Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06586541

The Family-ICU Trial

Led by Lady Davis Institute · Updated on 2026-03-31

194

Participants Needed

2

Research Sites

240 weeks

Total Duration

On this page

Sponsors

L

Lady Davis Institute

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

The Family-ICU Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult family members (age 218 years or older2)
  • Family member of ICU patients with expected ICU stay of 48 hours or more
  • For virtual participation, must have a phone or computer with internet and audio/video capabilities and understand how to use them
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Jewish General Hospital

Montreal, Quebec, Canada

Actively Recruiting

2

McGill University Health Centre

Montreal, Quebec, Canada

Not Yet Recruiting

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Research Team

J

Jillian Kifell, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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