Family Participation for Intensive Care Engagement
(Family-ICU Trial)
Trial Summary
What is the purpose of this 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.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the treatment Family Participation in ICU Rounds?
Is family participation in ICU rounds safe for humans?
How is family participation in ICU rounds different from other treatments for ICU care?
Family participation in ICU rounds is unique because it involves family members directly in the medical discussions and decision-making process during bedside rounds, which can improve communication and potentially enhance patient outcomes. Unlike traditional treatments that focus solely on medical interventions, this approach emphasizes family involvement as a key component of care.12457
Research Team
Michael J Goldfarb, MD, MSc
Principal Investigator
Lady Davis Institute, McGill University, Jewish General Hospital
Eligibility Criteria
This trial is for adult family members of ICU patients expected to stay in the ICU for at least 48 hours. Participants must be over 18 and able to join medical rounds virtually, meaning they need a phone or computer with internet and audio/video capabilities.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Control Phase
Participants engage in care as per current family engagement practices without participating in daily ICU rounds.
Intervention Phase
Participants in the intervention group are invited to participate in attending team rounds.
Follow-up
Participants are monitored for family engagement, satisfaction, and psychological outcomes post-hospital discharge.
Treatment Details
Interventions
- Participation in attending team rounds
Participation in attending team rounds is already approved in Canada for the following indications:
- Improving family engagement in care
- Enhancing family satisfaction
- Reducing anxiety and depression
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lady Davis Institute
Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator