The Family-ICU Trial

Recruiting now · Not applicable

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

In brief

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.

Key facts

Study ID

NCT06586541

Run by

Lady Davis Institute

People needed

194

Starts

2024-11-18

Expected to finish

2029-07-01

Last updated by the study team

2026-03-31

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
• Family members wishing to participate in rounds virtually must have the technological capability and understanding to participate virtually (must have a phone or computer with internet and audio/video capabilities)

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

Full record on ClinicalTrials.gov

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