Reducing errors made by clinicians when making a diagnosis with an electronic decision support
| ISRCTN | ISRCTN18343639 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18343639 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | McMaster University |
| Funder | Physicians' Services Incorporated Foundation |
- 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
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
Scientific
1200 Main St West
Hamilton
L6L 4Z7
Canada
 ORCID ID |
0000-0002-0022-2370 |
|---|---|
| Phone | +1 905-521-2101 |
| sibbald@mcmaster.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicenter interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Enhancing Clinicians’ diagnostic Hypotheses with Electronic Differential Diagnosis support (ECH-EDS) |
| Study acronym | ECH-EDS |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
1. Number of diagnostic suggestions before and after use of the electronic differential support |
| Completion date | 22/06/2020 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | All |
| Sex | All |
| Target sample size at registration | 180 |
| Total final enrolment | 190 |
| Key inclusion criteria | Medical students, residents, or practicing physicians |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/05/2020 |
| Date of final enrolment | 22/06/2020 |
Locations
Countries of recruitment
- Canada
Study participating centre
Hamilton
L8N 3Z5
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/11/2020: Trial’s existence confirmed by Hamilton Integrated Research Ethics Board.
