The Family-ICU Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLady Davis Institute

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult family members (age ≥ 18 years) of ICU patients

Expected ICU stay ≥ 48 hours

Disqualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Participation in attending team rounds

    Other intervention

    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.

Treatment groups

194 Participants
are divided into 2 treatment groups
Group A: Phase 1 (Control group)No intervention 0 interventions
Group B: Phase 2 (Intervention)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1-week post-hospital discharge
2

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.

Time frame
1-week post-hospital discharge

Secondary outcomes

1

Anxiety and depression (HADS)

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.

Time frame
6 months post-hospital discharge
2

Anxiety and depression (HADS)

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.

Time frame
1-week post-hospital discharge
3

Post-traumatic stress (IES-Revised)

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.

Time frame
6 months post-hospital discharge
4

Family satisfaction in the ICU (FS-ICU)

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.

Time frame
1-week post-hospital discharge

Other outcomes

Sponsors and contacts

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Lady Davis Institute

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator