The Family-ICU Trial

NCT06586541 | Recruiting

• 1 other identifier: 2025-4182
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 2

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (2)

• FAMily Engagement (FAME) score within 1 week of ICU discharge

  The FAMily Engagement (FAME) tool is a self-administered 12-item questionnaire that assesses an individual's current engagement practice. FAME uses a five-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree), and scale results are changed to a 0-100 scoring system, with higher scores indicating greater engagement in care. The following subdomains are evaluated: engagement perception, family presence, communication, education, decision-making, care contribution, and family needs. FAME includes the following engagement domains: family presence, family needs, communication and education, decision making, and direct care. FAME also captures the following family-centered care principles: dignity and respect, information sharing, participation, and collaboration.

  1-week post-hospital discharge

• Quality of communication (QOC score)

  The Quality of Communication tool is a 13-item questionnaire that was developed and validated in an ICU setting to measure the perceived quality of communication. Scores range from 0 to 100, with higher scores indicating better clinician-family communication.

  1-week post-hospital discharge

Secondary Outcomes (5)

• Anxiety and depression (HADS)

  6 months post-hospital discharge

• Anxiety and depression (HADS)

  1-week post-hospital discharge

• Post-traumatic stress (IES-Revised)

  6 months post-hospital discharge

• Family satisfaction in the ICU (FS-ICU)

  1-week post-hospital discharge

• Quality of life (EuroQOL-5D-5L score)

  6 months post-hospital discharge

Study Arms (2)

Phase 1 (Control group)

NO INTERVENTION

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

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

Other: Participation in attending team rounds

Interventions

Participation in attending team rounds OTHER

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.

Phase 2 (Intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR): collaborator
• Lady Davis Institute: lead

Study Sites (2)

Jewish General Hospital

Montreal, Quebec, Canada

RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

NOT YET RECRUITING

Study Officials

• Michael J Goldfarb, MD, MSc

  Lady Davis Institute, McGill University, Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jillian Kifell, MSc

CONTACT

5143408222; jillian.kifell.ccomtl@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Staff, Division of Cardiology

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: November 18, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)