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Идёт набор NCT05400707

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

Наблюдательное Triage Risk Stratification

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Assessment of vital signs, Assessment of patient mobility at presentation, Assessment of level of consciousness by AVPUC scale, Assessment of symptoms patients presenting when admitted to ED.
Кому может быть актуально
Состояния в реестре: Triage Risk Stratification. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест Assessment of vital signs
    heart rate, blood pressure, body temperature, respiration rate, peripheral capillary haemoglobin oxygen saturation)
  • Диагностический тест 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).
  • Диагностический тест Assessment of level of consciousness by AVPUC scale
    Assessment of level of consciousness by AVPUC scale (alert, new confusion, verbal, pain, unresponsive, new confusion)
  • Диагностический тест Assessment of symptoms patients presenting when admitted to ED
    Questionnaire with a predefined list of 37 symptoms
  • Диагностический тест 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?".
  • Диагностический тест 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.
  • Диагностический тест 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"))
  • Диагностический тест 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.
  • Диагностический тест 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.
  • Диагностический тест 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.

Первичные конечные точки

  • 30-day mortality [Срок оценки: within 30 days of the day of presentation to the ED]
Вторичные конечные точки (6)
  • Number of hospitalizations [Срок оценки: at baseline (= day of presentation to the ED)]
  • Number of ICU-admissions [Срок оценки: at baseline (= day of presentation to the ED)]
  • Death rate (In-hospital mortality) [Срок оценки: 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 [Срок оценки: within 100 days of the day of presentation to the ED]
  • Number of institutionalisations [Срок оценки: within 100 days of the day of presentation to the ED]
  • Morbidity [Срок оценки: within 100 days of the day of presentation to the ED]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швейцария · 1 центр
  • Department of Emergency Medicine, University Hospital Basel — Basel

Публикации

  • 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. PMID 38875501
  • 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. PMID 37971677

Идентификаторы

NCT: NCT05400707 · PB_2016-02667; am22Bingisser

Первоисточники (государственные реестры)

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