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临床试验/NCT02429479
NCT02429479已完成不适用

Preparing Family Caregivers of Very Ill Patients for End-of-Life Decision Making

Milton S. Hershey Medical Center4 个研究点 分布在 1 个国家目标入组 285 人开始时间: 2013年6月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Benjamin H. Levi

Co-PI

Milton S. Hershey Medical Center

研究点 (4)

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