Increasing Family Engagement in Critical Care

Recruiting now · Not applicable

Conditions studied: Family Engagement, Critical Care, Intensive Care, Patient and Family Engagement, Health Care Delivery, Family-centered Care

In brief

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.

Key facts

Study ID

NCT06586528

Run by

Lady Davis Institute

People needed

194

Starts

2025-03-26

Expected to finish

2027-09-01

Last updated by the study team

2025-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult family members (age ≥ 18 years) of ICU patients
• Expected ICU stay ≥ 48 hours
• Able to participate in English or French

You may not qualify if…

• 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

Where it is running

• Jewish General Hospital — Montreal, Quebec, Canada (enrolling)
• McGill University Health Centre — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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