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临床试验/NCT06646614
NCT06646614进行中(未招募)不适用

Group Advanced Care Planning Pilot for Veterans

VA Palo Alto Health Care System1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
Goals of Care Documentation

研究概览

简要总结

The proposed research aims to engage participants in group educational sessions to facilitate learning of topics related to advanced care planning and to determine whether this approach is more effective than usual care alone.

详细描述

The purpose of this study is to compare usual care against a group advanced care planning intervention comprised of two sessions led by trained community health workers or health educators from VA Palo Alto. A total of 60 participants will be randomly assigned to either usual care (n=30) or usual care + group advanced care planning intervention (n=30). Usual care includes written, mailed educational materials about advanced care planning that patients may review independently. Those in the group advanced care planning arm will receive usual care along with the written materials and will participate in two 60-90 minute educational sessions led by a community health worker that will either be conducted in person on-site or by VA-approved video conference or a hybrid model. Topics will include an introduction to advanced care planning, goals of care topics, advance directives, and physicians order of life sustaining treatment. Both usual care and the group advanced care planning arms will also participate in pre/post surveys and/or interviews.

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)

盲法说明

The statistician analyzing the data will be masked from the experimental treatment and the control as will all research staff who are abstracting or collecting outcomes data.

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

  • •All patients >18 years old with newly diagnosed cancer are eligible.
  • •Patients must have the ability to understand and willingness to provide verbal consent
  • •Participants must speak English

排除标准

  • •Inability to consent to the study
  • •Plans to move within the area and leave the VA system within 4 months

研究组 & 干预措施

Usual Care

No Intervention

The patient will continue to receive as normal and usual care. The participant will also receive educational materials in writing regarding advance care planning mailed to their preferred mailing address. The participants will complete surveys and interviews at baseline at again at 2 months post-enrollment.

Group Advance Care Planning

Experimental

The participant will receive normal and usual care which also consists of educational materials in writing regarding advance care planning mailed to their preferred mailing address. They will also engage in 2 group educational sessions with 4-5 participants which will last 60-90 minutes regarding advance care planning. They participants will complete surveys and interviews at baseline and again at 2 months post-enrollment.

干预措施: Group Advance Care Planning Education (Behavioral)

结局指标

主要结局

Goals of Care Documentation

时间窗: Month 2 after patient enrollment

Documentation of goals of care discussions will be analyzed for each patient at 8 weeks after patient enrollment.

次要结局

  • Feeling Heard and Understood(Baseline and Month 2 after patient enrollment)
  • Change in patient activation using the Patient Activation Measure(Baseline and Month 2 after patient enrollment)
  • Change in patient satisfaction with decision using the Satisfaction with Decision Measure(Baseline and Month 2 after patient enrollment)
  • Palliative Care Use (Self-reported and Chart Review)(At Baseline and Month 6 after patient enrollment)
  • Hospice Care Use (Self-reported and Chart Review)(At Baseline and Month 6 after patient enrollment)
  • Hospitalization Visits (Self-reported and Chart Review)(At Baseline and Month 6 after patient enrollment)
  • Change in patient activation using the Patient Activation Measure(Baseline and Week 8 after patient enrollment)

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Manali I. Patel

Staff Physician

VA Palo Alto Health Care System

研究点 (1)

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