Triage - Symptoms and Other Predictors in an All-comer Emergency Department Population

NCT ID: NCT05400707

Last Updated: 2026-01-26

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

RECRUITING

Total Enrollment

6467 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-17

Study Completion Date

2026-12-31

Brief Summary

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This study is to evaluate a tool capable of improved risk prediction regarding the 30-day mortality. The primary objective of this study is hospitalization, ICU-admission, morbidity and mortality in correlation with external validation of International Early Warning Score (IEWS) and decision-making processes regarding diagnosis, treatment and disposition in the ED.

Detailed Description

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Most emergency departments (EDs) perform an initial risk stratification of patients, called triage. Triage defines the process of systematically grouping patients according to their treatment priority on the base of algorithms in an environment with scarce health care resources. 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. All of these systems have their shortcomings, especially in nonspecific ED presentations and in older patients. The primary objective of this study is hospitalization, ICU-admission, morbidity and mortality in correlation with external validation of International Early Warning Score (IEWS) and decision-making processes regarding diagnosis, treatment and disposition in the ED.

In this national single centre, prospective, consecutive, observational all-comers study patients entering the ED undergo triage and will be verbally informed about the study. First, each patient's vital signs (respiratory rate, oxygen saturation, heart rate, blood pressure, temperature) are measured and pain is rated on a scale of 0 to 10. In addition, the patient's level of consciousness is assessed using the AVPUC scale (alert, new confusion, verbal, pain, unresponsive, new confusion). Patients are asked to rate their own mobility between stable walking without aids or limited mobility with aids (walking aid, wheelchair, lying down). In addition, the patient's mobility is observed by the triage staff. The probability that the patient will be admitted as an inpatient is then assessed. A Clinical Frailty Scale (CFS) is also completed for patients over 65. After triage, patients are transferred to the treatment unit. Patients in need of immediate therapy, such as analgesia, will receive therapy before start of the interview. Patients will then be approached by a member of the study personnel and will be asked "which symptoms are you experiencing at the moment?". The question will be repeated 3 times, Answers will be recorded by ticking boxes in the CRF for a predefined list of 37 symptoms. Then, patients will be asked "which of the symptoms you reported is most important to you?". Patients are asked for their opinion on whether they should be discharged home after emergency treatment or whether they should stay in the hospital. Patients over the age of 65 are asked the following: "generally asked: what matters most to you at the moment?" and "why is that important for you?".

Then, the attending senior physicians are asked how injured/ill they rate the patients on a scale from 0 (not ill/injured) to 10 (very ill/injured). The senior physicians are asked questions about decision-making in the emergency department. With regard to diagnostics, they are asked what type of diagnostic decision is involved (simple or complex decision), whether there was time pressure when making the diagnostic decision and which factors formed the basis for their diagnostic decision (list of 14 factors, numbered according to importance if applicable). Regarding therapy, respondents were also asked what type of therapeutic decision was involved (simple or complex decision), whether there was time pressure in making the therapeutic decision, and which factors formed the basis for their therapeutic decision (list of 14 factors, numbered according to importance if applicable). Then the disposition of the patient (ambulatory or hospitalized) is defined. For ambulant patients, senior physicians are asked which factors formed the basis for their ambulant disposition (list of 9 factors, numbered according to importance if applicable). For hospitalized patients, the senior physicians are asked which factors were the basis for their inpatient disposition (list of 17 factors, numbered according to importance if applicable). Finally, the attending physicians are asked who made the disposition decision.

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

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Triage Risk Stratification

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients admitted to emergency ward of the University Hospital Basel.

Assessment of vital signs

Intervention Type DIAGNOSTIC_TEST

heart rate, blood pressure, body temperature, respiration rate, peripheral capillary haemoglobin oxygen saturation)

Assessment of patient mobility at presentation

Intervention Type DIAGNOSTIC_TEST

Patients are asked how they assess their own mobility: - Stable walking without aids or limited mobility with aids (walking aid, wheelchair, lying down).

Assessment of level of consciousness by AVPUC scale

Intervention Type DIAGNOSTIC_TEST

Assessment of level of consciousness by AVPUC scale (alert, new confusion, verbal, pain, unresponsive, new confusion)

Assessment of symptoms patients presenting when admitted to ED

Intervention Type DIAGNOSTIC_TEST

Questionnaire with a predefined list of 37 symptoms

Assessment of what matters most in patients of 65 years and older

Intervention Type DIAGNOSTIC_TEST

Patients over the age of 65 are asked the following: "generally asked: what matters most to you at the moment?" and "why is that important for you?".

Assessment of Decision-making in senior physicians

Intervention Type DIAGNOSTIC_TEST

Questionnaire consisting of 10 questions about the decision-making processes in the emergency department and the factors that form the basis of their decisions regarding the diagnosis, treatment, and disposition of the patient.

Pain Numeric Rating Scale (NRS)

Intervention Type DIAGNOSTIC_TEST

The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain ('0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine"))

Clinical Frailty Scale (CFS)

Intervention Type DIAGNOSTIC_TEST

The CFS is a commonly used score to assess frailty. It was developed within the Canadian Study of Health and Aging and consists of a 9-level ordinal scale ranging from very fit (score 1) to living with very severe frailty (score 8), and score 9 reserved for those who are terminally ill.

Peripheral Perfusion Index (PPI)

Intervention Type DIAGNOSTIC_TEST

The PPI is derived from the photoplethysmography signal of pulse oximetry and represents the ratio between the pulsatile component (arterial compartment) and the non-pulsatile component (non-arterial tissues) of the light detected by the sensor. PPI can provide information for resuscitation in shock, outcome prediction in critically ill patients and may serve as an adjunct triage tool.

Capillary Refill Time (CRT)

Intervention Type DIAGNOSTIC_TEST

CRT provides a standardized assessment of capillary flow dynamics and is most assessed at the fingertip in clinical practice. A prolonged CRT in patients with septic, traumatic and cardiogenic shock has been associated with increased mortality and might be used as a resuscitation target in patients with septic shock.

Mottling Score (MS)

Intervention Type DIAGNOSTIC_TEST

Mattling is a characteristic discoloration of the skin resulting from reduced skin blood flow and has been shown to be associated with tissue hypoperfusion. The MS provides a simple scale (0-5) to characterize the extent of skin mottling around the knee and the severity of mottling is associated with adverse outcomes.

Mental health complaints

Intervention Type DIAGNOSTIC_TEST

Mental health complaints require safe, efficient risk stratification to distinguish primary psychiatric conditions from medical causes or comorbidities. Because current medical screening practices are inconsistent and unvalidated, this study will use prospective routine ED data to evaluate triage assessments of psychiatric likelihood and identify opportunities for standardized, evidence-based screening.

Altered mental status - a vital sign

Intervention Type DIAGNOSTIC_TEST

Delirium is a common and high-risk condition in older ED patients, and early detection is crucial to improve short- and long-term outcomes. This study will use routinely collected ED screening data (modified Confusion Assessment Method for the Emergency Department (mCAM-ED) and the four-item Abbreviated Mental Test (AMT-4)) to describe delirium prevalence and evaluate delirium identification in the emergency setting.

Interventions

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Assessment of vital signs

heart rate, blood pressure, body temperature, respiration rate, peripheral capillary haemoglobin oxygen saturation)

Intervention Type DIAGNOSTIC_TEST

Assessment of patient mobility at presentation

Patients are asked how they assess their own mobility: - Stable walking without aids or limited mobility with aids (walking aid, wheelchair, lying down).

Intervention Type DIAGNOSTIC_TEST

Assessment of level of consciousness by AVPUC scale

Assessment of level of consciousness by AVPUC scale (alert, new confusion, verbal, pain, unresponsive, new confusion)

Intervention Type DIAGNOSTIC_TEST

Assessment of symptoms patients presenting when admitted to ED

Questionnaire with a predefined list of 37 symptoms

Intervention Type DIAGNOSTIC_TEST

Assessment of what matters most in patients of 65 years and older

Patients over the age of 65 are asked the following: "generally asked: what matters most to you at the moment?" and "why is that important for you?".

Intervention Type DIAGNOSTIC_TEST

Assessment of Decision-making in senior physicians

Questionnaire consisting of 10 questions about the decision-making processes in the emergency department and the factors that form the basis of their decisions regarding the diagnosis, treatment, and disposition of the patient.

Intervention Type DIAGNOSTIC_TEST

Pain Numeric Rating Scale (NRS)

The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain ('0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine"))

Intervention Type DIAGNOSTIC_TEST

Clinical Frailty Scale (CFS)

The CFS is a commonly used score to assess frailty. It was developed within the Canadian Study of Health and Aging and consists of a 9-level ordinal scale ranging from very fit (score 1) to living with very severe frailty (score 8), and score 9 reserved for those who are terminally ill.

Intervention Type DIAGNOSTIC_TEST

Peripheral Perfusion Index (PPI)

The PPI is derived from the photoplethysmography signal of pulse oximetry and represents the ratio between the pulsatile component (arterial compartment) and the non-pulsatile component (non-arterial tissues) of the light detected by the sensor. PPI can provide information for resuscitation in shock, outcome prediction in critically ill patients and may serve as an adjunct triage tool.

Intervention Type DIAGNOSTIC_TEST

Capillary Refill Time (CRT)

CRT provides a standardized assessment of capillary flow dynamics and is most assessed at the fingertip in clinical practice. A prolonged CRT in patients with septic, traumatic and cardiogenic shock has been associated with increased mortality and might be used as a resuscitation target in patients with septic shock.

Intervention Type DIAGNOSTIC_TEST

Mottling Score (MS)

Mattling is a characteristic discoloration of the skin resulting from reduced skin blood flow and has been shown to be associated with tissue hypoperfusion. The MS provides a simple scale (0-5) to characterize the extent of skin mottling around the knee and the severity of mottling is associated with adverse outcomes.

Intervention Type DIAGNOSTIC_TEST

Mental health complaints

Mental health complaints require safe, efficient risk stratification to distinguish primary psychiatric conditions from medical causes or comorbidities. Because current medical screening practices are inconsistent and unvalidated, this study will use prospective routine ED data to evaluate triage assessments of psychiatric likelihood and identify opportunities for standardized, evidence-based screening.

Intervention Type DIAGNOSTIC_TEST

Altered mental status - a vital sign

Delirium is a common and high-risk condition in older ED patients, and early detection is crucial to improve short- and long-term outcomes. This study will use routinely collected ED screening data (modified Confusion Assessment Method for the Emergency Department (mCAM-ED) and the four-item Abbreviated Mental Test (AMT-4)) to describe delirium prevalence and evaluate delirium identification in the emergency setting.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients presenting to the ED of the University Hospital Basel over a timecourse of 9 weeks in 2022, 2024, 2026

Exclusion Criteria

* Obstetric, ophthalmologic, and paediatric patients will not be included
* unwillingness to participate
* insufficient ability to communicate with the study personnel.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roland Bingisser, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, Department of Emergency Medicine

Locations

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Department of Emergency Medicine, University Hospital Basel

Basel, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Roland Bingisser, Prof. Dr. med.

Role: CONTACT

+41 61 265 58 30

Christian Nickel, Prof. Dr. med.

Role: CONTACT

+41 61 265 53 15

Facility Contacts

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Roland Bingisser, Prof. Dr. med.

Role: primary

+41 61 265 58 30

Christian Nickel, Prof. Dr. med.

Role: backup

+41 61 265 53 15

References

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Riedel HB, Espejo T, Dreher-Hummel T, Bingisser R, Nickel CH. Screening for elder mistreatment in a Swiss emergency department: a prospective cohort study. Swiss Med Wkly. 2024 Jun 10;154:3775. doi: 10.57187/s.3775.

Reference Type DERIVED
PMID: 38875501 (View on PubMed)

Albrecht R, Espejo T, Riedel HB, Nissen SK, Banerjee J, Conroy SP, Dreher-Hummel T, Brabrand M, Bingisser R, Nickel CH. Clinical Frailty Scale at presentation to the emergency department: interrater reliability and use of algorithm-assisted assessment. Eur Geriatr Med. 2024 Feb;15(1):105-113. doi: 10.1007/s41999-023-00890-y. Epub 2023 Nov 16.

Reference Type DERIVED
PMID: 37971677 (View on PubMed)

Other Identifiers

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PB_2016-02667; am22Bingisser

Identifier Type: -

Identifier Source: org_study_id

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