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NCT Number: NCT06586541

The Family-ICU Trial

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jewish General Hospital, Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult family members (age ≥ 18 years) of ICU patients
  • Expected ICU stay ≥ 48 hours

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

Treatment and study plan

Participation in attending team rounds

Other

Family members participate in-person. If the family member wishes to participate in-person, they will be invited to be present when the team rounds in the ICU.

Primary outcomes

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

    Time frame: 1-week post-hospital 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.

  2. Quality of communication (QOC score)

    Time frame: 1-week post-hospital discharge

    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.

Secondary outcomes

  1. Anxiety and depression (HADS)

    Time frame: 6 months post-hospital discharge

    The Hospital Anxiety and Depression Scale (HADS) is a simple to use, validated, and widely used self-reported tool to measure anxiety and depression in medical patients. The survey is composed of 14 questions: 7 depression-related and 7 anxiety-related questions. The score for each item ranges from 0 to 3, and subscale scores greater than 8 denotes anxiety or depression.

  2. Anxiety and depression (HADS)

    Time frame: 1-week post-hospital discharge

    The Hospital Anxiety and Depression Scale (HADS) is a simple to use, validated, and widely used self-reported tool to measure anxiety and depression in medical patients. The survey is composed of 14 questions: 7 depression-related and 7 anxiety-related questions. The score for each item ranges from 0 to 3, and subscale scores greater than 8 denotes anxiety or depression.

  3. Post-traumatic stress (IES-Revised)

    Time frame: 6 months post-hospital discharge

    The IES-Revised is a 22-item questionnaire that has been validated and is widely used for measuring post-traumatic stress symptoms and yields a total score ranging from 0 to 88 and subscale scores for the Intrusion, Avoidance, and Hyperarousal subscales. Items are rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely). High scores indicate greater severity of PTSD.

  4. Family satisfaction in the ICU (FS-ICU)

    Time frame: 1-week post-hospital discharge

    The Family Satisfaction in the ICU survey (FS-ICU) is a 24-item instrument that was developed and validated to assess family satisfaction and experience with care in the ICU. Scores range from 0 to 100, with higher scores indicate greater satisfaction.

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

    Time frame: 6 months post-hospital discharge

    The EuroQOL-5D-5L is a 5-item questionnaire that has been validated and is widely used for measuring health-related quality of life. Each dimension has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). The scores are combined to generate a single index value for overall health status. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state

Study contacts

Contact information is provided by the study sponsor or research team.

Kabisan Vilvaratnam

CONTACT

[email protected]

5143408222 ext. 25806

Sponsors and collaborators

Lead sponsor

Lady Davis Institute

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Family Participation in Intensive Care Unit Rounds (The Family-ICU Trial)

Acronym: Family-ICU

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Sep 19, 2024
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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