Relieving the Burden of Psychological Symptoms Among Families of Critically Ill Patients With COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Symptoms of Post-Traumatic Stress Disorder (PTSD) Initial
研究概览
简要总结
Families of patients in Intensive Care Units (ICUs) are at increased risk for developing psychological symptoms that can last for months after the patient is discharged. These symptoms can have significant impact on both the patient and family member's quality of life.
The investigators have found that families of patients admitted to the Rush University Medical Center ICU during to the COVID-19 pandemic were more likely to develop clinically significant psychological symptoms than families of patients admitted prior to the COVID-19 pandemic. The investigators suspect that this finding is due in part to the hospital-wide no visitation policy that altered our standard communication practices and may have prevented families from being active participants in the patient's medical care.
The goals of this project are 1) to determine the prevalence of psychological disorders among families of COVID-19 patients after ICU discharge 2) to determine the characteristics of ICU care that were associated with the development of psychological disorders among family members and 3) to pilot a program in which families with psychological disorders after ICU discharge receive therapy from mental health professionals.
详细描述
Part 1- Post-ICU discharge survey and Interview Upon enrollment in this post-ICU discharge follow-up study, the subject (surrogate of the ICU patient) will complete a survey dealing with the patient's course since Rush discharge
-
Is the patient still alive?
-
If deceased, did the patient pass away at Rush or after discharge from Rush?
-
If alive, is the patient at home?
i. If at home, for how long? Is he/she receiving home health services? 2. If the patient did not pass away at Rush, did the patient spend time in a rehabilitation hospital, nursing home, or long-term acute care hospital after discharge from Rush? 3. Is the patient currently having any of the following symptoms (check all that apply).
- Fatigue
- Trouble Breathing
- Difficulty speaking
- Difficulty eating
- Difficulty thinking or paying attention
- Pain or discomfort
- Anxiety
- Depressed mood
- Difficulty moving or walking
- Difficulty performing activities of daily living such as dressing or bathing
- Have the subject used mental health services since the time the patient was admitted?
- What is the subject's overall impression of mental health services (choices ranging from very unhelpful to very helpful)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient's surrogate was enrolled in "ICU Rounding Summaries for Families of Critically Ill Patients" (NCT03969810) and the patient had COVID-19
- •The patient has been discharged from the hospital
排除标准
- 未提供
结局指标
主要结局
Symptoms of Post-Traumatic Stress Disorder (PTSD) Initial
时间窗: Measured once upon enrollment
Score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.
Symptoms of Anxiety and Depression Initial
时间窗: Measured once upon enrollment
Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.
次要结局
- Interview Initial(Measured once upon enrollment)
- Interview Final(Measured after behavioral intervention (12-24 weeks after enrollment))
- Surrogate Satisfaction With the Patient's ICU Care:(Measured once upon enrollment)
- Symptoms of Post-Traumatic Stress Disorder (PTSD) Final(Measured after behavioral intervention (12-24 weeks after enrollment))
- Symptoms of Anxiety and Depression Final(Measured after behavioral intervention (12-24 weeks after enrollment))