Improving Advance Care Planning in Oncology: A Pragmatic, Cluster-Randomized Trial Integrating Patient Videos and Clinician Communication Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13,800
- 试验地点
- 4
- 主要终点
- Number of Participants With Advance Care Planning Documentation
研究概览
简要总结
In this research study, the investigators are working to help oncologists better serve patients by delivering more patient-centered, goal-concordant care that may improve health care delivery.
- It is expected that about 30,000 people will take part in this research study, 29,550 of these patients, the vast majority, will be included only for medical record review.
详细描述
The purpose of this study is to improve the quality of care provided to millions of older Americans with cancer. The investigators are working to help oncologists better serve patients by delivering more patient-centered, goal-concordant care that may dramatically improve health care delivery.
This is pragmatic stepped wedge cluster randomized trial (SW-CRT) of a Comprehensive ACP (Advance Care Planning) Program among older oncology patients. The ACP Program will include training clinicians in communication skills and using video decision aids for participants.
- This study will involve medical record review of 30,000 people age 65 or older with advanced cancer.
We will also recruit 450 eligible patients (150 patients from each of our three sites broken down into 75 patients during the control phase and 75 patients during the intervention phase) to conduct a survey for our secondary patient-centered outcomes (confidence, satisfaction with physician communication, patient decisional satisfaction and regret). From among this sub-group we will engage 240 participants (80 from each of our three sites broken down into 40 patients during the control phase and 40 patients during the intervention phase) in an activity to film video declarations of their preferences.
During the first year, three pilot sites (one at each health care system) will trial the intervention. The subjects recruited at these pilot sites will not be included in the final analysis. Thus, the main trial will begin during year 2 and continue through year 5 with recruitment of 30,000 subjects for the primary outcome at 30 oncology clinics. The first year pilot will serve to inform the larger roll-out and the intervention may change during the first year based on pilot-clinic experience.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for clinics:
- •Clinic eligibility criteria include:
- •More than one oncologist
- •Serve a patient population that is at least 30% aged 65 or older
- •Disease-based oncology clinic
- •Subject Eligibility: (for the in-person surveys):
- •- Any patient affiliated with one of the study clinics who speaks English and is aged 65 or older with advanced cancer is eligible for participation. Advanced cancer is defined as metastatic disease for solid tumors and recurrent or refractory disease for hematological malignancies. There are no exclusions based on gender, race, or ethnicity.
排除标准
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
研究组 & 干预措施
Advance Care Planning
-Survey:
- A group of older patients with advanced cancer (N=450) will have a survey over the course of the 36 months of recruitment.
- Participants will be provided written copies of the questions to follow along during the interviews
干预措施: Clinician Communication Skills Training (Other)
Advance Care Planning
-Survey:
- A group of older patients with advanced cancer (N=450) will have a survey over the course of the 36 months of recruitment.
- Participants will be provided written copies of the questions to follow along during the interviews
干预措施: Advance Care Planning (ACP) Decisions Videos Decisions Aids (Other)
Advance Care Planning-Video Declaration
Video Declaration:
- From among this group of 450 participants, the video declaration of preferences activity will be conducted with 240 patients.
- For those participants that agree to the video declaration, they will proceed with recording of their video declarations
- The RA will begin by reading a standardized introduction to aid the subject do the video
干预措施: Clinician Communication Skills Training (Other)
Advance Care Planning-Video Declaration
Video Declaration:
- From among this group of 450 participants, the video declaration of preferences activity will be conducted with 240 patients.
- For those participants that agree to the video declaration, they will proceed with recording of their video declarations
- The RA will begin by reading a standardized introduction to aid the subject do the video
干预措施: Advance Care Planning (ACP) Decisions Videos Decisions Aids (Other)
Advance Care Planning-Video Declaration
Video Declaration:
- From among this group of 450 participants, the video declaration of preferences activity will be conducted with 240 patients.
- For those participants that agree to the video declaration, they will proceed with recording of their video declarations
- The RA will begin by reading a standardized introduction to aid the subject do the video
干预措施: Video Declarations (ViDec) (Other)
Comprehensive Record Review of ACP
- A review of Medical orders for resuscitation preferences in the electronic health record
- A review of Medical orders for Palliative care consultations preferences in the electronic health record
- A review of Medical orders for Hospice use preferences in the electronic health record
干预措施: Clinician Communication Skills Training (Other)
Comprehensive Record Review of ACP
- A review of Medical orders for resuscitation preferences in the electronic health record
- A review of Medical orders for Palliative care consultations preferences in the electronic health record
- A review of Medical orders for Hospice use preferences in the electronic health record
干预措施: Advance Care Planning (ACP) Decisions Videos Decisions Aids (Other)
Comprehensive Record Review of ACP
- A review of Medical orders for resuscitation preferences in the electronic health record
- A review of Medical orders for Palliative care consultations preferences in the electronic health record
- A review of Medical orders for Hospice use preferences in the electronic health record
干预措施: Video Declarations (ViDec) (Other)
Main Study Arm
Patients with cancer being seen at the 30 oncology clinics will be exposed to clinicians who have had communication skills training (Vital Talk) and who are using video decision aids (ACP Decisions). Our main outcome is advance care planning documentation.
干预措施: Clinician Communication Skills Training (Other)
Main Study Arm
Patients with cancer being seen at the 30 oncology clinics will be exposed to clinicians who have had communication skills training (Vital Talk) and who are using video decision aids (ACP Decisions). Our main outcome is advance care planning documentation.
干预措施: Advance Care Planning (ACP) Decisions Videos Decisions Aids (Other)
Main Study Arm
Patients with cancer being seen at the 30 oncology clinics will be exposed to clinicians who have had communication skills training (Vital Talk) and who are using video decision aids (ACP Decisions). Our main outcome is advance care planning documentation.
干预措施: Video Declarations (ViDec) (Other)
结局指标
主要结局
Number of Participants With Advance Care Planning Documentation
时间窗: 6 months
Any advance directive (e.g., living will, POLST, etc.) and changes of resuscitation orders or any indication in the EHR of a goals-of-care or advance care planning conversation
次要结局
- Number of Participants With CODE Status Limitations(6 months)
- Rate of Palliative Care Consultation(6 months)
- Rate of Hospice Use(6 months)
- Confidence in Future Care(6 months)
- Communication and Decisional Satisfaction(6 months)
- Decisional Regret(6 months)
研究者
James A. Tulsky
Principal Investigator
Dana-Farber Cancer Institute