跳至主要内容
临床试验/NCT04311190
NCT04311190Unknown不适用

Family ENgagement in Intensive Care Environments (FENICE): a Quasi-experimental Study

University of Udine0 个研究点目标入组 188 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
188
主要终点
Family satisfaction (FS)

研究概览

简要总结

We hypothesized that engaging families in the care of critically ill patients could improve outcome both at the family and at the patient levels. Thus, the aim of this project is to assess the effects of a family engagement program on family members' satisfaction and on patients' well-being and quality of life.

详细描述

Despite the health care professionals should consider the active involvement of families in Intensive Care Unit (ICU), little research investigating family member's contributions to care, including its outcomes on family itself and on patient care, has been rendered available. To assess the effects of a family engagement program on family members' satisfaction and on patients' well-being and quality of life. A quasi-experimental study with two non-randomized groups (94 per each group) will be performed in two general ICUs of an Academic Italian Hospital. The intervention will be carried out in a single ICU and consists of family members' involvement in the care of their beloved one with bed physical exercises and simple care tasks. Participants will be assessed for outcomes including the family satisfaction, assessed with the FS-ICU tool within 48 hours after the patient's discharge from ICU, the patient's sense of well-being, measured with a visual analogue scale within 30 minutes after the time period of a visit, and the quality of life, investigated with the SF-12 questionnaire within the first 48 hours after admission in ICU, at three and six months after ICU discharge by telephone. First, this study constitutes a significant step in a research agenda aimed at deepening the nursing sensitive outcomes in ICUs and the quality of hospital care. Secondly, result from this study may have the potential to better understand how families may modify patients' outcomes and whether the family members would benefit from an engagement program.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
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

  • 18 years of age and older;
  • expected to stay in-ICU at least three days;
  • with high or low acuity conditions.
  • FAMILY MEMBER
  • being the patient's spouse, or in a blood relation, or next of kin, and/or with whom the patient spends most of the time;
  • 18 of age or above;
  • willing to visit the patient on a daily basis;
  • willing to participate in the study.

排除标准

  • PATIENT Patients' discharge from ICU, transfer to another hospital, or death.
  • FAMILY MEMBER The unexpected suspension of visiting their loved ones in ICU daily

结局指标

主要结局

Family satisfaction (FS)

时间窗: Within 48 hours after the patient's discharge from ICU

FS-ICU tool

次要结局

  • Patient's sense of well-being(30 minutes after the family involvement for the intervention group and in the same hours after the ICU visiting hours for the control group)
  • Quality of Life (QoL)(At three and six months after ICU discharge)

研究者

申办方类型
Other
责任方
Sponsor

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