Decision Making Support for Parents and Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Enrollment Rate (Critically Ill Infants)
研究概览
简要总结
The purpose of this study is to test the feasibility and acceptability of a tool to support decision making for parents of critically ill infants.
详细描述
In this single-arm mixed methods prospective feasibility study, we will enroll infants, parents, and clinicians. The intervention is a paper-based decision guide that contains a values clarification exercise and question prompt list.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Enrollment Rate (Critically Ill Infants)
时间窗: At enrollment (approximately 9 months)
Intervention and study procedures considered feasible if infant enrollment rate is greater than or equal to 50%.
Complete Data Collection (Critically Ill Infants)
时间窗: approximately 9 months
Complete data collection defined as all eligible infant, parent, and clinician data points collected for a given case and was determined at the level of the critically ill infant. Data points for which the participant withdrew prior to relevant data collection were excluded. Intervention and study procedures considered feasible if complete data collection rate is greater than or equal to 80%.
次要结局
- Parent and Clinician Acceptability(Up to 4 weeks following use of the tool)
- Parent Psychological Distress, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)(Baseline, and up to 4 weeks following use of the tool)
- Parent Preparation for Decision Making, as Measured by the PrepDM(Up to 4 weeks following use of the tool)