A Multisite RWCT Comparing the Effectiveness of a Goals of Care Video and Navigator Intervention, the VIDEO-PEDS Experience, Versus Usual Care in Pediatric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 567
- 试验地点
- 4
- 主要终点
- Goals-of-Care Discussion
研究概览
简要总结
The goal of this clinical trial is to learn if the VIDEO-PEDS intervention works to improve Goals of Care communication between clinicians and parents of children with cancer.
The main questions it aims to answer are:
Does the intervention improve Goals of Care documentation? Does it improve patient outcomes (including less invasive preferences for resuscitation and interventions, less hospital utilization, and more palliative care and hospice use)? Does it improve parent outcomes (including health satisfaction and feeling heard and understood per survey scores)?
详细描述
Background
Parents of children with advanced cancer often face challenging decisions about goals of care (GOC) amidst high stress and limited understanding of medical interventions. Despite evidence that early and informed GOC discussions improve end-of-life experiences and align care with family values, such conversations remain infrequent in pediatric oncology. Barriers such as communication gaps, literacy challenges, and cultural differences exacerbate disparities, particularly among African American, Hispanic, and rural populations. The Video Images about Decisions for Ethical Outcomes in Pediatrics (VIDEO-PEDS) trial aims to address these gaps through an innovative video-based intervention. Similar interventions were effective in an adult cancer population.
Aims
- To refine and finalize a theory-based video decision aid tailored to parents of children with advanced cancer.
- To evaluate the feasibility, acceptability, and preliminary impact of the intervention through a pilot study.
- To conduct a randomized waitlist-controlled trial (RWCT) assessing the effectiveness of the intervention in improving GOC communication and documentation.
Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0-12 years
- •Diagnosed with any type or stage of cancer
- •Receiving cancer directed treatment
- •Decision maker for the child.
- •Biological parent, step-parent, legal guardian (e.g., adoptive parent), or grandparent with medical consent authority.
- •Has a child meeting the child inclusion criteria listed above.
- •Able to communicate in English or Spanish (the languages of the video decision aids).
排除标准
- •Not receiving primary medical care from the cancer clinic (e.g., second-opinion consultations only)
- •Already referred to and fully consulted by the palliative care team
- •Prognosis of less than a 2-month life expectancy
- •Visually impaired beyond 20/200 corrected and unable to view the video (note: hearing impaired is not an exclusion as the videos are closed captioned).
- •Psychological state not appropriate for GOC discussions, as determined by the primary oncologist per the opt-out.
- •Participants who do not speak English or Spanish
研究组 & 干预措施
UH3 RWCT Arm - Control
This group will receive usual care until the 9-month wait period expires.
UH3 RWCT Arm - Intervention
This group will receive the VIDEO-PEDS intervention.
干预措施: VIDEO-PEDS (Other)
UG3 Pilot Intervention
This group will receive the 3-month pilot version of the VIDEO-PEDS intervention.
干预措施: VIDEO-PEDS pilot (Other)
UG3 Focus Group
This group will participate in the virtual parent focus groups.
干预措施: Focus Group (Other)
结局指标
主要结局
Goals-of-Care Discussion
时间窗: At the end of Cycles 1, 2, and 3 (each cycle is 9 months)
Percentage of parents who held conversations with their medical team about goals, values, or priorities for treatment and outcomes as per documentation in the medical record.
Code Status Limitation
时间窗: At the end of Cycles 1, 2, and 3 (each cycle is 9 months)
Percentage of parents who communicate limitations to cardiopulmonary resuscitation and intubation with their medical team as per documentation in the medical record.
Palliative Care
时间窗: At the end of Cycles 1, 2, and 3 (each cycle is 9 months)
Percentage of parents who mention a visit with a specialty palliative care clinician, mention of specialist palliative care discussion, or patient preferences regarding seeing a palliative care clinician to their medical team as per documentation in the medical record.
Time-Limited Trial
时间窗: At the end of Cycles 1, 2, and 3 (each cycle is 9 months)
Percentage of parents who engage in conversations with their medical team about the use of a treatment or procedure for a set amount of time with a pre-defined goal and plan related to the outcome at the end of the trial as per documentation in the medical record.
次要结局
- Acceptability themes from qualitative data(2 years)
- Feasibility by % of parents(2 years)
- Parent Satisfaction scores(2 years)
研究者
Joanne Wolfe, MD, MPH
Chief of Pediatrics
Massachusetts General Hospital