Preparing Family Caregivers of Very Ill Patients for End-of-Life Decision Making
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 285
- 试验地点
- 4
- 主要终点
- Self-efficacy
研究概览
简要总结
The overarching goal of the project is to improve the process and experience of surrogate decision-making by family caregivers. Since feeling unprepared to make surrogate decisions is a major contributor to caregiver stress, the primary outcome is caregiver self-efficacy --i.e., caregivers' assessment of how well prepared they feel to serve effectively as a surrogate decision-maker. Through follow-on Renewal funding, we are now also qualitatively examining family caregivers' experience with surrogate decision-making.
详细描述
The long-term goal is to help family caregivers of seriously ill patients be better prepared to serve as surrogate decision-makers when their loved ones can no longer make medical decisions for themselves. Research shows that family caregivers find surrogate decision-making highly stressful and emotionally burdensome, in part because they feel unprepared for surrogate decision-making. To date, no studies have determined which advance care planning (ACP) process best prepares caregivers for this role. The investigators' prior work shows that a computer-based decision aid can help patients make more informed decisions and communicate their wishes more effectively. The investigators now propose to determine if family caregivers of patients with life-threatening illnesses are better prepared for surrogate decision-making: 1) when they engage in a structured ACP process together with patients; and 2) when they use this online decision aid for ACP. This will be accomplished via a randomized, controlled trial with a 2 x 2 factorial design comprising 4 groups: Standard ACP/Patient Alone (Group 1), Decision Aid/Patient Alone (Group 2), Standard ACP/Patients and Caregivers Together (Group 3), and Decision Aid/Patients and Caregivers Together (Group 4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •18 years of age or older
- •Diagnosis of kidney disease (e.g. chronic kidney disease, end stage renal disease ) OR advanced cancer (Stage IV disease or having an estimated survival of <2 years) OR severe heart failure (e.g. New York Heart Assoc. Class III or Class IV) OR severe lung disease (e.g. Stage III or Stage IV COPD by modified GOLD Spirometric Classification, Idiopathic Pulmonary Fibrosis).
- •Able to read and understand English at an 8th grade level (word 26 on either blue or tan version of the WRAT-3 reading subtest)
- •Neuro-cognitively able to engage in ACP (Mini Mental State Exam (MMSE) score >23)
- •No active suicidal ideations (i.e., score of 0 or 1 on item 9 of the BDI-II).
排除标准
- •Failure on any of the above inclusion criteria.
结局指标
主要结局
Self-efficacy
时间窗: 6 weeks
Family caregiver self-efficacy is measured using a validated questionnaire to determine if they feel better prepared to serve as surrogates for their loved one.
次要结局
- Accuracy of medical decisions(6 weeks)
- Family caregiver knowledge(6 weeks - 2 years)
- Satisfaction with advance care planning(1st study visit)
- Family caregivers' stress associated with actual (i.e., real-life) surrogate decision-making(1-2 years)
- Depth of communication(2 years)
研究者
Benjamin H. Levi
Co-PI
Milton S. Hershey Medical Center
