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Набор по приглашению NCT04987840

A Multi-Center Diagnostic Stewardship Program to Improve Respiratory Culture Utilization in Critically Ill Children

Наблюдательное Ventilator Associated Pneumonia Tracheobronchitis

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: Ventilator Associated Pneumonia, Tracheobronchitis. Базовые параметры: Без ограничений · 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 →

Обзор

The objective of this study is to evaluate implementation of diagnostic stewardship programs as a strategy to safely reduce antibiotic use, and to generate evidence and tools to support dissemination of diagnostic stewardship programs to a large and diverse group of hospitals.

Подробное описание

The Bright STAR Collaborative, or Testing STewardship to reduce Antibiotic Resistance Collaborative, is a prospective multicenter quality improvement (QI) program with the goal of implementing diagnostic stewardship interventions to reduce bacterial culture use as a strategy to reduce antibiotic overuse. Investigators will use data collected by participating sites to determine whether reliable implementation of clinical practice guidelines for evaluation of patients can decrease antibiotic use in pediatric intensive care units. Investigators will perform a quasi-experimental study to compare outcome data in pre- and post- periods.

Greater than or equal to 10 institutions will participate in this collaborative. Participating institutions will develop and implement an evidenced-based clinical decision-making tool as part of their quality improvement (QI) program in their pediatric intensive care unit (PICU).

Specific Aim 1: Evaluate whether locally devised quality improvement programs focused on diagnostic stewardship of respiratory cultures lead to a reduction in respiratory cultures and antibiotic use.

Specific Aim 2: To determine whether these quality improvement initiatives are associated with unintended consequence of patient harm such as mortality, length of stay, readmissions, ventilator associated infections, sepsis and septic shock.

Variables: total respiratory culture rates, culture results, ICU length of stay, mortality rates, hospital and ICU readmission, cause of death, ventilator-associated infection/ventilator-associated condition rate, sepsis, septic shock.

Analysis: The analytic approach equates to estimating and comparing the respiratory culture incidence during the "baseline/pre-implementation" and "post-implementation" periods, using a generalized linear mixed model (GLMM) assuming a Poisson distribution for the monthly number of respiratory cultures with the monthly number of ventilator days as an offset. Similar analyses will be performed for secondary outcomes.

Первичные конечные точки

  • Respiratory Culture Rate [Срок оценки: up to 42 months]
Вторичные конечные точки (9)
  • Broad spectrum antibiotic use for ICU days >2 days [Срок оценки: up to 42 months]
  • New initiations - Broad spectrum antibiotic use for ICU days >2 days [Срок оценки: up to 42 months]
  • Mortality [Срок оценки: up to 42 months]
  • Length of ICU stay [Срок оценки: up to 42 months]
  • ICU readmission [Срок оценки: up to 42 months]
  • Hospital readmission [Срок оценки: up to 42 months]
  • ventilator associated infections [Срок оценки: up to 42 months]
  • Sepsis [Срок оценки: up to 42 months]
  • Septic shock [Срок оценки: up to 42 months]

Критерии участия

Критерии включения

  • Institutions that plan to develop and implement a quality improvement program to reduce respiratory culture use in their Pediatric ICUs

Критерии исключения

  • Institutions that do not plan to develop and implement a quality improvement program to reduce respiratory culture use in their Pediatric ICUs

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 8 центров
  • Johns Hopkins Children's Center — Baltimore
  • Boston Children's Hospital — Boston
  • Children's Minnesota Hospital — Minneapolis
  • Children's Hospital and Medical Center Omaha — Omaha
  • Cleveland Clinic Children's Hospital — Cleveland
  • Le Bonheur Children's Hospital — Memphis
  • Monroe Carell Jr. Children's Hospital — Nashville
  • Dell Children's Medical Center — Austin

Идентификаторы

NCT: NCT04987840 · IRB00263269 · K24AI141580 · R01HS028634

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗