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

NCT ID: NCT04055298

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-21

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Triage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

SMASS-Triage

Intervention Type 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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cantonal Hospital of Baden

UNKNOWN

Sponsor Role collaborator

Andreas Meer

INDUSTRY

Sponsor Role lead

Responsible Party

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Andreas Meer

Medical Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Andreas Meer, MD, MHIM

Role: PRINCIPAL_INVESTIGATOR

in4medicine Ltd.

Locations

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Cantonal Hospital Baden

Baden, Aarau, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 38809606 (View on PubMed)

Other Identifiers

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SMASS-Triage_001

Identifier Type: -

Identifier Source: org_study_id

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