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临床试验/NCT00471016
NCT00471016已完成不适用

An Intervention to Improve End of Life Decision Making Among Homeless Persons

University of Minnesota2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2006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
59
试验地点
2
主要终点
Completion of an advance directive

研究概览

简要总结

This project is a prospective, randomized controlled trial to improve the end of life experience for homeless persons by facilitating the expression of their wishes and enhancement of their dignity when facing serious illness, death, or the prospect of dying. Our main hypothesis is that homeless persons will engage in this intervention and increase rates of advance directive completion.

详细描述

This project is a prospective, randomized controlled trial to improve the end of life experience for homeless persons by facilitating the expression of their wishes and enhancement of their dignity when facing serious illness, death, or the prospect of dying. Our main hypothesis is that homeless persons will engage in this intervention and increase rates of advance directive completion.

Participants were recruited from Listening House, a drop-in center for homeless individuals located in St. Paul, Minnesota and represent a convenience sample. Participants were required to speak English, not be overtly intoxicated, and have been homeless during the previous six months. The study was reviewed and approved by the institutional review board of the University of Minnesota. All participants who entered the study gave written and oral consent for randomization and data measurement and screening.

After recruitment and consent, participants were randomized into two intervention arms, minimal intervention (MI) and guided intervention (GI). All participants received educational materials about advance directives and advance care planning, pre-intervention surveys, and an advance care planning document, designated HELP, specifically designed for marginalized populations to preserve autonomy and elicit preferences of EOL care.

All participants completed a baseline written pre-test and survey. For this, they received compensation of $5. Those randomized to the minimal intervention were provided the opportunity to complete a HELP document if they so desired. Participants randomized to the GI group were provided with the written instructions and tools and asked to return to meet with investigators for one-on-one counseling and assistance in completion of the HELP document on one of several days later during the week of enrollment. Three months after enrollment, post-intervention evaluations were sought from both MI and GI subjects. There was no financial incentive offered for completion of the HELP form.

Measurement The primary outcome of interest was the completion of a legally valid advance directive, the HELP document, which was measured by inspection of HELP documents as well as self-report. Secondary outcomes include knowledge, attitude, and behavior variables measured through a questionnaire administered at baseline and at follow-up. Demographic information, including education and living situations, was also collected at baseline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Homeless in last six months
  • Speak English
  • Age 18-65

排除标准

  • Intoxicated

结局指标

主要结局

Completion of an advance directive

时间窗: Three months

次要结局

  • Knowledge, attitude, and behavioral measures(Three months)

研究者

申办方类型
Other

研究点 (2)

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