Patient-centered and Efficacious Advance Care Planning in Cancer: the PEACe Comparative Effectiveness Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 672
- 试验地点
- 1
- 主要终点
- Advance Care Planning Engagement
研究概览
简要总结
The overall goal of this study is to identify the most effective and efficient advance care planning (ACP) strategy for patients with advanced cancer.
The specific aims are to:
Aim 1. Compare the effectiveness of in-person, facilitated ACP versus web-based ACP on patient and family caregiver outcomes.
Aim 2. Assess implementation costs and the effects of in-person, facilitated ACP and web-based ACP on healthcare utilization at end of life.
Aim 3. Identify contexts and mechanisms that influence the effectiveness of in-person, facilitated ACP versus web-based ACP.
详细描述
Study investigators will conduct a single-blind, patient-level randomized trial to compare the effectiveness of two different patient-facing advance care planning (ACP) interventions. Investigators will enroll 400 patients with advanced cancer and their family caregivers to receive either (1) in-person discussions with trained facilitators or (2) web-based ACP using interactive videos. Because these approaches have never been compared directly, it is unclear whether one form of advance care planning is more potent, and if so, for whom and under what circumstances.
Aim 1 compares the effectiveness of in-person, facilitated ACP versus web-based ACP on patient and family caregiver outcomes (ACP engagement, ACP discussions, advance directive completion, goal attainment, and caregiver psychological symptoms). Aim 2 assesses implementation costs of each intervention and effects on healthcare utilization at end of life. Aim 3 identifies contexts and mechanisms influencing the effectiveness of each approach. Primary patient outcomes will be assessed at 12 weeks. Participants will be followed until 12 weeks after the patient's death or completion of the 48-month data collection period, whichever occurs first. In-depth interviews with patients, caregivers, and clinicians will begin in Year 2 of the grant and continue until thematic saturation is reached.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (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
- •Patient Inclusion Criteria:
- •18 years of age or older
- •Solid tumor
- •The oncologist "would not be surprised" if the patient died within the next year
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1, or 2
- •Planning to receive ongoing care at a participating oncology clinic
- •Willing to participate in either a web-based or facilitated program
排除标准
- •Does not speak English
- •Inability to consent, using a validated teach-back method
- •Hematologic malignancy
- •No phone for additional study contacts and follow-up interviews
- •Unable to participate in advance care planning, as assessed by clinician
- •Unable to complete the baseline interview
- •Patients will be able to identify and enroll a caregiver, designated by the patient as the primary family member or friend involved in their care and best able to participate in the study.
- •Caregiver Inclusion criteria:
- •18 years of age or older
- •Family member or friend of an eligible patient
- •Primary person involved in patient's care and best able to participate in the study, as assessed by patient
- •Caregiver Exclusion criteria:
- •Does not speak English
- •No phone for additional study contacts and follow-up interviews
- •Unable to complete the baseline interview
研究组 & 干预措施
Facilitated advance care planning (in-person or telephonic)
Patients randomized to this arm will participate in in-person or telephonic facilitated advance care planning (ACP) discussions using the Respecting Choices model.
干预措施: Facilitated advance care planning (in-person or telephonic) (Behavioral)
Web-based advance care planning
Patients randomized to this arm will participate in web-based ACP via the PREPARE website.
干预措施: Web-based advance care planning (Behavioral)
结局指标
主要结局
Advance Care Planning Engagement
时间窗: 12 weeks
15-item Advance Care Planning (ACP) engagement survey assesses ACP processes related to choosing a medical decision maker, discussing and documenting preference for care at end of life, flexibility for surrogate decision making, and asking questions of medical providers. A single summary score will be reported (range 0-5 with higher scores indicating higher engagement).
次要结局
- Number of Participants Who Have Had Advance Care Planning Discussions With Caregivers(12 weeks)
- Number of Participants Who Have Had Advance Care Planning Discussions With Physicians(12 weeks)
- Number of Participants Who Have Completed an Advance Directive(12 weeks)
- Documented Care Goals(12 weeks)
- Caregiver Depression Symptoms(bereavement, up to 60 months)
- Caregiver Anxiety Symptoms(during bereavement, up to 60 months)
- Receipt of Goal-concordant End-of-life Care - Patient Wishes Followed(during bereavement, up to 60 months)
- Receipt of Goal-concordant End-of-life Care - Place of Death(during bereavement, up to 60 months)
- Quality of End-of-life Care(during bereavement, up to 60 months)
- Caregiver Post-traumatic Stress Symptoms(during bereavement, up to 60 months)
- Caregiver Depression Symptoms(12 weeks)
- Caregiver Anxiety Symptoms(12 weeks)
研究者
Yael Schenker, MD, MAS
Associate Professor
University of Pittsburgh