The Influence of Default Options in Advance Directives for Older Patients: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Proportion of Subjects Who Select Palliative Care Options
研究概览
简要总结
The investigators aim to assess the influence of default options in advance directives on older patients selections of life- extending therapies and to determine whether alerting patients to the spectrum of possible default options in advance directives influences their selections of life-extending therapies by manipulating the default options of advance directives given to patients in with severe respiratory disease
详细描述
The project is designed to document that default options influence terminally ill patients end-of-life decisions (in this case, adults with advance forms of lung disease) and that our team can recruit and retain patients in a study of advance care planning. In addition, because a larger-scale randomized clinical trial will require that the investigators alert participants to the range of possible default options, the investigators must also determine the effects that this alerting will have on their selections of life-extending therapies. Therefore, the investigators seek to achieve three aims: (1) assess the influence of default options in advance directives on patients selections of life-extending therapies; (2) determine whether alerting patients to the spectrum of possible default options in advance directives influences their selections of life extending therapies; and (3) document the feasibility of recruiting and retaining patients with advanced lung diseases from university-based clinical settings into a randomized trial of default options in advance directives.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), non-small-cell lung cancer, or other interstitial or fibrotic lung disease
- •Neither listed for nor considering solid organ transplantation
- •Anticipated survival of less than 2 years
- •Must be fluent and literate in English
排除标准
- •Diagnosis of small-cell lung cancer or other respiratory diseases for which life extending medical therapies may be available
研究组 & 干预措施
Positive default
Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections
干预措施: Advance Directive Forms (Other)
Negative default
Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections
干预措施: Advance Directive Forms (Other)
Forced Choice
Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
干预措施: Advance Directive Forms (Other)
结局指标
主要结局
Proportion of Subjects Who Select Palliative Care Options
时间窗: 6 months
The primary outcome variable will be the proportion of subjects that select palliative care options compared to the those who request aggressive treatment in each study arm. We will analyze the effects of manipulating default options and delays in alerting subjects to the presence of multiple default options on each selection in the ADs in order to see how default options influence decisions on general treatment goals and instructions for specific procedures.
次要结局
- Patient Satisfaction With Advance Care Planning.(Two months after AD completion)
研究者
Scott Halpern
Assistant Professor of Medicine
University of Pennsylvania