TriageNCT04055298
Is Self-triage by Patients Using a Symptom-checker Safe?
A study testing SMASS-Triage in people with Triage, run by Andreas Meer at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triage
- What is being tested?
- SMASS-Triage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Nov 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Triage
- Being tested
- SMASS-Triage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SMASS-Triage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start21 Nov 2019
- Primary completion1 May 2020
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TriageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andreas Meer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cantonal Hospital of Baden
- Responsible party
- Sponsor-investigator, Andreas Meer, in4medicine AG
- Investigators
- Andreas Meer, MD, MHIM, Principal investigator, in4medicine Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055298
- Sponsor's protocol ID
- SMASS-Triage_001
- Status last verified
- Feb 2023
- First submitted
- 10 Aug 2019
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38809606
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Self-triage by Patients Using a Symptom-checker Safe?
- ClinicalTrials.gov ID
- NCT04055298
- Acronym / sponsor ID
- SMASS-Triage_001
- Conditions
- Triage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Andreas MeerIndustry (pharma, biotech, devices)
- Collaborators
- Cantonal Hospital of Baden
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Device: SMASS-TriageThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMASS-TriageSMASS-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). | Device | Patients |
Primary outcome
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.
1 secondary outcome
Proportion of self-triage with an over- or under-triage
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Derived from this study: PubMed 38809606Meer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Meer, MD, MHIM principal investigator
in4medicine Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMASS-Triage in people with Triage, run by Andreas Meer at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of self-triage assessed to be a hazardous under-triage (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04055298, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.