Implementing an Intensive Care Unit (ICU) Diary Program at a Large Academic Medical Center: Results From a Randomized Control Trial Evaluating Psychological Morbidity Associated With Critical Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in PTSD symptoms
研究概览
简要总结
Psychological morbidity in both patients and family members related to the intensive care unit (ICU) experience is an often overlooked, and potentially persistent, healthcare problem recognized by the Society of Critical Care Medicine as Post-intensive Care Syndrome (PICS). ICU diaries are an intervention increasingly under study with potential to mitigate ICU-related psychological morbidity, include ICU-related PTSD (post-traumatic stress disorder), depression and anxiety.
详细描述
The investigators compared the efficacy of the ICU diary, prospectively written by third-parties during the patient's intensive care course, versus education-alone, on reducing acute PTSD symptoms after discharge. Patients with an ICU stay greater than 72 hours, and who were intubated and mechanically ventilated over 24 hours, were recruited and randomized to either receive a diary at bedside with psychoeducation, or psychoeducation alone. Intervention patients received their ICU diary within the first week of admission into the intensive care unit. Psychometric testing with IES-R, PHQ-8, HADS and GAD-7 was conducted at weeks 4, 12, and 24 after ICU discharge.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •admitted to the intensive care unit for at least 72 hours
- •sedated and mechanically ventilated for at least 24 hours.
- •available over-the-phone, up to 6 months post-ICU discharge
排除标准
- •any patients who do not voluntarily agree to participate
- •not fluent in the English language
- •patients who have stayed in the ICU for less than 72 hours
- •patients who have been sedated and mechanically ventilated for less than 24 hours
- •patients with pre-existing severe psychotic illness, bipolar disorder, substance use disorder, PTSD, stroke, traumatic brain injury, neurocognitive impairment, or intellectual disability
- •patients with no phone number or reliable contact information for the sake of follow-up
- •prisoners
- •pregnant patients
研究组 & 干预措施
ICU Diary Group
Patients randomized to this group receive the ICU diary, along with PTSD education
干预措施: Diary (blank journal) plus PTSD psycho-education (Other)
ICU Diary Group
Patients randomized to this group receive the ICU diary, along with PTSD education
干预措施: PTSD psycho-education alone (Other)
PTSD Education-only Group
Control Group: patients randomized to this group only receive PTSD education
干预措施: PTSD psycho-education alone (Other)
结局指标
主要结局
Change in PTSD symptoms
时间窗: at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge
Revised Impact of Event Scales (IES-R) score, measuring areas of hyperarousal, avoidance, and intrusion as subscales. Total score ranges from 0-88, higher score associated with worse PTSD symptoms. Scores from 1-22 are consistent with mild PTSD, and scores greater than 22 signal clinically significant PTSD symptoms.
次要结局
- Change in Hospital-associated Depression and Anxiety symptoms(at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge)
- Change in Depression symptoms(at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge)
- Change in Anxiety symptoms(at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge)