Algorithm-Enabled Engagement of Patients With Advanced Cancer (A-EPAC) to Improve Goals of Care Communication Among Veterans With Advanced Stages of Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Life Sustaining Treatment Documentation
研究概览
简要总结
In 2017, the VA launched the Life-Sustaining Treatment Decisions Initiative (LSTDI), a national program to promote Goals of Care communication between clinicians and patients regarding goals and preferences for care. Despite clinician training and standardized Life Sustaining Treatment (LST) notes in the electronic health record (EHR), 60% of Veterans with cancer have not engaged in such communication with their oncology clinicians before death. Over the past 10 years, the team developed and tested: 1) a lay health worker-led intervention to improve these conversations and reduce unwanted, intensive end-of-life care, and 2) an algorithm-driven approach to identify patients in need of urgent conversations with their clinical teams. This randomized study will evaluate the effectiveness of an intervention combining these two approaches across 7 VA oncology sites. The outcomes include LST documentation, Veteran-reported anxiety and depression, and the identification of factors to inform broad scale of Veteran-centric interventions to improve GoC communication.
详细描述
The investigators developed the Engagement of Patients with Advanced Cancer (EPAC) intervention - a 6-month telephone-based intervention in which trained lay health workers (LHWs) educate and empower Veterans with cancer to engage in goals of care conversations with their oncology clinical teams. To facilitate scale, the investigator propose Algorithm-Enabled EPAC (A-EPAC), which uses the VA Care Assessment Needs (CAN) score to automatically identify patients with cancer who could benefit from EPAC. This intent-to-treat randomized trial is conducted in collaboration with the NTO and the National VA Oncology Programs (NOP). The investigators will randomize 200 Veterans with cancer receiving care across 7 VA facilities to either the A-EPAC intervention (algorithm-based identification and referral to EPAC for 6-months) or usual cancer care alone (cancer care provided by oncology teams at the local site). Participants will be followed for 12-months post enrollment. The primary outcome is Life Sustaining Treatment documentation at 3 months post-enrollment. Secondary outcomes are patient anxiety and depression at 3 months measured by PROMIS® short forms. Exploratory outcomes include intensive end-of-life care, advance directive documentation, and acute care use. Using a quant-qual framework, the investigators will conduct validated surveys with 40 Veterans with cancer and Veteran and clinician interviews at 6 months to identify factors associated with feasibility, adoption, acceptability, and A-EPAC fidelity.
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
- Triple (Care Provider, 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
- •Veteran patients with diagnosis of a solid malignancy with any cancer stage
- •English or Spanish-speaking
- •Can self-administer questionnaires in English or Spanish
- •Valid telephone number
- •Receiving oncology care at one of 7 sites
- •Receiving systemic anti-cancer therapy, defined as oral, injection, or intravenous therapy
- •chemotherapy
- •hormone therapy
- •targeted therapy
- •or immunotherapy defined by the National Cancer Institute A to Z List of Cancer Drugs)
- •CAN risk score ≥98th percentile (may be adjusted after examining site-level CAN performance)
排除标准
- •No capacity to consent
- •Actively receiving hospice care
研究组 & 干预措施
Usual Care + A-EPAC
Participants will be assigned to a lay health worker who will conduct education sessions over 30-45 minutes by phone initially followed by 15 minute conversations twice monthly for 6 months to discuss goals of care and how to engage in these discussions with their clinical teams. Participants will also receive usual cancer care for a total of 12 months or until death, whichever is first.
干预措施: Usual Care (Behavioral)
Usual Care + A-EPAC
Participants will be assigned to a lay health worker who will conduct education sessions over 30-45 minutes by phone initially followed by 15 minute conversations twice monthly for 6 months to discuss goals of care and how to engage in these discussions with their clinical teams. Participants will also receive usual cancer care for a total of 12 months or until death, whichever is first.
干预措施: Usual Care + A-EPAC (Behavioral)
Usual Care
Participants will receive usual cancer care for 12 months or until death whichever is first.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Life Sustaining Treatment Documentation
时间窗: 3 months
Proportion of participants in both study groups who have a life sustaining treatment document in the electronic health record.
次要结局
- Patient-reported Anxiety and Depression(3 months)
- Advance Directive Documentation(12 months)
- Acute Care Use(12 months)
- Life Sustaining Treatment Documentation(6 months)
- Life Sustaining Treatment Documentation(9 months)
- Life Sustaining Treatment Documentation(12 months)