NCT06586528 Increasing Family Engagement in Critical Care
| NCT ID | NCT06586528 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lady Davis Institute |
| Condition | Family Engagement |
| Study Type | INTERVENTIONAL |
| Enrollment | 194 participants |
| Start Date | 2025-03-26 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 194 participants in total. It began in 2025-03-26 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Michael J Goldfarb, MD, MSc
PRINCIPAL INVESTIGATOR
Lady Davis Institute, McGill University, Jewish General Hospital
Frequently Asked Questions
Who can join the NCT06586528 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Family Engagement. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06586528 currently recruiting?
Yes, NCT06586528 is actively recruiting participants. Contact the research team at jillian.kifell.ccomtl@ssss.gouv.qc.ca for enrollment information.
Where is the NCT06586528 trial being conducted?
This trial is being conducted at Montreal, Canada, Montreal, Canada.
Who is sponsoring the NCT06586528 clinical trial?
NCT06586528 is sponsored by Lady Davis Institute. The principal investigator is Michael J Goldfarb, MD, MSc at Lady Davis Institute, McGill University, Jewish General Hospital. The trial plans to enroll 194 participants.