The Family-ICU Trial

Lady Davis Institute

Status: Enrolling

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

Treatments: Other: Participation in attending team rounds

Study type: Interventional

Funder types: Other

Identifiers

NCT06586541

2025-4182

Details and patient eligibility

About

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.

Enrollment: 194 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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194 participants in 2 patient groups

Phase 1 (Control group)

No Intervention group

Description:

Participants will be able to engage in care as per current family engagement practices. Family members in the usual care group will not participate in daily ICU rounds. In-person or virtual family participation in rounds is not routinely performed at any of the trial sites.

Phase 2 (Intervention)

Experimental group

Description:

Participants in the Intervention group will be invited to participate in attending team rounds.

Treatment:

Other: Participation in attending team rounds