Default Options in Advance Directives for Veterans With Serious Illnesses: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Evaluate how the setting of defaults influences the proportion of Veterans selecting comfort-oriented plans of care in real ADs
研究概览
简要总结
Default options represent the events or conditions that are set into place if no alternatives are actively chosen. The setting of default options has well-established effects on a broad range of human decisions, but its influence on patients' preferences for end-of-life care is only beginning to be understood.
This is a 3-armed randomized clinical trial in Veterans at high risk for critical illness, assessing the impact of Advance Directive (AD) forms framed with different default options. The central goals are to assess how default options in ADs influence the end-of-life care choices made by patients at risk for critical care, and these patients' hospital and ICU utilization.
The investigators hypothesize that setting defaults in real ADs will increase the proportion of Veterans selecting comfort-oriented plans of care, decrease selections of life-extending therapies such as mechanical ventilation and dialysis, and reduce the proportion of time during follow-up that Veterans spend in the hospital and/or ICU, without affecting patient satisfaction with end-of-life care planning.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Chronic Obstructive Pulmonary Disease (COPD) with severe or very severe airflow obstruction on pulmonary function testing and or receiving or eligible to receive long-term oxygen therapy AND/OR
- •Idiopathic Pulmonary Fibrosis (IPF) AND/OR
- •Other interstitial lung disease without curative therapy AND/OR
- •Any stage 3B or 4 solid tumor AND/OR
- •Congestive Heart Failure (CHF) either New York Heart Association NYHA) class IV or NYHA class III plus 1 hospitalization in the past year
- •No previously signed advance directive in the medical record
- •Neither listed for nor considering lung or heart transplantation
- •High anticipated risk for critical illness in the next 2 years based on clinical judgment
- •Interest in thinking about filling out an Advance Directive
排除标准
- •Diseases for which life-extending medical therapies may be available
- •Inability to speak and/or read English proficiently
- •New clinic patients meeting the clinic provider for the first time
- •Patients being actively evaluated or already listed for transplants
- •Patients already having an AD
- •Cognitive impairment necessitating proxy consent
结局指标
主要结局
Evaluate how the setting of defaults influences the proportion of Veterans selecting comfort-oriented plans of care in real ADs
时间窗: 18 months
The primary outcome is the proportion of patients in each of the 3 groups who select a general plan of care that prioritizes comfort over life extension.
次要结局
- Assess the influence of default options in ADs on Veterans' selections of specific life-extending therapies(18 months)
- Determine whether setting defaults in ADs influences the proportion of time during follow-up that Veterans spend in the hospital or ICU(18 months)
研究者
Joshua B. Kayser
Assistant Professor of Clinical Medicine
Corporal Michael J. Crescenz VA Medical Center