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Идёт набор NCT07118306

COPD Exacerbation Follow Up

Наблюдательное COPD (Chronic Obstructive Pulmonary Disease)

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: COPD (Chronic Obstructive Pulmonary Disease). Базовые параметры: от 40 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 →
Официальное название

A Multicenter Study of the Impact of a COPD Identification and Referral System on Patient Follow Up and Outcomes After an Acute COPD Exacerbation Resulting in an Emergency Department Visit or Hospitalization

Обзор

The goal of this study is to evaluate the impact of implementing an AI-enabled clinical workflow tool (Viz COPD) on respiratory specialist follow up and clinical outcomes after an acute exacerbation.

Подробное описание

Time perspective: This study will collect data prospectively for the Experimental cohort and retrospectively for the Control cohort. There is also an Exploratory cohort which will collect retrospective and prospective data.

Первичные конечные точки

  • To assess the effect of a digital health tool implementation on patient follow up with a respiratory specialist within 30 days after discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization. [Срок оценки: From time of exacerbation to 30 days after discharge]
  • To assess the effect of a digital health tool implementation on time to respiratory specialist follow-up after an acute COPD exacerbation resulting in an emergency department visit or hospitalization. [Срок оценки: Up to 1 year]
Вторичные конечные точки (12)
  • To assess the effect of a digital health tool implementation on patient follow up with a respiratory specialist within 90 days after discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization. [Срок оценки: Enrollment to 90 days after discharge]
  • To assess the effect of a digital health tool implementation on readmission following an acute, severe COPD exacerbation. [Срок оценки: Enrollment to 30 days after discharge]
  • To assess the effect of a digital health tool implementation on readmission following an acute, severe COPD exacerbation. [Срок оценки: Enrollment to 90 days after discharge]
  • To compare exacerbation rate (moderate, moderate and severe, severe) in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization. [Срок оценки: Enrollment to 30 days after discharge]
  • To compare exacerbation rate (moderate, moderate and severe, severe) in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization. [Срок оценки: Enrollment to 90 days post discharge]
  • To compare exacerbation rate (moderate, moderate and severe, severe) in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization. [Срок оценки: Enrollment to 1 year post discharge]
  • To compare healthcare resource utilization in the experimental and control cohort following discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization. [Срок оценки: Enrollment through 30 days after discharge]
  • To compare healthcare resource utilization in the experimental and control cohort following discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization. [Срок оценки: Enrollment through 90 days after discharge]
  • To compare healthcare resource utilization in the experimental and control cohort following discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 1 year [Срок оценки: Enrollment through 1 year after discharge]
  • To compare the rate of cardiovascular events in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 30 days [Срок оценки: Enrollment through 30 days after discharge]
  • To compare the rate of cardiovascular events in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 1 year [Срок оценки: Enrollment through 1 year after discharge]
  • To compare patient mortality in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 30 days [Срок оценки: Enrollment through 30 days after discharge]

Критерии участия

Критерии включения

  • Patients aged 40 years or older at the time of arrival to the emergency department.
  • Patients with a clinical diagnosis of COPD who present to the emergency department for a moderate or severe COPD exacerbation.
  • A moderate exacerbation is defined as an acute exacerbation requiring either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics.
  • A severe exacerbation is defined as an acute exacerbation requiring hospitalization, or observation for >24 hours in emergency department/urgent care facility or resulting in death.
  • Patients on dual (LABA/LAMA, LABA/ICS, LAMA/ICS) or triple (LABA/LAMA/ICS) long-acting bronchodilator inhalers.

Критерии исключения

  • Patients on bronchodilator inhaler monotherapy.
  • Patients leaving against medical advice or expiring during hospitalization.
  • Patients with tracheostomy.
  • Patients with advanced cancer.
  • Patients who have received a lung transplant.
  • Discharge to hospice care.
  • Transfer to another hospital.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 4 центра
  • Advocate Lutheran General Hospital — Park Ridge
  • Cooper University Health Care — Cherry Hill
  • Thomas Jefferson University — Philadelphia
  • Aurora St. Luke's Medical Center — Milwaukee

Идентификаторы

NCT: NCT07118306 · VIZCOPD03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗