The Family-ICU Trial

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.

Conditions

• Virtual Care
• Family Engagement
• Patient and Family Engagement
• Health Care Delivery
• Family-centered Care
• Physician Rounds
• Critical Care, Intensive Care

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.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Lady Davis Institute

  lead OTHER

Principal Investigators

• Michael J Goldfarb, MD, MSc · Lady Davis Institute, McGill University, Jewish General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-18

Primary Completion

2028-02-29

Completion

2029-07-31

Countries

• Canada

Study Locations