Family Connections: Structured Family Deliberation for Decisions About Home Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Feasibility as assessed by proportion of families enrolled
研究概览
简要总结
This study seeks to evaluate a Structured Family Deliberation that will serve as the primary intervention in a multicenter controlled trial involving families considering tracheostomy and home ventilation for the child. In this study, the investigators will evaluate the feasibility, usefulness, face validity, and preliminary impact of this approach on preparedness for decision making among participants.
详细描述
The investigators will recruit 10 intervention families and 5 control families who are currently admitted to the neonatal or pediatric intensive unit and whose physician anticipates a decision about home ventilation within the next 30 days. Intervention families will receive the Structured Family Deliberation, which includes a guided review of a web-based decisional aid. Control families will receive a link to the website for independent review. All families will be assessed at 1 month with a survey assessing preparedness for decision-making, parental stress and coping, and a qualitative interview.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents/legal guardians of children admitted to the neonatal or pediatric intensive care unit and whose physician anticipates a decision about home ventilation within the next month.
排除标准
- •Parents will be excluded if:
- •their child is in foster care or state guardianship
- •they are unable to understand the purpose of the study
- •they cannot reasonably participate in study demands
- •are not fluent in English (the web-based decisional aid is not yet available in other languages).
结局指标
主要结局
Feasibility as assessed by proportion of families enrolled
时间窗: Duration of study period (12 months)
Feasibility will be measured by the proportion of families approached that are successfully enrolled.
Feasibility as assessed by time spent engaging with the website by parents
时间窗: Assessed at 30 day follow-up interview
Feasibility will be measured by time parents spend engaging with the website.
Feasibility as assessed by proportion of successfully completed interventions
时间窗: Duration of study period (12 months)
Feasibility will be measured by success completing the intervention by the study team
次要结局
- Factors in decision making as assessed by participants responses to qualitative interview questions(Assessed at 30 day follow-up interview)
- Preparedness in decision making as assessed by Preparation for Decision-Making Scale(Assessed at 30 day follow-up interview)
- Parental stress and coping as assessed by participants responses to qualitative interview(Assessed at 30 day follow-up interview)
- Usefulness of the Structured Family Deliberation Process will be assessed by participant responses to qualitative interview questions(Assessed at 30 day follow-up interview)