跳至主要内容
临床试验/NCT03609658
NCT03609658已完成不适用

Integrated Approach to Patient and Family Engagement for Advance Care Planning for Vulnerable Older Adult Within an Accountable Care Organization (ACO)

Wake Forest University Health Sciences18 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2018年11月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
146
试验地点
18
主要终点
Number of Patient's Documented Advance Care Planning Discussions - Provider

研究概览

简要总结

The purpose of this study is to compare ways to engage sick patients and their family members in Advance Care Planning (ACP) discussions. Two pathways will be tested, discussions using a Nurse Navigator led pathway versus usual care.

详细描述

This study is a randomized, pragmatic, comparative effectiveness trial for determining better ways to engage multimorbid patients and their family members in Advance Care Planning through a Nurse Navigator led pathway versus usual care. Investigators propose to utilize Zelen's design (a more recent label/generalization for this type of design is the cohort multiple randomized controlled trial (cmRCT), a pragmatic clinical trial design whereby all participants are randomized prior to informed consent, and then only patients randomized to the interventional arm are approached for consent and subsequently enrolled in the intervention group.

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

入选标准

  • Aged 65 or older patient within the Wake Forest/Cornerstone ACO
  • Have seen their primary care provider within the Wake Forest/Cornerstone network in the past 12 months
  • English speaking
  • No documented Advance Directive in the EHR
  • Impairments in either physical function, cognition, and/or frailty

排除标准

  • No available proxy (e.g. in setting of cognitive impairment)
  • Severe/advanced dementia
  • Moderate to severe hearing loss
  • Non-English speaking
  • No phone number available for patient

结局指标

主要结局

Number of Patient's Documented Advance Care Planning Discussions - Provider

时间窗: End of Study (Month 13)

Reported as the number of documentations completed in the newly created ACP note template for provider note templates.

Quality of Advance Care Planning Discussion - Nurse Navigator

时间窗: End of Study (Month 13)

Measured by the newly created ACP note template for both nurse navigator (score ranging from 0-8). Score of 5 or higher determines better outcome.

Quality of Advance Care Planning Discussion From the Patient's Perspective

时间窗: End of Study (Month 13)

Measured by the Quality about End of Life (EOL) Communication (QOC), The instrument is reported as 2 subscales: "general communication skills" and "communication about end-of-life care." Score range for the subscales is 1-11 Higher scores determine better outcomes.

Number of Patient's Documented Advance Care Planning Discussion- Nurse Navigator

时间窗: End of Study (Month 13)

Reported as the number of documentations completed in the newly created ACP note template for nurse navigator note templates.

Quality of Advance Care Planning Discussion - Provider

时间窗: End of Study (Month 13)

Measured by the newly created ACP note template for provider note templates (score ranging from 0-15). Score of 8 or higher in the provider template determines better outcome.

次要结局

  • Advance Directive Completion(End of Study (Month 13))
  • Number of Designated Surrogate Decision Makers(End of Study (Month 13))
  • Advance Care Planning Billing Code Usage(End of Study (Month 13))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (18)

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