跳至主要内容
临床试验/NCT05891860
NCT05891860已完成不适用

Virtual Family Participation in ICU Rounds (The VR-Family Study)

Lady Davis Institute2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
84
试验地点
2
主要终点
Recruitment rate of 3 participants per month per site completing initial FAME questionnaire

研究概览

简要总结

Barriers to family participation in ICU rounds exist at the health care system level (e.g., restriction on visitation, infection control) and the individual level (e.g., caretaker role, illness, disability, inability to miss work). While virtual family participation in ICU rounds may contribute to addressing these barriers, its feasibility, impact, and effectiveness are yet unknown. The primary objective of this study is to assess the feasibility of virtual family participation in adult ICU rounds. The secondary objectives are: to assess the effect size of virtual family participation in ICU rounds on family engagement, satisfaction, and anxiety and depression; and to explore family and physician experiences of family participation in ICU rounds.

This will be a pilot prospective trial of 72 family members at 4 Canadian adult ICUs, with an embedded qualitative study that will sample family members and critical care physicians. The primary outcome will reflect feasibility metrics (i.e., recruitment, uptake, technical, and follow-up). Secondary outcomes include data regarding family engagement, satisfaction, mental health, and perceived experiences of participation in ICU rounds. This study will assess the feasibility of conducting a larger, hypothesis-testing randomized controlled trial to assess virtual family participation in adult ICU rounds.

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

  • Family member of ICU patient with expected ICU stay > 48 hours (as per treating team)
  • Age ≥ 18 years old
  • Willing and able to participate in virtual ICU rounds
  • Ability to communicate in English or French
  • Able: technological capability and understanding to participate virtually in ICU rounds (must have a phone or computer with internet and audio/video capabilities).
  • "Family member" is anyone with a biological, legal, or emotional relationship with the patient.

排除标准

  • Intends to participate in in-person rounds (if available and offered at participating site)
  • Another family member already participating in the study

结局指标

主要结局

Recruitment rate of 3 participants per month per site completing initial FAME questionnaire

时间窗: 6 months

Recruitment rate

% of participants completing at least one virtual rounding session

时间窗: Within 1-week of ICU discharge

Uptake

% of virtual rounds without technical issues

时间窗: Within 1-week of ICU discharge

Technical issues

% of participants completing follow-up

时间窗: Within 1-week of ICU discharge

Follow-up of participants

次要结局

  • Family satisfaction as measured by FS-ICU 24R(Within 1-week of ICU discharge)
  • Anxiety and depression as measured by HADS(Within 1-week of ICU discharge)
  • Family care engagement as measured by FAME(Within 1-week of ICU discharge)

研究者

发起方
Lady Davis Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Goldfarb

Attending Staff, Division of Cardiology

Lady Davis Institute

研究点 (2)

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