Comparison of Tele-Critical Care Versus Usual Care On ICU Performance: A Cluster Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 19,360
- 试验地点
- 1
- 主要终点
- Intensive Care Unit Length of Stay
研究概览
简要总结
TELESCOPE will be a cluster randomized clinical trial to ascertain whether the use of an intervention including multidisciplinary round with a board certified physician through tele-critical care and periodic meetings to discuss strategies to improve quality indicators can reduce ICU length of stay of patients admitted to intensive care units (ICUs).
详细描述
Cluster randomized trial involving ICUs in Brazil. ICU is the unit of randomization.
The trial will have two stages:
Stage I - Baseline data:
- Characterize participant ICUs and quality indicators
- Characterize patients from each participant ICU to describe baseline outcomes
Stage II - Intervention:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •for Clusters:
- •Intensive care units from public hospitals and with at least eight beds
- •Intensive care units with physician and nurses available 24 hours a day
排除标准
- •for Clusters:
- •Intensive care units with structured multidisciplinary round more than three times a week based in a formal instrument
- •Intensive care units already doing audit & feedback
- •Dedicated coronary care units/cardiac intensive care units or other specialized units
- •Step-down units
- •Inclusion Criteria for Patients:
- •Adult patients (> 18 years old)
- •Admitted after the beginning of the study
- •Exclusion Criteria for Patients:
- •Admission for other reasons than medical (e.g., judicial cause)
- •Previously included in TELESCOPE (for the primary outcome analysis)
研究组 & 干预措施
Usual Care
Usual Care.
Tele-Critical Care
Tele-Critical Care + Audit & Feedback.
干预措施: Tele-Critical Care (Behavioral)
结局指标
主要结局
Intensive Care Unit Length of Stay
时间窗: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
Time until discharge from the intensive care unit
次要结局
- In-Hospital Mortality(From date of randomization until the date of hospital discharge or death, whichever comes first, assessed up to 90 days)
- Incidence Density of Urinary Tract Infection Associated with Catheter(From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days)
- Patient-Days Receiving Oral or Enteral Feeding(From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days)
- Patient-Days Under Light Sedation or Alert and Calm(From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days)
- Standardized Resource Use(From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days)
- Standardized Mortality Rate(From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days)
- Incidence Density of Central Line-Associated Bloodstream Infection (CLABSI)(From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days)
- Incidence Density of Ventilator-Associated Pneumonia (VAP)(From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days)
- Ventilator-Free Days at Day 28(28 Days)
- Rate of Patients Under Normoxia(From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days)
