Four Conversations Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 357
- 试验地点
- 2
- 主要终点
- Change in patient/caregiver decision making self-efficacy as measured by the Decision Self-efficacy Scale
研究概览
简要总结
The purpose of this study is to see whether patients with metastatic breast cancer, their caregivers, and their healthcare providers can improve in shared decision making (SDM) and preparedness around end of life (EOL) planning through participation in Reimagine's online Four Conversations™ program. The goal is to close clinical practice gaps and enhance the quality of care for patients with metastatic breast cancer through increased competence and performance of healthcare providers and healthcare systems.
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
- •Diagnosed with metastatic breast cancer (MBC), caregiver to patient with MBC who is enrolled in this study, or MBC provider
- •Age ≥ 18 years
- •Internet access through a computer, laptop, tablet, or other mobile device
- •Able/willing to have an online interaction with a Reimagine Pillar Guide
- •Providing informed consent
- •Able to read/write English
排除标准
- 未提供
研究组 & 干预措施
Four Conversations Intervention
Subjects in this arm will participate in Reimagine's online Four Conversations program during the initial study period of four weeks.
干预措施: Four Conversations (Behavioral)
Waitlisted Control
Subjects in this arm will continue to receive standard care from their healthcare providers during the initial study period (i.e. no intervention). After four weeks, subjects will then participate in Reimagine's online Four Conversations program.
干预措施: Four Conversations (Behavioral)
结局指标
主要结局
Change in patient/caregiver decision making self-efficacy as measured by the Decision Self-efficacy Scale
时间窗: Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
The Decision Self-efficacy Scale is a reliable and validated instrument that measures self-confidence or belief in one's abilities in decision making, including shared decision making (SDM). Items are summed, divided by 11, and multiplied by 25. Scores range from 0 to 100 (very confident).
Change in patient self-conflict as measured by the Decisional Conflict Scale
时间窗: Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
The Decisional Conflict scale is a reliable and validated measure of the state of uncertainty about a course of action. Items are summed, divided by 16, and multiplied by 25. Scores range from 0 to 100 (high decisional conflict).
Change in patient/caregiver and provider preparedness for decision making as measured by the Preparation for Decision Making Scale
时间窗: Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
The Preparation for Decision Making Scale is a reliable and validated self-reported measure of the patient/caregiver or provider's perception of how useful a decision support intervention is in preparing the respondent to communicate with others making a health decision. Items are summed and scored, then divided by 10; scores can be converted to a 0-100 scale. Higher scores indicate higher perceived level of preparation for decision making.
次要结局
- Change in patient/caregiver and provider end of life (EOL) conversations as measured by EOL Conversations(Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8))
- Change in provider end of life (EOL) care knowledge as measured by revised City of Hope EOL Knowledge Assessment(Baseline, Post-Intervention (Week 4))
- Change in patient and caregiver quality of life (QOL) as measured by the PROMIS Global Scale(Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8))