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Clinical Trials/NCT05400707
NCT05400707
Recruiting
Not Applicable

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

University Hospital, Basel, Switzerland1 site in 1 country6,467 target enrollmentMay 17, 2022

Overview

Phase
Not Applicable
Intervention
Assessment of vital signs
Conditions
Triage Risk Stratification
Sponsor
University Hospital, Basel, Switzerland
Enrollment
6467
Locations
1
Primary Endpoint
30-day mortality
Status
Recruiting
Last Updated
3 months ago

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 17, 2022
End Date
December 31, 2026
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Basel, Switzerland
Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

patients admitted to emergency ward of the University Hospital Basel.

Intervention: Assessment of vital signs

patients admitted to emergency ward of the University Hospital Basel.

Intervention: Assessment of patient mobility at presentation

patients admitted to emergency ward of the University Hospital Basel.

Intervention: Assessment of level of consciousness by AVPUC scale

patients admitted to emergency ward of the University Hospital Basel.

Intervention: Assessment of symptoms patients presenting when admitted to ED

patients admitted to emergency ward of the University Hospital Basel.

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

patients admitted to emergency ward of the University Hospital Basel.

Intervention: Assessment of Decision-making in senior physicians

patients admitted to emergency ward of the University Hospital Basel.

Intervention: Pain Numeric Rating Scale (NRS)

patients admitted to emergency ward of the University Hospital Basel.

Intervention: Clinical Frailty Scale (CFS)

patients admitted to emergency ward of the University Hospital Basel.

Intervention: Peripheral Perfusion Index (PPI)

patients admitted to emergency ward of the University Hospital Basel.

Intervention: Capillary Refill Time (CRT)

patients admitted to emergency ward of the University Hospital Basel.

Intervention: Mottling Score (MS)

patients admitted to emergency ward of the University Hospital Basel.

Intervention: Mental health complaints

patients admitted to emergency ward of the University Hospital Basel.

Intervention: Altered mental status - a vital sign

Outcomes

Primary Outcomes

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

  • Number of ICU-admissions(at baseline (= day of presentation to the ED))
  • Number of hospitalizations(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)
  • Morbidity(within 100 days of the day of presentation to the ED)

Study Sites (1)

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