Increasing Family Engagement in Critical Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NGAGE tool.
- Who it may be relevant to
- Registry conditions: Family Engagement, Critical Care, Intensive Care, Patient and Family Engagement, Health Care Delivery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Increasing Family Engagement in Critical Care: The NGAGE Trial (The NGAGE Trial)
Overview
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.
Interventions
- Other NGAGE tool
Access to NGAGE tool
Primary outcome measures
- FAMily Engagement (FAME) score within 1 week of ICU discharge [Time frame: 1-week post-hospital discharge]
Secondary outcome measures (6)
- Family satisfaction in the ICU (FS-ICU) [Time frame: 1-week post-hospital discharge]
- Quality of communication (QOC score) [Time frame: 1-week post-hospital discharge]
- Anxiety and depression (HADS) [Time frame: 1-week post-hospital discharge]
- Anxiety and depression (HADS) [Time frame: 6 months post-hospital discharge]
- Post-traumatic stress (IES-Revised) [Time frame: 6 months post-hospital discharge]
- Quality of life (EuroQOL-5D-5L score) [Time frame: 6 months post-hospital discharge]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Health services research
Study locations
Canada · 2 centers
- Jewish General Hospital — Montreal
- McGill University Health Centre — Montreal
Identifiers
NCT: NCT06586528 · 2025-4301