Increasing Family Engagement in Critical Care: The NGAGE Trial (The NGAGE Trial)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Family Engagement
- Sponsor
- Lady Davis Institute
- Enrollment
- 194
- Locations
- 2
- Primary Endpoint
- FAMily Engagement (FAME) score within 1 week of ICU discharge
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Investigators
Michael Goldfarb
Attending Staff, Division of Cardiology
Lady Davis Institute
Eligibility Criteria
Inclusion Criteria
- •Adult family members (age ≥ 18 years) of ICU patients
- •Expected ICU stay ≥ 48 hours
- •Able to participate in English or French
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
FAMily Engagement (FAME) score within 1 week of ICU discharge
Time Frame: 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.
Secondary Outcomes
- 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)