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临床试验/NCT00214344
NCT00214344已完成2 期

Evaluating the Usefulness of Preparing Families For Withdrawal of Mechanical Ventilation From Their Family Member: A Pilot Study

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2003年10月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
20
试验地点
2
主要终点
Are the families who received education/counseling better prepared for the experience of the dying patient

研究概览

简要总结

Using the self-regulation theory, an intervention to prepare families for that experience was developed. This study will assess the impact of the intervention on a family's evaluation of their preparation and their short-term coping. The site used for this study will be the Trauma and Life Support Center (TLC), University of Wisconsin (UW) Hospital. After a decision has been made to withdraw life support, a member of the TLC staff will approach the next of kin of the patient to inform him/her about the study and inquire about his/her interest to participate. Using an experimental design, 10 family members will be assigned to the control group and 10 to the intervention group. Upon agreement, a research nurse will use a "coin toss method" for group assignment of the subjects until there are ten in each group. Experimental group subjects will receive the intervention after the family meeting. Demographics of the next of kin will be collected at this time. Patient information such as demographics, diagnosis, and time of withdrawal and death will be collected too. Two to four weeks after death, a telephone interview will be conducted with the next of kin using the "Evaluation of the Experience of Withdrawal" questionnaire and the Profile of Mood State - shortened version.

Potential benefits are that the families will be prepared for the experience of the dying patient, which will help them cope better during withdrawal and after their loss. There are no major risks to the subjects but there might be an increase in psychological distress.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
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

  • Next of kin of a patient who will have withdrawal of life support
  • Participant must be 18 years of age or older and read, write, and speak English

排除标准

  • Family is unusually highly emotional
  • Patient will be a living donor
  • Patient is conscious

结局指标

主要结局

Are the families who received education/counseling better prepared for the experience of the dying patient

次要结局

  • This is a feasibility Pilot Study

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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