The Impact of nUrsiNg DEliRium Preventive INterventions in the Intensive Care Unit (UNDERPIN-ICU): A Multi-centre, Stepped Wedge Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,750
- 试验地点
- 12
- 主要终点
- The number of delirium-coma-free days
研究概览
简要总结
Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with serious short- and long-term consequences. This study focuses on a program of standardized nursing and physical therapy interventions to prevent delirium in the ICU, and determines the effect of the program on the number of delirium-coma-free days in 28 days and several secondary outcomes in a multicenter randomized controlled trial.
详细描述
Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with serious short- and long-term consequences, including re-intubations, ICU readmissions, prolonged ICU and hospital stay, persistent cognitive problems, and higher mortality rates. Considering the high incidence of delirium and its consequences, prevention of delirium is imperative. This study focuses on a program of standardized nursing and physical therapy interventions to prevent delirium in the ICU, called UNDERPIN-ICU (nUrsiNg DEliRium Preventive INterventions in the ICU).
Objective
To determine the effect of the UNDERPIN-ICU program on the number of delirium-coma-free days in 28 days and several secondary outcomes, such as delirium incidence, the number of days of survival in 28 and 90 days and delirium-related outcomes.
Design and Setting: A multicenter stepped wedge cluster randomized controlled trial.
Methods: Eight to ten Dutch ICUs will implement the UNDERPIN-ICU program in a randomized order. Every two months the UNDERPIN-ICU program will be implemented in an additional ICU following a two months period of staff training. UNDERPIN-ICU consists of standardized protocols focusing on several modifiable risk factors for delirium, including cognitive impairment, sleep deprivation, immobility and visual and hearing impairment.
Participants: ICU patients aged ≥ 18 years (surgical, medical, or trauma) and at high risk for delirium, E-PRE-DELIRIC ≥35%, will be included, unless delirium was detected prior ICU admission, expected length of ICU stay is less then one day or when delirium assessment is not possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- •aged ≥ 18 years
- •surgical, medical or trauma patients
- •admitted to one of the participating ICUs
- •at high risk for delirium (>35% determined with the E-PRE-DELIRIC prediction tool)
排除标准
- •delirious before ICU admission
- •an ICU stay < one day
- •reliable assessment for delirium is not possible due to: sustained coma; serious auditory or visual disorders; inability to understand Dutch; severely mentally disabled; serious receptive aphasia.
结局指标
主要结局
The number of delirium-coma-free days
时间窗: 28 days
The number of days a patient is not delirious and not in coma in 28 days starting from the day of inclusion in the study after ICU admission.
次要结局
- Incidence of physical restraints(28 days)
- Health related quality of Life (HRQoL)(365 days after ICU admission)
- ICU length of stay(365 days)
- Hospital length of stay(365 days)
- Post-hoc analysis(During admission)
- Duration of mechanical ventilation(28 days)
- Incidence of re-intubation(28 days)
- Incidence of unplanned removal of tubes/catheters(28 days)
- Delirium incidence(28 days)
- The number of days of survival(90 days)
- Incidence of ICU re-admission(28 days)
- Cost-effectiveness(During ICU admission)