The Caregiver Pathway - An Intervention to Support Caregivers of Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 2
- 主要终点
- Anxiety and Depression
研究概览
简要总结
The aim of the project is to test the efficacy of a systematic intervention for individual follow-up of caregivers at the intensive care unit during a 12 month randomized controlled trial.
详细描述
Caregivers of patients admitted to an intensive care unit (ICU) often experience the situation as traumatic and stressful. Long term consequences such as fatigue, anxiety, depression and symptoms of post-traumatic stress are reported among 30-50 percent of the caregivers of critically ill patients. The need for supportive interventions is called for.
The overall goal of this project is to improve the support for caregivers of intensive care patients. A systematic intervention for individual support of caregivers, The Caregiver Pathway Intervention, has been developed with a multidisciplinary approach, based on existing evidence, through interviews with former caregivers, workshops with health care personnel and user input and testing. The intervention consist of mapping of caregivers' prioritized symptoms, needs and preferences with a digital assessment tool, followed by a meeting with a nurse to address these issues, a structured conversation at discharge, and an invitation to a follow-up conversation 4-6 weeks after discharge/patients death.
The aim of the project is to test the efficacy of The Caregiver Pathway Intervention among caregivers at the ICU in a randomized controlled trial, using outcome measures such as symptoms of post-traumatic stress, anxiety/depression, cost-utility measures and health-related quality of life. The participants will be randomly assigned to The Caregiver Pathway Intervention or the follow-up as usual group. Both groups will receive outcome measures at baseline and at 3, 6 and 12 months.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caregivers of patients admitted to the intensive care unit that is expected to receive invasive mechanical ventilation for at least 48 hours
- •Between 18 and 70 years old
- •Able to understand and speak Norwegian
排除标准
- 未提供
研究组 & 干预措施
Follow up as usual (Control)
Follow up as usual at the ICU
Intervention
Structured follow up at the ICU
- 1-3 days after admittance: Map caregivers' prioritized symptoms, needs and preferences with a digital assessment tool, followed by a meeting with a nurse to address these issues.
- Every 1-2 weeks: Repeat assessment of symptoms and needs with the assessment tool followed by a meeting with a nurse.
- At discharge: Structured conversation focusing on information and preparation for the transition to a regular ward or to another hospital including a card with information and support.
- Bereavement: Individualized support based on caregiver expressed needs, preferences and previous mapping, including a card with information and support.
- Follow up: Caregivers or bereaved will be contacted after 4-6 weeks, and will be offered a follow up conversation either on phone or at the unit.
干预措施: Structured support of caregivers at the ICU (Behavioral)
结局指标
主要结局
Anxiety and Depression
时间窗: Change from baseline to f-up month 12
Anxiety and Depression will be measured with the Hospital Anxiety and Depression Scale (HADS). HADS consists of 14 items, and two subscales with seven items respectively. Score range is 0-21 for each subcale. Scores: 0-7= Normal, 8-10= Borderline abnormal (borderline case), 11-21= abnormal (case).
Quality Adjusted Life Years (QUALYs)
时间窗: Group differences at f-up month 12
Quality Adjusted Life Years (QUALYs), an economic evaluation of the quality and quantity of life lived, will be derived from the RAND-12 (Short form health survey, developed by the non profit RAND corporation). QUALY scores range from 1 (perfect health) to 0 (death).
Post traumatic stress
时间窗: Group differences at f-up month 12
Post traumatic stress will be measured with the Impact of Event Scale-Revised (IES\_R). The total score for the IES\_R ranges from 0 to 88. A higher score represents more severe symptoms of post traumatic stress disorder.
Post traumatic stress
时间窗: Group differences at f-up month 3
Post traumatic stress will be measured with the Impact of Event Scale-Revised (IES\_R). The total score for the IES\_R ranges from 0 to 88. A higher score represents more severe symptoms of post traumatic stress disorder.
Post traumatic stress
时间窗: Group differences at f-up month 6
Post traumatic stress will be measured with the Impact of Event Scale-Revised (IES\_R). The total score for the IES\_R ranges from 0 to 88. A higher score represents more severe symptoms of post traumatic stress disorder.
次要结局
- Health related quality of life(Change from baseline to f-up month 12)
- Hope(Change from baseline to f-up month 12)
- Caregiver satisfaction.(Group differences at f-up month 3)
- Caregivers burden(Group differences at f-up month 12)
- Self-Efficacy.(Change from baseline to f-up month 12)
- Complicated grief(Group differences at f-up month 12)
研究者
Elin Børøsund
Senior researcher
Oslo University Hospital