The Family-ICU Trial

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.

NCT Number	NCT06586541
Lead Sponsor	Lady Davis Institute Collaborators: Canadian Institutes of Health Research (CIHR)
Conditions	Family Engagement, Patient and Family Engagement, Health Care Delivery, Family-centered Care, Physician Rounds, Critical Care, Intensive Care
Enrollment	194 participants
Start Date	2024-11-18
Primary Completion	2028-02 (estimated)
Study Completion	2029-07 (estimated)
Updated on ClinicalTrials.gov	2026-08-14