Building Relationship, Improving Dialogue, and Growing Empathy (BRIDGE): An Intervention to Support Decision Making for Critically Ill Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 495
- 试验地点
- 6
- 主要终点
- Parent Preparation for Decision Making, as measured by the PrepDM
研究概览
简要总结
Parents of young children in the intensive care unit may be faced with decisions about their child's care. The Building Relationship, Improving Dialogue, and Growing Empathy (BRIDGE) intervention was designed to help support parents as they make decisions for their child and communicate with the health care team. The main questions this study aims to answer are:
- Do parents who receive the BRIDGE intervention report being better prepared to make decisions for their child?
- Do parents who receive the BRIDGE intervention report less regret about the decisions they made for their child?
Participants will complete surveys at baseline and approximately 2 weeks, 6 months, and 12 months following enrollment. Some participants will also participate in interviews about their experiences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child inclusion criteria will include:
- •Age < 5 years
- •Admission to a critical care unit within the preceding 14 days
- •An anticipated serious health care decision, defined as a decision about initiating, not initiating, or withdrawing life-sustaining treatment and/or a decision about major intervention.
- •Parent inclusion criteria will include:
- •Age ≥ 18 years
- •The ability speak English or Spanish.
- •Clinician inclusion criteria will include
- •Clinical team member of an enrolled child and parent in the intervention group
- •Completion of residency or equivalent training.
排除标准
- •Children, parents or clinicians who do not meet the inclusion criteria above.
研究组 & 干预措施
Usual Care
Usual Care
Intervention
In the BRIDGE intervention arm, parents will receive a paper-based tool that includes an introduction to decision-making, a values clarification exercise, and a question prompt list. The tool additionally prompts parents to share how they define decision-relevant concepts like quality of life and suffering for their child. The completed tool is shared with the medical team in the electronic health record.
干预措施: BRIDGE intervention (Behavioral)
结局指标
主要结局
Parent Preparation for Decision Making, as measured by the PrepDM
时间窗: Approximately 10-14 days following enrollment
Items can be summed and scored. Score ranges from 0-100, where a higher score indicates higher perceived preparedness for decision making.
Decisional Regret, as measured by the Decision Regret Scale
时间窗: Approximately 6 and 12 months following enrollment
Decisional Regret will be measured by the Decision Regret Scale (DRS): The DRS is a 5- item scale used to measure distress or remorse after a health care decision.
次要结局
- Shared Decision Making Quality, as measured by the CollaboRATE (Parent version)(Approximately 10-14 days following enrollment)
- Communication Quality, as measured by the Interpersonal Processes of Care (IPC-18)(Baseline; Approximately 10-14 days following enrollment)
- Decisional Conflict, as measured by the Decisional Conflict Scale(Approximately 10-14 days following enrollment; Approximately 6 and 12 months following enrollment)
- Parent Self-efficacy, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for Managing Chronic Conditions(Approximately 6 and 12 months following enrollment)