Serious Illness Communication Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 994
- 试验地点
- 2
- 主要终点
- PEACE
研究概览
简要总结
The purpose of the study is to evaluate the impact of implementing a "Serious Illness Conversation Guide" to guide patient/family-clinician discussions and planning about end-of-life care decisions. The goal of the intervention is to improve achievement of patient care priorities and peacefulness at the end of life for patients with serious and life-threatening illness and their families. We hypothesize that patients whose physician is trained to use and adheres to the elements of the Serious Illness Conversation Guide will demonstrate enhanced consistency between documented key priorities and care received, and will experience greater peace in the final month of life; similarly, their families will experience higher satisfaction with care.
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
- 是
入选标准
- •Dana-Farber Cancer Institute medical oncology clinician
- •Care for patients with selected high-risk cancers
排除标准
- •DFCI Gynecology-Oncology specialist
- •Seeing patients only in the Phase I clinical trial disease center
- •Patient Inclusion Criteria
- •Over 18 years of age
- •English speaker
- •Patient at Dana-Farber Cancer Institute, including satellite sites at Milford Regional Medical Center and South Shore Hospital
- •Diagnosis of one of the following high mortality or advanced cancers: breast, gastric, intestinal, esophageal, pancreatic, biliary, colorectal, hepatocellular, head and neck, renal, bladder, prostate, acute myeloid lymphoma (AML), acute lymphoblastic lymphoma (ALL), lymphoma, melanoma, glioblastoma multiforme (GBM), sarcoma, and lung.
- •Ability to provide consent
- •Patient Exclusion Criteria
- •Diagnosis of advanced obstetric-gynecological cancer
- •Cognitive impairment
- •Family Member Inclusion Criteria
- •Over 18 years of age
- •English speaker
- •Friend or family member of study patient (Health care proxy, or close friend or family member who is involved in helping the patient think about decisions related to their health care)
- •Ability to provide consent
研究组 & 干预措施
Trained Clinicians
Clinicians randomized into this group will receive training in using the Serious Illness Conversation Guide with their patients. Patients of these clinicians will also be in the intervention arm.
干预措施: Training (Behavioral)
Non-trained Clinicians
Clinicians randomized into this group will not receive training in using the Serious Illness Conversation Guide with their patients. They will provide usual care. Patients of these clinicians will also be in the control arm.
Non-volunteer Clinicians
These clinicians do not agree to participate in the study. They will continue to provide usual care. Their patients will be invited to participate and be followed.
结局指标
主要结局
PEACE
时间窗: up to 2 years
Patients whose physician is trained to use and adheres to the SICG will be more likely to report being at peace in the final 3 months of life than patients whose physician is not trained to use the SICG. Being at peace will be measured by the PEACE scale, a 13-item validated questionnaire in cancer patients.
Enhanced goal-consistent care
时间窗: up to 2 years
Patients whose physician is trained to use and adheres to the SICG will receive care that is more consistent with their key life priorities during the last week and the last 3 months of life than patients whose physician is not trained to use the SICG. Goal consistent care will be measured by comparing goals identified by the patient during the final 3 months and final week of life, to care received by the patient, which will be measured by chart review and family report. For each priority/goal listed by the patient as important, we will give a score from 0 to 3 to quantify the extent to which that goal was achieved by the patient. Higher overall score will show more goal-consistent care.
次要结局
未报告次要终点
研究者
Rachelle Bernacki
Principal Investigator
Dana-Farber Cancer Institute