NCT05400707

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,467

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
May 2022Dec 2026

Study Start

First participant enrolled

May 17, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

May 24, 2022

Last Update Submit

January 22, 2026

Conditions

Keywords

risk predictionElectronic triage systems (ETS)undertriageovertriage30-day mortality

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Number of hospitalizations

    at baseline (= day of presentation to the ED)

  • Number of ICU-admissions

    at baseline (= day of presentation to the ED)

  • Death rate (In-hospital mortality)

    from day of presentation to the ED to day of hospital discharge (assessed within 365 days of the day of presentation to the ED)

  • 100-day mortality

    within 100 days of the day of presentation to the ED

  • Number of institutionalisations

    within 100 days of the day of presentation to the ED

  • +1 more secondary outcomes

Study Arms (1)

patients admitted to emergency ward of the University Hospital Basel.

Diagnostic Test: Assessment of vital signsDiagnostic Test: Assessment of patient mobility at presentationDiagnostic Test: Assessment of level of consciousness by AVPUC scaleDiagnostic Test: Assessment of symptoms patients presenting when admitted to EDDiagnostic Test: Assessment of what matters most in patients of 65 years and olderDiagnostic Test: Assessment of Decision-making in senior physiciansDiagnostic Test: Pain Numeric Rating Scale (NRS)Diagnostic Test: Clinical Frailty Scale (CFS)Diagnostic Test: Peripheral Perfusion Index (PPI)Diagnostic Test: Capillary Refill Time (CRT)Diagnostic Test: Mottling Score (MS)Diagnostic Test: Mental health complaintsDiagnostic Test: Altered mental status - a vital sign

Interventions

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

patients admitted to emergency ward of the University Hospital Basel.

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

patients admitted to emergency ward of the University Hospital Basel.

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

patients admitted to emergency ward of the University Hospital Basel.

Questionnaire with a predefined list of 37 symptoms

patients admitted to emergency ward of the University Hospital Basel.

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?".

patients admitted to emergency ward of the University Hospital Basel.

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.

patients admitted to emergency ward of the University Hospital Basel.
Mottling Score (MS)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.

patients admitted to emergency ward of the University Hospital Basel.

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"))

patients admitted to emergency ward of the University Hospital Basel.

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.

patients admitted to emergency ward of the University Hospital Basel.

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.

patients admitted to emergency ward of the University Hospital Basel.

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.

patients admitted to emergency ward of the University Hospital Basel.

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.

patients admitted to emergency ward of the University Hospital Basel.

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.

patients admitted to emergency ward of the University Hospital Basel.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will consist of all patients presenting to the ED of the University Hospital Basel and awaiting triage.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Emergency Medicine, University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Related Publications (2)

  • 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.

  • 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.

Study Officials

  • Roland Bingisser, Prof. Dr. med.

    University Hospital Basel, Department of Emergency Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roland Bingisser, Prof. Dr. med.

CONTACT

Christian Nickel, Prof. Dr. med.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2022

First Posted

June 1, 2022

Study Start

May 17, 2022

Primary Completion (Estimated)

May 27, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations