Increasing Family Engagement in Critical Care: The NGAGE Trial (The NGAGE Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 194
- 试验地点
- 2
- 主要终点
- FAMily Engagement (FAME) score within 1 week of ICU discharge
研究概览
简要总结
The primary aim of this trial is to evaluate if the NGAGE tool improves care engagement in family members of ICU patients. The secondary objectives are to assess if the NGAGE tool improves communication, care satisfaction, psychological symptoms, and quality of life in family members of ICU patients.
The NGAGE trial is a stepped wedge cluster randomized trial of 6 Canadian adult ICUs, involving 194 family members. A family member will be considered anyone with a biological, emotional, or legal relationship with the patient and whom the patient wishes to be involved in their care. There will be random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed. The intervention group will have access to the NGAGE tool, which has modules to Learn, Engage, and Report. "Engage" allows the family member to indicate their desired engagement activity, which is then transmitted to the treating healthcare team to provide the requested activity. "Learn" contains educational capsules about the ICU environment and information about care participation. "Report" allows the family member to provide real-time feedback to the healthcare team. The primary endpoint is the FAMily Engagement (FAME) score within 1 week of ICU discharge. Secondary endpoints are family-centered outcomes, including communication quality, satisfaction, and mental health (anxiety and depression) scores within 1 week of ICU discharge, and quality of life and mental health (anxiety, depression, and post-traumatic distress symptoms) at 6 months. The mean difference of the validated FAME score, a continuous variable, will be compared between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult family members (age ≥ 18 years) of ICU patients
- •Expected ICU stay ≥ 48 hours
- •Able to participate in English or French
排除标准
- •Family members who do not wish to participate in care
- •Repeat admissions within the study period
- •Another family member has already participated in the study
结局指标
主要结局
FAMily Engagement (FAME) score within 1 week of ICU discharge
时间窗: 1-week post-hospital discharge
The FAMily Engagement (FAME) tool is a self-administered 12-item questionnaire that assesses an individual's current engagement practice. FAME uses a five-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree), and scale results are changed to a 0-100 scoring system, with higher scores indicating greater engagement in care. The following subdomains are evaluated: engagement perception, family presence, communication, education, decision-making, care contribution, and family needs. FAME includes the following engagement domains: family presence, family needs, communication and education, decision making, and direct care. FAME also captures the following family-centered care principles: dignity and respect, information sharing, participation, and collaboration.
次要结局
- Family satisfaction in the ICU (FS-ICU)(1-week post-hospital discharge)
- Quality of communication (QOC score)(1-week post-hospital discharge)
- Anxiety and depression (HADS)(6 months post-hospital discharge)
- Post-traumatic stress (IES-Revised)(6 months post-hospital discharge)
- Quality of life (EuroQOL-5D-5L score)(6 months post-hospital discharge)
研究者
Michael Goldfarb
Attending Staff, Division of Cardiology
Lady Davis Institute