Is Self-triage by Patients Using a Symptom-checker Safe?

Triage Clinical Trial

Official title:

Is Self-triage by Patients Using a Symptom-checker Safe?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04055298
• Other study ID #: SMASS-Triage_001
• Status: Completed
• Phase: N/A
• Start date: November 21, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: in4medicine AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, non-randomized, no placebo-controlled interventional study. The study aims to assess the safety of the web-based symptom checker SMASS-Triage and its tolerability in terms of incidence of under-triaged self-assessments and the potential risk to be life-threatening or harmful. The patient's self-triage using a symptom checker will be compared with the urgency assessments conducted sequentially by three interdisciplinary panels of physicians (panel A, B and C). The risk assessments will be based on the structured reports generated by the symptom checker and the discharge summaries of the WIC/ED.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: December 31, 2022
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All German-, French-, Italian-, English-speaking patients attending the WIC/ED are eligible.
• Informed Consent as documented by signature ( Informed Consent Form)
• Age 18-years and older
• Capable of judgment
• Not under tutelage

Exclusion Criteria:

• Patients with an Emergency Severity Index 1
• Leading complaint of the patient can't be found and assessed with the symptom checker
• Patients not being able to use a tablet-computer
• Patients not speaking German, French, Italian or English
• Minors under the age of 7-years
• Patients incapable of judgment
• Participants under tutelage
• Known or suspected non-compliance, drug or alcohol abuse,
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

Related Conditions & MeSH terms

• Triage

Intervention

Device:
• SMASS-Triage
SMASS-Triage is a web-based symptom checker developed by In4medicine Ltd. SMASS-Triage is based on a computerized transparent neural network, which was trained with the evidence of more than 1200 studies and the expertise of various panels of specialists in the field of preclinical medical triage. SMASS-Triage provides digitalized questionnaires of 87 frequent reasons of encounters (e.g. fever, cough, abdominal pain) and their associated red flags. The triage-result of SMASS-Triage encompasses the appropriate time-to-treat (T2T) and the adequate point-of-care (PoC).

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital Baden	Baden	Aarau

Sponsors (2)

Lead Sponsor	Collaborator
Andreas Meer	Cantonal Hospital of Baden

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of self-triage assessed to be a hazardous under-triage	The primary endpoint will be the proportion of self-triage and the according confidence interval assessed by the physicians to be a hazardous under-triage.	Baseline
Secondary	Proportion of self-triage with an over- or under-triage	Secondary endpoints will be the proportion of self-triage with an over- or under-triaged self-assessment.	Baseline