Family Information Management in the Intensive Care Unit: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- Subjective distress
研究概览
简要总结
Relatives in intensive care units (ICU) are important partners in decision-making in the treatment of critically ill patients and provide a significant resource in the care and recovery of patients. Therefore, a professional, educational intervention targeting these caregivers may have fundamental benefits with little risk. As in other fields, information is searched in the internet, but this unselected information is often overwhelming and of little use in this context.
Symptoms of anxiety, stress and depression are common in affected relatives. The majority of family members report some level of anxiety, depression and stress, sometimes even resulting in post-traumatic stress disorder (PTSD). Importantly, an association between lack of information and post-traumatic stress disorder PTSD has been reported. The large number of potentially affected families poses a particular challenge to healthcare and may cause substantial secondary costs to national economy.
详细描述
Design:
- Phase: Empirical study (quantitative) of information needs - semi-structured interviews with family members, physicians and caregivers
- Phase: Development of user friendly homepage with University of Applied Sciences Joanneum and validation of the homepage with medical professionals and laypersons
- Phase: Randomized Controlled Trial (non-blinded) with "placebo home page" (N=110)
Background:
Relatives in intensive care units (ICU) are important partners in decision-making in the treatment of critically ill patients and provide a significant resource in the care and recovery of patients. Therefore, a professional, educational intervention targeting these caregivers may have fundamental benefits with little to no risk. As in other fields, information is searched in the internet, but this unselected information is often overwhelming and of little use in this context.
In Austria there are 2784 systemized intensive care beds with an average occupation of 3,6 days, representing 100 new admissions per year/ICU bed. This may translate to 500.000 affected family members per year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •anticipated further ICU stay ≥3 days (index patient)
排除标准
- •lack of Basic Information Technology (IT) user knowledge or German language skills
- •DNR (Do not resuscitate) orders (index patient)
结局指标
主要结局
Subjective distress
时间窗: 30 Days
Impact of Event Score (IES: symptoms of post traumatic stress disorder)
次要结局
- Subjective usefulness of the website for relatives(30 days)
- Length of stay(90 days)
- Mortality(90 days)
- Readmissions(90 days)
- User-statistics(30 days)
- Levels of anxiety and depression(30 days)