A Randomized Trial of Expanded Choice Sets to Increase Completion of Advance Directives
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 321
- 试验地点
- 15
- 主要终点
- advance directive
研究概览
简要总结
There is a large gap between the care seriously ill patients want and the care they receive. Advance directives (ADs) offer an opportunity for patients to express specific end-of-life preferences to avoid unwanted care. As promising as ADs may be for improving the quality of care near the end of life, rates of AD completion remain low and previous efforts to encourage their completion have had limited success. Principles of behavioral economics, such as the effects of defaults and other framing effects, may offer a novel approach to bridge the gap in end-of-life care. The goal of this study is to test whether the framing effect of expanding choice sets can increase the completion of and specification of choices within advance directives.
详细描述
This study has been designed as two sequential randomized trials to test two separate expanded choice set interventions, with the second randomization enrollment being contingent on results from the first. All enrolled subjects will be asked if they would like to complete an advance directive and will have been randomized to receive either an expanded answer choice set or a standard answer choice, as described in detail elsewhere. Only those subjects who express a desire to complete an advance directive from both arms will then be randomized again in a stratified fashion to receive either a standard advance directive or one with an expanded choice set for the decisions regarding life-sustaining therapy, as described in detail elsewhere.
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
- Double (Participant, Investigator)
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
- •Age 18 or older
- •Proficient in English
- •Chronic hemodialysis for minimum 90 days
- •Does not currently have a living will
排除标准
- •Blindness
- •Cognitive impairment that prohibits subject's provision of informed consent
研究组 & 干预措施
Expanded AD Choice
"Would you like to complete an advance directive with the assistance of any person(s) you choose?"
4 answer choices:
- Yes, I would like to complete a comprehensive version of an advance directive.
- Yes, I would like to complete an expanded version of an advance directive.
- Yes, I would like to complete a brief version of an advance directive.
- No, I do not wish to complete an advance directive.
干预措施: Expanded AD Choice (Behavioral)
Standard AD Choice
"Would you like to complete an advance directive with the assistance of any person(s) you choose?"
2 answer choices:
- Yes, I would like to complete an AD.
- No, I do not wish to complete an advance directive.
Expanded Life-sustaining therapy Choice
For each hypothetical illness state described in the living will:
4 answer choices:
- No, I would not want life support.
- Yes, I would want life support.
- I would want life support if my doctor believes it could help, but I want to stop receiving life support if at any time my doctor believes it is only delaying the moment of my death.
- I do not wish to specify a preference at this time.
干预措施: Expanded Life-sustaining Therapy Choice (Behavioral)
Standard Life-sustaining Therapy Choice
For each hypothetical illness state described in the living will:
3 answer choices:
- No, I would not want life support.
- Yes, I would want life support.
- I do not wish to specify a preference at this time.
结局指标
主要结局
advance directive
时间窗: up to 4 weeks
return of a completed and signed advance directive
次要结局
- Medical Outcomes Study Short Form-12v2(baseline and 3 months)
- no life-sustaining therapy preference specified(up to 4 weeks)
- McGill Quality of Life Questionnaire(baseline and 3 months)
- Satisfaction with Decision Scale(baseline)
- Decisional Conflict Scale(up to 4 weeks)