跳至主要内容
临床试验/NCT05149040
NCT05149040进行中(未招募)不适用

Very Elderly Patients' Treatment Preferences and Participation in Shared Decision-making in the Event of Acute Life-threatening Illness

Haukeland University Hospital1 个研究点 分布在 1 个国家目标入组 1,472 人开始时间: 2021年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
1,472
试验地点
1
主要终点
Older Respondents Treatment Preferences in an Event of Acute Life-threatening Illness Warranting ICU Admission as Stated by Themselves and by Their Next of Kin Acting as Proxy

研究概览

简要总结

Do very elderly adults wish intensive care in the event of acute life-threatening illness and are their next of kin able to predict these preferences?

Very elderly patients are a steeply increasing patient population in intensive care units (ICUs), but the overall benefit of intensive care for these patients remains controversial. Will ICU admission improve survival and quality of life, or will it prolong suffering and delay natural death? Little is known about very elderly Norwegians life sustaining treatment (LST) preferences in these situations where treatment benefit is uncertain.

This project aims to improve critically ill very elderly patients' ICU trajectories by bringing forth knowledge about their treatment preferences, their family members' ability to predict these preferences, and by directing attention to the challenges of consent to critical care in cases of medical uncertainty.

A selv administered, mailed survey will be distributed among 400 outpatients aged 80 years or older and their next of kin. Respondents will be recruited at the ophthalmologic, ear-nose-and-throat and orthopaedic outpatient clinics at Haukeland University Hospital Bergen, Norway.

The investigators developed and validated a survey tool for this purpose, containing 3 hypothetical scenarios of acute life-threatening illness. The scenarios are randomly chosen from 20 hypothetical patient histories and are representative for ICU admission diagnoses in Norway and Europe. The participants will be asked for treatment choices, i.e. wishing admission to intensive care or not. A response option 'not wishing to engage in the treatment decision' is also provided.

Furthermore, the questionnaire includes factors that may influence elderlies' treatment preferences and proxies' ability to predict these preferences including: demographics, religion, previous experience with and / or communication about critical illness, comorbidity, frailty, quality of life, and projections (i.e. the proxy's own treatment preferences).

The respondents are requested to explain their choices by free-text comments after each scenario. They are also asked to elaborate how they wish next-of-kin should contribute to decision making in these cases. Additional space for free-text comments is provided in the end of the questionnaire.

The study design is exploratory. Responses will be analysed with both quantitative statistics and qualitative methods.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Outpatients aged 80 years or older who register for appointment at the ophthalmologic, ear-nose-and-throat, and orthopaedic outpatient clinic at Haukeland University Hospital, Bergen, Norway.

排除标准

  • not consenting to participate
  • living in permanent care facility / nursing home
  • not able to complete the questionnaire owing to:
  • severely reduced vision / blindness
  • high degree of frailty (Clinical frailty scale ≥ 7)
  • cognitive impairment

结局指标

主要结局

Older Respondents Treatment Preferences in an Event of Acute Life-threatening Illness Warranting ICU Admission as Stated by Themselves and by Their Next of Kin Acting as Proxy

时间窗: within 2 weeks of recruitment / upon completion of the questionnaire

Three mutually exclusive answer options in three randomly assigned clinically scenarios of acute critical illness in advanced age 1. Wishing ICU admission 2. Not wishing ICU admission 3. Not wanting to decide

次要结局

未报告次要终点

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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