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

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.

Study Overview

• Status: Completed
• Conditions: Triage
• Intervention / Treatment: Device: SMASS-Triage

• Study Type: Interventional
• Enrollment (Actual): 2500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Aarau
    • Baden, Aarau, Switzerland, 5404
      • Cantonal Hospital Baden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Patients; The study will be performed at the Walk-in-Clinic (WIC) and Interdisciplinary Emergency Department (ED) of the cantonal hospital of Baden, Switzerland. During their stay at the WIC or ED the patients will be invited to use the triage-symptom-checker SMASS-Triage. In this study, the patient's self-triage using a symptom checker will be compared with the urgency assessments conducted by three interdisciplinary panels of physicians (panel A, B and C). In order to appropriately reflect the complex interaction in medical decision-making, which usually leads to a low inter-rater reliability, the cases assessed to be undertriaged by panel A, are subsequently assessed a second time by two panelist of panel B. Cases which are adjudged to be undertriaged by all panelist (panel A and B), are assessed for a risk to health or life by panel C. The risk assessments of panel C will be based on the structured reports generated by the symptom-checker and the discharge summaries of the WIC/ED.

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Andreas Meer
• Collaborators: Cantonal Hospital of Baden
• Investigators: Principal Investigator: Andreas Meer, MD, MHIM, in4medicine Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2019
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: August 10, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SMASS-Triage_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No