NCT04055298

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

November 21, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

August 10, 2019

Last Update Submit

February 28, 2023

Conditions

Triage

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Proportion of self-triage with an over- or under-triage

    Baseline

Study Arms (1)

Patients

OTHER

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

Interventions

SMASS-TriageDEVICE

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).

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cantonal Hospital Baden

Baden, Aarau, 5404, Switzerland

Location

Related Publications (1)

  • Meer A, Rahm P, Schwendinger M, Vock M, Grunder B, Demurtas J, Rutishauser J. A Symptom-Checker for Adult Patients Visiting an Interdisciplinary Emergency Care Center and the Safety of Patient Self-Triage: Real-Life Prospective Evaluation. J Med Internet Res. 2024 Jun 27;26:e58157. doi: 10.2196/58157.

    PMID: 38809606DERIVED

Study Officials

  • Andreas Meer, MD, MHIM

    in4medicine Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

August 10, 2019

First Posted

August 13, 2019

Study Start

November 21, 2019

Primary Completion

May 1, 2020

Study Completion

December 31, 2022

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)