Enhanced Recovery After Intensive Care (ERIC) - a Multi-Center Stepped Wedge Cluster-Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,463
- 试验地点
- 26
- 主要终点
- QI 'Daily multiprofessional and interdisciplinary clinical visits with documentation of daily goals'
研究概览
简要总结
The primary objective of the multi-center stepped-wedge cluster-randomized controlled trial ERIC is to evaluate the effects of a multi-component telemedicine-based intervention delivered by the ICU on the adherence to quality indicators (QI) in intensive care medicine compared to usual care.
Critically ill patients treated on the interventional condition receive daily tele-medical rounds during their ICU stay.
Further secondary objectives are to demonstrate whether the intervention improves patient outcomes 3 and 6 months post ICU discharge, compared to usual care.
详细描述
Rationale:
Survivors of critical illness frequently develop long-term mental, cognitive, and/or physical impairments summarized as Post Intensive Care Syndrome (PICS). On the national society level, Germany uses 10 core QIs that are evidence-based to improve treatment quality at ICUs.
Objective:
To investigate whether a tele-medical intervention delivered at ICU improves the adherence to established evidence-based QIs in intensive care medicine compared to the adherence at ICUs delivering usual care.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Expected to receive treatment in a medical or surgical ICU connected to the project for more than 24 hours
- •Coverage by a German statutory health insurance company
- •Written informed consent of patient or legal representative
排除标准
- •Age < 18 years
- •Institutional level:
- •Inclusion Criteria:
- •Located in the Berlin/Brandenburg metropolitan region
- •Adherence to general legal obligations to participate in the study funded by the German Innovation Fund and participate in the respective contracts.
- •Adherence to cluster-randomization
- •Exclusion Criteria:
- •No intensive care beds available
结局指标
主要结局
QI 'Daily multiprofessional and interdisciplinary clinical visits with documentation of daily goals'
时间窗: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
QI 'Management of sedation, analgesia, and delirium'
时间窗: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
QI 'Patient-adapted ventilation'
时间窗: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
QI 'Early weaning from invasive ventilation'
时间窗: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
QI 'Measures for infection management'
时间窗: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
QI 'Early enteral nutrition'
时间窗: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
QI 'Documentation of structured patient and family communications'
时间窗: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
QI 'Early mobilization'
时间窗: From enrolment to ICU discharge; Patients assessed for the duration of their ICU stay after enrolment, expected average of 14 days.
The adherence \[fulfilled yes/no\] to this intra-hospital QI is daily assessed on a patient-level
次要结局
- All-cause mortality(Up to 6 months following the first study-related ICU admission)
- Mental Health Condition - Depression and Anxiety(3 and 6 months after ICU discharge)
- Mental Health Condition - Post-traumatic Stress(6 months after ICU discharge)
- Cognition - MiniCog(3 and 6 months after ICU discharge)
- Cognition - Animal Naming Test(3 and 6 months after ICU discharge)
- Physical Function - Timed Up & Go Test(3 and 6 months after ICU discharge)
- Physical Function - Hand grip strength test(3 and 6 months after ICU discharge)
- Health-related quality of life(3 and 6 months after ICU discharge)
- Organ dysfunction(3 and 6 months after ICU discharge)
- Pulmonary Function - Dyspnea(6 months after ICU discharge)
- Outpatient ventilation(Up to 6 months after ICU discharge)
- Patient-reported Functioning and Disability (WHO Disability Assessment Schedule).(6 months after ICU discharge)
研究者
Claudia Spies
Head of the Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK
Charite University, Berlin, Germany