Patient*Innenbezogene Auswirkungen Prozessverantwortlicher Pflege
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- duration of delirium
研究概览
简要总结
After a one-year phase of development, primary nursing (process-responsible nursing; PP) has been practically implemented on a pilot ICU since January 2022 at the Heart and Diabetes Center NRW. PP plan, coordinate and evaluate the nursing carried out. In the further course, an examination between the project ICU and another ICU without PP with a focus on thoracic and cardiovascular surgery (surgical ICU) is to be carried out.
The primary goal of this pilot study is to test the feasibility of a large-scale RCT with patient-related outcomes.
详细描述
After a one-year phase of development, primary nursing (process-responsible nursing; PP) has been practically implemented on a pilot ICU since January 2022 at the Heart and Diabetes Center NRW.
Previously, the system of room care (standard care) was carried out. PP plan, coordinate and evaluate the nursing carried out. In addition, they take on the care responsibility for a maximum of two patients and also carry out the care at the same time. In the further course, an examination between the project ICU and another ICU with a focus on thoracic and cardiovascular surgery (surgical ICU) is to be carried out.
The primary goal of this pilot study is to test the feasibility of a large-scale RCT. For this purpose, the duration of delirium after the introduction of a PP on the project ICU should be compared with the previous care organization as standard care in a surgical ICU. Secondary goals e.g. include: the incidence of delirium, anxiety, as well as the satisfaction of the relatives and the effects of PP on nurses are shown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients are included who are at least 65 years old,
- •understand German language,
- •whose health insurance company has concluded a quality contract with the Heart and Diabetes Center NRW (HDZ NRW),
- •Elective thoracic and cardiovascular surgery,
- •Intensive care for at least three days on ICU.
- •at least 18 years old,
- •patients have to receive PP.
- •Focus group interview with nurses of the intervention-ICU:
- •Nurses have to be at least 18 years old,
- •Nurses belong the the intervention-ICU.
排除标准
- •Patients who
- •are < 65 years old,
- •whose health insurance company has not concluded a quality contract with the HDZ NRW,
- •cannot be admitted due to allocation by randomization and a lack of free bed on the destination ICU,
- •have not given their informed consent,
- •cannot participate in the CAM-ICU screening due to neurological diseases,
- •in whom the screening using CAM-ICU could not be carried out over the entire intensive care stay and/or
- •belong to the target group but stay less than three days after their elective operation in the ICU.
- •not at least 18 years old and/or
- •the patients do not receive PP.
- •Focus group interview with nurses of the intervention-ICU:
- •Nurses who are not at least 18 years old and
- •Nurses do not belong to the intervention-ICU.
结局指标
主要结局
duration of delirium
时间窗: 3 times per day over one year.
As a syndrome, delirium represents a serious brain-organic emergency situation with dangerous consequences. The incidence of delirium in cardiac surgery ranges from \<10% to \>25%. Data collection: Confusion Assessment Method for Intensive Care Unit (CAM-ICU).
次要结局
- pain (incidence and strength of pain)(3 times per day over one year.)
- anxiety(3 times per day over one year.)
- satisfaction of the relatives(Once during ICU-care over one year.)
- incidence and risk of decubitus(Once per day over one year.)
- incidence of delirium(3 times per day over one year.)
- need of care (Barthel-Index)(Once per week over one year.)
- effects of PP on nurses (only intervention group)(Once during the study in one year.)