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Набор скоро начнётся NCT07592598

Simulation-Based Cardiac Point-of-Care Ultrasound Program to Improve Clinical Outcomes in Acute Heart Failure Patients

Без фазы С лечением Heart Failure Acute Point-of-care Ultrasound Simulation Training Implementation Science

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: Simulation POCUS training, Clinical Practice Guidelines.
Кому может быть актуально
Состояния в реестре: Heart Failure Acute, Point-of-care Ultrasound, Simulation Training, Implementation Science. 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 →
Официальное название

Co-design and Implementation of a Simulation-Based Cardiac Point-of-Care Ultrasound Program to Improve Clinical Outcomes in Acute Heart Failure Patients

Обзор

The aim of this study is to co-design a cardiac POCUS simulation training intervention and implementation strategy for EM clinicians and evaluate the effectiveness of the cardiac point-of-care ultrasound (POCUS) simulation-based training (CPST) and CPG implementation. By performing this study, the investigators hope to improve diagnostic processes and time-to-diuretic dosing for acute heart failure (AHF) patients.

Подробное описание

Cardiac disease is the leading cause of mortality worldwide, with over 6.7 million Americans with acute heart failure (AHF) presenting with 1 million annual emergency department (ED) visits. Point-of-care ultrasound (POCUS) is a critical bedside tool that can expedite diagnosis and treatment in AHF patients. However, gaps in POCUS training remain that limit clinical utilization. Simulation-based training reinforces technical skills for clinical application. Prior work achieved high procedural knowledge (70% passed, 18% SD) and technical skills (95%, 6% SD) in emergency medicine (EM) clinicians using a simulation nerve block model, with retention at 3-months post-intervention. The current proposed study builds on this work, using the Implementation Research Longitudinal Framework (IRLM) to translate knowledge into clinical skills through simulation-based POCUS training for EM physicians and Advanced Practice Providers (APPs) to improve time-to-diuretics and AHF patient clinical outcomes. Specific Aim 1 uses adaptive Experience-Based Co-design (EBCD) to co-design a cardiac POCUS simulation training intervention and implementation strategy for EM clinicians The cardiac POCUS training workshop and reinforcement sessions will be co-designed with ED leadership, ultrasound faculty, and key stakeholders. Participants will then perform cardiac and lung POCUS using standardized clinical practice guidelines (CPG) in AHF patients as part of clinical care. Specific Aim 2 is the intervention assessment. We will assess pre-, post, and 6-month post-simulation participant POCUS skills using validated ultrasound self-efficacy scales, image interpretation tests (knowledge), and simulated scenario performance (technical skills). Specific Aim 3 evaluates the effectiveness of the cardiac POCUS simulation-based training and clinical practice guideline implementation. The investigators will perform a quasi-experimental pre-/post design by interrupted time series with one year of data before and after intervention implementation. We will perform a quasi-experimental pre-/post design interrupted time series with one year of data before and after intervention implementation in three diverse EDs. Our primary clinical outcome is time-to-diuretic dose in ED heart failure patients.11 PROCTOR-guided outcomes include effectiveness, provider adoption, and clinical POCUS uptake/utilization.

Вмешательства

  • Поведенческое Simulation POCUS training
    Uses adaptive Experience-Based Co-design (EBCD) to co-design a cardiac POCUS simulation training intervention and implementation strategy for EM clinicians. The cardiac POCUS training workshop and reinforcement sessions will be co-designed with ED leadership, ultrasound faculty, and key stakeholders. Participants will then perform cardiac and lung POCUS using standardized clinical practice guidelines (CPG) in AHF patients as part of clinical care.
  • Поведенческое Clinical Practice Guidelines
    Clinical practice guidelines will instruct clinicians on how to perform POCUS, save the images, complete worksheets on the archiving platform, and signed so that images are saved to the patient's chart and billed.

Первичные конечные точки

  • Effectiveness of the simulation-based cardiac POCUS (Point-of-Care Ultrasound) training implementation as measured by time-to-diuretic dose in ED (Emergency Department) heart failure patients [Срок оценки: 12 months pre and 12 months post-intervention]
Вторичные конечные точки (12)
  • Acceptability of the Intervention as measured by the Acceptability of Intervention Measure (AIM) [Срок оценки: up to 6 months post-workshop]
  • Appropriateness of the Intervention as measured by the Intervention Appropriateness Measure (IAM) [Срок оценки: up to 6 months post-workshop]
  • Feasibility of the Intervention as measured by the Feasibility of Intervention Measure (FIM) survey tool [Срок оценки: up to 6 months post-workshop]
  • Feasibility of implementing a cardiac point-of-care ultrasound (POCUS) simulation training and clinical practice guidelines for physicians and advanced practice providers (APPs) [Срок оценки: 12 months pre and 12 months post-intervention]
  • Effectiveness of the simulation-based cardiac POCUS training implementation as measured by the number of clinical POCUS performed in the ED [Срок оценки: 12 months pre and 12 months post-intervention]
  • Effectiveness of the simulation-based cardiac POCUS training implementation as measured by image quality review scores [Срок оценки: 12 months pre and 12 months post-intervention]
  • Clinical impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance as measured by the time to initial cardiology consult [Срок оценки: 12 months pre and 12 months post-intervention]
  • Clinical impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance as measured by emergency department length-of-stay [Срок оценки: 12 months pre and 12 months post-intervention]
  • Clinical impact of the training model on heart failure patients as measured by the number of participants with serious cardiac outcomes [Срок оценки: 12 months pre and 12 months post-intervention]
  • Ultrasound Self-efficacy Scale [Срок оценки: 6 months]
  • Provider adoption as measured by the number of cardiac/lung POCUS exams performed by each participant for ED acute heart failure patients [Срок оценки: 12 months pre and 12 months post-intervention]
  • Ultrasound image interpretation test [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Emergency medicine provider practicing at the study site, including physician assistants and nurse practitioners

Критерии исключения

  • ED nurses and technicians are excluded due to differing ultrasound training needs

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07592598 · Pro00120135

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗