Clinical trial NCT06586541: The Family-ICU Trial
Official title: Family Participation in Intensive Care Unit Rounds (The Family-ICU Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Virtual Care
Family Engagement
Patient and Family Engagement
Health Care Delivery
Family-centered Care
Physician Rounds
Critical Care, Intensive Care
Keywords: Patient- and Family-Centered
Patient- and Family-Centered Care
Family Engagement
Critical Care
Intensive Care Unit
Person-Centered Care
Delivery of Health Care
Virtual Rounds
Family Participation in Rounds
Physician Rounds
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2024-09-19
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


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

Primary outcomes:
measure: FAMily Engagement (FAME) score within 1 week of ICU discharge
timeFrame: 1-week post-hospital discharge
Secondary outcomes:
measure: Quality of communication (QOC score)
timeFrame: 1-week post-hospital discharge
measure: Anxiety and depression (HADS)
timeFrame: 6 months post-hospital discharge
measure: Anxiety and depression (HADS)
timeFrame: 1-week post-hospital discharge
measure: Post-traumatic stress (IES-Revised)
timeFrame: 6 months post-hospital discharge
measure: Family satisfaction in the ICU (FS-ICU)
timeFrame: 1-week post-hospital discharge
measure: Quality of life (EuroQOL-5D-5L score)
timeFrame: 6 months post-hospital discharge
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: Lady Davis Institute, McGill University, Jewish General Hospital
name: Michael J Goldfarb, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: