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Completed

NCT Number: NCT03892551

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

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.

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Key information

Conditions

Triage Risk Stratification

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Emergency Medicine, University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Assessment of symptoms patients presenting when admitted to ED

Other

Questionnaire with a predefined list of 35 symptoms

Reason for patient presentation at ED

Other

Exploratory interview assessing reason for patient presentation at ED

physicians rating of severity of illness

Other

numeric scale ranging from 0 (perfect condition) to 10 (extremely ill)

Assessment of vital signs

Diagnostic Test

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

Clinical Frailty Scale

Other

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 diagnoses

Other

Assessment of treating physician's suspected diagnosis and differential diagnoses. Answers will be recorded in free text form.

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of hospitalizations

    Time frame: day of presentation to the ED

    Hospitalization is defined as the direct admission from the ED to any hospital in-patient department with a stay of over 24 hours

  2. Number of ICU-admissions

    Time frame: day of presentation to the ED

    ICU-admission is defined as any direct admission to the ICU of the University Hospital of Basel

  3. 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)

    In-hospital mortality is defined as death occurring during presentation to the ED and hospital discharge

  4. Number of institutionalisations

    Time frame: within 365 days of the day of presentation to the ED

    Institutionalisation is defined as no time spent at home during 365 days following presentation

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: EMERGE IV

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 27, 2019
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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