Triage Risk StratificationEMERGE IVNCT03892551
Triage - Symptoms and Other Predictors in an All-comer Emergency Department Population; (EKBB 236/13)
An observational study of Triage Risk Stratification, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study is to develop a tool capable of improved risk prediction regarding the 30-day mortality. Based on vital signs, impaired mobility on presentation (IMOP), Clinical Frailty Scale (CFS) and patients' symptomatology three risk categories (low, intermediate, high risk) will be established. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triage Risk Stratification
- What is being tested?
- Assessment of symptoms patients presenting when admitted to ED, Reason for patient presentation at ED and physicians rating of severity of illness
- How many people
- 7,309 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Mar 2019to 30 Nov 2020
- Phase
- Observational
- 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
Study population: Patients presenting to the ED of the University Hospital Basel over a time-course of 9 weeks from 25.03.2019 to 27.05.2019.
Who may be able to join
- patients presenting to the ED of the University Hospital Basel and awaiting triage
Who cannot join
- unwillingness to participate
- insufficient ability to communicate with the study personnel.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Emergency Medicine, University Hospital Basel
Basel, 4031
About this study
Official title: Triage - Symptoms and Other Predictors in an All-comer Emergency Department Population (EMERGE IV)
This study is to develop a tool capable of improved risk prediction regarding the 30-day mortality. Based on vital signs, impaired mobility on presentation (IMOP), Clinical Frailty Scale (CFS) and patients' symptomatology three risk categories (low, intermediate, high risk) will be established.
Read the detailed description
Most Emergency Departments (EDs) perform an initial risk stratification of patients, called Triage. Establishing a diagnosis is key for the administration of the appropriate treatment and the following disposition decision. The earlier and the more accurate the final diagnosis is established, the shorter the time to treatment and time to disposition, and thus, the more efficient the patient flow. New ways to improve diagnosis accuracy early on in patients' ED visits are needed. Although a great number of well validated and widely used triage systems exists, to this date no gold standard in triage risk stratification has been established. Most of the existing triage systems rely on the measurement of vital signs and a list of chief complaints.
This study is to develop a tool capable of improved risk prediction regarding the 30-day mortality. Based on vital signs, impaired mobility on presentation (IMOP), Clinical Frailty Scale (CFS) and patients' symptomatology three risk categories (low, intermediate, high risk) will be established.
According to acuity patients undergo triage or directly proceed to the treatment unit. Patients awaiting triage will be approached by a member of the study personnel and will be verbally informed about the study. Afterwards, patients will be interviewed asking about their symptoms and their reason for presentation. Patients in need of immediate therapy will receive therapy before start of the interview. Following the interview, patients undergo routine triage.The physician performing initial triage will be asked to rate how ill patients appear to be using a numeric scale ranging from 0 (perfect condition) to 10 (extremely ill). Treating physician's will be asked to state their suspected diagnosis as well as differential diagnoses. Follow-up to assess 30-day and 1-year mortality rate and date of death will start one year after the end of the inclusion period.
- Conditions
- Triage Risk Stratification
- Being tested
- Assessment of symptoms patients presenting when admitted to ED, Reason for patient presentation at ED, physicians rating of severity of illness, Assessment of vital signs, Clinical Frailty Scale
- Keywords
- risk prediction, Electronic triage systems (ETS), undertriage, overtriage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of symptoms patients presenting when admitted to EDOther
Questionnaire with a predefined list of 35 symptoms
Reason for patient presentation at EDOther
Exploratory interview assessing reason for patient presentation at ED
physicians rating of severity of illnessOther
numeric scale ranging from 0 (perfect condition) to 10 (extremely ill)
Assessment of vital signsDiagnostic test
Assessment of vital signs (heart rate, blood pressure, body temperature, respiration rate, peripheral capillary haemoglobin oxygen saturation)
Clinical Frailty ScaleOther
Assessment of frailty by Clinical Frailty Scale (CFS): assess patients' frailty level from 1, very fit, to 9, terminally ill
Impaired mobility on presentation (IMOP)Other
Assessment of IMOP: defined as being unable to stand unaided or walk without help
Assessment of suspected diagnosis and differential diagnosesOther
Assessment of treating physician's suspected diagnosis and differential diagnoses. Answers will be recorded in free text form.
| Study group | Role | What they receive |
|---|---|---|
| patients admitted to emergency ward | all patients admitted to the emergency ward and awaiting triage are observed Receives: Other: Assessment of symptoms patients presenting when admitted to ED; Other: Reason for patient presentation at ED; Other: physicians rating of severity of illness; Diagnostic Test: Assessment of vital signs; Other: Clinical Frailty Scale; Other: Impaired mobility on presentation (IMOP); Other: Assessment of suspected diagnosis and differential diagnoses |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
30-day mortality is defined as death within 30 days of the day of presentation to the ED
Measured: within 30 days of the day of presentation to the ED
Secondary outcomes (4)
Number of hospitalizations
Hospitalization is defined as the direct admission from the ED to any hospital in-patient department with a stay of over 24 hours
Measured: day of presentation to the ED
Number of ICU-admissions
ICU-admission is defined as any direct admission to the ICU of the University Hospital of Basel
Measured: day of presentation to the ED
Death rate (In-hospital mortality)
In-hospital mortality is defined as death occurring during presentation to the ED and hospital discharge
Measured: from day of presentation to the ED to day of hospital discharge (assessed within 365 days of the day of presentation to the ED)
Number of institutionalisations
Institutionalisation is defined as no time spent at home during 365 days following presentation
Measured: within 365 days of the day of presentation to the ED
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start18 Mar 2019
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Triage Risk StratificationStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,309 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland Bingisser, Prof. Dr., Principal investigator, Department of Emergency Medicine, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892551
- Sponsor's protocol ID
- PB_2019_00008; me19Bingisser
- Acronym
- EMERGE IV
- Status last verified
- May 2022
- First submitted
- 20 Mar 2019
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rueegg M, Nissen SK, Brabrand M, Kaeppeli T, Dreher T, Carpenter CR, Bingisser R, Nickel CH. The clinical frailty scale predicts 1-year mortality in emergency department patients aged 65 years and older. Acad Emerg Med. 2022 May;29(5):572-580. doi: 10.1111/acem.14460. Epub 2022 Apr 23.
PubMed 35138670Kaeppeli T, Rueegg M, Dreher-Hummel T, Brabrand M, Kabell-Nissen S, Carpenter CR, Bingisser R, Nickel CH. Validation of the Clinical Frailty Scale for Prediction of Thirty-Day Mortality in the Emergency Department. Ann Emerg Med. 2020 Sep;76(3):291-300. doi: 10.1016/j.annemergmed.2020.03.028. Epub 2020 Apr 24.
PubMed 32336486
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triage - Symptoms and Other Predictors in an All-comer Emergency Department Population (EMERGE IV)
- ClinicalTrials.gov ID
- NCT03892551
- Acronym / sponsor ID
- EMERGE IV / PB_2019_00008; me19Bingisser
- Conditions
- Triage Risk Stratification
- Keywords
- risk prediction, Electronic triage systems (ETS), undertriage, overtriage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,309 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 27 Mar 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 study is to develop a tool capable of improved risk prediction regarding the 30-day mortality. Based on vital signs, impaired mobility on presentation (IMOP), Clinical Frailty Scale (CFS) and patients' symptomatology three risk categories (low, intermediate, high risk) will be established.
Detailed description
Most Emergency Departments (EDs) perform an initial risk stratification of patients, called Triage. Establishing a diagnosis is key for the administration of the appropriate treatment and the following disposition decision. The earlier and the more accurate the final diagnosis is established, the shorter the time to treatment and time to disposition, and thus, the more efficient the patient flow. New ways to improve diagnosis accuracy early on in patients' ED visits are needed. Although a great number of well validated and widely used triage systems exists, to this date no gold standard in triage risk stratification has been established. Most of the existing triage systems rely on the measurement of vital signs and a list of chief complaints.
This study is to develop a tool capable of improved risk prediction regarding the 30-day mortality. Based on vital signs, impaired mobility on presentation (IMOP), Clinical Frailty Scale (CFS) and patients' symptomatology three risk categories (low, intermediate, high risk) will be established.
According to acuity patients undergo triage or directly proceed to the treatment unit. Patients awaiting triage will be approached by a member of the study personnel and will be verbally informed about the study. Afterwards, patients will be interviewed asking about their symptoms and their reason for presentation. Patients in need of immediate therapy will receive therapy before start of the interview. Following the interview, patients undergo routine triage.The physician performing initial triage will be asked to rate how ill patients appear to be using a numeric scale ranging from 0 (perfect condition) to 10 (extremely ill). Treating physician's will be asked to state their suspected diagnosis as well as differential diagnoses. Follow-up to assess 30-day and 1-year mortality rate and date of death will start one year after the end of the inclusion period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients admitted to emergency ward | – | Other: Assessment of symptoms patients presenting when admitted to ED, Other: Reason for patient presentation at ED, Other: physicians rating of severity of illness, Diagnostic Test: Assessment of vital signs, Other: Clinical Frailty Scale, Other: Impaired mobility on presentation (IMOP), Other: Assessment of suspected diagnosis and differential diagnosesall patients admitted to the emergency ward and awaiting triage are observed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the ED of the University Hospital Basel over a time-course of 9 weeks from 25.03.2019 to 27.05.2019.
Key inclusion criteria (1 listed)
- patients presenting to the ED of the University Hospital Basel and awaiting triage
Key exclusion criteria (2 listed)
- unwillingness to participate
- insufficient ability to communicate with the study personnel.
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 |
|---|---|---|
| Assessment of symptoms patients presenting when admitted to EDQuestionnaire with a predefined list of 35 symptoms | Other | patients admitted to emergency ward |
| Reason for patient presentation at EDExploratory interview assessing reason for patient presentation at ED | Other | patients admitted to emergency ward |
| physicians rating of severity of illnessnumeric scale ranging from 0 (perfect condition) to 10 (extremely ill) | Other | patients admitted to emergency ward |
| Assessment of vital signsAssessment of vital signs (heart rate, blood pressure, body temperature, respiration rate, peripheral capillary haemoglobin oxygen saturation) | Diagnostic test | patients admitted to emergency ward |
| Clinical Frailty ScaleAssessment of frailty by Clinical Frailty Scale (CFS): assess patients' frailty level from 1, very fit, to 9, terminally ill | Other | patients admitted to emergency ward |
| Impaired mobility on presentation (IMOP)Assessment of IMOP: defined as being unable to stand unaided or walk without help | Other | patients admitted to emergency ward |
| Assessment of suspected diagnosis and differential diagnosesAssessment of treating physician's suspected diagnosis and differential diagnoses. Answers will be recorded in free text form. | Other | patients admitted to emergency ward |
Primary outcome
30-day mortality
Time frame: within 30 days of the day of presentation to the ED
30-day mortality is defined as death within 30 days of the day of presentation to the ED
4 secondary outcomes
Number of hospitalizations
Time frame: day of presentation to the ED
Number of ICU-admissions
Time frame: day of presentation to the ED
Death rate (In-hospital mortality)
Time frame: from day of presentation to the ED to day of hospital discharge (assessed within 365 days of the day of presentation to the ED)
Number of institutionalisations
Time frame: within 365 days of the day of presentation to the ED
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 25 May 2022.
- Derived from this study: PubMed 35138670Rueegg M, Nissen SK, Brabrand M, Kaeppeli T, Dreher T, Carpenter CR, Bingisser R, Nickel CH. The clinical frailty scale predicts 1-year mortality in emergency department patients aged 65 years and older. Acad Emerg Med. 2022 May;29(5):572-580. doi: 10.1111/acem.14460. Epub 2022 Apr 23.
- Derived from this study: PubMed 32336486Kaeppeli T, Rueegg M, Dreher-Hummel T, Brabrand M, Kabell-Nissen S, Carpenter CR, Bingisser R, Nickel CH. Validation of the Clinical Frailty Scale for Prediction of Thirty-Day Mortality in the Emergency Department. Ann Emerg Med. 2020 Sep;76(3):291-300. doi: 10.1016/j.annemergmed.2020.03.028. Epub 2020 Apr 24.
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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.
Roland Bingisser, Prof. Dr. principal investigator
Department of Emergency Medicine, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Triage Risk Stratification, run by University Hospital, Basel, Switzerland 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 1 inclusion and 2 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 25 May 2022. 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?
30-day mortality (time frame: within 30 days of the day of presentation to the ED). 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 NCT03892551, which also lists 2 linked publications.
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 25 May 2022.