Actively Recruiting
The Family-ICU Trial
Led by Lady Davis Institute · Updated on 2026-03-31
194
Participants Needed
2
Research Sites
240 weeks
Total Duration
On this page
Sponsors
L
Lady Davis Institute
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Family inclusion in adult intensive care unit (ICU) rounds is recommended by critical care professional societies, yet widespread uptake of this practice is limited. A key barrier cited by ICU clinicians is insufficient evidence to support this practice. There is a need for robust evidence to support family participation in adult ICU rounds and influence change to routine clinical care. The primary purpose of this study is to assess whether family participation in adult ICU rounds improves family engagement in care. The secondary objectives are to assess family satisfaction, and anxiety and depression, to explore user experiences of family participation in ICU rounds, and to evaluate strategies to improve family member recruitment and retention rates. This is a stepped-wedge cluster randomized trial (n=194) at 6 Canadian ICUs. The stepped wedge cluster randomized trial is a pragmatic study design that overcomes methodological limitations in evaluating a healthcare service delivery intervention. In the stepped-wedge cluster design, there is random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed. The stepped-wedge design also allows each site to function as its own control. The stepped-wedge design is more powerful than a parallel design when substantial cluster level effects are present.
CONDITIONS
Official Title
The Family-ICU Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult family members (age 218 years or older2)
- Family member of ICU patients with expected ICU stay of 48 hours or more
- For virtual participation, must have a phone or computer with internet and audio/video capabilities and understand how to use them
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Jewish General Hospital
Montreal, Quebec, Canada
Actively Recruiting
2
McGill University Health Centre
Montreal, Quebec, Canada
Not Yet Recruiting
Research Team
J
Jillian Kifell, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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