Accelerating Access and Improving Imaging in Heart Failure Care (A2I2HF) Pilot Study
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: AI-assisted point-of-care ultrasound (POCUS).
- Кому может быть актуально
- Состояния в реестре: Heart Failure. 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
- Список центров уточняется — проверьте первичный протокол.
- 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 prospective, multicenter, cluster randomised trial which will assess the feasibility and acceptability of AI-assisted point of care echocardiography on HF detection and downstream care processes for patients with suspected HF discharged from the Emergency Department.
Подробное описание
Heart failure remains underdiagnosed in frontline care settings, in part due to limited access to timely echocardiography. Recent advances in artificial intelligence (AI)-assisted echocardiography may facilitate scalable bedside screening through automated image acquisition support and interpretation.
This is a prospective, multicenter, cluster randomised trial which will assess the feasibility and acceptability of routine implementation of AI-assisted point of care echocardiography on HF detection and downstream processes of care for patients with suspected HF being discharged from the Emergency Department.
This study will be carried out at 2 participating Emergency Departments (EDs) in Alberta, Canada. Each ED site will alternate monthly between Intervention (AI-assisted echocardiography) and Control (Usual Care) periods.
During intervention periods, patients with suspected HF will undergo AI-assisted echocardiography using a handheld point of care EchoNous Kosmos device by the treating ED physician. The US2.ai algorithm will generate an AI-automated echo report. During control periods, patients will be managed according to usual care.
Вмешательства
- Устройство AI-assisted point-of-care ultrasound (POCUS)
ED physicians at both sites will be provided with 1 session of in person training in the use of the AI-assisted POCUS device within 4 weeks of randomization including, * Device set up * Demo of patient exam with POCUS device (to be used within its CE/Health Canada marked intended purpose or where deemed clinically appropriate by the treating physician). * Generation of AI-automated echocardiogram report for LVEF and diastolic dysfunction.
Первичные конечные точки
- Feasibility of AI Assisted Point of Care Echocardiography Implementation [Срок оценки: During the enrollment period.]
Вторичные конечные точки (6)
- Diagnosis of heart failure (HF) within 90 days [Срок оценки: At 90 days.]
- Downstream health care resource utilization at 90 days and 1 year (e.g. rates of requests for echocardiography, cardiology referral, primary care appointments, HF hospitalization). [Срок оценки: At 90 days and 1 year.]
- Proportion of patients with HF receiving GDMT within 90 days [Срок оценки: At 90 days.]
- Difference in ratio of the incidence of diagnoses of HF via hospital admission-based versus community-based pathways [Срок оценки: At 90 days.]
- Uptake and utilization: differential rates of uptake and utilization of AI Assisted echocardiography in the emergency department [Срок оценки: During the enrollment period.]
- Determinants of uptake and utilization of AI assisted echocardiography in the emergency department (clinician questionnaire) [Срок оценки: During the enrollment period.]
Критерии участия
Критерии включения
- Adult patients age ≥18 years presenting to the emergency department (ED);
- with signs or symptoms of HF as per the treating physician and
- elevated natriuretic peptides (NT-proBNP >125pg/mL or BNP >50pg/mL), drawn as part of standard of care of evaluation in the ED.
Критерии исключения
- prior documented diagnosis of HF;
- any patient receiving renal replacement therapy;
- any patient receiving comfort or palliative care;
- pregnant or nursing patients;
- patient is planned for admission.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Простое слепое
- Основная цель
- Диагностика
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07624565 · A2I2HF