Randomized Clinical Study Comparing the Effectiveness of the Stanford Letter to the Traditional Advance Directive in Bone Marrow Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- ACP completion rate defined as a completed Advance Directive tool (either Stanford Letter or standard CA AD) brought to Stanford University for upload into the medical record
研究概览
简要总结
The purpose of the proposed research study is to evaluate whether bone marrow transplant patients prefer the Stanford letter advance care planning tool to the standard Advance directive.
Completion of advance care planning prior to BMT is very important, but not often done. The investigators believe that the Stanford Letter will be preferred by patients and will allow them to feel more comfortable and share more of their wishes with family members and the medical team.
详细描述
PRIMARY OBJECTIVES I. To compare advance care planning (ACP) completion rate amongst bone marrow transplant (BMT) recipients receiving the Stanford Letter versus the traditional advance directive (AD) through a prospective, pilot randomized controlled trial (RCT).
SECONDARY OBJECTIVES:
I. To evaluate differences in patient preference for choice to prolong life following completion of the ACP tool in each group.
II. To assess uncertainty with decision making regarding end of life care following completion of the ACP tool in each group.
III. To explore patient understanding of and satisfaction with the ACP tool in each group.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All BMT patients at Stanford who are adults and give consent
排除标准
- •Less than 18 years of age
研究组 & 干预措施
Group I (Stanford Letter, interview)
Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the Stanford Letter and complete and return the form by the day of BMT. After completion of the Stanford Letter, patients undergo a semi-structured, research staff-led interview to evaluate personal perceptions of uncertainty with end-of-life decisions, understanding of the ACP form received, and satisfaction with the ACP form.
干预措施: Stanford Letter (Other)
Group I (Stanford Letter, interview)
Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the Stanford Letter and complete and return the form by the day of BMT. After completion of the Stanford Letter, patients undergo a semi-structured, research staff-led interview to evaluate personal perceptions of uncertainty with end-of-life decisions, understanding of the ACP form received, and satisfaction with the ACP form.
干预措施: Interview (Other)
Group II (traditional advance directive, interview)
Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the CA Advance Health Care Directive Form and complete and return the form by the day of BMT. After completion of the CA Advance Health Care Directive Form, patients undergo interview as in Group I.
干预措施: Interview (Other)
Group I (Stanford Letter, interview)
Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the Stanford Letter and complete and return the form by the day of BMT. After completion of the Stanford Letter, patients undergo a semi-structured, research staff-led interview to evaluate personal perceptions of uncertainty with end-of-life decisions, understanding of the ACP form received, and satisfaction with the ACP form.
干预措施: Questionnaire Administration (Other)
Group II (traditional advance directive, interview)
Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the CA Advance Health Care Directive Form and complete and return the form by the day of BMT. After completion of the CA Advance Health Care Directive Form, patients undergo interview as in Group I.
干预措施: Questionnaire Administration (Other)
Group II (traditional advance directive, interview)
Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the CA Advance Health Care Directive Form and complete and return the form by the day of BMT. After completion of the CA Advance Health Care Directive Form, patients undergo interview as in Group I.
干预措施: CA Advance Health Care Directive Form (Other)
结局指标
主要结局
ACP completion rate defined as a completed Advance Directive tool (either Stanford Letter or standard CA AD) brought to Stanford University for upload into the medical record
时间窗: Up to BMT day 0
The chi-square (X\^2) test will be used to determine a significant difference in proportion of ACP tool completion and preferences for choice to prolong life between the two groups.
次要结局
- Satisfaction with the ACP tool measured using qualitative and quantitative data obtained through the semi-structured interview and DCS(within 28 days of ACP completion)
- Patient preferences for life sustaining measures measured via answers to the ACP questions related to use of cardiopulmonary resuscitation and use of mechanical intubation(Up to BMT day 0)
- Uncertainty with decision making regarding end of life care measured related to the Decisional Conflict Scale (DCS) results(Up to BMT day 0)
- Understanding of the ACP tool measured using qualitative and quantitative data obtained through the semi-structured interview and DCS(within 28 days of ACP completion)