Triage - Symptoms and Other Predictors in an All-comer Emergency Department Population; (EKBB 236/13)

Triage Risk Stratification Clinical Trial

— EMERGE IV  

Official title:

Triage - Symptoms and Other Predictors in an All-comer Emergency Department Population (EMERGE IV)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03892551
• Other study ID #: PB_2019_00008; me19Bingisser
• Status: Completed
• Start date: March 18, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: May 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7309
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients presenting to the ED of the University Hospital Basel and awaiting triage

Exclusion Criteria:

• unwillingness to participate

• insufficient ability to communicate with the study personnel.

Related Conditions & MeSH terms

• Emergencies
• Triage Risk Stratification

Intervention

Other:
• Assessment of symptoms patients presenting when admitted to ED
Questionnaire with a predefined list of 35 symptoms
• Reason for patient presentation at ED
Exploratory interview assessing reason for patient presentation at ED
• physicians rating of severity of illness
numeric scale ranging from 0 (perfect condition) to 10 (extremely ill)

Diagnostic Test:
• Assessment of vital signs
Assessment of vital signs (heart rate, blood pressure, body temperature, respiration rate, peripheral capillary haemoglobin oxygen saturation)

Other:
• Clinical Frailty Scale
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)
Assessment of IMOP: defined as being unable to stand unaided or walk without help
• Assessment of suspected diagnosis and differential diagnoses
Assessment of treating physician's suspected diagnosis and differential diagnoses. Answers will be recorded in free text form.

Locations

Country	Name	City	State
Switzerland	Department of Emergency Medicine, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality	30-day mortality is defined as death within 30 days of the day of presentation to the ED	within 30 days of the day of presentation to the ED
Secondary	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	day of presentation to the ED
Secondary	Number of ICU-admissions	ICU-admission is defined as any direct admission to the ICU of the University Hospital of Basel	day of presentation to the ED
Secondary	Death rate (In-hospital mortality)	In-hospital mortality is defined as death occurring during presentation to the ED and hospital discharge	from day of presentation to the ED to day of hospital discharge (assessed within 365 days of the day of presentation to the ED)
Secondary	Number of institutionalisations	Institutionalisation is defined as no time spent at home during 365 days following presentation	within 365 days of the day of presentation to the ED