APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System
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: APPRAISE Trauma Clinical Decision Support System.
- Кому может быть актуально
- Состояния в реестре: Wounds and Injuries. 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
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This is a pilot evaluation of the APPRAISE trauma decision-support software system ("the System"). The specific objections are as follows: 1. Evaluate the robustness of the System (i.e., whether the software performs in real-time in accordance with a priori technical specifications during real-time clinical use); 2. Evaluate whether the real-time display of the System causes distraction or confusion to clinicians treating the trauma patient such that its risks exceed its benefits; 3. Collect pilot data to allow for a statistical power analysis to design a future clinical trial evaluating efficacy.
Вмешательства
- Устройство APPRAISE Trauma Clinical Decision Support System
Real-time bedside decision-support system for trauma patient management
Первичные конечные точки
- Software session with error messages or critical software errors [Срок оценки: From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation).]
- Clinician surveys that the software negatively affected patient care [Срок оценки: From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation)]
- Clinician surveys that the software positively affected patient care [Срок оценки: From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation)]
- Clinician surveys that ongoing use of the software poses risks that exceeds benefits [Срок оценки: From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation)]
Критерии участия
Критерии включения
- Adult (≥18 yrs) Emergency Department (ED) patient
- Triaged to the "Acute" area of the ED. (The "Acute" area is the designated area for ED patients with potential or established critical illness. Triage to Acute is a routine ED operation that is performed based on departmental guidelines and the professional judgement of an experienced triage nurse).
- Clinical concern for acute injury (based on either an explicitly chief complaint of acute injury, or clinical team with documented concern for acute injury as a relevant part of patient presentation).
Критерии исключения
- Prisoners
- Patients known to be pregnant, based on patient report, physical exam, or bedside ultrasound
- Patients wearing an "EFIC Opt-Out" bracelet
- Any concern about the suitability of the software system for a specific patient by any clinician involved in the patient's ED care, or by the patient themselves (or by any LAR \[lawfully authorized representative\] of the patient).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Оценка устройства
Центры проведения
США · 1 центр
- Massachusetts General Hospital — Boston
Идентификаторы
NCT: NCT06121661 · 2022P001136