electronic differential support will improve the diagnostic accuracy of clinicians, whether improvements will be most marked among students compared with residents and practicing physicians, and whether improvements will be most marked when the electronic differential support is used early in the diagnostic process.
Who can participate?
This study will recruit medical students, residents, and practicing physicians.
What does the study involve?
Participants will be invited to complete 16 cases on an online platform providing a list of possible diagnoses at three timepoints during the case presentation as more information is provided. Participants will be randomly allocated to either use the EDS early or late in the diagnostic process for each case.
What are the possible benefits and risks of participating?
There is minimal risk to participants anticipated.
Where is the study run from?
McMaster University (Canada)
When is the study starting and how long is it expected to run for?
From December 2017 to June 2020
Who is funding the study?
The PSI Foundation (Canada)
Who is the main contact?
Dr Matthew Sibbald
sibbald@mcmaster.ca
Trial website
Contact information
Type
Scientific
Primary contact
Dr Matthew Sibbald
ORCID ID
http://orcid.org/0000-0002-0022-2370
Contact details
1200 Main St West
Hamilton
L6L 4Z7
Canada
+1 905-521-2101
sibbald@mcmaster.ca
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Enhancing Clinicians’ diagnostic Hypotheses with Electronic Differential Diagnosis support (ECH-EDS)
Acronym
ECH-EDS
Study hypothesis
1. Use of electronic differential support will improve the diagnostic accuracy of clinicians
2. Improvements will be most marked among students compared with residents and practicing physicians
3. Improvements will be most marked when the electronic differential support is used early in the diagnostic process
Ethics approval
Approved 06/05/2019, Hamilton Integrated Research Ethics Board (293 Wellington Street North, Suite 102, Hamilton, ON Canada L8L 8E7; +1 905.521.2100; no email address available), ref: 4945
Study design
Multicenter interventional randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Internet
Trial type
Diagnostic
Patient information sheet
No participant information sheet available
Condition
Medical diagnosis
Intervention
Students, residents, and practicing physicians will be recruited. Each group will be randomized in a 1:1 ratio to receive access to electronic differential diagnosis support early (after the chief complaint) or late (after all information is available) while solving 16 medical cases on an online platform.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Correct diagnosis present is measured as either present or absent (1 or 0) within the differential diagnosis, before and after use of the electronic differential support
Secondary outcome measures
1. Number of diagnostic suggestions before and after use of the electronic differential support
2. Priority of the correct diagnosis on the list before and after use of the electronic differential support
Overall trial start date
22/12/2017
Overall trial end date
22/06/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Medical students, residents, or practicing physicians
Participant type
Health professional
Age group
All
Gender
Both
Target number of participants
180
Total final enrolment
190
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/05/2020
Recruitment end date
22/06/2020
Locations
Countries of recruitment
Canada
Trial participating centre
McMaster University
1200 Main St West
Hamilton
L8N 3Z5
Canada
Sponsor information
Organisation
McMaster University
Sponsor details
1200 Main St West
Hamilton
L8N 3Z5
Canada
+1 905-521-2101
merit@mcmaster.ca
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Physicians' Services Incorporated Foundation
Alternative name(s)
PSI Foundation, PSI
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Canada
Results and Publications
Publication and dissemination plan
Planned publication in a high impact peer reviewed journal.
IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication
Intention to publish date
22/06/2021
Participant level data
Other
Basic results (scientific)
Publication list