NCT02940028Unknown不适用
ICU Experience Among Family Members of ICU Patients
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Posttraumatic Growth Inventory
研究概览
简要总结
The ICU is a stressful and challenging place for patients and their families. Many family members experience anxiety, depression, and post-traumatic stress disorder during and after their ICU experience. The investigators are studying post-traumatic growth in this study. Post-traumatic growth (PTG) is a set of positive changes that occurs after a challenging or difficult life experience. This study investigates the effects of expressive writing on positive changes that occur after a difficult experience. PTG will be compared between the intervention group receiving the expressive writing intervention and the control group (non-expressive or fact based writing).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Family members of ICU patients are eligible for the study. We will enroll one study participant per patient admitted to a study ICU (Shock Trauma or Respiratory ICU at Intermountain Medical Center) who meets the following inclusion criteria:
- •Participant can be a family member of a patient admitted to a study ICU for >24 hours and ≥1 of the following:
- •mechanical ventilation via endotracheal tube for ≥ 12 hours
- •non-invasive ventilation (CPAP, BiPAP) for > 4 hours in a 24-hour period provided for acute respiratory failure in an ICU (not for obstructive sleep apnea or other stable use)
- •high flow nasal cannula or face mask O2 with FiO2 ≥ 0.5 for ≥4 hours
- •use of vasopressors for shock of any etiology for >1 hour
- •Both participant and ICU patient must be adult (age ≥18 years of age)
- •Participant must be able to read, speak, and write in English
- •Participant must be enrolled within 72 hours of the patient's meeting mechanical ventilation criteria
- •Participants who live with the patient will be accorded higher priority than those who do not live with the patient because they are more likely to be involved as caregivers. The preference would be for the participant to be the designated power of attorney; if there is no designated power of attorney living with the patient, then the primary informal caregiver (identified either by the patient or by the family) would be enrolled; if either of these is not available, the default surrogate (defined in figure 1) would be enrolled. If no one living with the patient meets these criteria, then family members and informal caregivers not living with the patient will be screened for the study. The preference would again be for first, the designated power of attorney, then a primary caregiver and a default surrogate. An informal caregiver provides care without reimbursement.
排除标准
- •Pregnant or breastfeeding females
- •Prisoners
- •Children (age <18 years of age)
- •Known history of PTSD, dementia, or schizophrenia. Presence of these illnesses will be per participant report of physician diagnosis and treatment
- •If a patient has been transferred from another ICU after an ICU course greater than 24 hours, or if the patient has had a previous ICU or long term acute care (LTAC) admission in the last 90 days, the family member or caregiver will be excluded.
- •Patients admitted for hospice
- •Participants who live more than 200 miles away or who have no specified domicile
- •Non-English speaking
结局指标
主要结局
Posttraumatic Growth Inventory
时间窗: 4 months
次要结局
- Groningen Activity Restriction Scale (GARS)(4 months)
- Impact of Event Scale Revised (IES-R)(4 months)
- Perceived Stress Scale(4 months)
- Brief COPE(4 months)
- Activity Restriction Scale(4 months)
- Essay Evaluation Measure(4 months)
- Hospital Depression and Anxiety Scale(4 months)
- Physical Symptoms Scale(4 months)
研究者
研究点 (2)
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