Bundle Consent and Expectation Setting in Pediatric Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 333
- 试验地点
- 2
- 主要终点
- Parent/Caregiver Stress 48 to 72 Hours Following Admission to the Pediatric ICU
研究概览
简要总结
The purpose of this research study is to find out about how obtaining consent for procedures in the PICU affects parental/caregiver stress. The researchers think that alleviating some of the uncertainly of a PICU stay by discussing types of procedural support offered and obtaining informed consent prior to their immediate necessity may help decrease stress experienced by caregivers. This study will allow the researchers to learn more about it.
详细描述
Having a child admitted to the Pediatric Intensive Care Unit (PICU) is a deeply challenging and stressful experience for parents and caregivers. Despite the high survival when compared to adult ICUs, a PICU admission can have meaningful long-term, negative health consequences for adult caregivers including symptoms of depression, anxiety and PTSD. There is little known in regards to what specific factors impact the mental health of parents/caregivers of PICU patients. However, research into stress and anxiety has suggested that uncertainty is a significant contributor to stress when faced with a new environment.
Usual informed consent for procedures performed in the PICU is obtained immediately prior to the procedure. Participants will be randomly assigned (like the flip of a coin) to either usual informed consent prior to each procedure or to a single consent form obtained upon admission to PICU for possible procedures their child may undergo. In this study participants will be asked to complete a survey at two separate times during the child's PICU hospitalization- 48-72 hours after admission and again upon transfer or discharge from the PICU. Data will be collected about the child from the medical record including age, diagnosis/reason for PICU admission, length of stay, and any procedures performed in PICU requiring consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Parents/caregivers (>18 years) of children admitted to the Pediatric ICU during the designated study period
排除标准
- •Anticipated length of PICU stay < 24 hours
- •Non-English speaking parents/caregivers
结局指标
主要结局
Parent/Caregiver Stress 48 to 72 Hours Following Admission to the Pediatric ICU
时间窗: 48 - 72 hours after admission of child to PICU
Stress will be assessed using the Short Stress Overload Scale (SOS-S). The SOS-S is a 10 item questionnaire. Items are rated not at all (1) to a lot (5). Ratings are assigned a score and the scores are summed. Summed scores range from 10 - 50 with higher scores indicating greater stress. The SOS-S generates two subscores, Personal Vulnerability (PV) and Event Load (EL), with a score range from 5 to 25 for each. An individual's PV score corresponds to that individual's readiness to take on new stressors. Parents may be asked to complete the questionnaire multiple times depending on how long their child is in the PICU. This outcome measure only represents the PV portion of the SOS scale making the range from 5-25 (total of 5 questions each with a 1-5 scale).
次要结局
- Parent/Caregiver Stress at Time of Discharge From the Pediatric ICU(At discharge or transfer out of PICU or 30 days after admission to the PICU, whichever comes first.)
- Number of Procedures Performed Without Appropriately Documented Consent(At discharge or transfer out of PICU or 30 days after admission to the PICU, whichever comes first.)