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OpenTrials
Completed

NCT Number: NCT04055298

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.

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Key information

Conditions

Triage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cantonal Hospital Baden

Baden, Aarau, 5404, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMASS-Triage

Device

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).

Primary outcomes

  1. Proportion of self-triage assessed to be a hazardous under-triage

    Time frame: Baseline

    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.

Secondary outcomes

  1. Proportion of self-triage with an over- or under-triage

    Time frame: Baseline

    Secondary endpoints will be the proportion of self-triage with an over- or under-triaged self-assessment.

Sponsors and collaborators

Lead sponsor

Andreas Meer

Industry

Collaborators

  • Cantonal Hospital of Baden

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Aug 13, 2019
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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