Family EngagementFamily-ICUNCT06586541
The Family-ICU Trial
A study testing Participation in attending team rounds in people with Family Engagement and Patient and Family Engagement, run by Lady Davis Institute at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Family Engagement, Patient and Family Engagement, Health Care Delivery
- What is being tested?
- Participation in attending team rounds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 2 sitesCanada
- Study dates
- 18 Nov 2024to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult family members (age ≥ 18 years) of ICU patients
- Expected ICU stay ≥ 48 hours
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Jewish General Hospital
Montreal, Quebec
Kabisan Vilvaratnam, 5143408222 ext. 25806, kabisan.vilvaratnam.ccomtl@ssss.gouv.qc.ca
Michael J Goldfarb, MD, MSc
- Recruiting
McGill University Health Centre
Montreal, Quebec
Kabisan Vilvaratnam, 5143408222 ext. 25806, kabisan.vilvaratnam.ccomtl@ssss.gouv.qc.ca
Michael J Goldfarb, MD, MSc
About this study
Official title: Family Participation in Intensive Care Unit Rounds (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.
- Conditions
- Family Engagement, Patient and Family Engagement, Health Care Delivery, Family-centered Care, Physician Rounds, Critical Care, Intensive Care
- Being tested
- Participation in attending team rounds
- Keywords
- Patient- and Family-Centered, Patient- and Family-Centered Care, Family Engagement, Critical Care, Intensive Care Unit, Person-Centered Care, Delivery of Health Care, Family Participation in Rounds, Physician Rounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participation in attending team roundsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 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. Receives: Other: Participation in attending team rounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1-week post-hospital discharge
Secondary outcomes (5)
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.
Measured: 6 months post-hospital discharge
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.
Measured: 1-week post-hospital discharge
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.
Measured: 6 months post-hospital discharge
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.
Measured: 1-week post-hospital discharge
Quality of life (EuroQOL-5D-5L score)
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
Measured: 6 months post-hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start18 Nov 2024
- Primary completionFeb 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family EngagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Michael Goldfarb, Lady Davis Institute
- Investigators
- Michael J Goldfarb, MD, MSc, Principal investigator, Lady Davis Institute, McGill University, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586541
- Sponsor's protocol ID
- 2025-4182
- Acronym
- Family-ICU
- Status last verified
- Aug 2026
- First submitted
- 4 Sep 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Participation in Intensive Care Unit Rounds (The Family-ICU Trial)
- ClinicalTrials.gov ID
- NCT06586541
- Acronym / sponsor ID
- Family-ICU / 2025-4182
- Conditions
- Family Engagement, Patient and Family Engagement, Health Care Delivery, Family-centered Care, Physician Rounds, Critical Care, Intensive Care
- Keywords
- Patient- and Family-Centered, Patient- and Family-Centered Care, Family Engagement, Critical Care, Intensive Care Unit, Person-Centered Care, Delivery of Health Care, Family Participation in Rounds
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 family participation in rounds is not routinely performed at any of the trial sites. |
| Phase 2 (Intervention) | Experimental | Other: Participation in attending team roundsParticipants in the Intervention group will be invited to participate in attending team rounds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult family members (age ≥ 18 years) of ICU patients
- Expected ICU stay ≥ 48 hours
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participation in attending team roundsFamily 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. | Other | Phase 2 (Intervention) |
Primary outcome
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.
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.
5 secondary outcomes
Anxiety and depression (HADS)
Time frame: 6 months post-hospital discharge
Anxiety and depression (HADS)
Time frame: 1-week post-hospital discharge
Post-traumatic stress (IES-Revised)
Time frame: 6 months post-hospital discharge
Family satisfaction in the ICU (FS-ICU)
Time frame: 1-week post-hospital discharge
Quality of life (EuroQOL-5D-5L score)
Time frame: 6 months post-hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael J Goldfarb, MD, MSc principal investigator
Lady Davis Institute, McGill University, Jewish General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participation in attending team rounds in people with Family Engagement and Patient and Family Engagement, run by Lady Davis Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kabisan Vilvaratnam (5143408222 ext. 25806, kabisan.vilvaratnam.ccomtl@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FAMily Engagement (FAME) score within 1 week of ICU discharge (time frame: 1-week post-hospital discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.