End-of-Life Health Care Decisions by Patients With Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Participant knowledge of advance care planning
研究概览
简要总结
This study is designed to help the investigators understand more about how people plan for their future medical needs, a process known as "advance care planning."
The study is under the direction of Michael J. Green, M.D., and Benjamin Levi, M.D. physicians at Penn State Hershey Medical Center.
Participation in the project takes place during a single visit to the Medical Center campus. During this one-to-three hour visit, participants complete several questionnaires and use a computer program that produces a printed advance directive that can be shared with their physicians and loved ones. Participants will receive compensation toward travel expenses.
详细描述
Background: Despite widespread agreement that individuals ought to plan for their medical futures, few people (even seriously ill patients with cancer) actually complete advance directives, fewer yet understand key elements, and even when advance directives do exist, there are often barriers to their being implemented.
Objectives: The investigators innovative, multimedia, interactive, computer-based decision aid, "Making Your Wishes Known: Planning Your Medical Future," offers tailored education, values clarification exercises, and a sophisticated decision aid that translates an individual's goals and preferences into a specific medical plan that can be implemented by a health care team. This project aims to evaluate its impact on decision-making and health care received by individuals at the end of life in a randomized clinical trial among a population of patients with advanced cancer who have life expectancies of < 12 months.
Specific Aims:
Aim 1: To evaluate the impact of a computer-based advance care planning intervention on end-of-life decision-making by cancer patients with estimated life expectancies < 12 months. The investigators hypothesize that, compared to standard care (paper/pencil living will form), use of the computer-based intervention will:
H1: Improve individuals' decision-making about end-of-life health care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •18 years of age or older
- •able to give informed consent
- •interested in participating in advance care planning
- •able to read and understand English at an 8th grade level (per WRAT-3 screening test)
- •advanced cancer (primary or metastatic), with estimated lifespan < 6 months (as determined by their treating physician)
- •cognitively able to engage in advance care planning (Mini Mental State Exam (MMSE) score >23)
- •absence of moderate or severe depression (BDI-II score <20/63)
排除标准
- •unable to read and understand English at an 8th grade level (per Wide Range Achievement Test (WRAT-3))
- •not cognitively able to engage in advance care planning (Mini Mental State Exam (MMSE) score < 23)
- •moderate or severe depression (BDI-II score >20/63)
结局指标
主要结局
Participant knowledge of advance care planning
时间窗: Pre and post-intervention
Knowledge of advance care planning will be compared between control and intervention groups, using a true/false and multiple choice questionnaire about advance care planning.
次要结局
- Participant decisional conflict(post-intervention)
- Participant satisfaction with decision(post-intervention)
- Participant self-determination(pre and post-intervention)
- Participant anxiety(pre and post-intervention)
- Participant hopelessness(pre and post-intervention)
- Participant satisfaction with advance care planning(post-intervention)
- Physician adherence to patients' health care wishes(post-death chart review)
- Physician awareness of patients' health care wishes(post-death chart review)
研究者
Michael J. Green
Professor of Humanities
Milton S. Hershey Medical Center