The Family-ICU Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Participation in attending team rounds.
- Who it may be relevant to
- Registry conditions: Virtual Care, Family Engagement, Patient and Family Engagement, Health Care Delivery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Family Participation in Intensive Care Unit Rounds (The Family-ICU Trial)
Overview
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.
Interventions
- Other Participation in attending team rounds
Family members can participate both in-person and virtually, which can vary daily if desired. If the family member wishes to participate in-person, they will be invited to be present when the team rounds in the ICU. If the family member wishes to participate virtually, they will be provided with a personalized link by email to attend rounds.
Primary outcome measures
- FAMily Engagement (FAME) score within 1 week of ICU discharge [Time frame: 1-week post-hospital discharge]
- Quality of communication (QOC score) [Time frame: 1-week post-hospital discharge]
Secondary outcome measures (5)
- Anxiety and depression (HADS) [Time frame: 6 months post-hospital discharge]
- Anxiety and depression (HADS) [Time frame: 1-week post-hospital discharge]
- Post-traumatic stress (IES-Revised) [Time frame: 6 months post-hospital discharge]
- Family satisfaction in the ICU (FS-ICU) [Time frame: 1-week post-hospital discharge]
- Quality of life (EuroQOL-5D-5L score) [Time frame: 6 months post-hospital discharge]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Health services research
Study locations
Canada · 2 centers
- Jewish General Hospital — Montreal
- McGill University Health Centre — Montreal
Identifiers
NCT: NCT06586541 · 2025-4182