跳至主要内容
临床试验/NCT04730986
NCT04730986已完成不适用

A Nurse-led, Advance Care Planning Intervention in the Emergency Department: a Pilot Study

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2021年1月29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
76
试验地点
2
主要终点
Identification of key care coordination components from outpatient clinicians.

研究概览

简要总结

ED GOAL is a 6-minute, motivational interviewing, advance care planning intervention.

In this study, the investigators will pilot test (Part I) ED GOAL by training research nurses to demonstrate its intervention fidelity and acceptability on older adults with serious illness in the emergency department (ED). Upon demonstrating the intervention fidelity of this intervention in Part I, the investigators will collect patient-centered outcomes (Part II) of 100 older adults with serious illness after leaving the ED. Further in Part III, the investigators will conduct a survey to the participants' outpatient clinicians to find out how to optimize the care coordination from the ED to the outpatient office to facilitate advance care planning conversations.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥50 years of age AND ≥1 Serious illness* OR ED clinician would not be surprised if patient died in the next 12 months
  • English-speaking
  • Capacity to consent

排除标准

  • Acute physical or emotional distress
  • Determined by EM physician not to be appropriate
  • Clearly documented goals for medical care** (Unless the treating clinician recommends that the patient needs the intervention)
  • Delirium (assessed using 3D-CAM)
  • Mild cognitive impairment or dementia (assessed using MiniCog or SBT)
  • Already enrolled in this study
  • Unable/unwilling to schedule the follow-up outcomes assessment on the calendar.
  • Inclusion Criteria:
  • ≥50 years of age AND ≥1 Serious illness* OR ED clinician would not be surprised if patient died in the next 12 months
  • English-speaking
  • Patient with mild cognitive impairment or mild dementia with caregiver has a capacity to consent
  • Caregivers of patients with moderate/severe dementia has a capacity to consent
  • Exclusion Criteria:
  • Acute physical or emotional distress
  • Determined by EM physician not to be appropriate
  • Clearly documented goals for medical care** (Unless the treating clinician recommends that the patient needs the intervention)
  • Delirium (assessed using 3D-CAM)
  • Already enrolled in this study
  • Unable/unwilling to schedule the follow-up outcomes assessment on the calendar.
  • (*NYHA Stage III/IV congestive heart failure, chronic obstructive lung disease on home oxygen, chronic kidney disease on dialysis, or metastatic solid tumor cancer. In addition, patients with NYHA Stage I/II congestive heart failure, chronic obstructive lung disease not on home oxygen, chronic kidney disease not on dialysis, solid tumor cancer without metastasis will be included if recent hospitalization in the last 12 months exists.) (**MOLST, medical order for life-sustaining treatment.)

结局指标

主要结局

Identification of key care coordination components from outpatient clinicians.

时间窗: One month after the intervention

Conduct a survey on the outpatient clinicians of ED GOAL study participants one month (28 days) after the participating patients leave the ED to identify key care coordination components to maximize the intervention efficacy.

Measurement of Intervention Fidelity

时间窗: Immediately after the the intervention

Measure the intervention fidelity of ED GOAL Nursing administered by trained research nurses to seriously ill older adults or caregivers of patients with cognitive impairment in the ED (N=30). Trained research nurses will demonstrate intervention fidelity \>70% on a prespecified checklist.

Measurement of change in ACP conversations before and after the intervention

时间窗: Before and one month after the intervention

Conduct a pre-/post-intervention study (N=100) of ED GOAL Nursing on advance care planning (ACP) conversations one month (28 days) after leaving the ED (confirmed by EMR documentation of new/changes in ACP conversations, advance directive forms, or healthcare proxy, as well as changes in patient's or caregiver's self-reported ACP engagement). ≥25% of participants will have reported completing an ACP conversation, or changed advance directive forms or healthcare proxy, or change in patient's or caregiver's self-reported ACP engagement at one month after leaving the ED.

次要结局

  • Documentation of new ACP in the electronic health records(Before and one month after the intervention)
  • Patient-reported ACP conversation after the intervention(One month after the intervention)

研究者

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

Kei Ouchi

Assistant Professor of Emergency Medicine

Brigham and Women's Hospital

研究点 (2)

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