Reducing errors made by clinicians when making a diagnosis with an electronic decision support

ISRCTN ISRCTN18343639
DOI https://doi.org/10.1186/ISRCTN18343639
Submission date
09/11/2020
Registration date
13/11/2020
Last edited
12/11/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Matthew Sibbald
Scientific

1200 Main St West
Hamilton
L6L 4Z7
Canada

ORCiD logoORCID ID 0000-0002-0022-2370
Phone +1 905-521-2101
Email sibbald@mcmaster.ca

Study information

Study designMulticenter interventional randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Internet/virtual
Study typeDiagnostic
Participant information sheet No participant information sheet available
Scientific titleEnhancing Clinicians’ diagnostic Hypotheses with Electronic Differential Diagnosis support (ECH-EDS)
Study acronymECH-EDS
Study objectives1. 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(s)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
Health condition(s) or problem(s) studiedMedical diagnosis
InterventionStudents, 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 typeBehavioural
Primary outcome measure1. 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 measures1. 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 study start date22/12/2017
Completion date22/06/2020

Eligibility

Participant type(s)Health professional
Age groupAll
SexBoth
Target number of participants180
Total final enrolment190
Key inclusion criteriaMedical students, residents, or practicing physicians
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/05/2020
Date of final enrolment22/06/2020

Locations

Countries of recruitment

  • Canada

Study participating centre

McMaster University
1200 Main St West
Hamilton
L8N 3Z5
Canada

Sponsor information

McMaster University
University/education

1200 Main St West
Hamilton
L8N 3Z5
Canada

Phone +1 905-521-2101
Email merit@mcmaster.ca
Website http://www.mcmaster.ca/
ROR logo "ROR" https://ror.org/02fa3aq29

Funders

Funder type

Charity

Physicians' Services Incorporated Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
PSI Foundation, PSI
Location
Canada

Results and Publications

Intention to publish date22/06/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned publication in a high impact peer reviewed journal.
IPD sharing planThe datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Editorial Notes

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