Condition category
Not Applicable
Date applied
09/11/2020
Date assigned
13/11/2020
Last edited
12/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.mcmaster.ca/

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

Publication citations

Additional files

Editorial Notes

12/11/2020: Trial’s existence confirmed by Hamilton Integrated Research Ethics Board.